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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported it submitted a Patent Cooperation Treaty (PCT) application for the combination therapy of olinvacimab, the Company’s anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 antibody, for the treatment of cancer (Press release, PharmAbcine, SEP 9, 2021, View Source [SID1234649188]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The PCT application is an international application that preserves the priority date. The PCT is an international treaty that has over 150 Contracting States worldwide. It assists applicants in seeking patent protection internationally for their inventions, helps patent offices with their patent granting decisions, and facilitates public access to a wealth of technical information relating to those inventions.

The application, which was submitted jointly with MSD, is based on the Phase Ib olinvacimab and pembrolizumab combo trial in metastatic Triple-Negative Breast Cancer (mTNBC). According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, the combo therapy showed encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts).

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. In early September 2021, PharmAbcine initiated a Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia. Also, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients at multiple sites in both US and Australia and two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

"Submission of this patent application will be our first step in securing the novelty of the combo therapy." said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will move onto getting our patent secured in multiple countries with great needs for a cancer treatment."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

On September 14, 2021, Denovicon Therapeutics Founder & CEO, Scott Bembenek, presented on Denovicon’s ‘AI–Molecular Modeling Platform for Enhanced Small-Molecule Drug Discovery’ at the Biovia User Group Meeting 2021 (Press release, Denovicon Therapeutics, SEP 9, 2021, View Source [SID1234587487]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!