On June 6, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies reported that it mandated Transbiotech Biotechnology Research and Transfer Center to initiate testing its cellular anti-cancer ARM vaccine against deadly pancreatic cancer (Press release, Defence Therapeutics, JUN 6, 2023, View Source;utm_medium=rss&utm_campaign=defence-begins-testing-its-arm-vaccine-against-pancreatic-cancer [SID1234632509]).

Using the AccumTM technology, Defence developed a ground-breaking approach to convert the innate suppressive mesenchymal stromal cells (MSCs) into potent antigen presenting cells capable of mounting an effective anti-tumoral response against solid tumors. Defence tested this vaccine using various in vivo animal models including solid T-cell lymphoma and melanoma. The vaccine was consistently effective against these models and cured 80-100% of treated animals, whereby the tumor completely regressed.

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Based on these impressive data, Defence contracted Transbiotech Biotechnology Research and Transfer Center, to test the potency of its ARM vaccine in animals with pre-established pancreatic tumors. The study will consist of using the lysate of the Pan02 cell line (serving as a source of tumor antigens) mixed with the A1 dimer prior to in vitro pulsing MSCs. The final ARM vaccine will then be administered to allogeneic animals in combination with the anti-PD-1 immune-checkpoint inhibitor.

"This study should demonstrate the potency of Defence’s ARM vaccine at treating the deadly pancreatic cancer for which standard of care has failed and to confirm the versatility of this off-the-shelf universal vaccine. Therefore, developing a cancer vaccine capable of eradicating this disease will be a major leap in the global fight against cancer. A successful treatment of pancreatic cancer with the ARM vaccine would certainly widen the application of this therapy to other "hard to treat" cancers," says Mr. Plouffe, CEO and president of Defence.

TransBIOTech was founded in 1999 with the mandate to lead innovations and support Canadian biotech businesses. It provides access to state-of-the-art biotechnological expertise in life sciences to rapidly support and accomplish project goals in accordance with internationally recognized quality standards.

According to Hirshberg Foundation for Pancreatic Cancer Research, pancreatic cancer has the highest mortality rate of all major cancers. For all stages combined, the 5-year survival rate is 12%.

On June 6, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $125 million of shares of its common stock (Press release, Cogent Biosciences, JUN 6, 2023, View Source [SID1234632508]). In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock. All of the shares of common stock in the offering are being offered by Cogent.

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Cogent intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

J.P. Morgan, Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above will be offered pursuant to an automatic shelf registration statement (File No. 333-269707) filed with the Securities and Exchange Commission (SEC) on February 10, 2023.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or by telephone at 877-821-7388, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, or by telephone at 212 518-9544, or by email at [email protected].

On June 6, 2023 Almac Discovery, the drug discovery biotech operating within the Almac Group of companies, reported that the highly selective WEE1 inhibitor which it licensed to Debiopharm (Switzerland) and now known as Debio 0123, has been progressed into further clinical studies (Press release, Almac, JUN 6, 2023, View Source [SID1234632506]). The first patients have now received treatment in two separate clinical studies involving glioblastoma (GBM) and small cell lung cancer (SCLC).

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In both studies, Debiopharm has combined Debio 0123 with standard of care therapy in patients with either GBM, one of the most aggressive and common lethal tumours of the central nervous system, or SCLC, a highly aggressive, hard-to-treat cancer with poor prognosis.

The Debio 0123 programme offers the potential to improve clinical outcomes and quality of life for patients suffering from GBM or SCLC. In cancer cells, DDR pathways are often upregulated due to genomic instability, providing potential resistance pathways to DNA-damaging therapies. Therefore, blocking kinases such as WEE1 which play essential roles in DNA repair is likely to increase the cancer’s vulnerability to SOC therapies. Preclinical results have shown that Debio 0123 successfully crosses the blood brain barrier and inhibits tumour growth.

Dr Stephen Barr, Managing Director and President, Almac Discovery said: "Since the discovery of our highly selective WEE1 inhibitor, we have looked forward to understanding its potential therapeutic benefit for cancer patients across the globe. We are delighted that it has progressed into further clinical development in these two cancer indication studies with high unmet medical need and look forward to seeing further progress from this ongoing clinical research."

"The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Optimizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the fruition of these factors, Debio 0123 could become the first choice WEE1 inhibitor." Angela Zubel, Chief Development Officer, Debiopharm.

On June 6, 2023 AbbVie (NYSE: ABBV) reported that it will participate in the Goldman Sachs 44th Annual Global Healthcare Conference on Wednesday, June 14, 2023 (Press release, AbbVie, JUN 6, 2023, View Source [SID1234632505]). Robert A. Michael, vice chairman and president, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, will present at 10:00 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On June 5, 2023 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported an equity investment round of €255 million led by Temasek with participation from BlackRock Alternatives1, Qatar Investment Authority (QIA), Nextech2, ATHOS and Carbyne. The round comprised mostly of primary capital alongside a minority transaction of secondary shares. Primary net proceeds to the company will support further development of ITM’s broad Targeted Radionuclide Therapies (TRT) oncology pipeline and enhance commercial readiness as the company nears the final stages of phase III clinical development for its lead pipeline candidate, ITM-11 (n.c.a. 177Lu-edotreotide) in gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In addition, the company will expand its market-leading manufacturing capacities and infrastructure for n.c.a. 177Lu, scale GMP-manufacturing for 225Ac, and expand in-house drug product manufacturing capabilities to accelerate the global access to radiopharmaceuticals worldwide.

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Since its inception, ITM has made substantial progress in delivering on its ambitious corporate and clinical goals:

Advancing lead drug candidate ITM-11 into two phase III clinical trials for GEP-NETs and ITM-31 (Lu-177 labeled 6A10 Fab-fragments) into clinical studies for glioblastoma. Full details of ITM’s pipeline are described at View Source;
Expanding production capacity by building a second state-of-the-art manufacturing facility in Germany equipped with the full spectrum of capabilities to manufacture multiple radioisotopes and radiotherapies at scale – to be opened soon;
Opening the U.S. Headquarters in Princeton, New Jersey; and
Establishing a subsidiary in Shanghai, China to accelerate introduction of precision oncology products in the region.
"ITM is a leading radiopharmaceutical company with an advanced proprietary pipeline and has established itself as the major radioisotope supplier globally. This financing supports our objective to serve a broad patient population by ensuring a consistent supply of radionuclides and radiopharmaceuticals to meet the growing demand of medical professionals and our partners across the pharmaceutical, healthcare and research sectors globally," commented Udo J. Vetter, Chairman of the Supervisory Board at ITM.

"Securing one of the largest private biotechnology financing rounds ever in our home market from major, globally active investors with deep biotech experience underscores our presence at the forefront of the radiopharmaceutical space on an international scale," added Steffen Schuster, CEO of ITM. "As we near the final stages of clinical development for ITM-11 in GEP-NETs, this substantial investment will help to further grow our supply network and accelerate our efforts to bring new, targeted treatments to patients living with hard-to-treat cancers."

ITM also announced that Petrichor’s €90 million convertible loan was converted into equity per the terms of that initial agreement.

(Press release, ITM Isotopen Technologien Munchen, JUN 5, 2023, View Source,_Plans_to_Advance_Radiopharmaceutical_Pipeline_and_to_Expand_Radioisotope_Production_Capacities-643/ [SID1234661155])