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I-Mab Strengthens Management Team Designed to Accelerate Global Pipeline Development and Transformation Towards Commercialization

On December 20, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported strategic leadership changes and a new governance initiative designed to facilitate its global pipeline development and accelerate its ongoing transformation towards an integrated global biopharma company (Press release, I-Mab Biopharma, DEC 20, 2021, View Source [SID1234597530]). The announcement is an integral part of I-Mab’s strategic growth plans to position the Company for the next phase of development.

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Dr. Andrew Zhu, an internationally renowned oncologist, joined I-Mab as President and board director to lead the Company’s global R&D organization, focusing on delivering the pipeline milestones and enhancing clinical development capability in the U.S. and China. With his rich experience in global drug development, Dr. Zhu has worked with numerous pharmaceutical companies, including Merck, Eli Lilly, Roche, and Bayer. He has led and participated in more than 50 global clinical trials. Dr. Zhu will be based in Shanghai and report directly to company Founder and Chairman Dr. Jingwu Zang.

"We’re excited to welcome Dr. Zhu to I-Mab. Dr. Zhu is an established and world-renowned expert in clinical oncology with an impressive track record in clinical research and clinical development of novel drugs. As I-Mab’s pipeline has reached a critical proof-of-concept and registrational stage, Dr. Zhu’s deep clinical research expertise and novel drug development experience at the world’s top academic institutions will be key to ensuring that we deliver the planned clinical milestones successfully and further enhance our competitive position in the global field of immuno-oncology," Dr. Zang commented.

"As a truly global biotech company with a rich and innovative pipeline, I-Mab has accomplished remarkable achievements within a short period of time. I am very excited to take on this role at I-Mab where I can effectively invest my passion and oncology expertise in leading the R&D team to the next level of clinical development capability and competitiveness and accelerating the delivery of I-Mab’s global innovative clinical compounds to patients in need around the world," said Dr. Zhu. Previously, Dr. Zhu served as a member of I-Mab’s Scientific Advisory Board.

To better prepare the transition towards the next phase of development, the Board has appointed Dr. Jingwu Zang, Founder and Chairman of I-Mab, as Acting Chief Executive Officer, effective January 1, 2022. Dr. Zang founded I-Mab Biopharma and has served as Chairman and CEO since 2016 (remaining as Chairman since October 2019). Under his vision and leadership, the Company has set an ambitious agenda to focus on innovation in immuno-oncology and has rapidly emerged as an innovative clinical stage biotech with globally competitive assets, such as lemzoparlimab (CD47 antibody), uliledlimab (CD73 antibody) and plonmarlimab (GM-CSF antibody), which are now among the global front-runners.

"Within a short period of time, I-Mab has evolved to become a significant global player in immuno-oncology field with a global reputation for its pursuit of first-in-class and best-in-class therapies. We trust that Dr. Zang will continue to help propel the Company to new levels and ensure a successful transition," said Mr. Wei Fu, Director and Chairman of the Nominating and Corporate Governance Committee of I-Mab.

With a well-positioned management team in place, the Company is progressing rapidly towards its staged transformational goal as governed by a newly established Commercialization Executive Council (CEC) to drive partnerships, corporate investment and potential merger & acquisition. The CEC provides a critical internal cross-functional governance body responsible for planning and overseeing the full spectrum of the Company’s commercialization activities. The key members of the CEC are composed of Mr. Jielun Zhu (Chief Strategy Officer), Mr. Yifei Zhu (Chief Commercial Officer), Dr. Weimin Tang (Chief Business Officer), Dr. Andrew Zhu (President) and Mr. John Long (Chief Financial Officer).

As part of this leadership change, Dr. Joan Shen, will step down as CEO on December 31, 2021 to pursue other interests.

"On behalf of the Board, I would like to express our gratitude to Joan for her impactful contributions to the Company over the past years. She was instrumental to the progress that we have made to advance our globally competitive pipeline, laying a solid foundation for I-Mab’s future," said Dr. Zang.

I-Mab Conference Call Information

I-Mab will also host an investor call on December 21, 2021, at 8:00 a.m. ET to introduce the new management members.

About Dr. Andrew Zhu

Dr. Andrew Zhu is an internationally renowned oncologist. He was Professor of Medicine at Harvard Medical School and served as Director of Liver Cancer Research at Massachusetts General Hospital (MGH) Cancer Center. In collaboration with his colleagues, Dr. Zhu established and led the multidisciplinary liver cancer clinic at the MGH and created one of the most productive clinical and translational research programs in hepatobiliary cancers in the U.S. Prior to joining I-Mab, Dr. Zhu was Director of Jiahui International Cancer Center of the Jiahui International Hospital in Shanghai, China and subsequently served as Chief Scientific Officer of Jiahui Health.

Dr. Zhu has an excellent track record in clinical development of innovative oncology drugs. He has led early-stage development of numerous targeted therapy and immuno-oncology drugs for liver cancer and several pivotal studies that led to regulatory approval by the FDA, including the development of pembrolizumab (KEYNOTE-224) and ramucirumab (REACH-2) for advanced liver cancer, and the successful development of the first IDH-1 inhibitor (Ivosidenib) for cholangiocarcinoma. Dr. Zhu also served on the Steering Committee of several phase III trials in the development of combination immunotherapies for liver cancer, including atezolizumab combined with bevacizumab. He has also served on the committee for the establishment of many global HCC Clinical Trial Design and Practice Guidelines, including the NCCN Guidelines for Hepatobiliary Cancers, AASLD Guidelines for the Treatment of Hepatocellular Carcinoma, and ASCO (Free ASCO Whitepaper) Guidelines on Systemic Therapy for Advanced Hepatocellular Carcinoma.

Dr. Zhu received his medical degree from Peking University Health Science Center and his Ph.D. from Columbia University. Following his postdoctoral research training at Harvard Medical School. he completed his clinical training in internal medicine at Yale New Heaven Hospital, Yale School of Medicine, and a fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center. Dr. Zhu has published more than 300 scientific papers and reviews in top international journals such as New England Journal of Medicine, Lancet, JAMA, Nature Medicine, Lancet Oncology, Journal of Clinical Oncology and Cancer Discovery.

BIOATLA TO PRESENT AT 40th ANNUAL J.P. MORGAN VIRTUAL HEALTHCARE CONFERENCE

On December 20, 2021 BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported that Jay M. Short, Ph.D., Chief Executive Officer, and Scott Smith, President, with participation by other BioAtla executives, will present at the 40th Annual J.P. Morgan Virtual Healthcare Conference on Tuesday, January 11, 2022, at 3:00 PM Eastern Time (Press release, BioAtla, DEC 20, 2021, prnewswire.com/news-releases/bioatla-to-present-at-40th-annual-jp-morgan-virtual-healthcare-conference-301448052.html [SID1234597500]). An audio webcast link, when available, will be posted to BioAtla’s website in the Investors-Events and Presentations section.

Henlius’ anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population

On December 20, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that successfully held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005) in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) of serplulimab (novel anti-PD-1 mAb) (Press release, Shanghai Henlius Biotech, DEC 20, 2021, View Source [SID1234597497]).

The study states that serplulimab combined with carboplatin-etoposide prolonged median overall survival (OS) in both the overall population and the Asian subgroup, the median OS in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, reducing risk of death by 38% (41% in the Asian subgroup), p <0.001. The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. Serplulimab also has a manageable safety profile. It is expected that serplulimab will become the first anti-PD-1 mAb in first-line SCLC treatment, providing a new treatment option for patients.

An urgent need for new drugs to break the enduring plight
According to GLOBOCAN 2020, lung cancer (LC) is the second commonly diagnosed and the first mortality cancer around the world, and the leading cause of cancer incidence and mortality in China. It is estimated that there are more than 810,000 new cases reported in 2020, accounting for 17.9% of new cancer cases in China, in which SCLC is the most malignant subtype of LC with 15%-20% among LC. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Most patients are in extensive stage when diagnosed. Their clinical condition deteriorates rapidly and the overall prognosis is poor. In the past 20 years, etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients with extensive stage relapse within one year, with a median OS of only 10 to 11 months. The advent of immune checkpoint inhibitors brings hope to patients. At present, anti-PD-L1 mAb combined with chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for ES-SCLC. Data showed that the median OS was about 12-13 months in the anti-PD-L1 mAb groups and about 10 months in the chemotherapy groups. However, the application of immunotherapy in ES-SCLC still faces challenges. In recent years, a number of PD-1 mAbs have failed in the area. Therefore, more effective first-line treatment of PD-1 inhibitors is urgently needed.

Significantly improved patients’ OS, serplulimab vs. placebo groups: OS 15.38 months vs. 11.10 months, 2-year OSR 43.2% vs. 8.0%
ASTRUM-005 is the international multi-cetner clinical research and its principal investigator is Professor Ying Cheng, Director of Jilin Department of Medical Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, and Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center. This study has set up about 128 sites in China, Poland, Russia, Turkey, Ukraine and Georgia, etc. 585 subjects were enrolled, among whom 31.5% were Caucasian. The enrolled patients are randomised 2:1 to receive intravenous infusion of either serplulimab or placebo in combination with chemotherapy every-3-week, until disease progression, death, intolerable toxicity, withdrawal of informed consent or other reasons specified in the protocol (whichever occurs first). The primary objective of this study is to compare the clinical efficacy of the two treatments as first-line therapies for ES-SCLC patients, and the secondary objectives are to evaluate the safety and tolerability. The primary endpoint is OS, and secondary endpoints include progression-free survival (PFS), PFS2, objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic characteristic, and immunogenicity, etc.

By the cut-off date (Oct 22, 2021), 585 eligible subjects were enrolled in this study (serplulimab group: n=389; placebo group: n=196), with a median follow-up duration of 12.3 months. The median OS in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, with a hazard ratio (HR) of 0.62 (95% CI: 0.48, 0.80), p <0.001. The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. In Asian subgroup, the median OS in the serplulimab and placebo groups were 16.03 and 11.10 months, respectively, with a hazard ratio (HR) of 0.59 (95% CI: 0.44, 0.79), p <0.001. The results demonstrated that as first-line therapy, serplulimab in combination with carboplatin-etoposide significantly improved the OS in ES-SCLC patients with a manageable safety profile. On December 7, an interim analysis was conducted by the Independent Data Monitoring Committee (IDMC) for this study. IDMC suggested that the company can hence communicate with healthy authority.

Based on the promising data of this study, Henlius will proceed to file the regulatory applications for this indication as soon as possible. In the future, the company will continue putting the unmet clinical needs as the first priority, proactively promoting the combination immunotherapy of serplulimab and international regulatory registration, to benefit more patients around the world.

McKesson Corporation Enters Agreement to Sell its Austrian Business to Quadrifolia Management GmbH

On December 20, 2021 McKesson Corporation (NYSE: MCK) reported that it has entered into an agreement to sell its Austrian business to Quadrifolia Management GmbH ("Quadrifolia") (Press release, McKesson, DEC 20, 2021, View Source [SID1234597496]). The transaction includes the sale of McKesson Austria’s Herba Chemosan Apotheker-AG, together with Sanova Pharma GesmbH. The transaction is expected to close in fiscal 2022, subject to customary closing conditions, including receipt of required regulatory approvals.

"Today’s transaction marks another milestone in advancing McKesson’s intent to streamline the portfolio and prioritize investments in areas where we have deep expertise and are central to our long-term growth strategy. We are making good progress in executing our strategy to exit Europe and continue to evaluate suitable exit alternatives for our businesses in Norway and Denmark," said Brian Tyler, chief executive officer, McKesson.

Quadrifolia will be conducting a management buyout which will see the existing management of the Austrian business buy all of the Herba Chemosan Apotheker-AG and Sanova Pharma GesmbH, backed by Invest AG. Invest AG has a solid track record of backing businesses in Austria over 25 years and will provide the new owners with further strength to fuel innovation and competition.

Palantir and Dewpoint Therapeutics Announce Strategic Partnership

On December 20, 2021 Palantir Technologies Inc. (NYSE: PLTR), a leading builder of operating systems for the modern enterprise, and Dewpoint Therapeutics ("Dewpoint"), the leading biomolecular condensates company, reported a partnership for Palantir’s Foundry platform to help power Dewpoint’s efforts to discover treatments and cures for the most challenging diseases (Press release, Dewpoint Therapeutics, DEC 20, 2021, View Source [SID1234597495]).

Palantir Foundry will help to enable researchers at Dewpoint to further their understanding of condensates biology by analyzing lab data along with other data sources, including data from the published literature and databases, to identify new compounds and therapeutic approaches.

Dewpoint will also use Foundry as the primary platform for its centralized knowledge repository, helping it contextualize its experimental results and prioritize the most viable outcomes. This multi-year agreement marks one of Palantir’s most comprehensive partnerships with a biotechnology company.

Palantir Foundry is designed to integrate disparate and siloed information sources to lead to data-driven analysis and decision making. It allows users to track lineage across systems, making it particularly suited for work in life sciences and the biotechnology sector, where data sources come from several unique and separate systems.

At Dewpoint, Foundry will be able to work seamlessly with the existing systems in its laboratories to provide researchers with a comprehensive foundation for exploration and analysis.

"We think Dewpoint is changing the way the world approaches drug design by exploring new frontiers of disease biology, requiring a game changing solution that goes beyond just cloud and infrastructure to drive their R&D and scale with their vision as they grow," said Lalarukh Haris Shaikh, Palantir’s Head of Biotech. "We are proud to partner with Dewpoint and share their passion of working on one of the most exciting translational medicine approaches of our time."

Foundry will help researchers make decisions around compound and target viability and streamline experiments and automate analysis by creating a digital twin of the research environment. One concrete example of Foundry’s use at Dewpoint Therapeutics is the expansion of the data foundation to include advanced genetic analysis for disease association and correlation with condensate content, empowering future discoveries.

"Key to our approach has been creating a seamless connection between our wet-lab and dry-lab capabilities, with machine learning and AI at the center. Foundry has provided us with a solid foundation for us to fully connect and operationalize our entire lab to enterprise and enable the discovery and development of new drugs," said Dewpoint CEO Ameet Nathwani.

About Biomolecular Condensates

Biomolecular condensates, formed through a process called phase separation, are membraneless droplets inside cells that facilitate molecular interactions and help cells perform vital functions. Condensates have been shown to play a critical role in key biological processes and in serious, intractable diseases across areas including neurodegeneration, cancer, inflammation, infectious disease, metabolic disease, and rare genetic disorders. The first condensates were observed more than 100 years ago. It is only in the last dozen years, though, that scientists—including Dewpoint founders Tony Hyman of the Max Planck Institute in Dresden and Rick Young of the Whitehead Institute—have begun to understand the dynamic nature and function of condensates. Dewpoint develops drugs that exploit this biology.