On December 9, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that its Board of Directors has approved a new share repurchase program effective immediately, which authorizes the Company to purchase up to $750 million of the Company’s outstanding common stock over the next three years (Press release, Halozyme, DEC 9, 2021, View Source [SID1234596698]). The Company plans to enter into an accelerated share repurchase (ASR) program transaction with a financial institution in the coming week, subject to market conditions. The Company plans to purchase up to $250 million worth of shares by the end of 2022, including the $150 million ASR, pending market conditions and other factors.

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"Our second share repurchase authorization demonstrates Halozyme’s commitment to a balanced capital allocation strategy that includes investing in our operations, capital return and potential M&A," said Dr. Helen Torley, president and chief executive officer. "We are pleased that our strong cash generation and balance sheet enables us to return capital to investors while maintaining our ability to invest in our future to sustainably grow our business."

This share repurchase program follows the recent completion of the Company’s prior $550 million three-year share repurchase program, which was completed in less than two years.

The amount and timing of shares repurchased under the share repurchase program will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements. Repurchases may be commenced or suspended at any time or from time-to-time at the Company’s discretion without prior notice. Repurchases may be made through both public market and private transactions. The Company plans to fund repurchases from its existing cash balance. The Company’s Board of Directors will regularly review this capital return policy in connection with a balanced capital allocation strategy focused on funding growth.

On December 9, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has entered into a clinical collaboration with Clover Biopharmaceuticals, Ltd. ("Clover"; Stock Code: 2197.HK) to evaluate Ascentage Pharma’s APG-1387, a second mitochondria-derived activator of caspase (SMAC)-mimetic/inhibitor of apoptosis proteins (IAP) antagonist, in combination with Clover’s SCB-313, a recombinant human TRAIL-trimer fusion protein, in a Phase Ib/II study in patients with advanced peritoneal carcinomatosis (Press release, Ascentage Pharma, DEC 9, 2021, View Source [SID1234596720]).

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Ascentage Pharma and Clover will jointly conduct this open-label, multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics (PK/PD), and efficacy of APG-1387 in combination with SCB-313 for the treatment of patients with primary or secondary peritoneal carcinomatosis from different primary tumor origins in China and Australia.

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly specific next-generation IAP antagonist and the first IAP antagonist entering clinical development in China. To advance the clinical development of APG-1387 globally, Ascentage Pharma has completed a Phase I dose-escalation for the treatment of solid tumors in China and Australia, and is currently conducting multiple clinical studies of APG-1387 combinations for the treatment of solid tumors in China and the US. Meanwhile, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

Clover’s SCB-313 is a trimeric fusion protein in clinical development for the treatment of intracavitary malignancies. Based on positive Phase I interim analyses, Clover plans to advance SCB-313 into a Phase II clinical trial for malignant ascites in the first half of 2022. SCB-313 is also in Phase I clinical trials for malignant pleural effusions and peritoneal carcinomatosis. Clover also plans to initiate new Phase I trials for SCB-313 in new indications, such as bladder cancer, in 2022.

"Safe and effective combination therapies represent an increasingly important approach in cancer treatment. We hope APG-1387 in combination with Clover’s SCB-313 will demonstrate synergistic effect," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We look forward to working closely with Clover to advance this clinical collaboration which hopefully will offer a new treatment option to patients with peritoneal carcinomatosis."

"Clover is excited to enter into this partnership with Ascentage Pharma to explore innovative treatment options and alternatives to surgery for patients suffering from peritoneal carcinomatosis," said Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals. "Combination treatment is a cornerstone of cancer therapy. By targeting different nodes within the apoptosis pathway, we believe the combination of SCB-313 and APG-1387 could provide a synergistic benefit to patients."

About APG-1387

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly selective next-generation inhibitor of apoptosis proteins (IAP) antagonist that can degrade IAPs by mimicking endogenous second mitochondria-derived activator of caspase (SMAC) molecule to induce programmed cell death or apoptosis. To advance the clinical development of APG-1387 globally, Ascentage Pharma has already completed a Phase I dose-escalation study in patients with solid tumors in China and Australia, and is currently conducting a Phase Ib/II clinical study of the APG-1387 plus pembrolizumab combination in patients with solid tumors in the US, and a Phase Ib/II study of APG-1387 plus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer in China. Moreover, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

About SCB-313

SCB-313, an innovative, recombinant human TNF-related apoptosis-inducing ligand (TRAIL)-Trimer fusion protein engineered using the Trimer-Tag technology platform to target the extrinsic apoptosis pathway. Binding of SCB-313 to the death receptors (DR4 and DR5) leads to physiologic trimerization and potent activation of the extrinsic apoptosis pathway.

On December 9, 2021 HiberCell, a clinical-stage biotechnology company developing therapeutics to address therapeutic resistance, cancer relapse and metastasis, reported that it will deliver a virtual presentation on the clinical applications of our odetiglucan (Imprime PGG) therapy for patients with metastatic and late-stage cancer at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2021, December 8-11, 2021 (Press release, HiberCell, DEC 9, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-to-present-clinical-applications-of-odetiglucan-and-the-role-of-beta-glucan-in-cancer-treatment-at-esmo-immuno-oncology-virtual-congress-2021 [SID1234596646]).

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This 20-minute presentation will focus on the broad applicability of odetigulcan in combination with different therapeutic agents and across multiple cancers.

Title: Beta-glucan in cancer treatment
Presenter: Nandita Bose, Ph.D., Senior Vice President of Clinical and Translational Medicine, HiberCell
Session: Trained Immunity Educational Session
Time/Date: Saturday, December 11, 2021: 10:00 – 10:20 am CT
Odetiglucan is a Dectin-1, pattern recognition receptor agonist that is currently in a phase 2 clinical trial in combination with pembrolizumab, an anti-programmed death receptor-1 (PD-1) used in cancer immunotherapy, for the treatment of metastatic, hormone-refractory breast cancer patients. The World Health Organization assigned "odetiglucan" as the International Nonproprietary Name (INN) for Imprime PGG as of November 2021.

For more information about HiberCell’s clinical trials, visit the website at www.HiberCell.com.

On December 9, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, reported that it signed the collaboration on a rare disease research agreement with the Peking Union Medical College Hospital (PUMCH), on December 9, 2021 (Press release, CANbridge Life Sciences, DEC 9, 2021, View Source [SID1234596699]). Under terms of the agreement, the two parties will collaborate on research and development in rare disease drug innovation, translational medicine and clinical verification, leveraging their respective strengths to further improve the development of innovative rare disease drugs and drive medical research and the development of industrial systems for diagnosis and treatment.

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"We are delighted and honored to enter into the collaboration agreement with PUMCH, the only national lead organization of the National Collaborative Network for the Diagnosis and Treatment of Rare Diseases with extensive experience in the diagnosis, treatment and clinical research of rare diseases," said James Xue, Ph.D., CANbridge Founder, Chairman and CEO. "Working together, I believe we’ll be able to find a characteristically Chinese path for the development and innovation of rare disease treatments and to provide hope for patients with rare diseases and their families."

About the Peking Union Medical College Hospital (PUMCH)

Founded in 1921, the Peking Union Medical College Hospital (PUMCH) is a modern AAA hospital. In addition to providing medical services, it is also a teaching and research hospital. PUMCH is a national center designated by the National Health Commission (NHC) for guiding the diagnosis and treatment of intractable diseases and critical illness. It is also one of the first hospitals designated to provide healthcare services for government officials and foreigners, one of the national demonstration centers for higher medical education and the standard training of resident doctors, and one of the key national centers for clinical medical research and innovation. The hospital is known both in China and abroad for its full range of services strong human resources, prominent specialties, and overall strength. PUMCH was ranked No.1 twice during the nationwide performance evaluation of AAA public hospitals and topped the "Ranking of Chinese Hospitals," by Fudan University Institute of Hospital Management, for 12 consecutive years.

PUMCH is a leader in rare diseases. In 2016, PUMCH led the national key research program, the Clinical Cohort Study of Intractable and Rare Diseases, and built China’s National Registration System for Intractable and Rare Diseases, which became one of the largest platforms for information about rare diseases in the world. Within the framework of the NHC’s Expert Committee on the Clinical Care and Accessibility for Rare Diseases, PUMCH led top Chinese experts to draft China’s First List of Rare Diseases and compiled and published Interpretation of China’s First List of Rare Diseases, Guidelines for the Diagnosis and Treatment of Rare Diseases (the 2019 edition) (released by the NHC), and Rare Diseases, a textbook for graduate students during the 13th Five-Year Plan period. The hospital has also been driving technical training on the diagnosis and treatment of rare diseases across the country. Currently, PUMCH is undertaking research projects of the State Key Laboratory of Rare Diseases, the National Center for Translational Medicine, the National Center of the National Collaborative Network for the Diagnosis and Treatment of Rare Diseases, and the National Center for the Quality Control of Rare Diseases. The hospital is building a national center for research and innovation with respect to the diagnosis and treatment of rare diseases with all the necessary clinical resources and expertise.

On December 9, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will hold a call with investors at 8:00 a.m. EST on December 14 to provide an in-depth analysis of the most recent clinical data from an ongoing clinical trial of lemzoparlimab in combination with rituximab in relapsed or refractory non-Hodgkins’s lymphoma (Press release, I-Mab Biopharma, DEC 9, 2021, View Source [SID1234596722]).

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I-Mab Conference Call Information

Investors and analysts are invited to join the conference call at 8:00 a.m. EST on December 14 via Zoom:

Meeting URL: View Source
Meeting ID: 914 2193 6788
Password: 249389

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic maliglencies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies will potentially support registrational trials later in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.