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."

XBiotech Announces French National Agency (ANSM) Approval and National Cancer Institute (INSA) funding to Support Phase I/II/III Clinical Study for Natrunix™ in Combination with Trifluridine/Tipiracil (TASKIN) for Treatment of Metastatic Colorectal Cancer

On April 28, 2022 XBiotech (NASDAQ: XBIT) reported that the French National Agency for the Safety of Medicines and Health Products [L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)] approved the launch of a multicenter randomized clinical study for XBiotech’s candidate cancer treatment Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer (Press release, XBiotech, APR 28, 2022, View Source [SID1234613124]). The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.

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Investigators will combine Natrunix and trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer in subjects that have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. The study will randomize patients to receive the Natrunix plus chemotherapy or placebo plus chemotherapy and is designed to seamlessly proceed to a Phase III study based on achievement of certain early efficacy milestones.

Headed by Dr. François Ghiringhelli and Dr. Come Lepage, the clinical program will include over 20 participating clinical centers and enroll at least 160 subjects. Dr. François Ghiringhelli is Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Dr. Come Lepage, Prof. Department Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France. The study design was developed by the lead investigators in collaboration with XBiotech.

The first portion of the study will be an open label, dose escalation (3:3). The Phase II portion will be a multicenter, randomized, double blind, placebo-controlled, non-comparative trial that will enroll 160 subjects. The main objective of the phase II study is to evaluate the efficacy of Natrunix + trifluridine/tipiracil in comparison with placebo + trifluridine/tipiracil with respect to 6-month overall survival in patients with refractory metastatic colorectal cancer. Secondary efficacy measures in the phase 2 portion will include progression free survival, median overall survival, tolerance, quality of life, serum markers of inflammatory cytokines, and tumor markers by immunohistochemistry. With successful completion of the primary endpoint in the Phase II portion, the study will continue into a phase III trial with the number of additional patients enrolled based upon results from the Phase II.

Natrunix is a therapeutic monoclonal antibody discovered, manufactured and undergoing clinical development by XBiotech. The antibody blocks the activity of interleukin-1 alpha (IL-1α). Malignant tumors "trick" the body into producing IL-1α, which has multiple roles in supporting tumor growth and spread. IL-1α expression is also induced by cytotoxic chemotherapy. IL-1α is a potent activator of new blood vessel formation (upregulating VEGF and tumor neoangiogenesis); it mediates breakdown of connective tissue through stimulating matrix metalloproteinase production; facilitates metastasis (enhancing adhesion and migration across blood vessels); and mediates systemic illness (fatigue, anorexia, and anxiety) through activating the hypothalamic-pituitary-adrenal axis. Using Natrunix to block IL-1α in combination therapy could inhibit tumor growth and spread, reduce unwanted effects of chemotherapy, and improve outcomes.

Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths in the United States alone.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Delcath Systems to Host First Quarter 2022 Results

On April 28, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported it will host a conference call on May 10, 2022, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2022 (Press release, Delcath Systems, APR 28, 2022, View Source [SID1234613123]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

ImmunityBio To Present Data From Multiple Clinical Trials at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 28, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported its abstracts were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7, in Chicago (Press release, ImmunityBio, APR 28, 2022, View Source [SID1234613122]).

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QUILT 3.032 Oral Presentation: Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA, will present final clinical results of pivotal trial of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary non-muscle-invasive bladder cancer (NMIBC).
QUILT 88 Poster Session: Phase 2 clinical trial of DAMP inducers combined with IL15 superagonist, N-803, and anti–PD-L1 NK cell therapy more than doubles historical overall survival in patients with third- to sixth-line advanced pancreatic cancer.
ImmunityBio will be exhibiting at booth number 26135.

Quarterly Activities Report and 4C

On April 28, 2022 Patrys reported that has published its Quarterly Activities Report and 4C Quarterly Cash Flow Report (Press release, Patrys, APR 28, 2022, View Source [SID1234613121]).

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Highlights for this Quarter have included:

Work on second engineering run of PAT-DX1 expected to complete in current quarter;
Stable cell line for production of PAT-DX3 established;
Receipt of R&D Tax Incentive Refund of $1.2 million.
Our balance sheet closed with a cash balance of $10.16M at 31 March 2022 and an additional $2M in short-term investments.