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Palleon Pharmaceuticals to Present Preclinical Data on EAGLE-Her2 and Anti-Siglec-9 Antibody Programs at the 11th Annual Protein & Antibody Engineering Summit

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]).

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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."

Relay Therapeutics Strengthens Leadership Team with Key Team Appointments in Research and Development

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]).

"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).

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

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.

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.

OMEROS PRESENTS NEW GPR174 IMMUNO-ONCOLOGY DATA TODAY AT THE AMERICAN ASSOCIATION FOR CANCER RESEARCH CONFERENCE IN BOSTON

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]).

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."

Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

On November 19, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported that the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer (Press release, Myovant Sciences, NOV 19, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-97-response-rate-positive-phase-3 [SID1234551479]). These results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020 and future regulatory submissions in Europe and Japan.

"An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years," said Neal Shore, M.D., Medical Director of the Carolina Urologic Research Center and HERO Program Steering Committee Member. "If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer."

In the primary endpoint responder analysis, 96.7% (95% CI: 94.9%, 97.9%) of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels. A responder was defined as achieving and maintaining testosterone suppression to less than or equal to 50 ng/dL from Week 5 through Week 48. For the study to be successful, the lower bound of the 95% confidence interval of the response rate had to be at least 90%.

Five key secondary endpoints demonstrated superiority to leuprolide acetate, including rapid suppression of testosterone at Day 4 and Day 15, profound suppression of testosterone at Day 15, rapid suppression of prostate-specific antigen (PSA) at Day 15, and suppression of follicle-stimulating hormone (FSH) at Week 24 (all p-values < 0.0001). In addition, relugolix demonstrated non-inferiority to leuprolide acetate on sustained testosterone suppression through 48 weeks (96.7% vs. 88.8%, respectively) with a between-group difference of 7.9% (95% CI: 4.1%,11.8%), the primary endpoint required for regulatory submissions outside of the U.S. In addition, the pharmacodynamic results showed no testosterone flare after initiation of relugolix and mean testosterone levels returned to normal levels within 90 days after treatment discontinuation.

"With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA," said Lynn Seely, M.D., President and CEO of Myovant Sciences. "We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer."

The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). In the relugolix group, 3.5% of men discontinued the study early due to adverse events compared with 2.6% of men in the leuprolide acetate group. The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, diarrhea, and arthralgia. Unadjudicated major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality.

Conference Call
Myovant will hold a conference call today, November 19, 2019 beginning at 8:30 a.m. EST / 5:30 a.m. PST. The dial-in numbers are 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.

About the Phase 3 HERO Program
This randomized, open-label, parallel-group, multinational clinical study was designed to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Patients enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

The primary efficacy endpoint of the study to support U.S. approval was the ability of relugolix to achieve and maintain testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks.

Approximately 1,100 patients are planned to be enrolled in this study, including approximately 430 patients with metastatic prostate cancer to support the analysis of a secondary endpoint of castration resistance-free survival, data which are expected in the third quarter of 2020, and 138 Chinese patients (enrolled in China and Taiwan) to support registration in China.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Treatment for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH agonists, such as leuprolide acetate, or slow-release injections are the current standard of care for medical castration. However, GnRH agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial rise in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery if the drug is discontinued.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, the hormone primarily responsible for stimulating prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing a relugolix monotherapy tablet (120 mg) for men with advanced prostate cancer and relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with endometriosis-associated pain.

Earlier this year, Myovant announced positive top-line data from two Phase 3 studies, LIBERTY 1 and LIBERTY 2, evaluating relugolix combination therapy for uterine fibroids, as well as positive results from a separate bioequivalence study supporting a potential one tablet, once-daily dosing regimen. Myovant expects to submit an NDA to the FDA for uterine fibroids in April 2020. Myovant also expects to announce top-line results from two Phase 3 studies, SPIRIT 2 and SPIRIT 1, evaluating relugolix combination therapy for endometriosis-associated pain in the first and second quarters of 2020, respectively.