On November 19, 2019 Personalis, Inc. (Nasdaq:PSNL), a leader in advanced genomics for cancer, reported a collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to investigate novel biomarkers of response and mechanisms of resistance to cancer therapies. Merck KGaA, Darmstadt, Germany, will utilize Personalis’ newest cancer immunogenomics platform, ImmunoID NeXT, for clinical biomarker identification and development (Press release, Personalis, NOV 19, 2019, View Source [SID1234551484]).

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!

ImmunoID NeXT, through innovative assays and analytics, provides a comprehensive view of each cancer’s genomics and immune microenvironment from a single, limited tumor sample. The platform is an end-to-end solution built for precision oncology biomarker discovery through to clinical applications, enabling simultaneous analysis of cancer mutations, the immune repertoire, neoantigens, tumor escape mechanisms, DNA repair pathways, human leukocyte antigens (including typing, loss of heterozygosity, and somatic mutation detection), tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, immune checkpoints, gene expression, immune signatures, and other advanced biomarkers.

"Merck KGaA, Darmstadt, Germany, is a global leader in cancer therapeutic development and we’re thrilled to collaborate with them to identify the next generation of clinical biomarkers for cancer therapies," said Richard Chen, MD, CSO of Personalis. "We will work with Merck KGaA, Darmstadt, Germany, to leverage the NeXT Platform for novel biomarker identification, analysis of therapy resistance mechanisms, patient stratification, combination therapy strategy, and comprehensive molecular categorization of cancers for enabling precision therapy."

On November 19, 2019 Palleon Pharmaceuticals, a leading biotech company developing drugs that target the Siglec-Sialoglycan axis to treat cancer, reported that it will present preclinical data from two of its development programs today at the 11th Annual Protein & Antibody Engineering Summit (PEGS Europe) in Lisbon, Portugal (Press release, Palleon Pharmaceuticals, NOV 19, 2019, View Source [SID1234551483]).

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 Siglec-Sialoglycan axis, a previously underappreciated mechanism of immunosuppression in cancer, has recently emerged as a major tumor immune escape pathway. Palleon has leveraged its proprietary EAGLE and CONVERGENCE platforms to develop a suite of technologies that target both Siglec receptors and their sialoglycan ligands.

Li Peng, Ph.D., Senior Vice President of Research and Early Product Development at Palleon, will present preclinical data on the company’s lead candidate EAGLE-Her2, showing that selectively removing the terminal sialic acids of sialoglycans within the tumor microenvironment effectively inhibits the Siglec-Sialoglycan immune checkpoint and reinvigorates both the innate and adaptive responses to cancer. In addition, Dr. Peng will present Palleon’s anti-Siglec-9 monoclonal antibody program, including preclinical studies that detail the development of antagonistic anti-Siglec antibodies that block the Siglec-Sialoglycan axis.

Palleon Scientific Advisor, Joy Burchell, Ph.D. and Professor of Glyco-Oncology at Kings College London will also present at PEGS Europe. Dr. Burchell will discuss the role of a glycosylated form of tumor-associated mucin MUC1, which engages with Siglec-9 on monocytes and macrophages to create an immunosuppressive tumor microenvironment.

"Targeting the Siglec-Sialoglycan axis of immunosuppression is a truly novel approach to treating cancer that could potentially benefit patients who are resistant to first-generation immuno-oncology therapies," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "Our preclinical data demonstrates striking single agent efficacy across a range of animal models and human in vitro systems."

On November 19, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Ben B. Wolf, M.D., Ph.D., has joined as chief medical officer, Mrunal "Monica" Phadnis has joined as vice president of clinical operations and Iain Martin, Ph.D., has joined as vice president, drug metabolism and pharmacokinetics (Press release, Relay Therapeutics, NOV 19, 2019, View Source [SID1234551482]).

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 we advance multiple programs into the clinic in the coming year and continue to deepen our early stage pipeline, Ben’s extensive experience in clinical development and translational medicine, Monica’s background in clinical operations, and Iain’s expertise in drug discovery will be critical in helping propel the company in the next phase of our growth," said Don Bergstrom, M.D., Ph.D., executive vice president and head of research and development of Relay Therapeutics. "We are pleased to welcome these respected leaders, who together bring a wealth of expertise to our growing team."

Dr. Ben B. Wolf is a precision oncologist who brings to Relay Therapeutics nearly 20 years of experience in the biopharmaceutical industry, with expertise advancing new oncology programs in the clinic and optimizing patient selection to enable rapid proof of concept and registration. He has authored more than 30 peer-reviewed publications and multiple patents related to drug discoveries. Most recently, Dr. Wolf served as chief medical officer at KSQ Therapeutics, a biotechnology company advancing a pipeline of CRISPR-based tumor- and immune-focused drug candidates for the treatment of cancer. Prior to KSQ, Dr. Wolf was senior vice president, clinical development at Blueprint Medicines, where he advanced three oncology programs for novel kinase inhibitors from investigational new drug (IND) applications to clinical proof-of-concept. Prior to Blueprint, Dr. Wolf held clinical and medical director roles at Merrimack Pharmaceuticals, ImmunoGen, Amgen and Genentech. Dr. Wolf holds an M.D. and Ph.D. in biochemistry from the University of Virginia and a B.S. from Union College. He completed medical training in internal medicine and medical oncology at the University of California at San Diego.

Monica Phadnis is an end-to-end delivery expert with more than 15 years in clinical oncology research. Prior to joining Relay Therapeutics, she was the executive director of clinical development in oncology and hematology at Syneos Health, where she worked primarily on early phase solid tumors. Before Syneos, she was the director and clinical operations lead at EMD Serono, where she led Precision Medicine clinical programs in Non-Small Cell Lung Cancer. Additionally, she held roles of growing responsibility at Quintiles Translational Corporation, Sanofi-Aventis, Memorial Sloan-Kettering Cancer Center and Selventa Inc. Ms. Phadnis received a B.S. in mathematics from the University of Mumbai in Mumbai, India and a pre-medical diploma with specialization in genetics from Harvard University.

Dr. Iain Martin brings to Relay Therapeutics more than 30 years of experience in pharmaceutical drug metabolism and pharmacokinetics (DMPK) across therapeutic areas, including oncology and neuroscience. Prior to joining Relay Therapeutics, he was executive director within the department of pharmacokinetics, pharmacodynamics and drug metabolism at Merck, where he led groups responsible for DMPK support of small molecule and peptide programs across the company. Prior to Merck, Dr. Martin held roles of increasing responsibility at The Upjohn Company, AstraZeneca, Organon and Schering Plough. He received his Ph.D. in drug metabolism and a B.S. in biochemistry from the University of Surrey (UK).

On November 19, 2019 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTINi (bevacizumab) (Press release, Samsung Bioepis, NOV 19, 2019, View Source [SID1234551481]). The BLA for SB8 was submitted by Samsung Bioepis in September 2019.

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!

If approved, SB8 will be commercialized in the United States (US) by Merck & Co., Inc., Kenilworth, NJ, USA, which is known as MSD outside the US and Canada.

On November 19, 2019 Omeros Corporation (Nasdaq: OMER) reported new findings on GPR174, its novel cancer immunotherapy target, demonstrating that GPR174-deficiency enhances anti-tumor immune responses in animals (Press release, Omeros, NOV 19, 2019, View Source [SID1234551480]).

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 studies were conducted in mouse models of melanoma and of colon carcinoma, each of which was modified to partially deplete regulatory T cells, a subset of immunosuppressive T cells. Partial depletion of regulatory T cells in mice creates a T-cell composition more similar to that in humans. GPR174 deficiency in these mice resulted in significantly reduced tumor growth and improved survival of the animals (p=0.006 in melanoma; p=0.03 in colon cancer) versus normal mice.

These findings are being presented today by Marc Gavin, Ph.D., Omeros’ Director of Immunology, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts.

The presentation also features discoveries regarding phosphatidylserine (PS), a product of cell stress and death that is abundant in the tumor microenvironment. PS has been shown by Omeros to suppress T-cell activity through GPR174. The function of PS is similar to that of adenosine, which is also abundant in the tumor microenvironment and suppresses T cells through adenosine receptors. It was demonstrated that the combination of adenosine pathway inhibition together with Omeros’ novel GPR174 inhibitors results in maximal potentiation of T-cell responses, which should translate to a more effective cancer immunotherapy approach.

"The animal data nicely confirm our cell-based findings and further validate GPR174 as an important immuno-oncology target," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We look forward to advancing this program to the clinic and providing better treatment options and outcomes to cancer patients."