On September 20, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT (Press release, Alpha Tau Medical, SEP 20, 2024, View Source [SID1234646763]).

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The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the study is the objective response rate (ORR) to the treatment, as measured by best overall response. Secondary efficacy objectives include progression-free survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement of any related adverse events.

A 2015 article in Journal of Clinical Medicine noted that non-melanoma skin cancers represent a major cause of morbidity for patients after organ transplantation, and cSCC is the most common skin cancer seen in this population, with a 65–100 fold greater incidence in organ transplant recipients compared to the general population. For example, a 2003 article in the New England Journal of Medicine cited a number of sources indicating that 50% or more of Caucasian transplant recipients will ultimately develop cutaneous carcinomas.

In addition, a 2019 article in JAMA Otolaryngology – Head & Neck Surgery found that immunosuppression is independently associated with a worse outcome in cSCC, with a 2.32-times increased risk of disease-specific death, after adjusting for assorted demographic factors.

"As we continue to progress in our ReSTART multi-center pivotal trial for recurrent cutaneous SCC, a number of investigators asked about the ability to treat immunocompromised patients, who are ineligible for the ReSTART trial," commented Alpha Tau CEO Uzi Sofer. "Emory University is an important partner of ours and we are proud to work with them in initiating a trial for this population. Given the continued requests we receive from clinicians to help them treat immunocompromised patients, we are confident that a successful clinical trial can help deliver an important new potential alternative for these patients."

Zachary Buchwald, MD, PhD, an Assistant Professor of Radiation Oncology at Winship Cancer Institute of Emory University and Principal Investigator of the trial, noted, "We are thrilled to be able to initiate this trial and pioneer the use of the Alpha DaRT in immunocompromised patients. As we continue to see the promise of the Alpha DaRT through our participation in the ReSTART trial, it is obvious to us that we need to use this treatment elsewhere, particularly in populations at risk such as this."

Dr. Robert B. Den, Alpha Tau Chief Medical Officer, added, "This trial targets a particularly vulnerable population for whom treatment options are limited, which affords the ability to provide even more potential value to these patients. We are looking forward to treating patients in this trial soon."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On September 19, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported the pricing of its underwritten public offering of 2,000,000 American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis, at a price to the public of $150.00 per ADS (Press release, Ascendis Pharma, SEP 20, 2024, View Source [SID1234646743]). All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 300,000 ADSs at the public offering price, less the underwriting commissions.

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Ascendis estimates the net proceeds from the offering will be approximately $281.3 million (assuming no exercise of the underwriters’ option to purchase additional ADSs), after deducting the underwriting commissions and estimated offering expenses. Ascendis intends to use the net proceeds of the offering to support the commercial preparations, launch and commercial activities, clinical development and regulatory approvals for its products and product candidates, and for working capital and general corporate purposes.

J.P. Morgan, Morgan Stanley, Evercore ISI and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering. BofA Securities, Wells Fargo Securities and Citigroup are acting as lead managers for the offering and Oppenheimer & Co. is acting as co-manager for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on September 18, 2024, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected].

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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 19, 2024 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap technology to develop enhanced cancer therapies, reported significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA) (Press release, Xspray, SEP 19, 2024, View Source [SID1234649584]). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, incorporating feedback from the Complete Response Letter (CRL) issued by FDA in July 2024. If the FDA sets a two-month review period upon resubmission, the launch of Dasynoc could be expected as early as Q1 2025.

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The FDA recommends adjustments to Dasynoc’s tablet strengths to reduce the risk of medication errors. Although these changes are minor (within normal variability), the FDA has requested new batches to be produced before submission. Xspray Pharma has already initiated production of these batches. The company will also provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements.

Per Andersson, CEO of Xspray Pharma, commented: "We are very encouraged by the positive and collaborative discussions with the FDA. The new tablet strengths will enhance patient safety by reducing the potential for dosing errors, and we are working diligently to meet all the necessary requirements. Our production process is well underway, and we are on track to resubmit the NDA in Q4 2024."

He continued: "Xspray Pharma is particularly eager to bring Dasynoc to market because of the critical need we have identified in our research. Many patients, especially those relying on pH-altering medications like antacids, face challenges with existing cancer treatments due to inconsistent absorption. Dasynoc’s innovative pH-independent formulation directly addresses this issue, which minimizes the risks associated with fluctuating drug absorption ensuring that patients can receive consistent treatments. We believe this solution will be welcomed by healthcare providers and patients alike, who are in need of more reliable treatment options."

Upon resubmission, Xspray Pharma expects the FDA to assign a new Prescription Drug User Fee Act (PDUFA) date, with a final decision anticipated within two or six months of the resubmission, depending on the review timeline set by the FDA.

On September 19, 2024, FibroBiologics, Inc. (the "Company") reported to have entered into a Master Services Agreement (the "Agreement") with Charles River Laboratories, Inc. ("CRL") (Filing, 8-K, FibroBiologics, SEP 19, 2024, View Source [SID1234646838]).

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The Agreement governs the general terms under which CRL will provide development and manufacturing services as specified by the Company. Pursuant to the Agreement, the Company and CRL will enter into various Statements of Work to set forth the services to be performed by CRL and the payments to be made by the Company for each project (each, a "Statement of Work"). Each Statement of Work will be governed by the terms of the Agreement, unless expressly modified in such Statement of Work.

The Agreement has a term that expires on September 19, 2029 (the "Term"), unless earlier terminated by either party in accordance with the Agreement. The Company may terminate any services, Statement of Work or the Agreement upon ninety (90) days’ prior written notice. CRL may terminate the Agreement upon ninety (90) days’ prior written notice; provided all Statements of Work then in effect, and all ongoing services thereunder, will remain in effect, and the terms of the Agreement will continue to apply to them as if the Agreement remained in effect. Either party may terminate any services, Statement of Work, or the Agreement upon ninety (90) days’ prior written notice for material breach of the Agreement by the other party if such breach is not remedied within the ninety (90) day notice period or if such breach is not capable of cure within such ninety (90) day period.

The Agreement contains representations, warranties and indemnity obligations customary for agreements of this type.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which has been filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On September 19, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that an abstract highlighting NOX-A12 data from preclinical studies performed by the U.S. National Cancer Institute (NCI) has been selected for poster presentation at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Houston, Texas, USA, November 21-24, 2024 (Press release, TME Pharma, SEP 19, 2024, View Source [SID1234646758]). NCI is part of the National Institutes of Health.

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The research was conducted at the NCI under the material transfer agreement established with TME Pharma in June 2022 to explore the effects of TME Pharma’s CXCL12 inhibitor NOX-A12 in brain tumors.1

The SNO Annual Meeting, the world’s largest neuro-oncology conference, attracts researchers and clinician scientists from over 40 countries. As a premier forum for sharing knowledge and gaining insights into the future of neuro-oncology research and treatment, the meeting spans all neuro-oncology disciplines, professions, and interests. TME Pharma will participate at the annual event as a supporting partner, with its team attending the conference and available for meetings with industry leaders.

Details of the poster presentation at the 2024 SNO Annual Meeting are as follows:

Title: Potentiating the efficacy of immune check-point inhibitors in glioblastoma by inhibition of CXCL12
Presenter: Dr. Chen Cam-El Makranz, Neuro-Oncology Research Fellow, National Cancer Institute, National Institutes of Health
Session: Poster Session, Poster number EXTH12
Time and Date: 7.30-9.30 p.m. CDT, Friday, November 22, 2024

The full abstract will be published in the SNO official journal Neuro-Oncology on Friday, November 11, 2024. Both the abstract and poster presentation will be made available on the TME Pharma website following the conference.