On April 27, 2020 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, reported that management will host a conference call and webcast to discuss its first quarter 2020 financial results and other business highlights on Monday, May 4, 2020 at 9:00 a.m. ET (Press release, Epizyme, APR 27, 2020, View Source [SID1234556643]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 1329067. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call and presentation.

On April 27, 2020 INOVIO (NASDAQ:INO) reported that first quarter 2020 financial results will be released after the market close on May 11, 2020 (Press release, Inovio, APR 27, 2020, View Source [SID1234556641]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update, including the company’s ongoing vaccine developments for COVID-19.

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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

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10143530.

On April 27, 2020 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that the first patient has been dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed, refractory multiple myeloma (RRMM) (Press release, Harpoon Therapeutics, APR 27, 2020, View Source [SID1234556640]). HPN217 is being developed under a global license and option agreement with AbbVie Inc. (NYSE:ABBV) and dosing of the first patient in a clinical trial has triggered a $50 million milestone payment to Harpoon. HPN217 targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma calls. HPN217 is Harpoon’s third product candidate to enter the clinic and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC) platform designed to recruit a patient’s own immune cells to destroy tumors.

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"The initiation of a clinical trial for our third product candidate is another significant milestone for Harpoon and demonstrates the outstanding progress we are making in advancing our innovative oncology pipeline," said Gerald McMahon, Ph.D., President and CEO of Harpoon Therapeutics. "The $50 million milestone payment adds additional financial resources to support the HPN217 program and other development activities that we are conducting. The first patient was treated at Colorado Blood Cancer Institute and the Sarah Cannon Research Institute at HealthONE’s Presbyterian St. Luke’s Medical Center. We are excited to be advancing HPN217 in the clinic and look forward to reporting our progress as this program matures."

"Therapeutic choices for patients with RRMM are limited, and there is a need for additional therapeutic options," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon. "Our non-clinical data suggest that HPN217 has substantial anticancer activity and provide the rationale to investigate its potential benefit as an effective immunotherapy for patients with multiple myeloma."

About the Phase 1/2 Clinical Trial for HPN217

This Phase 1/2 trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN217 in patients with RRMM. The Phase 1 portion of the trial is a dose escalation phase, with the goal of determining a recommended dose for the Phase 2 portion of the trial. HPN217 will be administered to patients once weekly by intravenous infusion. The primary outcome measures will be an assessment of safety and tolerability, pharmacokinetics, and determination of a dose for the Phase 2 portion of the trial. Secondary endpoints include overall response rate, progression free and overall survival, and duration of response.

The Phase 2 portion of the trial will further evaluate the safety and activity of HPN217 in patients with RRMM. The trial is titled, "A Phase 1/2 open-label, multicenter, dose escalation and dose expansion study of the safety, tolerability, and pharmacokinetics of HPN217 in patients with relapsed/refractory multiple myeloma. For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT04184050.

About the Agreement with AbbVie

In November 2019, Harpoon entered into a Development and Option Agreement with AbbVie pursuant to which Harpoon granted AbbVie an option to license worldwide exclusive rights to HPN217. Harpoon will be responsible for developing HPN217 through a Phase 1/2 clinical trial. Upon exercise of the option, AbbVie would be responsible for all future clinical development, manufacturing and commercialization activities. The licensing option for HPN217 may be exercised at any time up to the completion of the Phase 1/2 clinical trial. The Development and Option Agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales. In November 2019, Harpoon also expanded its existing discovery collaboration agreement by up to six additional targets for a total of eight targets. AbbVie has the right to select four targets, representing a deal transaction value of approximately $1.2 billion plus royalties, with an option to select up to four additional targets. Harpoon would be eligible to receive up to $310 million plus royalties for each additional target selected. Harpoon received an initial upfront payment of $50 million in November 2019, with an additional $50 million payment due upon dosing the first patient with HPN217.

On April 27, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported that it has appointed Rudolf Baumgartner, M.D., as Chief Medical Officer and Head of Clinical Development starting on May 1, 2020 (Press release, Saniona, APR 27, 2020, View Source [SID1234556639]). Dr. Baumgartner brings more than 20 years of experience leading multiple pharmaceutical development programs from discovery through approval and launch, in both large and small pharmaceutical companies.

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"Rudi’s clinical development expertise will be critical as Saniona advances its’ mid/late stage development of Tesomet in two rare eating disorders: Prader Willi Syndrome and hypothalamic obesity," said Rami Levin, President and Chief Executive Officer of Saniona. "As we pursue our End of Phase 2 meeting with the FDA and determine the regulatory path for bringing Tesomet to patients in these indications, we look forward to Rudi’s insights and expertise to build out the clinical development team and progress our programs through to commercialization."

"This is an exciting time to join the Saniona team, as the company builds on its strong scientific roots to become a U.S.-based biopharmaceutical company preparing for late-stage trials of Tesomet in two rare diseases," said Baumgartner. "The two diseases for which we are evaluating Tesomet, hypothalamic obesity and Prader-Willi Syndrome, both lack approved treatment options and represent significant unmet needs for patients and their families."

Dr. Baumgartner is a physician-scientist with a proven track record of leading cross-functional teams through multiple development programs from Investigational New Drug (IND) applications through New Drug Application (NDA) submissions and product approvals. Trained in basic immunology, he brings to Saniona significant expertise across a broad array of therapeutic areas, including inflammation and auto-immune diseases. Most recently, he served as Chief Medical Officer for the Flatley Discovery lab, a non-profit foundation working in the rare disease space of Cystic Fibrosis. Prior to that, he was the Executive Vice President and Chief Medical Officer for Inotek Pharmaceuticals, where he was instrumental in writing the S1 and co-leading the company’s IPO. At Inotek Pharmaceuticals, he oversaw clinical development and operations, medical affairs, regulatory affairs, biostatistics, preclinical development, and intellectual property. Before Inotek, Dr. Baumgartner held senior-level development positions at Sepracor and Merck & Co. He began his medical career as a clinician-scientist at the National Institutes of Health (NIH), in the Laboratory of Molecular Immunology at the National Heart, Lung, and Blood Institute (NHLBI). He completed his M.D. at Pennsylvania State University, his residency in Internal Medicine at the University of Michigan, and his fellowship in Pulmonary and Critical Care Medicine at Johns Hopkins University.

On April 27, 2020 Xilio Therapeutics, a company developing potent, tumor-selective immuno-oncology (IO) therapies for patients with cancer, reported that Martin H. Huber, M.D. has joined the company as Chief Medical Officer (Press release, Xilio Therapeutics, APR 27, 2020, View Source [SID1234556638]). In this role, Dr. Huber will oversee all aspects of the Company’s clinical development strategy and operations and lead Xilio’s first two therapeutic candidates, XTX201 (tumor-selective IL-2) and XTX101 (tumor-selective aCTLA4 mAb) into clinical development in 2021, while advancing Xilio’s tumor-selective IL-12 and IL-15 cytokine pipeline programs.

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"Dr. Huber has had a long and distinguished career in immuno-oncology drug development, and he has successfully led multiple cancer immunotherapy programs, from early clinical stage through commercialization," said Rene Russo, Chief Executive Officer of Xilio. "His leadership will accelerate our broad pipeline of potent, tumor-selective IO therapies into clinical development and complement the outstanding team that has been assembled at Xilio."

Dr. Huber has over 20 years of academic, biotechnology, and pharmaceutical drug development experience, most recently serving as Senior Vice President and Chief Medical Officer at Tesaro, Inc. before its acquisition by GSK. While at Tesaro, he drove the expansion of the niraparib program and advanced the company’s immuno-oncology agents into the clinic. Prior to that, he was Vice President, Oncology Clinical Research at Merck Research Laboratories where he was instrumental in the advancement of Merck’s oncology programs, serving as program lead for pembrolizumab in non-small cell lung cancer. Prior to Merck, he served in roles of increasing responsibility at Schering-Plough, Hoffmann-La Roche and Rhone-Poulenc Rorer, where he led teams in the areas of oncology clinical development, drug safety and pharmacovigilance. He previously served as an Assistant Professor of Oncology at the University of Texas MD Anderson Cancer Center. Dr. Huber holds an M.D. from the Baylor College of Medicine.

"I am thrilled to join a deeply experienced oncology drug development team at Xilio and help realize its important mission of transforming cancer treatments by unleashing the full power of highly potent immuno therapies precisely in tumors," said Dr. Huber. "I believe in the potential of Xilio’s tumor-selective technology to revolutionize the efficacy of IO therapies for a broad range of patients living with cancer."

Xilio Therapeutics is developing its proprietary technology to create a new class of ultra-potent IO therapies that are activated selectively within the tumor. These tumor-selective therapies are designed to overcome the significant toxicities associated with clinically validated IO therapies, such as IL-2 and aCTLA4, which have historically limited the number of patients that can be treated and prevented patients from completing full courses of treatment. XTX201 (IL-2) and XTX101 (aCTLA4 mAb) have demonstrated tumor-selective activity in preclinical models, significantly widening the potential therapeutic index for these therapies.