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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]).

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"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.

Affimed Reports Third Quarter 2019 Financial Results and Recent Operational Progress

On November 19, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended September 30, 2019 and provided an update on clinical and corporate developments (Press release, Affimed, NOV 19, 2019, View Source [SID1234551478]).

"We are excited to commence patient dosing in our Phase 2 study of AFM13 in support of registration, bringing us one step closer to delivering a potential new treatment for pTCL patients, who have very few treatment options," said Dr. Adi Hoess, Affimed’s CEO. "In addition, the IND for the first ever clinical trial bringing together an innate cell engager (AFM13) and adoptive NK cell transfer has cleared. This study of AFM13 and MD Anderson’s NK cell product could address a much broader group of patients with CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse large B-cell lymphoma."

Program Updates
AFM13 (CD30/CD16A)

In November 2019, the first patient was dosed in a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). The results of the study, if positive, could form the basis for a Biologics License Application submission and support an accelerated approval given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population. The study will also enroll a cohort of patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma.
The U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies. The combination represents a novel approach to further improve response rates and durability of responses in this patient population.
AFM24 (EGFR/CD16A)

In October 2019, Affimed received clearance of its IND for AFM24 from the FDA, enabling the company to proceed with its planned Phase 1/2a clinical study of the tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager in patients with advanced cancers known to express EGFR. The clearance of the IND follows the company’s IND submission in late-September 2019. Affimed expects the study, which is aimed at establishing safety and identifying initial signals of efficacy of AFM24, to initiate in the first quarter of 2020.
Pipeline Updates
Affimed selected two new CD16A-binding innate cell engager candidates (AFM28 and AFM32) from our ROCK platform for undisclosed targets that the company plans to advance into preclinical studies in 2020 with the aim of supporting future IND submissions. The selection of the new development candidates follows Affimed’s evaluation of innate immune cell activity versus a number of potential targets that are expressed in multiple hematological and solid tumor malignancies.
Genentech Collaboration
In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers. The target selection triggers a payment in an undisclosed amount to Affimed from Genentech.
Management Changes
Affimed announced the appointment of Cassandra Choe-Juliak, MD, MS as Acting Chief Medical Officer to succeed Dr. Leila Alland, effective November 30, 2019. Dr. Alland will transition out of her current role and will serve as a consultant for the company. Dr. Choe-Juliak has over 13 years of experience in drug development and medical affairs in immuno-oncology/oncology for both hematological and solid tumor malignancies. Since joining Affimed in July 2017, she has served as the clinical leader for the AFM13 development program.
Dr. Hoess commented, "Cassandra’s deep expertise in drug development and strong leadership skills have been, and will continue to be, a tremendous asset to Affimed and our clinical team as we advance our pipeline of innate cell engagers. I would also like to thank Leila for her many contributions to Affimed and wish her success in her future endeavors."

Financial Highlights
(Figures for the third quarter and nine months ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €76.5 million as of September 30, 2019, compared to €108.8 million as of December 31, 2018. In November 2019, Affimed completed a public equity offering with net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, of approximately $32 million (€29 million). Based on its current operating and budget assumptions, the company anticipates that its cash, cash equivalents and current financial assets as of September 30, 2019, together with the proceeds from the stock offering, will enable the Company to fund its planned clinical development and early development activities at least into the fourth quarter of 2021.

Net cash used in operating activities was €30.6 million for the nine months ended September 30, 2019, compared to net cash used in operating activities of €24.9 million for the nine months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was €2.1 million for the three months ended September 30, 2019 compared to €0.3 million for the three months ended September 30, 2018. The increase in revenue is attributable to the recognition of €1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2019 were €11.7 million, compared to R&D expenses for the third quarter of 2018 of €9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in pTCL and early stage development and discovery activities.

General and administrative expenses for the third quarter of 2019 were €2.8 million compared to €2.4 million for the third quarter of 2018.

Net loss was €10.9 million, or €0.17 per common share, for the third quarter of 2019, compared to a net loss of €12.0 million, or €0.19 per common share, for the third quarter of 2018.

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, November 19, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 8758067 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.