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.

On October 10, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that the first patient of the Phase I part B clinical trial evaluating the combination of BT-001 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) has been dosed (Press release, Transgene, OCT 10, 2023, View Source [SID1234635723]).

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The Phase I Part B of the trial explores repeated intra-tumoral injections of BT-001 in combination with intravenous infusions of KEYTRUDA. Transgene and BioInvent plan to enroll a minimum of 12 patients with metastatic or advanced solid tumors, including melanoma. In accordance with our clinical trial and supply agreement, KEYTRUDA is being supplied by MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA). Trial endpoints include safety, evaluation of efficacy, and assessment of immune changes in the tumor microenvironment.

Transgene and BioInvent are co-developing BT-001, an oncolytic virus designed using Transgene’s Invir.IO platform encoding BioInvent’s differentiated anti-CTLA-4 antibody and human GM-CSF cytokine to elicit a strong and effective anti-tumoral response. The drug is currently being evaluated against solid tumors in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA.

The inclusion of the last patient in Part B of the study is expected in H1 2024.

Previously reported Phase I data confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumoral activity.

Dr. Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva, Chairman and CEO of Transgene, added: "By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are thrilled to enter this new phase of the development of the novel oncolytic virus BT-001 and further demonstrate its potential in combination with a reference treatment."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the trial

The ongoing Phase I/IIa (NCT: 04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.

This Phase I is divided into two parts. In part A, patients with metastatic/advanced tumors received single agent, intra-tumoral administrations of BT-001. Part B is exploring intra-tumoral injections of BT-001 in combination with KEYTRUDA. In this part, KEYTRUDA is being provided to the trial by MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA).

The Phase IIa will evaluate the combination regimen in several patient cohorts with selected tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BT-001

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Therefore, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody may be greatly improved.

BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here.