Gritstone Oncology to Present First Data Bridging Tumor Antigen Identification and Potent Immunotherapy Delivery in Primates at 2018 AACR Annual Meeting

Gritstone Oncology to Present First Data Bridging Tumor Antigen Identification and Potent Immunotherapy Delivery in Primates at 2018 AACR Annual Meeting

Data Support Plans to Initiate Clinical Trials in 2H18

EMERYVILLE, Calif., April 12, 2018 – Gritstone Oncology, a personalized cancer immunotherapy company, today announced that preclinical data highlighting the company’s tumor-specific neoantigen (TSNA) identification platform, EDGE™ (Epitope Discovery in cancer GEnomes), and a novel, potent TSNA delivery approach will be presented during two poster presentations at the 2018 American Association for Cancer Research (AACR) Annual Meeting. The meeting is being held April 14-18, 2018 in Chicago.

Gritstone Oncology will present prediction data from EDGE™ demonstrating its ability to select tumor-specific neoantigens that have generated anti-tumor immune responses in humans. In an analysis of independently validated, tumor-relevant T cell responses against neoantigens (including from the US National Cancer Institute), EDGE™ identified, with good specificity, the majority of neoantigens eliciting a CD8+ T cell response in patients with cancer.

Further, the company will present the first preclinical data, including in non-human primates (NHP), highlighting a potent immunotherapy approach to deliver selected TSNA to patients. The delivery approach comprises a chimpanzee adenoviral vector (ChAdV) for the prime immunization, and a self-replicating, synthetic viral RNA vector (srRNA) for repeated boost immunizations. In preclinical NHP studies, delivery of selected antigens using this sequential (heterologous) prime/boost immunization approach, showed a quick onset of immune activation with induction of high numbers of antigen-specific T cells. In addition, co-administration of anti-CTLA4 further enhanced both the number and function of the elicited T cells, suggesting the system’s potential in combination with checkpoint inhibitors.

“In patients with solid tumors, the generation of a very large number of tumor neoantigen-specific CD8+ T cells is one of the major challenges associated with today’s immunotherapies,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “To leverage the neoantigens selected by EDGE™, we have developed a potent immunotherapy regimen, which has produced high level CD8+ T cell responses in NHP. Historically, such models have been highly predictive of immune responses observed in humans, and these data support our plans to initiate clinical trials in in the second half of 2018. We are excited to be presenting our research at this year’s AACR meeting, demonstrating the applicability of our integrated platform for the development of personalized immunotherapies for difficult-to-treat-cancers.”

Abstract Title: A novel heterologous prime boost vaccine system drives tumor specific and potent CD8 T cell responses for cancer immunotherapy

Date & Time: April 15, 2018 from 1:00 to 5:00 p.m. CT

Abstract Findings: Gritstone Oncology has developed a potent heterologous prime/boost immunization approach to deliver predicted TSNAs to patients, which is comprised of a replication incompetent chimpanzee adenoviral vector (ChAdV) for the prime vaccination and a self-replicating, synthetic viral vector (srRNA) for repeated boost vaccinations. In a preclinical model, immunization with either vector resulted in strong antigen-specific CD8 T-cell responses and provided a statistically significant survival advantage to tumor bearing mice when compared to untreated mice. The potency was also tested in a non-human primate model, demonstrating quick onset of T-cell responses one week post ChAdV prime vaccination, with peak T-cell responses at two to three weeks and effectively boosted by the srRNA vector. In addition, co-administration of anti-CTLA4 with the vaccine demonstrated enhanced vaccine-induced immune response.

Abstract Title: Antigen identification for cancer immunotherapy by deep learning on tumor HLA peptides

Date & Time: April 18, 2018 from 8:00 a.m. to 12 p.m. CT

Abstract Findings: Using a large dataset of tumor transcriptomes and immunopeptidomes, Gritstone Oncology has trained a deep learning model (EDGE™) to predict the presentation of HLA peptides on tumor cells. The model was tested on HLA presented peptides from held-out tumor samples and demonstrated an approximately 10-fold improvement in positive predictive value compared to standard tools. The model was also tested for its ability to predict neoantigens recognized by T-cells and included the majority (16/23, 70%) of validated neoantigens from an independent test set in a putative 20-mutation personalized immunization.

About Gritstone Oncology

Gritstone Oncology is a privately-held, personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage artificial intelligence to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung, gastric, colorectal, and bladder cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform, EDGE™ (Epitope Discovery of cancer GEnomes), to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments, and Bay City Capital. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

Media Contact:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com

 

Gritstone Oncology Appoints Jayant Aphale, Ph.D. as Executive Vice President of Technical Operations

Gritstone Oncology Appoints Jayant Aphale, Ph.D. as Executive Vice President of Technical Operations

Senior Biopharma Executive Brings More Than 25 Years of Global Pharmaceutical
Production and Supply Experience Across Vaccines, Biologics and Oligonucleotides

 

Emeryville, CA, March 19, 2018 – Gritstone Oncology, a next-generation personalized cancer immunotherapy company, today announced that Jayant Aphale, Ph.D. has been appointed as Executive Vice President of Technical Operations. 

Dr. Aphale will be responsible for process development and optimization, clinical material manufacturing under cGMP, and ensuring close collaboration with FDA and other regulatory agencies as Gritstone develops novel processes and products for personalized immunotherapy treatments. He will report to Andrew Allen, M.D., Ph.D., President and Chief Executive Officer, and will be based in the company’s Pleasanton, CA manufacturing facility.

Dr. Aphale brings more than 25 years of global manufacturing and technical operations experience within the vaccines, biologics and oligonucleotide domains. Most recently, he was Vice President of Technical Operations at Sarepta Therapeutics, where he led the technical operations team for internal process development, global supply chain and drug manufacturing across its drug candidate portfolio. He participated directly in launching Sarepta’s first commercial product, an antisense oligonucleotide, by developing and scaling manufacturing processes from Phase 1 through launch and commercialization.

His previous experience includes senior manufacturing and technical operations roles at GSK Vaccines, Enobia Pharma, Acambis Vaccines, Wyeth Vaccines, Diosynth and Roche Diagnostics. Dr. Aphale received his Ph.D. in microbiology from Ohio State University and an MBA in finance and strategy from The University of North Carolina.

“Jayant’s career to date positions him very well to lead all aspects of our manufacturing program, both strategically and operationally. He has led technical operations at all stages of the product life cycle at global life sciences companies, he has worked on viral vectors and oligonucleotides, and he has succeeded in both large and small companies. He is a significant addition to our team at Gritstone,” said Dr. Allen. “His experience at Sarepta and leading vaccine companies will provide us with important leadership and insights as our first personalized immunotherapy program enters clinical development in mid-2018.”

About Gritstone Oncology

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage artificial intelligence to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung, gastric, colorectal, and bladder cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform, EDGE™ (Epitope Discovery of cancer GEnomes), to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments, and Bay City Capital. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

PR Contact:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
 

Gritstone Oncology Appoints Jean-Marc Bellemin as Chief Financial Officer

Gritstone Oncology Appoints Jean-Marc Bellemin as Chief Financial Officer

 

Emeryville, CA, January 23, 2018 – Gritstone Oncology, a next-generation personalized cancer immunotherapy company, announced today the appointment of Jean-Marc Bellemin as Executive Vice President of Finance and Chief Financial Officer, effective January 5, 2018.

Mr. Bellemin will lead Gritstone’s finance, accounting and investor relations functions, as well as Human Resources and Information Technology. He will report to Andrew Allen, M.D., Ph.D., President and CEO of Gritstone Oncology, and will be based in the company’s headquarters in Emeryville, CA.

Mr. Bellemin brings more than 23 years of international experience in finance and operations management within start-up and global commercial pharmaceutical organizations. Most recently, he was Senior Vice President and Chief Financial Officer of Actelion Pharmaceuticals USA, providing strategic leadership, plus financial and operations management of an international, profitable, publicly-traded biotechnology company. He led the long-term strategic process for the finance, project management, information technology and market access functions at Actelion until its acquisition by Johnson & Johnson in 2017.

His previous experience includes various leadership roles within the finance team over 11 years at Actelion in both Europe and the USA, and serving in financial management roles at GUERBET Pharmaceuticals, ELF AQUITAINE, Philips Electronic Company and Credit Lyonnais Bank. Mr. Bellemin holds a Bachelor of Science degree in Economics and Management from Paris Dauphine University, a Master’s degree in Finance and Accounting at Paris Sorbonne University and an M.B.A. from Essec Business School in Paris.

“With a significant Series B financing raised last September, Gritstone is well-capitalized and will benefit particularly from Jean-Marc’s experience leading the finance function at Actelion USA, an internationally-renowned biotechnology company which grew from an R&D company into a very successful commercial one,” said Dr. Allen. “We are fortunate to have Jean-Marc join our team as we prepare for our lead personalized immunotherapy program to enter clinical development in 2018 and beyond.”

About Gritstone Oncology

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage artificial intelligence to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung, gastric, and colorectal cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform, EDGE™ (Epitope Discovery of cancer GEnomes), to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments, and Bay City Capital. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

 

PR Contact:

Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com

Gritstone Oncology Opens New State-of-the-Art Personalized Cancer Immunotherapy Manufacturing Facility

Gritstone Oncology Opens New State-of-the-Art  Personalized Cancer Immunotherapy Manufacturing Facility

First Investigational Products Expected to be Manufactured for Clinical Trials by Mid-2018

Emeryville, CA, November 28, 2017 – Gritstone Oncology, a next-generation personalized cancer immunotherapy company, announced today the opening of a new 43,000 square-foot manufacturing facility in Pleasanton, CA.

This fully-operational biomanufacturing facility, which includes multiple clean rooms, each to be deployed for producing therapeutics on an individualized basis, will be the center of Gritstone’s personalized cancer immunotherapy manufacturing efforts. With capacity for further expansion, the Pleasanton facility has been built in compliance with current Good Manufacturing Practices (cGMP) standards. This complements the cGMP-compliant, next-generation sequencing capability based in Cambridge, MA., where Gritstone’s sequencing, informatics and deep learning teams are focused.

The company expects to manufacture its first investigational products at the Pleasanton facility for use in human clinical trials by mid-2018, and will ramp-up its dedicated staff at the facility over the next six months.

“Our team at Gritstone Oncology is focused on a unique vision within cancer immunotherapy development - leveraging the power of deep learning to guide the development of cancer immunotherapies tailored for each patient. We are excited to launch the core of our manufacturing capabilities in Pleasanton (a well-known Bay Area biomanufacturing hub) as we move closer towards the initiation of human clinical trials next year,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology.

About Gritstone Oncology
Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung and gastric cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, and Alexandria Venture Investments. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

PR Contact:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
 

Gritstone Oncology and Arbutus Biopharma Announce LNP Technology Licensing Agreement to Develop Novel RNA-Based Personalized Neoantigen Immunotherapies for Cancer Patients

Gritstone Oncology and Arbutus Biopharma Announce LNP Technology Licensing Agreement to Develop Novel RNA-Based Personalized Neoantigen Immunotherapies for Cancer Patients

 

Vancouver, BC; Warminster, PA; and Emeryville, CA, October 18, 2017 — Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, and Gritstone Oncology, a leader in personalized cancer immunotherapies, today announced a collaboration and license agreement. Arbutus is deploying its proprietary lipid nanoparticle (LNP) technology to deliver Gritstone’s RNA-based neoantigen immunotherapy products.

Under the terms of this license agreement, Gritstone obtains worldwide access to Arbutus’ portfolio of proprietary and clinically validated LNP products and associated intellectual property. Gritstone will pay Arbutus an upfront payment, payments for achievement of development, regulatory, and commercial milestones, as well as royalties. In addition, Gritstone will reimburse Arbutus for conducting technology development and providing manufacturing and regulatory support for Gritstone’s product candidates. The license is specifically directed to the novel RNA-based platform for neoantigen immunotherapies.

“The recent phase III validation of Arbutus’ LNP platform makes them the natural partner for Gritstone as we drive our proprietary two-component immunotherapy program into the clinic in mid-2018,” said Andrew Allen, M.D., Ph.D., president and chief executive officer of Gritstone Oncology. “Successful exploratory preclinical work with Arbutus fueled a strong bilateral desire to formalize and extend our relationship. We’re excited to continue our work with the team at Arbutus and its LNP technology as we advance our pipeline of immunotherapy product candidates.”

“This agreement again represents validation of our industry-leading LNP technology. We are excited to be working with Gritstone to advance their innovative personalized immunotherapies for the treatment of cancer,” said Dr. Mark J. Murray, Arbutus’ president and chief executive officer. “This transaction is part of realizing the value of our LNP platform, which has broad potential to deliver nucleic acid-based products including mRNA and gene editing therapeutics, and enable Arbutus to continue to focus on development of curative therapies for HBV.”

About Arbutus Biopharma
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, and has facilities in Warminster, PA. For more information, please visit www.arbutusbio.com.

About Gritstone Oncology
Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung and gastric cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, and Alexandria Venture Investments. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about deploying Arbutus’ proprietary lipid nanoparticle (LNP) technology to deliver Gritstone’s RNA-based neoantigen immunotherapy products; Gritstone paying Arbutus an upfront payment, payments for achievement of development, regulatory, and commercial milestones, as well as royalties; Gritstone reimbursing Arbutus for conducting technology development and providing manufacturing and regulatory support for Gritstone’s product candidates; the potential of Arbutus’ LNP platform to deliver nucleic acid-based products including mRNA and gene editing therapeutics; and discovering, developing and commercializing a cure for chronic hepatitis B virus (HBV) infection.  

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the successful implementation of the collaboration and license agreement; the continued demand for Arbutus’ assets, including its LNP technology; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the collaboration and license agreement may not be implemented to the extent expected, if at all; demand for Arbutus’ assets may lower; economic and market conditions may worsen; and market shifts may require a change in strategic focus.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K and Arbutus' continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.


Contact Information - Arbutus


Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com

Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com

Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com
 

Contact Information - Gritstone


Dan Budwick
1AB
Phone: 973-271-6085
Email: dan@1abmedia.com
 

FierceBiotech Names Gritstone Oncology as a “Fierce 15” Biotechnology Company of 2017

Fierce15LogoLarge.png

FierceBiotech Names Gritstone Oncology as a "Fierce 15" Biotechnology Company of 2017
  

Emeryville, CA, September 26, 2017 – Gritstone Oncology, a next-generation personalized cancer immunotherapy company, has been named by FierceBiotech as one of 2017’s Fierce 15 biotechnology companies, recognizing it as one of the most promising private biotechnology companies in the industry.

Founded in October 2015, Gritstone Oncology is focused on understanding each patient’s tumor antigens at a molecular level, using deep learning techniques, and then developing immune therapies targeted to that specific set of tumor antigens. The goal is to make therapeutic immune attack highly specific to the tumor, sparing normal tissues, and reducing toxicity. Gritstone is building a pipeline of personalized immunotherapies for patients with the most difficult-to-treat solid tumors. Its lead program is expected to enter clinical trials in mid-2018 for patients with non-small cell lung cancer and gastric cancer. These patients typically have many mutations in their tumors, some of which create new antigens (targets) for the immune system – termed neoantigens. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define tumor-specific, but shared, targets for immunotherapies, which would provide an opportunity to treat even more patients.

“On behalf of the employees of Gritstone Oncology, we are honored to be included in the ‘Fierce 15’ class of 2017. In 2017, we have made significant progress with our tumor antigen identification platform, expanded our product pipeline, raised a significant Series B financing, and made several key leadership and board appointments” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “We appreciate the validation of this important industry designation by FierceBiotech as we stay focused on executing our vision by starting clinical trials in 2018.”

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech's fifteenth annual Fierce 15.

Each annual selection highlights privately held companies that are working to develop products, services, or platforms that can advance the biotech industry and transform patient care. Companies are selected based on a variety of factors such as the strength of their technology, partnerships, venture backers and a competitive market position.

About FierceBiotech

An internationally recognized daily report reaching a network of more than 275,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day's top stories. Every business day, FierceBiotech and its family of publications covers the waterfront in drug development, from pre-clinical science to seed funding and venture capital, through IPOs and licensing, clinical testing, regulatory changes, M&A and beyond. FierceBiotech is a publication of Questex LLC. Signup is free on this registration page.

About Gritstone Oncology

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung and gastric cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA. The company launched in October 2015 and has received funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, Lilly Asia Ventures and GV. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

Gritstone Oncology Secures $92.7 Million in Series B Financing

Gritstone Oncology Secures $92.7 Million In Series B Financing
 

Proceeds Will Support Further Development of Proprietary Tumor Antigen Identification Platform and Advancement of Pipeline of Personalized Cancer Immunotherapies
 

Lead Program Expected to Enter Clinical Trials in Mid-2018
 

Personalized Immunotherapy Manufacturing Facility Under Construction and will Provide Investigational Products for Clinical Trial Program 

 

Emeryville, CA, September 7, 2017 – Gritstone Oncology, a next-generation personalized cancer immunotherapy company, today announced the successful completion of a $92.7 million Series B preferred stock financing. Proceeds from the financing will be used to advance Gritstone’s tumor antigen identification platform and pipeline of personalized cancer immunotherapies. The company’s lead program, targeting tumor-specific neoantigens, is expected to enter clinical trials in mid-2018, initially in patients with non-small cell lung cancer and gastric cancer. 
 

This investment will also support the ongoing construction and completion of Gritstone’s 43,000 square foot industrialized manufacturing facility in Pleasanton, CA. This state-of-the-art facility is being built in compliance with current Good Manufacturing Practices (cGMP) standards and will form the nucleus of Gritstone’s manufacturing program for personalized cancer therapeutics. The first investigational products for clinical research are expected to be manufactured in this facility in 2018.
 

“We are excited to expand our investor base with leading investors from the U.S. and Asia, and to continue driving Gritstone’s best-in-class approach to develop personalized immunotherapies,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “Since the formation of the company two years ago, Gritstone has made significant progress leveraging extensive human tumor molecular analysis and machine learning to develop and optimize the proprietary Gritstone EDGE tumor antigen identification platform. We have matched our breakthrough accuracy in tumor neoantigen identification with an antigen delivery system that builds on human immunity insights from infectious disease experts, culminating in an extremely potent neoantigen delivery platform expected to drive best-in-class cytotoxic T cell responses.”
 

The round was led by new investor Lilly Asia Ventures, with participation from GV (formerly Google Ventures), Trinitas Capital (Beijing) and Alexandria Venture Investments, all new investors. All existing investors are also all participating in the round, including Versant Ventures, The Column Group, Clarus Funds and Frazier Healthcare Partners. 
 

Cowen served as sole financial advisor to Gritstone in connection with this financing.
 

“Lilly Asia Ventures believes in the potential of targeted immunotherapy to transform the treatment of cancer, and is very actively investing in this domain” said Judith Li, partner at Lilly Asia Ventures, who will join the board of directors. “Gritstone is building a highly differentiated approach to tailor immunotherapy treatment to each patient’s own tumor, analogous to how tumor gene panel sequencing has enabled application of precisely targeted small molecule targeted therapies to some cancer patients. We believe Gritstone’s global perspective shows exceptional foresight, exemplified by their collection of tumors from Asia to inform antigen prediction in East Asian patients’ tumors. We see top companies increasingly pursuing geographic diversity even in early stages, mirroring the increasingly global nature of biotech innovation.”
 

“Gritstone is creating a new class of cancer immunotherapies that is revolutionary in its scope and ambition,” said Anthony Philippakis, venture partner at GV. “The company has made meaningful progress applying sophisticated deep learning technologies to create cancer therapeutics that are personalized for each patient. We’re looking forward to working with Gritstone’s experienced team as they continue to make significant steps towards developing a new class of cancer immunotherapies.”

 

ABOUT GRITSTONE ONCOLOGY

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumor to develop novel treatments for lung and gastric cancer. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Cambridge, MA. The company launched in October 2015 with initial funding from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, Clarus Funds and Frazier Healthcare Partners. More information can be found at www.gritstoneoncology.com or @gritstoneonc.

 

Gritstone Oncology Expands Scientific Advisory Board with Appointment of Immuno-Oncology Experts James L. Gulley and Alessandro Sette

Gritstone Oncology Expands Scientific Advisory Board with Appointment of Immuno-Oncology Experts James L. Gulley and Alessandro Sette

 

EMERYVILLE, Calif., June 1, 2017 — Gritstone Oncology, a next-generation personalized cancer immunotherapy company, today announced the expansion of its Scientific Advisory Board (SAB) with the appointment of James L. Gulley, M.D., Ph.D., chief of the Genitourinary Malignancies Branch at the Center for Cancer Research (CCR) of the National Cancer Institute (NCI), and Alessandro Sette, Dr.Biol.Sci., center head of the Division of Translational Immunology and Vaccine Discovery at the La Jolla Institute for Allergy and Immunology. Both are renowned experts in the field of immuno-oncology and will provide strategic guidance and insight to Gritstone as it advances its drug development technology platform to create personalized neoantigen therapies that harness the patient’s own immune system to attack solid tumors.

“Successful neoantigen-targeted therapy demands excellence in two scientific dimensions, and we are thrilled to have global leaders in both of those domains join our team of scientific advisors,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “First, we must predict which of a cancer patient’s many DNA mutations create truly neoantigenic proteins, and Alessandro has blazed the trail in understanding immune system-protein interactions. His fundamental insights have empowered companies like ours to consider tackling this problem and his counsel has already proven invaluable. Second, we must deliver tumor-specific neoantigens to patients in a highly immunogenic format. James has studied human immune responses to cancer immunotherapies for many years, deriving key observations into the link between immune response and clinical outcomes. The collective expertise of Alessandro and James will be essential as we advance our first personalized neoantigen immunotherapy into human trials and continue to assess solid tumors for their capacity to generate tumor-specific neoantigens.”

“Tumor neoantigens are an exciting actionable discovery, and Gritstone Oncology has the right team of seasoned individuals in place to advance this scientific understanding to the next level in order to improve response rates and survival in cancer patients. The team has already made exceptional progress in the 20 months since the company was founded,” said Dr. Sette. “With my long-term interest in how T cells recognize antigens, I am excited to join Gritstone’s Scientific Advisory Board to help advance its novel therapeutic concept into clinical trials next year.” 

About Dr. Gulley

Dr. Gulley also serves as senior investigator and head of the Immunotherapy Section and director of the Medical Oncology Service in the Office of the Clinical Director at the CCR. He is an internationally recognized expert in cancer immunotherapy, therapeutic cancer vaccines, immune checkpoint inhibitors, and the combination of immunotherapy with other therapies. Since 1998, he has conducted investigator-initiated clinical trials at the NCI evaluating cancer vaccines and other immunostimulatory agents, as well as the combination of immunotherapy with other treatment strategies. He played a central role in the clinical development of a prostate cancer vaccine that was created at the NCI, and currently serves as principal investigator of an international, randomized Phase 3 clinical trial of that vaccine. He is also the coordinating principal investigator for an international trial of an anti-PDL1 antibody.

About Dr. Sette

Dr. Sette also serves as director of the Center for Infectious Disease and Head of the Initiative for Emerging Diseases and Biodefense at the La Jolla Institute for Allergy and Immunology. He has devoted more than 30 years of study to understanding basic mechanisms of antigen recognition and immune responses, measuring and predicting immune activity, and developing disease intervention strategies against cancer, infectious diseases, autoimmune diseases and allergies. His research is focused on improving the understanding of how the body successfully battles infection, and conversely, how pathogens escape the immune system, causing the individual to succumb to disease. He has developed techniques to understand the T-cell response to common allergens, which has resulted in the development of bioinformatic tools used to map the human T-cell response to a large panel of common allergens. Dr. Sette earned a Doctor in Biological Sciences  at the University of Rome and completed post-doctoral work at the Laboratory of Pathology, Cassaccia, in Rome, and at the National Jewish Center for Immunology and Respiratory Medicine in Denver. He has authored more than 650 scientific publications in peer-reviewed journals and has nearly 30 issued patents.

Gritstone’s SAB Comprised of Pioneers in Immuno-Oncology and Other Relevant Disciplines
In addition to Drs. Gulley and Sette, other members of Gritstone Oncology’s distinguished Scientific Advisory Board include:

  • Timothy A. Chan, M.D., Ph.D., an expert in cancer immuno-genomics, is vice chair of the Department of Radiation Oncology and the Frederick Adler Chair at the Memorial Sloan Kettering Cancer Center (MSKCC). He also is a member of the Human Oncology and Pathogenesis Program at MSKCC and director of the Division of Translational Oncology in the Department of Radiation Oncology.

  • Mark Cobbold, M.D., Ph.D., an expert in HLA-peptide mass spectrometry, is associate professor of medicine at the Massachusetts General Hospital (MGH) Cancer Center. He also is a member of the MGH Center for Cancer Immunology.

  • Graham Lord, M.D., Ph.D., an expert in T-cell biology, is professor of medicine at King’s College London. He also is head of the Department of Experimental Immunobiology and director of the National Institute for Health Research (NIHR) Biomedical Research Center at Guy’s and St. Thomas’ Hospital and King’s College London.

  • Naiyer A. Rizvi, M.D., an expert in clinical immuno-oncology, is the Price Chair of Clinical Translational Medicine and director of thoracic oncology and immuno-therapeutics at Columbia University Medical Center.

  • Jean-Charles Soria, M.D., Ph.D., an expert in clinical cancer research, is a professor of medicine and medical oncology at South-Paris University. He also is a cancer specialist at Institut Gustave Roussy (IGR) in Paris, chair of the Drug Development Department at IGR, and a member of the lung cancer unit with a focus on targeted therapies.

About Gritstone Oncology
Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology and immunotherapy design. The company’s initial goal is to identify and deploy therapeutic neoantigens from individual patients’ tumor to develop novel treatments for lung cancer. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Cambridge, Mass. The company launched in October 2015 with a Series A financing of $102 million from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group and Clarus Ventures. More information can be found at www.gritstoneoncology.com

 

Media Contact: 
Dan Budwick
1AB Media
(973) 271-6085
dan@1abmedia.com

Investor Contact:
Matt Clawson
Pure Communications
(949) 370-8500
mclawson@purecommunications.com

Gritstone Oncology Appoints Raphaël F. Rousseau, M.D., Ph.D., as Chief Medical Officer

Gritstone Oncology Appoints Raphaël F. Rousseau, M.D., Ph.D., as Chief Medical Officer

Veteran of Biotechnology Industry and Academia Brings Deep Immunotherapy Experience to Support Company’s Cutting-Edge Neoantigen Immunotherapy Platform 

Company Building Strong Cadre of Leadership with Promotion of Roman Yelensky, Ph.D., to Chief Technology Officer

 

EMERYVILLE, CA, May 3, 2017 — Gritstone Oncology, a next-generation personalized cancer immunotherapy company, today announced the appointment of Raphaël F. Rousseau, M.D., Ph.D., as chief medical officer. Dr. Rousseau, an experienced biotechnology drug developer in oncology and hematology, joins the Company from Genentech, where he was most recently global franchise head, pediatrics, in the Product Development Oncology division. Additionally, Gritstone recently promoted Roman Yelensky, Ph.D., to chief technology officer, where he will oversee the company’s genomics, proteomics and informatics programs.

“The addition of Raphaël to our executive team, as well as the promotion of Roman, come at a critical time for Gritstone Oncology. We have made significant inroads toward our goal of combining multi-omic tumor profiling and deep learning to create personalized neoantigen immunotherapies for patients with difficult-to-treat cancers,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “Raphaël’s expertise in applying translational research to immunotherapy in oncology and hematology and his experience overseeing clinical trials of innovative therapeutic compounds will be invaluable as we advance our first neoantigen immunotherapy into the clinic in 2018.”

He added, “Since day one when Roman joined as our first employee, he has been instrumental in developing our cutting-edge neoantigen identification platform. Under Roman’s leadership, the Gritstone team has characterized large numbers of human tumors at the molecular level. These efforts have generated a tremendous amount of data, driving deep learning and the construction of a high-performance model that takes neoantigen prediction to the next level. Roman has been indispensable in building this unique and powerful tool, and will continue to be instrumental in our research and development program as chief technology officer.”

 

About Dr. Rousseau

Dr. Rousseau joins Gritstone with experience in both the biotechnology industry and academia. He has expertise in innovative study designs and in Phase 1-3 studies of targeted therapies, including small molecule inhibitors, monoclonal antibodies, gene-modified immune effector cells and vaccines, and nanosize vectors. Prior to Gritstone, he spent eight years at Genentech, a member of the Roche group, where he held positions of increasing responsibility. Dr. Rousseau created the innovative Pediatric Oncology Drug Development (iPODD) team and the pediatric franchise at Roche-Genentech, a unique approach to pediatric drug development in the pharma industry. As global franchise head, pediatrics, in the Product Development Oncology division, he managed a clinical team of physicians and scientists across sites as well as a cross-functional development and study management team of more than 60 people across several key functions, including clinical science, safety, regulatory, research, biomarkers, clinical pharmacology and operations. He served as chair of the Development Review Committee for pediatric oncology, reviewing and making decisions about early- and late-stage compounds across the Roche-Genentech oncology portfolio. He also launched the iMATRIX master trial concept, an innovative Phase 1-2 multi-tumor, multi-drug collaborative drug development platform for patients with high-risk pediatric malignancies. Before Genentech, Dr. Rousseau was international medical leader, hematology at Roche. Before joining Roche in 2009, Dr. Rousseau was a professor of medical and pediatric oncology at the Université Claude Bernard in Lyon, France. At the Léon Bérard Comprehensive Cancer Center in Lyon, Dr. Rousseau was head of the pediatric translational research program where he created and led the first European consortium for the conduct of an EMA-approved phase 1 study using CD19-targeting CAR T cells for the treatment of pediatric high-risk leukemias. Earlier in his career, he was a clinical fellow at Texas Children’s Cancer Center and a research fellow at the Center for Cell and Gene Therapy at Baylor College of Medicine in Houston, where he co-developed a translational, GMP-grade, FDA-approved antitumor approach using genetically-modified autologous and allogeneic tumor cells to treat high-risk pediatric acute leukemias, chronic lymphocytic leukemia and neuroblastoma. He earned a Ph.D. in therapeutic biotechnologies at the Université Denis Diderot and an M.D. from Université René Descartes, both in Paris. He is board certified in pediatrics and has a sub-specialty certification in pediatric hematology-oncology.

 

About Dr. Yelensky

Dr. Yelensky joined Gritstone at its inception in October 2015 as executive vice president of sequencing and bioinformatics. Prior to that, he was vice president of biomarker and companion diagnostic development at Foundation Medicine, which he joined at its inception. While at Foundation Medicine, he co-led sequence data analysis for FoundationOne™ and led validation studies supporting clinical laboratory accreditation and testing of >100,000 patients. Dr. Yelensky established Foundation Medicine’s FDA-regulated products program, leading to the FDA approval of FoundationFocus CDxBRCA, the first NGS-based companion diagnostic. He also contributed to key national initiatives on the clinical implementation of next-generation sequencing (NGS), leading the diagnostic implementation of Lung-MAP, a first-of-its-kind NCI-sponsored trial matching lung cancer patients to investigational treatments using comprehensive genomic testing. Prior to Foundation Medicine, Dr. Yelensky was a senior scientist in biomarker development at Novartis. He has co-authored more than 75 manuscripts on bioinformatics, statistical genetics, NGS biomarker and assay development and cancer genomics. He earned an M.S. in computer science from Stanford University and a Ph.D. in bioinformatics and integrative genomics from the Harvard-MIT Division of Health Sciences and Technology.

 

About Gritstone Oncology

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The company’s initial goal is to identify and deploy therapeutic neoantigens from individual patients’ tumor to develop novel treatments for lung cancer. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Cambridge, MA. The company launched in October 2015 with a Series A financing of $102 million from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group and Clarus Ventures. More information can be found at www.gritstoneoncology.com


Media Contact: 
Dan Budwick
1AB Media
(973) 271-6085
dan@1abmedia.com

Investor Contact:
Matt Clawson
Pure Communications
(949) 370-8500
mclawson@purecommunications.com

First Public Data Presented from Gritstone Oncology’s Tumor Antigen Identification Platform for Personalized Cancer Immunotherapy

First Public Data Presented from Gritstone Oncology’s Tumor Antigen Identification Platform for Personalized Cancer Immunotherapy

Achieving a Breakthrough in Predictive Accuracy for Tumor Neoantigens 

Gritstone’s Novel Approach Presented at the American Association for Cancer Research Annual Meeting

 

EMERYVILLE, CA, March 31, 2017—Gritstone Oncology, a next-generation personalized cancer immunotherapy company, today announced the first reported data supporting its novel approach to tumor-specific neoantigen (TSNA) identification through integrated tumor tissue analysis and deep learning. The data are being presented in the Tumor Antigens and Adaptive Immunity poster session on Sunday, April 2 from 1:00 – 5:00 PM EDT at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C.

“For years, cancer immunotherapy has been one of the most exciting fields in oncology research, yet it also poses some of the greatest challenges,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “We believe these early data underscore the significant impact our approach could make in advancing this field. By leveraging our best-in-class genomics, proteomics, and computational platform, we are working toward personalized immunotherapies to address difficult-to-treat cancers – because every cancer and every patient is unique.”

Gritstone performed deep tumor exome and transcriptome next-generation sequencing (NGS) and mass spectrometry human leukocyte antigen (HLA) class I peptide sequencing on tumor specimens from 22 non-small cell lung cancer (NSCLC) patients. A median of 286 nonsynonymous somatic mutations were found per patient, with 62% transcribed in mRNA. Down-sampling tumor NGS data to a more typical lower average coverage revealed a 20% loss of candidate neoantigens, demonstrating the importance of NGS sequencing depth.

Gene expression measurement at the RNA level was strongly predictive of HLA presentation, with peptides from genes detected in RNA found presented >20X more often than peptides from non-detected genes. With this and public datasets, a deep learning model was created to predict HLA presentation and compared to standard binding affinity prediction. While a binding affinity-based approach gave a positive predictive value (PPV) of only ~3%, Gritstone’s platform showed ~30% PPV, a near ten-fold gain. Initial in vitro results also indicated that HLA presented TSNA can prime T cells from HLA-matched donors.

 

About Gritstone Oncology

Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The company’s initial goal is to identify and deploy therapeutic neoantigens from individual patients’ tumor to develop novel treatments for lung cancer. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Cambridge, MA. The company launched in October 2015 with a Series A financing of $102 million from leading blue-chip biotechnology investors, including Versant Ventures, The Column Group, and Clarus Ventures. More information can be found at www.gritstoneoncology.com.


Media Contact: 
Dan Budwick
Pure Communications
(973) 271-6085
dbudwick@purecommunications.com

Investor Contact:
Matt Clawson
Pure Communications
(949) 370-8500
mclawson@purecommunications.com