On October 10, 2023 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, reported positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company’s investigational oral innate immune activator, in combination with KEYTRUDA (pembrolizumab) in patients with small cell neuroendocrine prostate cancer (SCNC) (Press release, BioXcel Therapeutics, OCT 10, 2023, View Source [SID1234635801]). As of a data cutoff of September 6, 2023, evaluable patients with SCNC (n=28) showed a median OS of 13.6 months (95% CI 10.9–NR), and a 12-month survival rate of 56.5%.

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"OS is the most meaningful measure by which the effectiveness of an oncology treatment is evaluated. Though these results are based on a non-randomized cohort of patients, observing a median OS of this duration including patients with long-term survival at 12 months and beyond shows exceptional promise, bearing in mind historic data with checkpoint inhibitor monotherapy in this high-risk subset of prostate cancer," said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Professor of Medicine at the University of California San Francisco (UCSF). "SCNC represents a major unmet medical need, with the majority of patients unfortunately succumbing to their disease in less than one year following chemotherapy. The results of this trial suggest that BXCL701 has the potential to extend the lives of patients, and I look forward to its continued clinical development."

SCNC, classified as a "cold" tumor, represents an underserved, growing patient population, with cases increasing due to earlier and more widespread use of androgen receptor inhibitors. In 2023, there will be an estimated 288,3002 new patients with prostate cancer in the United States, with approximately 11,532 patients progressing to SCNC.

"We believe our trial results are highly encouraging for patients with this disease and have potential implications for our evaluation of BXCL701 for the treatment of other high-grade neuroendocrine tumors, such as small cell lung cancer, where effective therapies are lacking," said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. "We intend to discuss these data with the FDA to help determine our next steps with clinical development."

The Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC. Twenty-eight (28) evaluable SCNC patients received 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of cycle 1) plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA50 and/or CTC count conversion. Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation as measured by changes in circulating cytokines and correlation of outcome with baseline tumor characteristics.

The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A.

Conference Call

BioXcel Therapeutics will host a conference call and webcast on October 10, 2023 at 8:00 a.m. ET to discuss the data results from the Phase 2 trial of BXCL701. To access the call, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A live webcast and presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a webcast replay will be available through January 10, 2024.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the "Email Alerts" option under the News/Events section of the Investors & Media website section and submitting your email address.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (SCNC)

mCRPC is a form of advanced prostate cancer that is no longer responding to testosterone-lowering hormone treatments and has spread to other areas of the body such as the lymph nodes, bones, bladder, rectum, liver, or lungs. Treatment-emergent SCNC is a particularly difficult-to-treat histologic subtype of mCRPC that emerges in approximately 20% of mCRPC patients, though this number is increasing due to earlier and more widespread use of androgen blockers.

On October 10, 2023 BioAffinity Technologies presented its corporate presentation (Presentation, BioAffinity Technologies, OCT 10, 2023, View Source [SID1234635799]).

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On October 10, 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 closing of its previously announced underwritten public offering of common stock and pre-funded warrants (Press release, ALX Oncology, OCT 10, 2023, View Source [SID1234635798]). ALX Oncology sold 8,663,793 shares of common stock, which included 1,293,103 shares of common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares 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 were sold at a public offering price of $6.38 per share, the closing price on October 4, 2023, and the pre-funded warrants were sold at a public offering price of $6.379 per pre-funded warrant. The gross proceeds to ALX Oncology from this offering were approximately $63.2 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 were offered by the Company.

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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 acted as joint lead book-running managers for the offering. UBS Investment Bank also acted as a book-running manager for the offering. LifeSci Capital and H.C. Wainwright & Co. acted 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 final prospectus supplement related to the offering has been filed with the SEC and is 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 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.

On October 10, 2023 Mural Oncology plc, the publicly-traded oncology company that Alkermes plc (Nasdaq: ALKS) plans to establish in the fourth quarter of 2023 (Mural Oncology), will hold an investor webcast during which members of Mural Oncology’s designated management team will provide an overview of the company, its pipeline and strategy (Press release, Alkermes, OCT 10, 2023, View Source [SID1234635797]). The event will be webcast live on Tuesday, Oct. 17, 2023, at 11:00 a.m. ET.

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"We are excited for the opportunities ahead for Mural Oncology and look forward to sharing an in-depth overview of our late-stage clinical asset, nemvaleukin alfa, an investigational immunotherapy, as well our preclinical pipeline candidates," said Dr. Caroline Loew, Chief Executive Officer designate of Mural Oncology.

Dr. Loew will be joined by members of the Mural Oncology team for a presentation followed by a question-and-answer session.

Alkermes expects to complete the separation of its oncology business into Mural Oncology plc in the fourth quarter of 2023, subject to customary conditions, including effectiveness of the Form 10 registration statement for Mural Oncology plc, a favorable opinion with respect to the tax-free nature of the separation, and final approval of Alkermes’ board of directors.

Investors are invited to listen to the live webcast, which can be accessed on the Investors section of Alkermes’ website at www.alkermes.com or by dialing the U.S. toll free number + 1 866 400 0049, confirmation code 1830332. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

On October 10, 2023 CanariaBio Inc. and Hikma MENA FZE, part of Hikma Pharmaceuticals PLC (Hikma), reported the signing of distribution and license agreement for oregovomab in the Middle East and North Africa (MENA) region (Press release, CanariaBio, OCT 10, 2023, View Source [SID1234635726]).

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"We are thrilled to partner with Hikma, a company with a strong presence in the MENA region and a proven track record of successful collaborations," said Michael Na, CEO of CanariaBio.

Oregovomab is being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer in the phase 3 FLORA-5 trial. In Phase 2, the addition of oregovomab yielded a median progression-free survival of 41.8 months compared with 12.2 months with standard chemotherapy (HR, 0.46, P=0.0027). The hazard ratio of overall survival was 0.35.

About Oregovomab

Oregovomab is a murine monoclonal antibody direct to the tumor-associated antigen CA125 that stimulates a host cytotoxic immune response against tumor cells expressing CA 125, a biomarker commonly found in ovarian cancer (OC). In a randomized Phase II clinical trial, oregovomab demonstrated a significant improvement in progression-free and overall survival in advanced OC treatment when administered simultaneously with first-line chemotherapy. This promising schedule is currently investigated in a phase III trial.