Erasca Announces First Patient Dosed in HERKULES-2 Phase 1b/2 Lung Cancer Master Protocol Evaluating ERAS-007 in Multiple Combinations

On September 9, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported dosing of the first patient in the HERKULES-2 Phase 1b/2 trial evaluating ERAS-007 in combination with various agents in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Erasca, SEP 9, 2021, View Source [SID1234639383]).

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"As the foundation of Erasca’s lung cancer platform, HERKULES-2 is a master protocol designed to inhibit multiple oncogenic drivers of the RAS/MAPK pathway to address high unmet needs in lung cancer. Initially focused on patients with mutant EGFR or KRAS NSCLC, HERKULES-2 will further progress to evaluate other combinations targeting additional subtypes of NSCLC," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Erasca’s series of HERKULES trials also includes tissue-specific master protocols in gastrointestinal cancers and hematological malignancies as well as a tissue-agnostic trial, tailored to evaluate promising combinations to inhibit oncogenic signaling and prevent the emergence of resistance."

HERKULES-2 will initially examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with osimertinib (TAGRISSO) in patients with advanced NSCLC harboring an epidermal growth factor receptor mutation (EGFRm). After a recommended dose is determined, the Phase 2 expansion portion will further evaluate the safety and efficacy of the combination in patients whose disease has developed resistance to osimertinib, a setting in which there are currently no approved targeted therapies. Future sub-studies of HERKULES-2 will explore ERAS-007 or the SHP2 inhibitor ERAS-601 in combination with other agents in patients with different mutational subtypes, including a KRAS G12C mutation.

ERAS-007, a potential best-in-class inhibitor of the extracellular signal-regulated kinases (ERK), targets the terminal node of the RAS/MAPK pathway. The broad applicability of ERAS-007 across a wide range of indications and tumor types was recently highlighted in a preclinical study published in Cell Reports Medicine, supporting durable ERK blockade and potent antiproliferative efficacy in both solid tumor and hematological malignancy cell lines. ERAS-007 demonstrated preferential anti-tumor activity for tumor types harboring mutant BRAF, KRAS, NRAS, or HRAS, as well as robust inhibitory activity across a range of mutant KRAS subtypes.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. The broad therapeutic potential of ERAS-007 is being investigated initially across four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1, a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors, and HERKULES-2, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with NSCLC, are currently enrolling patients. HERKULES-3, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers, is expected to begin by year-end. HERKULES-4, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies, is anticipated to begin in the first quarter of 2022.

Cue Biopharma to Present at Two Upcoming Investor Healthcare Conferences

On September 9, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in two fireside chats, Baird’s 2021 Global Healthcare Conference, September 14-15 and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, September 20-23, 2021 (Press release, Cue Biopharma, SEP 9, 2021, View Source [SID1234608272]). Both conferences will be held virtually.

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During the fireside chats, Cue Biopharma will provide a data update highlighting its lead clinical program, CUE-101, representative of the IL-2 based CUE-100 series for the treatment of second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer. The discussion will also focus on the Company’s latest developments and pipeline progress.

Presentation Details:
Baird’s 2021 Global Healthcare Conference
Date and Time: Tuesday, September 14, 3:45 – 4:15 p.m. EDT
The webcasted fireside chat will be hosted on the conference website and available only to conference participants. Please visit View Source for more information.

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Date and Time: Wednesday, September 22, 1:15 – 1:55 p.m. EDT
A live and archived webcast of the fireside chat will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

About Baird’s 2021 Global Healthcare Conference
Baird’s 2021 Global Healthcare Conference brings institutional and private equity investors together with senior management from over 100 public and privately held companies. The conference will feature companies across the following sectors: Biotechnology, Healthcare Supply Chain & Pharma Services, Healthcare Information Technology, Life Sciences & Diagnostics, Medical Technology and Facilities & Services.

About Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Oppenheimer & Co. Inc. hosts multiple conferences a year covering many different industries. These conferences bring together corporate leaders, financial sponsors and institutional investors to explore market and sector trends. September 20-22 will feature presentations and one-on-one meetings in a virtual format with a select group of public companies in the Healthcare Life Sciences and MedTech arena. Thursday, September 23 will be the Private Company Day within the Summit and will feature a select group of emerging biotechnology and life science private companies. Investors will have the opportunity to meet virtually with management teams to discuss in detail key therapeutic programs in development and recent corporate updates.

Gritstone to Host Data Update on Neoantigen Oncology Programs for the Treatment of Solid Tumors During ESMO 2021

On September 9, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that it will host a data update webcast for investors and analysts during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting 2021, September 17, 2021 at 1:30 p.m. ET (Press release, Gritstone Oncology, SEP 9, 2021, View Source [SID1234592012]).

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The event will highlight the GRANITE (individualized neoantigen immunotherapy) Phase 1/2 data in advanced solid tumors which is being presented during a mini- oral presentation at ESMO (Free ESMO Whitepaper) 2021, in addition to data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors.

Presenters:

Andrew Allen, M.D., Ph.D., Gritstone’s chief executive officer, will provide a brief overview of the company, its neoantigen directed approach to immunotherapy, and next steps for the GRANITE and SLATE oncology programs
Daniel Catenacci, M.D., assistant professor of medicine, University of Chicago, will review the most recent GRANITE data
Thierry Andre, M.D., professor of medical oncology, St. Antoine Hospital, Assistance Publique Hôpitaux de Paris, will discuss the current treatment landscape and unmet medical need in treating patients with microsatellite stable colorectal cancer (MSS-CRC)
The presentation will be followed by a Q&A session.

To register for the webinar, please click here. The call and accompanying slides will be webcast live on the "Events" page under the "Investors & Media" section of the company’s website at www.gritstone.com. A replay of the webcast will be accessible at the same link approximately one day after its completion.

Daniel Catenacci, M.D., is an associate professor of medicine and director of the gastrointestinal oncology program at the University of Chicago. He serves as the assistant director of Translational Research in the Comprehensive Cancer Center. In addition to his clinical practice as an adult gastrointestinal medical oncologist, Dr. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach) cancers. His bench-to-bedside translational research has an overarching goal to validate and improve personalized treatment, immunotherapy, and precision medicine for gastroesophageal cancer and other GI cancers. Additionally, Dr. Catenacci designs and executes novel clinical trials to implement treatment strategies based on these laboratory and clinical discoveries. Dr. Catenacci serves as an associate editor for the Journal of American Medical Association Network Open (JAMA Netw Open) and is on the editorial board of the Journal of Clinical Oncology Precision Oncology (J Clin Oncol PO).

Thierry André, M.D., is a professor of medical oncology at the University Pierre et Marie Curie (UMPC), Paris VI, and head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris. He is the founding member and general secretary of the GERCOR (Multidisciplinary Oncology Research Group) and leads the colorectal task force of GERCOR and also serves as a member of the Adjuvant Colon Cancer Endpoints (ACCENT) group. Dr. André’s main research interest is in gastrointestinal malignancies. Dr. André is a member of several scientific organizations including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), and was chairman of the GI Cancer Board for Research of the French National Institute (INCA).

Apexigen Announces Appointment of Dr. Frank Hsu as Chief Medical Officer

On September 9, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported the appointment of Frank J. Hsu, M.D., as Chief Medical Officer, effective immediately (Press release, Apexigen, SEP 9, 2021, View Source [SID1234590985]). An accomplished industry veteran, Dr. Hsu will lead the ongoing clinical development of Apexigen’s lead investigational immuno-oncology drug, sotigalimab, an anti-CD40 antibody. He will also oversee clinical and regulatory strategy and execution for Apexigen’s expanding pipeline of immuno-oncology therapeutics.

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"We are thrilled to welcome Frank to Apexigen," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "He brings comprehensive drug development and regulatory expertise, proven leadership abilities and a fierce drive to improve patient outcomes. Frank has been on the forefront of innovation in immuno-oncology and has successfully brought multiple drugs to patients. We are confident that Frank will help drive the full potential of sotigalimab, which we believe may offer an important breakthrough in this field, as well as our broader pipeline."

Dr. Hsu added, "I am excited to join Apexigen, whose emerging data suggest sotigalimab — a potentially first-in-class and best-in-class CD40 agonist — may provide superior clinical benefit in several critically important cancer indications. I look forward to working with Apexigen’s outstanding team as we drive sotigalimab through its broad Phase 2 program and into registrational trials. Apexigen’s technology has created an innovative pipeline of next-generation, high quality antibody therapeutics and I am excited to be part of bringing these novel agents into the clinic."

Dr. Hsu has extensive experience in cancer drug development in biotech and academia and has advanced multiple biologics from early preclinical development through first-in-human studies and late-stage clinical development. Most recently, he served as Chief Medical Officer at Oncternal Therapeutics and before that he served as Vice President and Head of Oncology at Immune Design Corporation, where he was responsible for development of several immuno-oncology programs, prior to its acquisition by Merck. Previously, Dr. Hsu served as Chief Medical Officer at Zyngenia, where he was responsible for development of its multivalent protein therapeutics, and as Senior Medical Director at Genzyme. Dr. Hsu was a faculty member at Yale University, serving as an Assistant Professor of Medicine in the Section of Oncology and Co-Director/Director of the Immunology Research Program of the Yale Cancer Center. He began his academic career as a Clinical and Research Fellow in oncology at Stanford.

Dr. Hsu holds a B.S. degree in biology from Stanford University, and an M.D. degree from Harvard Medical School and the Health Science and Technology Program at the Massachusetts Institute of Technology. He completed his internship/residency in Internal Medicine at the University of California, San Francisco and his oncology training at Stanford University.

AnaptysBio to Participate in the H.C. Wainwright 23rd Annual Global Investment Conference

On September 9, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported that Hamza Suria, chief executive officer of AnaptysBio, will present an overview of AnaptysBio at the H.C. Wainwright 23rd Annual Global Investment Conference (Press release, AnaptysBio, SEP 9, 2021, View Source [SID1234590737]). The presentation will be available on Monday September 13, 2021, at 7:00 a.m. ET via: View Source

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A webcast of the presentation will also be available through the investor section of the AnaptysBio website at View Source A replay of the webcast will be available for 90 days following the event.