Innovent Announces First Patient Outside China Dosed in the Phase 1 Clinical Trial of Anti-CD47/PD-L1 Bispecific Antibody

On February 28, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient outside China has been successfully dosed in a Phase 1 clinical trial of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) (Press release, Innovent Biologics, FEB 28, 2021, View Source [SID1234575801]).

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This is a Phase 1a clinical study conducted in the United States to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy.

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody. IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively binds to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and higher safety profile.

Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, there still remains many new challenges. A part of patients has developed drugs resistance and the efficacy of immune checkpoint inhibitors needs to be further enhanced. Therefore, it is of great value to develop the next generation of anti-tumor immune bispecific antibodies. CD47 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI322 clinical trials.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: " By targeting effector cells directly to tumor cells, bispecific monoclonal antibody enhances cytotoxicity, antibody selectivity and functional affinity. The preliminary results showed that IBI322 had higher efficacy in vivo, tumor-rich distribution and better safety than the single-specific anti-CD47 antibody. Bispecific monoclonal antibody could bring a lower-cost solution to patients compared with a combination of monoclonal antibody therapies. Therefore, the development of the anti-CD47/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope IBI322 could potentially benefit more patients in need."

About IBI322

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody developed by Innovent. As a class 1 innovative drug and a potentially first-in-class molecule, IBI322 can effectively induce the phagocytosis of tumor cells and stimulate the activation of T lymphocytes to exert anti-tumor activity. IBI322 is of more affinity to tumor cells, thus reducing the toxicity to normal tissue, providing more effective treatment to cancer patients. IBI322 has received an IND approval from both the NMPA and the U.S. FDA. Innovent is actively preparing to develop it globally.

Antengene (6996.HK) Selected as a Constituent Stock of Nine Benchmark and Thematic Indexes Including the Hang Seng Composite Index

On February 28, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the company has been selected as a constituent stock of the Hang Seng Composite Index (HSCI), the Hang Seng Stock Connect Hong Kong Index (HSHKI), the Hang Seng Stock Connect Hong Kong MidCap & SmallCap Index (HSHKMS), the Hang Seng Stock Connect Hong Kong SmallCap Index (HSHKS), the Hang Seng SCHK Mainland China Companies Index (HSSCMLC), the Hang Seng SCHK ex-AH Companies Index (HSSCNAH), the Hang Seng Healthcare Index (HSHCI), the Hang Seng Hong Kong-Listed Biotech Index (HSHKBIO) and the Hang Seng Small Cap (Investable) Index (HSSIV), according to the quarterly review results of the Hang Seng Family of Indexes, effective on March 15, 2021 (Press release, Antengene, FEB 28, 2021, View Source [SID1234575800]).

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The Hang Seng Composite Index offers a comprehensive Hong Kong market benchmark that covers about the top 95th percentile of the total market capitalization of companies listed on the Main Board of the Stock Exchange of Hong Kong (SEHK). Adopting the free float-adjusted market capitalization methodology, the HSCI can be used as a basis for index funds, mutual funds as well as performance benchmarks. The Hang Seng Stock Connect Hong Kong Index serves as a benchmark to reflect the overall performance of the securities listed in Hong Kong that are eligible for trading via the southbound trading link of Stock Connect; the Hang Seng Healthcare Index aims to reflect the overall performance of stocks listed in Hong Kong that are related to healthcare businesses; and the Hang Seng Hong Kong-Listed Biotech Index reflects the overall performance of the biotech companies that are listed in Hong Kong including stocks listed through the Listing Rules Chapter 18A of Hong Kong Exchange.

Antengene has the world’s only commercialized selective inhibitor of nuclear export (SINE), ATG-010 (selinexor), and with its successful IPO in November 2020, is one of the fastest growing Hong Kong-listed biopharmaceutical companies. In the past half a year, Antengene has achieved multiple milestones in clinical and business developments, and has submitted New Drug Applications (NDAs) in five APAC markets including China. Moreover, ATG-010 was granted Priority Review status by the China National Medical Products Administration (NMPA) and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS). These progress have taken the company one step closer to providing a novel therapeutic option to cancer patients.

"It is our great pleasure to see Antengene being included into nine indexes in the Hang Seng Family of Indexes. These inclusions will give Antengene greater exposure in the capital markets and further improve our visibility among the broader investor community," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "Our innovative products that are on the brink of commercialization, our fast-growing commercial team, and our clinical team possessing strong track record in the field of hematological malignancy are the source of our confidence in Antengene’s future growth. We will remain committed to our founding mission of ‘treating patients beyond borders’, and steadfastly pursue long-term growth in the field of innovative anti-tumor therapies."

Everest Medicines Announces Selection as a Constituent of Certain Indexes of Hang Seng Indexes Company Limited

On February 28, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the company has been selected as a constituent stock of the Hang Seng Composite Index, the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index in accordance with the latest index series release by Hang Seng Indexed Company Limited, with effect from March 15, 2021 (Press release, Everest Medicines, FEB 28, 2021, View Source [SID1234575799]).

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The Hang Seng Composite Index offers a comprehensive Hong Kong market benchmark that covers about the top 95th percentile of the total market capitalisation of companies listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Stock Exchange"). The Hang Seng Healthcare Index aims to reflect the overall performance of stocks listed in Hong Kong that are related to healthcare businesses. The Hang Seng Hong Kong-Listed Biotech Index reflects the overall performance of the biotech companies that are listed in Hong Kong, including stocks listed on the Stock Exchange through Chapter 18A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.

Being selected as a constituent stock of the above Hang Seng Indexes fulfills the eligibility criteria for Southbound Trading under the Stock Connect scheme, which is a channel that facilitates stock trading and investment between Hong Kong and a broader base of China investors.

InnoCare Appoints Dr. Sean Zhang as Chief Medical Officer

On February 28, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that the Company appointed Dr. Sean Zhang as Chief Medical Officer (CMO) (Press release, InnoCare Pharma, FEB 28, 2021, View Source [SID1234575798]). Reporting to the Co-founder, Chairwoman and CEO, Dr. Jasmine Cui. Dr. Zhang will be responsible for global clinical development strategy and execution for InnoCare. Dr. Zhang is based in U.S., thus demonstrating InnoCare’s ongoing commitment to globalization.

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As a physician scientist, Dr. Zhang has more than 30 years working experience in clinical practice, academic research and drug discovery and development. Before joining InnoCare, Dr. Zhang served as CMO and Member of the Board of Directors of Hengrui Therapeutics Inc. (HTI) before his promotion to CEO. HTI is a joint venture between Jiangsu Hengrui Medicine and a leading global investment firm focused on oncology, autoimmune and other unmet medical-need disease areas. Under Dr. Zhang’s leadership, his team has successfully launched two global phase III oncology studies in US and EU and one global phase II study for autoimmune disease, submitted more than ten U.S. FDA Investigational New Drug applications (INDs) and conducted a number of successful FDA meetings on several major development programs. Before HTI, Dr. Zhang assumed increasing responsibilities in clinical development at GlaxoSmithKline, Bristol-Myers Squibb, and Johnson and Johnson. He also worked as staff gastroenterologist and clinical investigator at 301 Hospital in Beijing in his early career.

"It is my pleasure to welcome Dr. Zhang to join InnoCare," said Dr. Cui. "We established this senior role in U.S. to not only expand our global footprint but also to enhance our clinical development competency globally. Dr. Zhang has accumulated solid experience in clinical development, drug discovery and business leadership, and he has established a broad network with physicians in both the U.S. and China. I believe his on-boarding will further advance our ongoing clinical trials in the field of oncology and autoimmune diseases worldwide."

"It is my honor and privilege to join InnoCare at this exciting moment in the company’s evolution," said Dr. Zhang. "I am very impressed with InnoCare’s strong innovation capabilities and rich product pipelines. I look forward to working closely with our clinical team and partners to further advance our clinical development pipelines to benefit patients worldwide."

Dr. Zhang completed his postdoctoral training at Sepulveda VA Hospital of UCLA School of Medicine in Los Angeles and Michigan State University. After passing the United States Medical License Examination (USMLE), Dr. Zhang completed his medical followship training at Clinical Center of U.S. National Institute of Health in 2006. He was elected Fellow of American College of Clinical Pharmacology (FCP) in 2012. He is also board of director of Sino-American Pharmaceutical Association (SAPA).

BriaCell Announces Closing of US$25 Million Public Offering

On February 26, 2021 BriaCell Therapeutics Corp. (TSX-V:BCT) (NASDAQ: BCTX, BCTXW) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported its previously announced underwritten public offering in the United States. The Company offered 4,852,353 common units at a public offering price of US$4.25 per unit, consisting of one share of common stock and one warrant to purchase one share of common stock ("Warrant"), and 1,030,000 pre-funded units at a public offering price of US$4.24 per unit, consisting of one pre-funded common stock purchase warrant ("Pre-Funded Warrant") and one Warrant (Press release, BriaCell Therapeutics, FEB 26, 2021, View Source [SID1234575804]). The Pre-Funded Warrants are exercisable at any time after the date of issuance at an exercise price of US$0.01 per common share. The Warrants have a per share exercise price of US$5.3125, can be exercised immediately, and expire five years from the date of issuance.

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The aggregate gross proceeds to the Company from the offering were approximately US$25 million, before deducting underwriting discounts, commissions and other offering expenses. The Company has granted the underwriter a 45-day option to purchase up to 882,352 additional shares of common stock and/or Pre-Funded Warrants and/or 882,352 additional warrants to cover over-allotments, if any. In connection with the closing of this offering, the underwriter has exercised its over-allotment option to purchase an additional 882,352 warrants. The underwriter has retained the right to exercise the balance of its over-allotment option within the 45-day period.

The common shares and warrants began trading on the Nasdaq Capital Market under the symbols BCTX and BCTXW respectively, on February 24, 2021.

The Company intends to use the net proceeds to fund clinical trials, research and development, and for general working capital and general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-234292) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on February 23, 2021. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected] Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.