On December 20, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the agreement by an healthcare-focused institutional investor to exercise certain warrants to purchase up to an aggregate of 150,000,000 ordinary shares represented by 5,000,000 American Depositary Shares (ADSs) having an exercise price of $2.00 per ADS issued by Can-Fite in August 2021, at an exercise price of $2.00 per ADSs (Press release, Can-Fite BioPharma, DEC 20, 2021, View Source [SID1234597540]).

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The ADSs and the ordinary shares issuable upon exercise of the warrants are registered pursuant to a registration statement on Form F-1 (File No. 333-259085) which became effective by the Securities and Exchange Commission (SEC) on August 31, 2021. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be $10.0 million, prior to deducting placement agent fees and offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holder will be issued new unregistered warrants to purchase ordinary shares represented by ADSs in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 180,000,000 ordinary shares represented by 6,000,000 ADS, at an exercise price of $2.00 per ADS and have a term of exercise equal to five (5) years following the effectiveness of an initial resale registration statement registering the ADSs issuable upon the exercise of the warrants.

Can-Fite intends to use the net proceeds from the offering for working capital including for the launch of the Phase II study in NASH and Phase III liver cancer study as well as other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the ADSs or the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs and ordinary shares of issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On December 20, 2021 Sandoz, a global leader in generic and biosimilar medicines, reported the submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the US Food and Drug Administration (FDA) (Press release, Sandoz, DEC 20, 2021, View Source [SID1234597539]).

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Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers1. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data.

"Approximately 15-20% of all breast cancer patients have tumors that are HER2- positive2 and, as these tumors tend to grow more quickly than HER2-negative tumors,3 getting treated swiftly can be live-saving," said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. "Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US."

Breast cancer is the most commonly diagnosed cancer among women in the US and associated death rates are the second highest of all cancers. It is estimated that about 30% of newly diagnosed cancers in women will be breast cancers in 20214.

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has well over 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.

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.

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.

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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]).

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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.