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Ensatinib hydrochloride approved for marketing

On November 19, 2022 Betta Pharmaceutical Co., Ltd. reported that the company received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration (NMPA) (Press release, Betta Pharmaceuticals, NOV 19, 2021, View Source [SID1234610680]). Ensatinib Hydrochloride Capsules (trade name: Bemena ) was officially approved for marketing , becoming the first domestic class 1 new drug for the treatment of ALK-mutated advanced non-small cell lung cancer in China.

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Lung cancer is the malignant tumor with the highest mortality and morbidity in China, of which non-small cell lung cancer (NSCLC) accounts for about 80%-85% of lung cancers. Anaplastic lymphoma kinase (ALK) is one of the important oncogenic drivers of NSCLC, and ALK mutations are found in 5%-7% of NSCLC patients . Because this mutation is more common in young, non-smoking or light-smoking lung adenocarcinoma patients, it is easier to achieve 5-year survival after using targeted drugs than other gene mutations. ALK fusion mutation is also known as "diamond mutation".

△Mechanism of action of Ensatinib

Ensatinib hydrochloride is a new-generation, potent and highly selective new-generation ALK inhibitor. It is a brand-new innovative drug with completely independent intellectual property rights jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery. In December 2018 , the drug registration application of ensatinib for patients with ALK -positive locally advanced or metastatic non-small cell lung cancer who had progressed after receiving crizotinib treatment or who were intolerant to crizotinib received national approval. Accepted by the Food and Drug Administration. In February 2019 , ensatinib was included in the priority review list by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration. Since then, the clinical verification and registration on-site inspection organized by the Center for Food and Drug Inspection and Inspection ( CFDI ) of the State Food and Drug Administration have been completed successively .

The domestic phase II registration clinical study of ensatinib hydrochloride was led by Professor Zhang Zhang from Sun Yat-sen University Cancer Center, and a total of 27 domestic medical centers participated. The results of the study were published in full in the internationally renowned medical academic journal "The Lancet Respiratory Medicine" in October 2019 . Subsequent updated data showed that the overall ORR of crizotinib-resistant patients treated with ensatinib was 52.6% , the disease control rate was 87.8% , the median PFS was 11.2 months, the intracranial ORR was 71.4% , and the intracranial disease was 71.4%. The control rate was 95.2% . Studies have shown that ensatinib has more advantages compared with similar imported drugs in efficacy, especially in patients with intracranial metastasis, it has a higher response rate and has a good and controllable safety.

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△The full text of the ensatinib clinical study was published in The Lancet Respiratory Medicine

International oncology authoritative expert – Professor Ross Camidge from the University of Colorado in the United States commented in the editor’s note of The Lancet Respiratory Medicine that ensatinib is effective and safe, and is the second-line treatment for patients with ALK-mutated advanced non-small cell lung cancer The new option , and as the first-line treatment research progresses, may become the first-line treatment drug. Professor Zhang Li said when ensatinib was awarded the "Top Ten Original Researches in China’s Oncology Field in 2019" for its registered clinical study : " Ensatinib has outstanding efficacy and safety, and it can be said to be the ‘J-20’ in China’s ALK field . We hope to continue to work with Betta to create more new drugs to better meet the needs of patients and contribute to China’s pharmaceutical innovation. "

As the second targeted new drug approved by Betta Pharmaceuticals after icotinib, ensatinib, like icotinib , fills the domestic blank of similar drugs. Promoting international multi-center head-to-head, first-line Phase III clinical research ( eXalt3 ) overseas. In August 2020 , Dr. Leora Horn of Vanderbilt University in the United States released the interim analysis results of the eXalt3 study to the world at the World Conference on Lung Cancer ( WCLC ) Bureau Symposium . Results showed that patients with ALK -positive non-small cell lung cancer ( NSCLC ) treated with ensatinib had significantly longer median progression-free survival ( mPFS ) than patients treated with crizotinib.

Professor Mao Li, Senior Vice President and Chief Medical Officer of Betta Pharmaceuticals and CEO of Xcovery in the United States, said: "I am very pleased to see ensatinib emerge as a dark horse in the field of ALK-TKI . The R&D process is the first step for Betta Pharmaceuticals to "base itself in China and go global". The company is also actively preparing for the listing application for first-line indications in China and the United States. It is believed that after successful listing in the future, it will launch a full-scale attack in the whole process of ALK-positive NSCLC patients. In the management, the patient’s life is fully protected."

Dr. Ding Lieming, Chairman and Chief Executive Officer of Betta Pharmaceuticals, said: " I am delighted that ensatinib has been approved for marketing, providing patients with a new treatment option. Ensatinib is confident that it will be the second icotinib, continued The next story of icotinib , and it is expected to become the first targeted new drug for lung cancer to be simultaneously marketed globally by a Chinese company, benefiting not only Chinese patients, but also patients in other countries in the world. Betta will focus on ‘ becoming a The vision of a multinational pharmaceutical company headquartered in China is to strive to develop more affordable Best-in-class and First-in-class new drugs and good drugs, so that people can live a better life. "

Tempus Signs Strategic Collaboration Agreement With AstraZeneca to Advance Oncology Therapeutics

On November 19, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported a multi-year, strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) in which the two companies will work together to gather insights, discover novel drug targets, and aim to develop therapeutics for the broader oncology community (Press release, Tempus, NOV 19, 2021, View Source [SID1234595857]). By combining the capabilities of a technology company with those of a biopharmaceutical company, the two companies hope to advance drug discovery and development, to more quickly deliver innovation to patients.

We are very pleased to collaborate with Tempus to enhance our data-driven R&D strategy and glean critical insights that will deepen our understanding of complex tumor biology, enhance access to predictive preclinical models, and increase the probability of clinical success across our diverse pipeline.

Artificial intelligence has the potential to advance precision medicine in ways that seemed unimaginable just a few short years ago," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working with AstraZeneca to apply AI-enabled solutions to advance its robust therapeutic pipeline in an effort to help patients live longer and healthier lives."

Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. "We are very pleased to collaborate with Tempus to enhance our data-driven R&D strategy and glean critical insights that will deepen our understanding of complex tumor biology, enhance access to predictive preclinical models, and increase the probability of clinical success across our diverse pipeline.

Gracell Biotechnologies Granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy Candidate GC012F for the Treatment of Multiple Myeloma

On November 19, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for GC012F, Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma (Press release, Gracell Biotechnologies, NOV 19, 2021, View Source [SID1234595861]).

"As our lead candidate currently being developed on Gracell’s FasTCAR next-day manufacturing technology platform, GC012F is a unique BCMA and CD19 dual-targeting CAR-T cell therapy," commented Dr. Martina Sersch, Chief Medical Officer of Gracell. "GC012F has demonstrated fast, deep and durable responses in patients with Relapsed/Refractory Multiple Myeloma in an ongoing IIT study in China with most patients on study being high risk according to mSMART 3.0 criteria, a difficult-to-treat patient population. We are very excited about being granted Orphan Drug Designation for the treatment of Multiple Myeloma by the U.S. FDA, another key milestone in advancing our program globally. Multiple Myeloma patients are in need of more efficacious and tolerable therapies providing deep and durable responses and ultimately extending progression free and overall survival."

The long-term follow-up data for GC012F was presented in June at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting and the EHA (Free EHA Whitepaper) 2021 Congress. GC012F is currently being evaluated in investigator-initiated trials in China, including in newly diagnosed Multiple Myeloma patients. The tech transfer to Lonza to support manufacturing of GC012F in the U.S. is currently ongoing, with U.S. IND filing targeting the first half of 2022.

Granted by the U.S. FDA, Orphan Drug Designation incentivizes the development of innovative drugs and biologics for the safe and effective treatment of rare diseases and conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation qualifies the sponsor of the therapy for certain development incentives, including up to seven years of market exclusivity upon regulatory approval, as well as tax credits for clinical testing and reduction of or exemption from prescription drug user fees.

About Multiple Myeloma

Multiple myeloma (MM) is the third most common type of blood cancer in the United States, originating from plasma cells, a type of immune cell that is typically responsible for secreting antibodies to fight infection. Globally, approximately 160,000 patients are diagnosed with MM every year with over 32,000 expected to be diagnosed in the United States in 2020. In recent years, many advances have been made to treat MM, however, the disease is still considered incurable.

Multiple myeloma patients with certain cytogenetic and other abnormalities are classified by the International Myeloma Working Group (IMWG) and Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART), criteria as high-risk patients. They represent 20-30% of the overall MM patient population. High-risk patients have a much higher risk of early relapse and shorter progression free and overall survival. These patients are considered the most difficult to treat MM patients, typically with a poor prognosis.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being studied in an ongoing investigator-initiated Phase 1 trial across multiple centers in China for the treatment of MM. GC012F tackles MM by simultaneously targeting both malignant plasma cells expressing BCMA and early progenitor cells expressing CD19 in order to drive fast, deep and durable responses in MM patients.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

RedHill Biopharma Announces Pricing of $15.5 Million Public Offering of American Depositary Shares

On November 19, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill (Press release, RedHill Biopharma, NOV 19, 2021, View Source [SID1234595860]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the underwriter a 30-day option to purchase up to an additional 0.7 million ADSs.

Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

The underwriter may offer the ADSs from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On November 18, 2021, the last sale price of the ADSs as reported on the Nasdaq Global Market was $3.88 per ADS.

RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

A preliminary prospectus supplement relating to the offering was filed with the SEC on November 18, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that RedHill has filed (or will file) with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about RedHill and the offering. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 registration or qualification under the securities laws of any such state or jurisdiction.

ViewRay Announces Closing of Public Offering of Common Stock

On November 19, 2021 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the completion of its previously announced underwritten public offering of 12,500,000 shares of common stock at a price to the public of $5.60 per share, for gross proceeds of approximately $70.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, NOV 19, 2021, View Source [SID1234595859]). All of the shares sold in the offering were sold by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

ViewRay intends to use the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, continued research and development and commercial expenses.

Piper Sandler and Stifel are acting as the joint book-running managers for the offering. Guggenheim Securities also is acting as a book-running manager for the offering. B. Riley Securities and BTIG are acting as co-managers for the offering.

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") and automatically became effective upon filing. This offering was made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 registration or qualification of these securities under the securities laws of any such state or jurisdiction.