Combotope Therapeutics and CiMaas Announce Oncology Research and License Option Agreement

On October 5, 2023 Combotope Therapeutics and CiMaas reported an oncology research and license option agreement (Press release, CiMaas, OCT 5, 2023, View Source [SID1234635678]). Under this agreement, CiMaas has the option to select three tumor glycoform protein targets, with the aim of discovering and developing next-generation CAR-NK and CAR-T antibody-based therapeutics for cancer treatment. The first selected target is the Mucin-1 tumor glycoform. CiMaas will provide funding for the preclinical and clinical development of these candidates up to clinical proof of concept.

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Ola Blixt, CEO of Combotope Therapeutics, expressed enthusiasm about the partnership with CiMaas for co-developing these antibody sequences into more effective CAR-NK and CAR-T cells for immunotherapy. The sequences are discovered using Combotope Therapeutics’ proprietary antibody development platform, iDEAL. This platform facilitates the rapid selection and optimization of tumor-specific antibodies that target aberrantly glycosylated proteins found solely on cancer cells. iDEAL has the potential to revolutionize cancer treatment by offering targeted therapy that is both safe and effective.

Søren N. Jakobsen, COO of Combotope Therapeutics, highlights that this strategic partnership exemplifies a win-win scenario, showcasing how Combotope intends to expedite the development and commercialization of a wide array of innovative scFv-based anti-cancer therapies, both off-the-shelf and personalized, through mutually beneficial pharmaceutical collaborations.

Wilfred Germeraad, CSO of CiMaas, highlighted the significance of Mucin-1 as a cancer cell target. CiMaas aims to utilize the antibodies developed by Combotope Therapeutics to create optimized CAR-NK cells with enhanced specificity for stronger binding activity against solid tumor cells. This enhancement will activate Natural Killer cells more effectively, enabling them to enhance their killing capacity. CiMaas has already demonstrated that such CAR-NK cells can eliminate more breast cancer cells than non-modified NK cells. Through this collaboration, CiMaas aims to bring this improved concept to clinical practice as swiftly as possible.

Gerard Bos, CEO of CiMaas, emphasized that this collaboration and exclusive license option enable them to further leverage NK cells against cancer. CiMaas, in conjunction with university partners in Maastricht (NL) and Utrecht (NL), is currently researching the role of Mucin-1 as a target in pre-clinical breast cancer models as a final step toward clinical application. In addition, tumor cells originating from T cell Non-Hodgin lymphoma are more sensitive to CAR-NK cell killing.

Financial Terms: According to the agreement, CiMaas will provide Combotope Therapeutics with an upfront payment. Combotope Therapeutics will be eligible for potential milestone payments per therapeutic candidate exclusively licensed, developed and commercialized by CiMaas, as well as tiered royalties.

BullFrog AI Announces Identification of Novel Potential Drug Targets for Colorectal Cancer Using Its AI-Driven bfLEAP™ Platform

On October 5, 2023 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported that it has identified multiple potential therapeutic targets, including three novel targets, for colorectal cancer using the Company’s proprietary AI-driven platform, bfLEAP (Press release, Bullfrog AI, OCT 5, 2023, View Source [SID1234635677]). The newly identified targets will be validated through BullFrog AI’s ongoing collaboration with the J. Craig Venter Institute (JCVI), a world-leading genomics research and innovation institution. JCVI will utilize its expertise in target validation and functional genomic screening to further investigate the potential of these targets in colorectal cancer.

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"Using bfLEAP to interrogate pan-cancer multi-modal data from The Cancer Genome Atlas (TCGA), we were able to rapidly identify new colon adenocarcinoma markers, yielding 14 candidates that were significantly over-expressed in tumors relative to healthy tissues, a remarkably smaller and more actionable gene set compared to traditional differential expression analysis, which yields more than 3,000 candidates for the same comparison. After further analyzing the 14 candidates, we were able to categorize three as novel, with no previous association with colon adenocarcinoma in the scientific literature, and six as near novel with little existing literature documenting such an association," said Enrique García-Rivera, Ph.D., Vice President of Artificial Intelligence for BullFrog AI.

"TCGA has been extensively analyzed by scientists for more than a decade, yet in a matter of weeks, we were able to identify multiple new drug target candidates with previously undocumented potential in colorectal cancer from this same dataset," stated Vin Singh, Chairman and CEO of BullFrog AI. "These findings demonstrate the power and potential of our bfLEAP platform, which combines advanced AI algorithms with rich biological data to identify novel targets for a wide range of diseases. Our platform has a remarkable ability to detect patterns, make predictions, and identify anomalies, and it can do this with multi-modal data, all while providing explanations of the results generated from its rapid analysis. Our ability to identify novel drug targets in a complex data set represents significant potential value for our internal programs, clients and partners."

According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed in both men and women in the U.S., excluding skin cancers, and is the third leading cause of cancer-related deaths in the U.S. The worldwide market for colorectal cancer treatments was valued at $11.5 billion in 2022 and is forecast to grow at a compound annual growth rate of 4.7% through 2030, according to Grand View Research.

Bayer to partner with Twist Bioscience to accelerate drug discovery

On October 5, 2023 Bayer AG reported that it has entered into an antibody discovery, option, and license agreement with Twist Bioscience Corporation, a company offering high-quality synthetic DNA using its silicon platform (Press release, Bayer, OCT 5, 2023, View Source [SID1234635676]).

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The company’s "Library of Libraries", a collection of synthetic antibody libraries that harness innovative structural and developability features to cover a wide range of antibody drug targets, is tailored to address specific challenges in antibody discovery.

It has the potential to increase the probability of success of antibody discovery programs across indications and focus areas.

"Partnering with Twist Bioscience complements our strategy to advance breakthrough innovations based on new scientific approaches and platform technologies," said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation. "Their ‘Library of Libraries’ offers an optimal design to accelerate drug discovery processes to make a meaningful impact in patients’ lives faster."

Under the terms of the agreement, Twist will receive payments connected with the initiation of research and will be eligible to receive fees associated with research activities. The antibody leads discovered under the collaboration that enter clinical development qualify for certain success-based clinical and commercial milestone payments as well as royalties from product sales. In total, Twist is eligible to receive up to USD 188 million in clinical and commercial milestone payments plus royalties. In return, Bayer receives exclusive rights to license the antibodies for commercialization in all global territories.

Artios to Present Initial Phase 1 Clinical Monotherapy Data for ATR Inhibitor ART0380 in Advanced Solid Tumors at the European Society of Medical Oncology Congress 2023

On October 5, 2023 Artios Pharma Limited (Artios), a clinical-stage biotech company led by pioneers of DNA damage response ("DDR") drug development, reported that the Company will unveil data from the initial Phase 1 study of its ataxia telangiectasia and Rad-3 related ("ATR") kinase inhibitor ART0380 as part of a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) 2023 taking place October 20 to 24, 2023 in Madrid, Spain (Press release, Artios Pharma, OCT 5, 2023, View Source [SID1234635675]).

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ART0380 is a competitive, oral, highly potent, and selective ATR inhibitor undergoing clinical evaluation as monotherapy in patients with solid tumors as well as in combination with chemotherapies in patients with molecularly selected cancers. Monotherapy data presented will include safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy.

Poster presentation details:

First results from the phase I trial of the ATR inhibitor, ART0380, in advanced solid tumors

Presenter: Kathleen Moore, Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, United States of America

Poster Number: 680P

Session and Location: Developmental Therapeutics, Hall 8

Presentation Date and Time: Monday, October 23 from 12 – 13 CEST

ALX Oncology Announces Pricing of Public Offering

On October 5, 2023 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported the pricing of its previously announced underwritten public offering of common stock and pre-funded warrants (Press release, ALX Oncology, OCT 5, 2023, View Source [SID1234635674]). ALX Oncology is selling 7,370,690 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $6.38 per share, the closing price on October 4, 2023, and the pre-funded warrants are being sold at a public offering price of $6.379 per pre-funded warrant, which represents the per share public offering price for each common share less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to ALX Oncology from this offering are expected to be approximately $55.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by the Company. In addition, ALX Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,293,103 shares of its common stock at the public offering price per share less underwriting discounts and commissions. The offering is expected to close on or about October 10, 2023, subject to the satisfaction of customary closing conditions.

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ALX Oncology anticipates using the net proceeds from the offering to fund the continued clinical development of evorpacept and the related clinical trials, including ASPEN-06 clinical trial, and for working capital and other general corporate purposes.

Piper Sandler and Cantor are acting as joint lead book-running managers for the offering. UBS Investment Bank is also acting as a book-running manager for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as lead managers for the offering.

The securities described above are being offered by ALX Oncology pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected] or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 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 under the securities laws of any such state or jurisdiction.