On April 11, 2024 Sprint Bioscience reported that previously unpublished results from the company’s DISA program targeting the protein TREX1 will be presented at the conference "Immuno-Oncology Summit Europe 2024" in London, England, 23 – 25 April 2024. The positive results from an in vivo proof-of-concept study show that treatment with the company’s TREX1 inhibitors results in an improved immune response and inhibited tumor growth.

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Results show that oral administration of the company’s TREX1 inhibitors reduced tumor growth in an animal model of colorectal cancer and at the same time increased the recruitment of immune cells to the tumors.

"Targeting TREX1 represents a novel approach to amplifying the immune response, with a mechanism that is different from existing approved immunotherapies. When blocking TREX1 in tumors, the body’s immune response is reactivated, resulting in inhibition of tumor growth. Our data support the therapeutic hypothesis in this program, and we look forward to presenting the program to scientists and potential partners in the immuno-oncology field." said Martin Andersson, CSO at Sprint Bioscience.

New publications show that the function of the TREX1 protein in cancer cells inhibits the immune response. This, in combination with the company’s data, confirms the hypothesis that TREX1 is an interesting new target for cancer therapy.

The poster "Inhibition of TREX1 Increases Interferon Signaling and Reduces Tumor Growth In Vivo" is presented by Camilla Silvander, PhD, Director Protein Science, Sprint Bioscience.

(Press release, Sprint Bioscience, APR 11, 2024, View Source [SID1234660962])

On April 11, 2024 LaNova Medicines Ltd. reported the initiation of its first Phase III clinical trial for LM-302 (anti-Claudin 18.2 ADC) in China (Press release, LaNova Medicines, APR 11, 2024, View Source [SID1234655991]). This marks the first antibody-drug conjugate candidate in LaNova’s pipeline to enter the pivotal clinical study.

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The clinical study (CTR20240955) is a randomized, open-label, multi-center, positive-controlled Phase III trial primarily assessing the efficacy and safety of LM-302 in patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma who are CLDN18.2 positive.

On April 11, 2024 Orion reported its interim report January to March 2024 (Presentation, Orion, APR 11, 2024, View Source [SID1234646732]).

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On April 11, 2024 Lamassu Biotech reported its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval from the Food and Drug Administration (FDA) to proceed in initiate Phase 1/2a clinical trials (Press release, Lamassu Pharma, APR 11, 2024, https://www.prnewswire.com/news-releases/possible-new-hope-for-metastatic-cancer-patients-food-and-drug-administration-grants-approval-for-clinical-trials-for-lamassus-groundbreaking-cancer-treatment-protocol-302114390.html [SID1234646266]).

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The trial will investigate novel therapy SA53-OS, a genetically targeted therapy that targets the MDM2 protein, a key regulator of the tumor suppressor p53 gene. By selectively activating p53, Lamassu aims to induce tumor cell death and inhibit growth, potentially providing a much-needed breakthrough in targeted cancer therapy.

Lamassu has been working in collaboration with the Cleveland Clinic on this trial, led by Peter Anderson, MD, which seeks to develop a new cancer treatment for patients with limited therapeutic options. With functional p53 present in about half of all cancers, the potential impact of this treatment could be transformative in the fight against cancer.

The IND approval by the FDA comes on the heels of Lamassu receiving one of the National Institutes of Health’s largest available SBIR grant awards to help launch the clinical trial study for its innovative approach to cancer treatment.

"This approval is the result of the vision and tenacity of our entire Lamassu team and our partners," said Dr. Gabi Hanna, CEO of Lamassu. "It is a critical step to move beyond conventional chemotherapy to targeted therapy to bring hope and healing to millions who suffer from stubborn cancers that don’t respond to conventional treatments and to reduce the toxicity of cancer treatments. With SA53-OS patented in 69 countries, successful trials could make a significant impact on the global fight against cancer."

"The initiation of this trial adds to Lamassu’s record of accelerating drug development, delivering innovative therapies that can go from the laboratory to the bedside faster and with improved outcomes," said Dr. Hanna.

On April 11, 2024, Precision BioSciences, Inc. (the "Company") reported to have received written notice from Prevail Therapeutics Inc. ("Prevail"), a wholly-owned subsidiary of Eli Lilly and Company, of Prevail’s termination of the Amended and Restated Development and License Agreement, dated June 30, 2023, between Prevail and the Company (the "Agreement") (Press release, Precision Biosciences, APR 11, 2024, View Source [SID1234642468]). Prevail’s notice informed the Company that Prevail was exercising its right pursuant to Section 15.3.2 of the Agreement to terminate the Agreement in its entirety without cause upon 90 days’ prior written notice to the Company. The termination will be effective on July 10, 2024.

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Pursuant to the terms of the Agreement, Precision and Prevail agreed to collaborate and develop the Company’s ARCUS nucleases for the research and development of potential in vivo therapies for three initial genetic disorder targets, including Duchenne muscular dystrophy ("DMD") in muscle, a liver directed target ("PBGENE-LLY2") and a central nervous system directed target ("PBGENE-LLY3" and together with DMD and PBGENE-LLY2, the "Programs"). Under the original agreement with Eli Lilly and Company signed November 19, 2020, Precision received $135 million in upfront investment consisting of $100 million upfront and $35 million from Lilly’s purchase of 125,406 shares of the Company’s common stock (on a post-reverse stock split basis). The Agreement was amended and restated in June 2023 with Prevail assuming and funding preclinical research and investigational new drug application-enabling activities, which had previously been conducted by the Company at its expense, as well as assuming responsibility for the manufacturing of initial clinical trial material for the first licensed product. Upon the achievement of various milestones, the Company would have been entitled to receive milestone payments of up to an aggregate of $390 million to $395 million per licensed product as well as nomination fees for additional targets and certain research funding. If licensed products resulting from the collaboration were approved and sold, Prevail would have also been required to pay tiered royalties ranging from the mid-single digit percentages to the low-teens percentages on world-wide net sales of the licensed products, subject to customary potential reductions. Prevail’s exercise of its termination right is contemporaneous with achievement of defined preclinical activities on the collaboration for the Programs, at which time Prevail would have taken over all remaining development activities for the Programs.

In connection with the termination, the Company has exercised its reversion option (the "Reversion Option") under the Agreement to regain control over development of the Programs and plans to explore opportunities to further develop the Programs. As a result, Prevail is required upon Precision’s request and to the extent permitted by law or terms of third party agreements, to assign and transfer to the Company all right, title and interest in and to all materials, preclinical and clinical data, safety data and all other supporting data in Prevail’s control related to the terminated products for the continued development and commercialization of such products.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the full text of the Agreement, a copy of which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 6, 2023, and is incorporated herein by reference.