On June 25, 2024 Manhattan BioSolutions, Inc. (MABS), an emerging biotech company developing new classes of precision biologics for the treatment of advanced cancers, and the Institute of Chemical Biology & Drug Discovery (ICB&DD) at Stony Brook University, led by University Distinguished Professor Iwao Ojima, reported to have signed a Letter of Intent (LOI) to establish a collaboration to develop next-generation antibody-drug conjugate (ADC) therapeutics for the treatment of solid tumors with high unmet medical need (Press release, Manhattan BioSolutions, JUN 25, 2024, View Source [SID1234644530]).

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The joint research program leverages the ICB&DD’s cutting-edge medicinal chemistry platforms, including novel fluorine-containing taxoid payloads with superior potency against drug-resistant cancers and a versatile tumor-targeting drug delivery system utilizing a triazine-based tripod linker. These innovative technologies, protected by patent applications filed by The Research Foundation of the State University of New York, have the potential to enhance the efficacy and selectivity of ADCs. MABS seeks to evaluate these technologies for potential use in its proprietary ADC program targeting a novel tumor-associated glycoprotein that is highly expressed across multiple aggressive solid tumor types while showing limited expression in healthy tissues.

"We are excited to collaborate with the ICB&DD to explore the potential of their innovative technologies in the context of ADC therapy," said Dr. Borys Shor, CEO of Manhattan BioSolutions. "This partnership brings together our deep experience in ADC development with the innovative taxoid platforms pioneered by Professor Ojima, creating an opportunity to address the limitations of current ADC therapies."

The MABS and ICB&DD teams will work together to design and evaluate novel ADC candidates with the goal of identifying a promising lead for advancement to preclinical development.

On June 25, 2024, a wholly-owned subsidiary of Kiniksa Pharmaceuticals, Ltd. (the "Company") reported to have entered into a Master Services Agreement (the "MSA") and Product Specific Agreement (the "PSA" and, together with the MSA, the "Agreement") with Samsung Biologics Co., Ltd. ("Samsung") pursuant to which Samsung will perform technology transfer, process performance qualification, manufacturing and supply services for the supply of the Company’s ARCALYST (rilonacept) drug substance (the "Product").

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Under the PSA, the Company committed to purchase process performance qualification and pre-approval inspection batches of the Product, which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition, the Company is obligated to purchase additional batches of the Product in the five-year period of 2027 through 2031. The PSA will continue until the later of December 31, 2031 or the completion of the services thereunder, unless the PSA is terminated earlier. Prior to the expiration of the PSA, the parties have agreed to use commercially reasonable efforts to negotiate in good faith and enter into a new PSA that would govern future manufacturing and supply services for the Product.

The MSA will have an initial term of ten (10) years and shall automatically renew for terms of two (2) years each unless either party gives the other party written notice of termination at least eighteen (18) months prior to the end of the then-current MSA term, provided that the MSA will remain in effect for so long as any product specific agreement is in effect.

Either party may terminate the MSA or PSA in the event of a material breach by the other party that is not cured within 30 days’ written notice or in the event of insolvency. The parties may also terminate the PSA if a force majeure event continues for more than 180 consecutive days and the parties are unable to negotiate a mutually satisfactory solution.

The Agreement includes customary indemnification, intellectual property protection, limitation of liability, and confidentiality provisions.

The foregoing descriptions of the MSA and PSA are qualified in their entirety by reference to the MSA and PSA, redacted copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

On June 25, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that its second-generation ARM-X anti-cancer vaccine is therapeutically effective against pre-established ovarian cancer (ID8 model) when combined with the anti-PD-1 immune-checkpoint inhibitor (Press release, Defence Therapeutics, JUN 25, 2024, View Source;utm_medium=rss&utm_campaign=defences-arm-x-anti-cancer-vaccine-inhibits-growth-of-pre-established-ovarian-cancer-resulting-in-complete-responses-in-treated-animals [SID1234644528]).

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Using Defence’s Accum platform, the Company previously demonstrated that AccuTOX treatment of MSCs results in the induction of antigen cross-presentation capacity (ARM-X cells), which can mount potent anti-tumoral responses in animal pre-clinical models. This was previously achieved using various cancer models including solid T-cell lymphoma, melanoma and pancreatic cancer. Defence just completed an additional study where animals with pre-established ovarian cancer responded to a combination therapy including ARM-X and anti-PD-1. The latter group prolonged animal survival beyond 80 days post-vaccination, and it led to a complete response in almost all treated animals as shown in Figure 1.

"This is the 4th cancer model that we efficiently targeted using our ARM-X antic-cancer vaccine. The purpose of testing our vaccine in various models is to highlight how ARM-X can be adapted to the needs of any patient, no matter the type of cancer, given that we have access to a tumor biopsy." says Mr. Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

One of the major advantages of Defence’s ARM-X vaccine is the need of lower antigen amounts to manufacture the vaccine. This is important as it avoids the need of a big tumor sample in the vaccine generation. Defence is currently testing its ARM-X vaccine on colon as an additional indication. These results will set the target indication for the Phase I-IIa trials, and it also shows how versatile and adaptable can the ARM-X anti-cancer vaccine be.

On June 25, 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 the publication of an article entitled "Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers" in the journal Cancers, with further detail on data previously announced by the Company in August 2023. The publication was authored by clinical investigators from Israel, Italy and the United States and can be accessed through the following link: View Source

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The aim of the analysis was to evaluate the long-term toxicity outcomes and disease control rates for patients treated with Alpha DaRT and followed for up to four years. In this pooled analysis of 81 treated head and neck, oral cavity and skin tumors from four clinical trials with a median follow-up of 14 months (range of 2—51 months), the overall response rate was 99%, with a complete response observed in 89% of treated lesions, a 10% partial response rate, and one patient non-evaluable. Two-year local recurrence-free survival was 77%, and there were no grade 2 or higher late toxicities observed. Clinical variables, including recurrent versus non-recurrent lesions, baseline tumor size, or histology, did not impact long-term outcomes.

The published results indicate that the Alpha DaRT treatment may provide tumor control even beyond the acute treatment period of short-term local responses, potentially leading to longer-term disease control. The lack of moderate or severe toxicities observed in this analysis is promising and suggests that Alpha DaRT may potentially offer an appropriate long-term treatment for these very difficult-to-treat cancers. Further follow-up and additional clinical studies are ongoing and will provide additional characterization of the safety and efficacy profile of Alpha DaRT.

Alpha Tau CEO Uzi Sofer stated, "We are encouraged by the perspective offered by this long-term data and its publication in a renowned journal such as Cancers. The publication of this comprehensive pooled analysis reinforces our belief in the sustained benefit of Alpha DaRT for patients with hard-to-treat cancers who have limited treatment options. We have additional ongoing studies in multiple tumor types and this long-term safety and efficacy snapshot shows great promise for the future when fighting the most difficult cancers. We are now poised for our next breakthrough and will continue working hard making excellent progress in our exciting clinical pipeline."

Dr. Robert Den, M.D., Alpha Tau CMO, commented, "The publication of this long-term analysis is extremely gratifying. After years of research, the combined picture shows great clinical promise with no moderate or severe long-term toxicity. Now that we have a published study with a range of up to 51 months with strong durability and a favorable safety profile, we are hopeful this will provide a new therapeutic pathway for patients who have few options. In addition, we are looking forward to results from several ongoing and planned clinical trials in pancreas, brain, vulva, lung and liver metastases."

Prof. Aron Popovtzer M.D., Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and lead author of the publication, commented, "This analysis presents in fully published form, for the first time, an enhanced clinical picture of the potential benefit that Alpha DaRT may provide to patients with these hard-to-treat skin, head and neck cancers. The long-term analysis of safety and efficacy compares very favorably to other radiotherapeutic studies using external beam radiation, but with a much lower incidence of complications. We are excited and hopeful about the future potential of Alpha DaRT in the treatment of various solid tumors and in combination with systemic therapies such as immunotherapy and chemotherapy."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intertumoral 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 June 25, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, reported a License Agreement with Cardiff University granting the Company exclusive rights to develop and commercialise anti-LAG-3 small molecules (Press release, Immutep, JUN 25, 2024, View Source [SID1234644513]).

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A number of promising compounds that block LAG-3, an immune checkpoint known to reduce the immune system’s response to fight cancer, have been identified under Immutep’s collaboration with the world-leading scientists at Cardiff University. Led by Professor Andrew Godkin of Cardiff University, Professor Andrea Brancale (now of the University of Chemistry and Technology, Prague), and Dr Frédéric Triebel, Immutep CSO, the compounds were identified by chemical library screening, molecular modelling (virtual screening) and synthetic chemistry.

Professor Andrew Godkin of Cardiff University said: "Our collaboration with Immutep has been exciting and fruitful, resulting in a number of small molecules with the potential to fight cancer by blocking the interaction between LAG-3 on T cells and MHC Class II on antigen-presenting cells. Small molecules represent the next generation of anti-LAG-3 therapies and hold tremendous promise, as they can be given to cancer patients as a convenient oral pill."

To date, over a dozen companies have initiated clinical trials investigating antagonist or "blocking" LAG-3 antibodies including Bristol Myers Squibb’s relatlimab, which was approved by the FDA in 2022 as part of a fixed dose combination with nivolumab for the treatment of metastatic melanoma. This new combination, known as Opdualag, achieved commercial sales of US$252 million and US$627 million in 2022 and 2023, respectively. Immutep’s program aims to develop an orally-available small molecule anti-LAG-3 treatment for cancer patients at a lower cost compared with the anti-LAG-3 monoclonal and bi-specific antibodies that are commercially available or under clinical development today.

Dr. Frédéric Triebel, Immutep CSO, said: "With our first-in-class MHC Class II agonist, eftilagimod alfa, entering late-stage clinical trials in oncology and IMP761, the world’s first LAG-3 agonist antibody targeting the root cause of autoimmune diseases scheduled to enter the clinic by mid-year, the team at Immutep continues to build on its pioneering leadership position in the LAG-3 therapeutic landscape with this novel program. This License Agreement harnesses many years of collaborative work with the expert team at Cardiff University and enables us to advance the most promising preclinical compounds towards the next stage of development."

A joint patent application has been filed by Immutep S.A.S. and University College Cardiff Consultants Limited (a Cardiff University affiliate) to protect the new intellectual property. The License Agreement builds on Immutep’s collaboration with Cardiff University which commenced in 2019. University College Cardiff Consultants Limited will receive an upfront payment of £25,000 and a milestone payment upon first commercial sale of a licensed product, and is eligible to receive low single-digit sales based royalties.