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Alpha Tau Receives FDA Approval to Initiate a Trial for Patients with Recurrent Glioblastoma

On April 2, 2025 Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology (Press release, Alpha Tau Medical, APR 2, 2025, View Source [SID1234651748]).

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"This is very exciting news for patients suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial, we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are not amenable to surgery," said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. "According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months."

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment following the Company’s promising results from pre-clinical studies.

"This IDE approval follows the FDA’s continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received the FDA’s Breakthrough Device Designation, followed by acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program to accelerate the Alpha DaRT treatment to market and to the GBM patients who may stand to benefit greatly," added Alpha Tau Chief Executive Officer Uzi Sofer.

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.

Allakos Inc. Enters into Agreement to Be Acquired by Concentra Biosciences, LLC for $0.33 in Cash per Share

On April 2, 2025 Allakos Inc. ("Allakos") (Nasdaq: ALLK), a biotechnology company that has been developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, reported it has entered into a definitive merger agreement (the "Merger Agreement") whereby Concentra Biosciences, LLC ( "Concentra") will acquire Allakos for $0.33 in cash per share of Allakos common stock ("Allakos Common Stock") (Press release, Allakos, APR 2, 2025, View Source [SID1234651747]).

Allakos’ Board of Directors has unanimously determined that the acquisition by Concentra is in the best interests of all Allakos shareholders and, following the unanimous recommendation of Allakos’ Transaction Committee, has approved the Merger Agreement and related transactions.

Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of Concentra will commence a tender offer (the "Offer") by April 15, 2025 to acquire all outstanding shares of Allakos Common Stock.

Closing of the Offer is subject to certain conditions, including the tender of Allakos Common Stock representing at least a majority of the total number of outstanding shares (including any shares held by Concentra), the availability of at least $35.5 million of cash (net of transaction costs, wind-down costs and other liabilities) at closing, and other customary closing conditions. Allakos officers, directors and their respective affiliates holding approximately 8.07% of Allakos Common Stock have signed support agreements under which such parties have agreed to tender their shares in the Offer and support the merger transaction. The merger transaction is expected to close in May 2025.

Alkermes to Participate in the 24th Annual Needham Virtual Healthcare Conference

On April 2, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a webcast panel discussion "Development of Orexin Receptor Agonist in Sleep-Wake Disorders" at the upcoming 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025 at 11:45 a.m. EDT (4:45 p.m. BST) (Press release, Alkermes, APR 2, 2025, View Source [SID1234651746]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

CuraCell to present patient named clinical results at AACR and ISCT 2025 in the USA

On April 1, 2025 CuraCell reported the company will present clinical outcomes of patients treated with our Tumor Infiltrating Lymphocytes (TIL)-based therapy this spring at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the International Society for Cell & Gene Therapy (ISCT) Annual Meeting, both taking place in the United States. All patients treated, on a patient-named basis, were diagnosed with late-stage solid tumors and refractory to all conventional therapies.

The presentations mark a significant milestone for our team as we share important data highlighting the potential of our TIL-product CC-38 to address the unmet medical need in cold solid tumors.

"We look forward to connecting with the scientific and clinical community during these events and continuing the conversation on advancing durable, personalized cancer immunotherapy." said Dr. Lucas Arruda, CSO of CuraCell.

(Press release, CuraCell, APR 1, 2025, View Source [SID1234661186])

U.S. Food and Drug Administration removes clinical hold of Oncopeptides’ pipeline drug OPD5

On April 1, 2025 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, reported the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on Oncopeptides’ next-gen drug OPD5 (Press release, Oncopeptides, APR 1, 2025, View Source [SID1234655619]).

Based on the company’s proprietary Peptide Drug Conjugate (PDC) platform, OPD5 is a follow-on molecule to Oncopeptides’ flagship drug melflufen (branded in Europe as Pepaxti) with a potentially improved risk/benefit profile and enhanced intellectual property protection. OPD5 would initially target multiple myeloma and could potentially be expanded with other indications and diseases over time.

"We continue to see a strong medical need for a PDC in the U.S. confirmed by leading experts in the country," says Sofia Heigis, CEO of Oncopeptides. "With the go-ahead from the regulator, we are now able to move ahead with plans for clinical development."

As a next step, Oncopeptides will continue to prepare for a new clinical study, OP-502, to assess the safety, tolerability and efficacy of OPD5. Given its similarities to melflufen and the experience gained from its’ U.S. approval process, Oncopeptides believes that OPD5 can fulfill an important medical need in U.S. as well as in the EU. To support continued development including a phase 1 study, the company is assessing various financing options, including partnerships.

For more information including a Q&A for investors, please visit Oncopeptides.com.

For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: +46 76 229 38 68