On November 15, 2023 Nykode Therapeutics reported its third quarter 2023 financial results (Presentation, Nykode Therapeutics, NOV 15, 2023, View Source [SID1234637726]).

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On November 15, 2023 Seneca Therapeutics, Inc., reported the publication of "TEM8 in Oncogenesis" in Cells (Press release, Seneca Therapeutics, NOV 15, 2023, View Source [SID1234637723]). The authors are Dr. Samuel Kareff and Dr. Aman Chauhan from Sylvester Cancer at University of Miami, Dr. Virginia Corbett from Mt. Sinai Tisch Cancer Center and Dr. Paul Hallenbeck from Seneca Therapeutics.

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"In the article, we underline TEM8’s prognostic and predictive abilities in various solid tumors by (1) highlighting its association with more aggressive disease biology and poor clinical outcomes and (2) assessing its associated clinical trial landscape," said Dr. Aman Chauhan. "Finally, we offer future directions for clinical studies involving TEM8, including incorporating preclinical agents into clinical trials and combining previously tested oncologic therapies with currently available treatments, such as immunotherapy."

"The evidence of TEM8’s abilities and role in a broad range of solid tumors continues to grow," said Dr. Paul Hallenbeck. "This review article provides an excellent update on both TEM8, ANTXR1 – the gene that encodes TEM8 – and SVV-001 which targets TEM8. This update provides a foundation for upcoming publications and clinical trials for SVV-001 and TEM8."

Seneca Therapeutics is developing SVV-001, a number of SVV-001 armed constructs and a multiple IV option for SVV-001 sensitive solid tumors. SVV-001 sensitivity is defined as high ANTXR1 (TEM8) expression and a microtumor environment which permits replication of SVV-001 in the tumor. Seneca has developed an SVV-001 Companion Diagnostic and received FDA clearance to use it in clinical trials to identify patients that would benefit from SVV-001.

On November 15, 2023 Foundation Medicine, Inc., and Pierre Fabre Laboratories reported a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOneCDx and FoundationOneLiquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC) (Press release, Foundation Medicine, NOV 15, 2023, View Source [SID1234637722]). The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI (encorafenib) and MEKTOVI (binimetinib), in the European Union. This combination therapy is currently under evaluation by the European Medicines Agency for patients with BRAFV600-mutant advanced NSCLC and was evaluated in a clinical trial sponsored by Pfizer and supported by Pierre Fabre.

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Lung cancer – the number one cause of cancer deaths worldwide – remains an area of high unmet need notably for those people living with BRAFV600E mutations, which occur in approximately 2% of all non-small cell lung cancer.1 FoundationOne CDx and FoundationOne Liquid CDx are U.S. Food and Drug Administration (FDA) approved in-vitro diagnostics used to identify potentially targetable mutations, including BRAF, in blood- and tissue-based solid tumor samples.

"Today, as the number of indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies. And that’s why we are excited to work with Foundation Medicine," said Núria Perez-Cullell, Head of Medical and Patient Consumer Department, Pierre Fabre Laboratories. "Thanks to those companion diagnostics, physicians will have comprehensive, reliable information about what is driving a patient’s cancer, such as BRAFV600E mutations, so they can make personalized treatment decisions."

Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests offering physicians both blood- and tissue-based testing options for detecting genomic alterations like BRAFV600E to help guide personalized treatment decisions. Foundation Medicine has demonstrated initial success in navigating the new In Vitro Diagnostics Regulation (IVDR) in Europe through activation of dozens of global clinical studies or using patient samples from over 20 European Union member states in compliance with IVDR Authorization and Notification pathways.2

"High-quality companion diagnostics play a crucial role in helping physicians match their patients with targeted treatment options," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We are excited to support Pierre Fabre Laboratories in offering more treatment options for cancer patients, and to increase access to precision therapies in the European Union."

On November 15, 2023 RefleXion Medical, a therapeutic oncology company, reported the initial closing of a $105M equity raise, led by The Rise Fund, TPG’s multi-sector global impact investing strategy (Press release, RefleXion Medical, NOV 15, 2023, View Source [SID1234637721]). These new funds will allow RefleXion to extend commercialization of its breakthrough SCINTIX therapy for treating all stages of indicated solid tumor cancers, including metastatic disease.

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"Closing an equity round of this size strongly affirms the conviction of our new and existing investors in fueling innovation for breakthrough treatment options, like SCINTIX therapy, in the battle against cancer," said Todd Powell, president and chief executive officer at RefleXion. "TPG’s support has been foundational in our journey, and we are gratified that they are leading a significant investment in RefleXion.

"We also welcome the support and contributions from new investors, including, Pictet and Square Point Capital," continued Powell.

In addition to TPG, existing RefleXion investors participating in the round include Ally Bridge, global pharmaceutical leaders, Pfizer Ventures and Johnson & Johnson Innovation (JJDC Inc.), funds and accounts advised by T.Rowe Price Associates, Inc., Venrock, Catalio and Hillenbrand.

"RefleXion is singularly focused on expanding the world of radiotherapy to include patients with all stages of disease, not just early-stage patients," said Matthew Hobart, co-managing partner of TPG Growth who leads the investment in RefleXion on behalf of TPG’s Rise Fund. "We are delighted to see RefleXion reach a stage where they can accelerate their impact and deliver treatment and outcomes at scale. We look forward to continuing to work with Todd and the team to support RefleXion’s growth."

SCINTIX is the first and only technology designed to transform an injected radiotracer into real-time signals that drive autonomous radiotherapy. In doing so, SCINTIX therapy becomes the first unified solution that overcomes targeting and motion management, two of the longest-standing barriers to using radiotherapy for definitive treatment of metastatic disease. SCINTIX therapy is delivered via the RefleXion X1 platform, the world’s only dual-treatment modality platform that also offers image-guided radiotherapy for treating early-stage disease.

On November 15, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 2,424,243 of its shares of common stock at a purchase price of $1.65 per share in a registered direct offering (Press release, MAIA Biotechnology, NOV 15, 2023, View Source [SID1234637720]). In a concurrent private placement, MAIA has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 2,424,243 shares of its common stock. The offering is expected to close on or about November 17, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The unregistered warrants will have an exercise price $1.86 per share, will become exercisable six months following issuance and will expire five and one-half years from the date of issuance.

The gross proceeds to MAIA from the offering are expected to be approximately $4 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. MAIA currently intends to use the net proceeds from the offering for working capital and general corporate purposes as well as to fund research and development activities.

The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-273984), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on August 15, 2023 and declared effective by the SEC on August 23, 2023. The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the unregistered warrants in the private placement are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants offered in the private placement and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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