I-Mab Announces Appointments of Richard Yeh as Chief Operating Officer and John Hayslip as Chief Medical Officer

On April 28, 2022 I-Mab ("I-Mab" or the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported the appointments of Mr. Richard Yeh as Chief Operating Officer and Dr. John Hayslip as Chief Medical Officer (Press release, I-Mab Biopharma, APR 28, 2022, View Source [SID1234613126]). The two key appointments add greater depth and breadth of industry experience to the Company’s leading management team, further accelerating its global ambition in innovation and to become a specialty global biopharmaceutical company.

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"I-Mab has been on an exciting transformation journey. As we continue to push forward on multiple fronts to expand our capabilities and deliver on key milestones, the invaluable experience brought by these two leaders will facilitate the Company’s growth to the next phase," said Dr. Jingwu Zang, Founder, Chairman and Acting CEO of I-Mab. "Mr. Yeh will play an integral role in further enhancing our global investor network and strengthening our global business partnerships. While Dr. Hayslip will apply his nearly two decades of clinical research expertise in oncology to advancing our globally competitive pipeline of innovative assets."

Mr. Yeh will be based in Shanghai, China and report directly to Dr. Jingwu Zang. He will join I-Mab’s Board after the necessary process is completed. As the Company upgrades its worldwide operations and strengthens network with international investors, Mr. Yeh will be leading key aspects of I-Mab’s strategic investor interactions, global alliance management and major facilities across the world.

Mr. Yeh is an industry veteran with over 25 years of experience spanning senior leadership positions with biopharmaceutical companies and prominent Wall Street firms. Before joining I-Mab, Mr. Yeh was Chief Financial Officer and Head of Strategic Operations at Abbisko Therapeutics (HKEX: 2256), overseeing financial transactions, strategic planning, financial & accounting reports, risk management and fundraising. He also held a series of leadership positions including Chief Financial Officer of CStone Pharmaceuticals (HKEX: 2616), Managing Director and Business Unit Leader of Asia Pacific healthcare equity research at Goldman Sachs (Asia), and Head of China and regional healthcare research team at Citigroup Capital Markets Asia. Mr. Yeh also had robust experience in equity research covering the U.S. biotechnology sector at major firms including Citigroup and Bank of America Securities. Before his career on Wall Street, Mr. Yeh worked in the global strategic marketing group at Wyeth Pharmaceuticals and conducted drug discovery research at Amgen. Mr. Yeh earned his M.B.A. from the Samuel Curtis Johnson Graduate School of Management at Cornell University and Master of Science in Medical Biophysics from the University of Toronto and Ontario Cancer Institute.

"I am thrilled to join I-Mab," said Mr. Yeh. "I-Mab has been at the forefront of creating globally competitive innovation and developed an extensive network of strategic partnerships with major players around the world. I am excited to be part of I-Mab’s global ambition by working with such a high-caliber management team."

Dr. Hayslip will be based in the United States and report directly to Dr. Andrew Zhu, President of I-Mab. In his new role, Dr. Hayslip will lead the Company’s pipeline development, addressing the key challenges in clinical sciences to increase the probability of success and the speed of clinical development for I-Mab’s innovative assets.

Before joining I-Mab, Dr. Hayslip was Vice President of Clinical Development at Nektar Therapeutics (Nasdaq: NKTR). Dr. Hayslip also led development activities for multiple therapies while at AbbVie Oncology. He also comes with a depth of experience on lemzoparlimab (TJC4), having assembled and led the AbbVie cross-functional team to complete setup for patient enrollment for the global partnership between I-Mab and AbbVie on lemzoparlimab. Prior to joining AbbVie Oncology, Dr. Hayslip was an accomplished researcher and physician at the University of Kentucky’s Markey Cancer Center, where he led numerous cancer research studies with a primary focus in lymphoma and leukemia. He also served as the Chief for Hematology and Bone Marrow Transplant and as Director of Clinical Research and Data Management at the Markey Cancer Center. Dr. Hayslip received his medical degree from Northeast Ohio Medical University and a master’s degree in Clinical Research from the Medical University of South Carolina. Following his residency in internal medicine, Dr. Hayslip completed his fellowship in Hematology-Oncology at the Medical University of South Carolina leading to dual board certifications in both Hematology and Medical Oncology. Dr. Hayslip holds multiple U.S. and international patents and has published dozens of scientific papers and reviews in renowned journals including Lancet Haematology, Clinical Cancer Research, Leukemia Research, Blood, and Journal of Clinical Oncology.

"I-Mab’s focus on transformational therapies to address unmet medical needs through innovation has been an inspiration," said Dr. Hayslip. "I am excited to work with this talented global team and looking forward to bringing innovative cancer therapies to patients in areas of high unmet need."

PerkinElmer Board Declares Quarterly Dividend

On April 28, 2022 The Board of Directors of PerkinElmer, Inc. (NYSE: PKI) reported a regular quarterly dividend of $0.07 per share of common stock (Press release, PerkinElmer, APR 28, 2022, View Source [SID1234613142]). This dividend is payable on August 12, 2022 to all shareholders of record at the close of business on July 22, 2022.

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Zymeworks Reports Last Patient Enrolled in Pivotal Study of Zanidatamab in Treatment of HER2-Expressing Late-Line Biliary Tract Cancer

On April 28, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that it has completed enrollment in its global HERIZON-BTC-01 pivotal clinical trial evaluating the antitumor activity of zanidatamab monotherapy in patients with previously treated advanced or metastatic HER2-amplified biliary tract cancers (BTC), including gallbladder cancer and cholangiocarcinoma (bile duct cancer) (Press release, Zymeworks, APR 28, 2022, View Source [SID1234613175]). Efficacy and safety results from HERIZON-BTC-01 are expected to be announced by early 2023.

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"Completing enrollment in our first pivotal trial is a tremendous accomplishment for Zymeworks. I’m extremely proud of our team and our collaborators at BeiGene for their hard work in reaching this milestone ahead of expectations," said Neil Josephson, M.D., Chief Medical Officer. "Currently there are limited options for patients with advanced HER2-amplified biliary tract cancer who experience disease progression after front-line therapy. Zanidatamab has the potential to meet the urgent global clinical need for a safe and effective therapy for patients with this difficult to treat cancer."

Biliary tract cancers, including gallbladder cancer and cholangiocarcinoma, account for approximately 3% of all adult cancers and is often associated with a poor prognosis1. Globally, more than 210,000 people are diagnosed with BTC every year2 and most patients (> 65%) with BTC are diagnosed with tumors that cannot be removed surgically. The human epidermal growth factor receptor 2 (HER2) is a well-described target for anti-cancer therapy. About 5% to 19% of patients with BTC have tumors that express HER23, suggesting that these patients may have the potential to benefit from HER2-targeted therapy. Currently no HER2-targeted therapy has been approved for the treatment of BTC.

HERIZON-BTC-01 is a global, multicenter, open-label, single-arm study (NCT04466891) with a primary endpoint of confirmed objective response rate (ORR) by independent central review (ICR) per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary endpoints are duration of response (DOR), proportion of subjects with a DOR ≥16 weeks, disease control rate (DCR), progression-free survival (PFS), overall safety (OS) and safety. HER2 amplification, as determined by in situ hybridization (ISH) in tumor tissue, was an inclusion criterion for all subjects enrolled into the two study cohorts: Cohort 1, the primary efficacy cohort, with tumor tissue showing HER2 immunohistochemistry (IHC) 2+ or 3+ staining, and cohort 2 with tumor tissue showing HER2 IHC 0 or 1+ staining. The study was initiated in July 2020 and has active sites in North America, Asia Pacific, Europe and South America.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2 -receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zanidatamab is currently being evaluated in two pivotal clinical trials, one for the first-line treatment of advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for previously treated HER2-amplified biliary tract cancer (HERIZON-BTC-01). Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2‑expressing gastroesophageal, colorectal, and breast cancers. The FDA has granted zanidatamab Breakthrough Therapy designation for patients with previously treated HER2 gene-amplified biliary tract cancer, as well as two Fast Track designations, one as monotherapy for refractory biliary tract cancer and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma. These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab received Break Through Designation from the Center of Drug Evaluation (CDE) in China for treating patients with biliary tract cancer who have failed prior systemic therapies. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

Zymeworks has an existing intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab in patients with HER2-positive advanced solid tumors who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab. Additional information is available on our website at View Source

About the Zymeworks-BeiGene Collaboration

In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2-expressing cancers and lines of therapy.

Lytix Biopharma to present at the American Society of Clinical Oncology (ASCO) Annual Meeting

On April 28, 2022 Lytix Biopharma AS (Lytix), a clinical-stage company with an in situ vaccination technology platform targeting cancer indications, reported that its abstract has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago June 3-7, 2022 (Press release, Lytix Biopharma, APR 28, 2022, View Source [SID1234613191]).

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Title: LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes in patients with metastatic soft tissue sarcoma.
Presenter: Morten Nielsen, MD | National Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, Herlev, Denmark

Prothena to Report First Quarter 2022 Financial Results on May 5th

On April 28, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it will report its first quarter 2022 financial results on Thursday, May 5, 2022 after the close of the U.S. financial markets (Press release, Prothena, APR 28, 2022, View Source [SID1234613235]).

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Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on May 5.