On September 9, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that Jennifer Buell, PhD, President and COO of Agenus, will participate in the following upcoming conferences (Press release, Agenus, SEP 9, 2021, View Source [SID1234587538]):

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H.C. Wainwright 23rd Annual Global Investment Conference presentation will be available on-demand from Monday, September 13, 2021, starting at 7:00 a.m. ET.
Baird 2021 Global Healthcare Conference presentation on Wednesday, September 15, 2021 from 4:20 p.m. to 4:50 p.m. ET.
A webcast and replay for the Baird 2021 Global Healthcare Conference may be accessed on the company’s website at View Source

On September 9, 2021 CG Oncology, Inc. reported a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study (Press release, CG Oncology, SEP 9, 2021, View Source [SID1234587554]).

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CG0070, CG Oncology’s lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

"We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with OPDIVO in metastatic urothelial cancer," said Arthur Kuan, CEO of CG Oncology. "The clinical results to date for CG0070 make it a potential promising agent in bladder cancer and other tumor types, as monotherapy or in combination with immune checkpoint inhibitors."

CG Oncology will sponsor the study and Bristol Myers Squibb will provide nivolumab. Additional details of the collaboration were not disclosed.

OPDIVO is a trademark of Bristol-Myers Squibb Company.

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.

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.

On September 9, 2021 Alkermes plc reported that it will begin accepting applications for its annual Alkermes Pathways Research Awards program on Sept. 13, 2021 (Press release, Alkermes, SEP 9, 2021, View Source [SID1234587464]). This competitive grant program is designed to support the next generation of researchers working on the front lines to advance understanding and awareness of disease states in the field of neuroscience. In its fourth year, the program will offer grants to early-career investigators who have demonstrated a commitment to helping people living with schizophrenia, bipolar disorder, alcohol use disorder (AUD) or opioid use disorder (OUD). The application period will run through Nov. 12, 2021.

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"As a leader in developing treatments for serious mental illness and addiction, Alkermes is committed to supporting and advancing research that has the potential to drive meaningful change for people living with these complex diseases," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "Now in its fourth year, the Pathways program has a track record of assisting early-career investigators working on important research projects across a variety of topics who share our commitment to these patient communities."

The 4th annual Alkermes Pathways Research Awards program will offer grants in amounts of up to $100,000 per project. To qualify, early-career investigators must be M.D.s, Ph.D.s, or equivalent, who are within five years of their initial academic appointment or are current post-doctoral fellows, and who are affiliated with a medical or research institution within the United States. Applicants will be evaluated by an independent review committee comprised of specialists in psychiatry, neurobiology, pharmacology, and behavioral science from academic research centers.

The Pathways program began in 2018 and has since provided funding to 16 researchers across the United States. Award recipients have undertaken important, mentor-supported research to help advance the field of neuroscience. For more information on the Alkermes Pathways Research Awards program, including full eligibility criteria and how to apply for the 4th annual edition of the program, visit www.PathwaysResearchAwards.com.