Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab

On September 18, 2023 Sandoz, a global leader in generic and biosimilar medicines, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use), developed by EirGenix, Inc (Press release, Novartis, SEP 18, 2023, View Source,their%20biosimilar%20trastuzumab%20(150%20mg%2C [SID1234635194]).

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The positive opinion for Sandoz trastuzumab, a monoclonal antibody, covers treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biologic.1

Sandoz and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix will remain responsible for the development and manufacturing of trastuzumab, while Sandoz will hold the rights to commercialize the medicine upon approval in respective markets.

Pierre Bourdage, Chief Commercial Officer, Sandoz, said: "Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines."

The impact of both breast and gastric cancers in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer and, with 92,000 deaths per year, it is the number one cause of cancer death among women.2 Gastric cancer is the sixth most common of all cancer types and, with 107,000 deaths annually, it is the fourth most common cause of cancer-related death in Europe.3 In up to 20% of breast cancers4 and up to 30% of gastric cancers5 diagnosed, an HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells.2,4 HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment.6,7

The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III study in breast cancer patients (EGC002). Both studies met their primary endpoints, confirming that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation.

Termination of a Material Definitive Agreement

As previously disclosed, on January 11, 2021, BeiGene Switzerland GmbH ("BeiGene Switzerland"), a wholly-owned indirect subsidiary of BeiGene, Ltd. (the "Company"), reported to have entered into a Collaboration and License Agreement (the "License Agreement") with Novartis Pharma AG ("Novartis"), pursuant to which BeiGene Switzerland granted Novartis the right to develop, manufacture and commercialize the Company’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (Filing, 8-K, BeiGene, SEP 17, 2023, View Source [SID1234635238]). Under the License Agreement, Novartis was responsible for regulatory submissions and had the right to commercialize in these licensed countries following regulatory approvals.

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On September 17, 2023, BeiGene Switzerland and Novartis entered into a Mutual Termination and Release Agreement (the "Agreement") to mutually terminate the License Agreement, effective immediately. Pursuant to the Agreement, BeiGene Switzerland regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis. Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to the Company’s approval. The Company has agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials. Pursuant to the Agreement, Novartis will provide transition services to the Company to enable key aspects of the tislelizumab development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support.

The foregoing description of the terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which the Company intends to file as an exhibit to a subsequent periodic report or on an amendment to this Current Report on Form 8-K.

Samsung Biologics announces expanded strategic agreement with Bristol Myers Squibb to manufacture an antibody cancer drug substance

On September 17, 2023 Samsung Biologics (KRX: 207940.KS) reported a new agreement with Bristol Myers Squibb (NYSE: BMY) for large-scale manufacturing of a Bristol Myers Squibb commercial antibody cancer drug substance (Press release, Samsung BioLogics, SEP 17, 2023, View Source [SID1234635193]).

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Bristol Myers Squibb and Samsung Biologics have an existing manufacturing agreement for a commercial antibody cancer drug and have expanded the strategic relationship over time. Under the terms of the new agreement, Samsung Biologics will provide drug substance manufacturing for an antibody cancer drug substance at the company’s latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea.

"Our relationship with Bristol Myers Squibb spans over a decade, and we are proud and excited to help bring important medicines to patients around the world," said John Rim, President and CEO of Samsung Biologics. "This collaboration with Bristol Myers Squibb underscores our commitment to expediting the delivery and ensuring the continuous supply of client pipelines, enabled by our commitment to manufacturing quality, innovation, and capacity."

Entry into a Material Definitive Agreement

On September 15, 2023, Ayala Pharmaceuticals, Inc. (the "Company") reported to have entered into a Side Letter Agreement for Conversion (the "Side Letter Agreement") with Israel Biotech Fund I, L.P., Israel Biotech Fund II, L.P. and certain other investors named therein (the "Investors") (Filing, 8-K, Advaxis, SEP 15, 2023, View Source [SID1234635303]). The Side Letter Agreement references (i) the merger contemplated by the Agreement and Plan of Merger and Reorganization, dated as of July 26, 2023, between the Company, Biosight Ltd. ("Biosight") and a wholly owned subsidiary of the Company (the "Merger Agreement"), pursuant to which such subsidiary shall merge with and into Biosight, with Biosight surviving as a wholly owned subsidiary of the Company (the "Merger"), (ii) that certain Senior Secured Convertible Promissory Note entered into between the Company and the investors named therein for an original principal amount of up to $2,000,000 (the "Promissory Note"), which was previously disclosed by the Company in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and (iii) a Simple Agreement for Future Equity by and between Biosight and the Investors, pursuant to which the Investors agreed to invest in Biosight up to $2,500,000, and Biosight agreed to issue equity interests in Biosight to the Investors in certain circumstances (the "SAFE").

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Pursuant to the Side Letter Agreement, the Company and the Investors agreed that should the Merger be consummated prior to the termination of the SAFE, then the Investors shall be entitled to receive, in consideration for amounts actually invested in Biosight up to $2,500,000, shares of the common stock, par value $0.001 per share, of the Company (the "Ayala Common Stock"). The number of shares to be so issued would be equal to the amounts actually invested by the Investors in Biosight, divided by a conversion price equal to sixty-five percent (65%) of either (a) if definitive agreements with respect to private investments in public equity transactions involving shares of the Ayala Common Stock ("PIPE Transaction") are executed prior to the consummation of the Merger and the PIPE Transaction is consummated substantially simultaneous with the closing of the Merger, the lowest effective price per share at which shares of Ayala Common Stock are purchased in the PIPE Transaction, or (b) if the conditions set forth in clause (a) are not satisfied, the average of the closing prices of the Ayala Common Stock on the OTCQB on the five trading days immediately preceding the date on which the closing of the Merger occurs. The Side Letter Agreement also provides that (i) should the Merger be closed prior to the termination of the SAFE, then, following the closing of the Merger, if the Company enters into definitive agreements for the PIPE Transaction, the Investors shall have the right (but not the obligation) to purchase, on the same terms of the PIPE Transaction, a number of shares of Ayala Common Stock equal to up to all of the portion, if any, of the $2,500,000 that they were entitled to invest under the SAFE that was never actually invested by the Investors (the "Uninvested Amount"), except that the price per share shall be equal to sixty-five percent (65%) of the lowest effective price per share at which shares of Ayala Common Stock are purchased in the PIPE Transaction, and (ii) if the PIPE Transaction is not consummated by the date that is six months following the closing of the Merger, then, for a period of 30 days following such date, the Investors shall have the right (but not the obligation) to purchase a number of shares of Ayala Common Stock equal to up to all of the Uninvested Amount at a price per share equal to sixty-five percent (65%) of the average of the closing prices of the Ayala Common Stock on the OTCQB on the five trading days immediately preceding the date on which notice of such purchase is delivered to the Company. The mechanics of conversion, including timing of delivery of the shares of Ayala Common Stock, under the Side Letter Agreement shall be substantially the same as the mechanics of conversion, including timing of delivery of the shares of Ayala Common Stock pursuant to the Promissory Note

The Side Letter Agreement, and the shares of Ayala Common Stock issuable pursuant thereto, are being offered and sold pursuant to the exemption from the registration requirements of the Securities Act of 1933, as amended, afforded by Section 4(a)(2) thereof, for the sale of securities not involving a public offering.

Therapeutic Solutions International Subsidiary Discloses Potential Solution to Immunotherapy Resistance in Cancer by “Healing Tumor” Before Killing It

On September 15, 2023 Therapeutic Solutions International, Inc. (TSOI) reported new data and a patent filing from its Subsidiary Company Res Nova Bio which, according to Company scientists, is a potential breakthrough in the field of immunotherapy of cancer (Press release, Therapeutics Solutions International, SEP 15, 2023, View Source [SID1234635189]).

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The conventional dogma, which is supported by numerous well performed studies, is that stem cell administration helps cancer to grow. This is because cancer cells thrive on growth factors generated by stem cells.

To the surprise of Res Nova scientists, administration of multiple types of mesenchymal stem cells increased the efficacy of immunotherapies which act through activation of T cells. Based on preliminary data it is believed that administration of regenerative cells results in altering the tumor environment which makes it easier for T cells to enter the cancer.

"Given that our founding company possesses a wealth of clinical data on mesenchymal stem cells, including FDA Phase III in ARDS, we are currently seeking partners to explore this potentially game-changing discovery," said Famela Ramos, President, and CEO of Res Nova.

"As a practicing physician I see first-hand the urgent need for out of the box approaches to cancer," said Dr. James Veltmeyer, Chief Medical Officer. "To think that in less than a year Res Nova has leveraged technologies ranging from stem cells to the abortion pill to create preclinical and early clinical products is unparallel in my opinion."

"We live in the Golden Age of cancer immunotherapy, and we are at the forefront. Unfortunately, some of the most effective of these therapies cannot enter solid tumors. For example, CAR-T cells have produced miraculous results in leukemias and lymphomas, but they lack efficacy in the majority of cancers," said Timothy Dixon, President, and CEO of Therapeutic Solutions International.