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.

On April 11, 2024 REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, reported the poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, REGimmune, APR 11, 2024, View Source [SID1234642233]). The poster presentation is to highlight RGI-2001 phase 2b result, including the latest correlative analyses of changes in regulatory T (Treg) and natural killer T (NKT) cell populations to assess the cellular kinetics of RGI-2001 in the prevention of acute Graft versus host disease.

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Based on literature, higher numbers of NKT cells are associated with a reduced risk of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) (Rubio et al. 2017; Rubio et al. 2012). Patients with rapid NKT cell expansion exhibit a lower risk of GVHD and improved survival (Chaidos et al. 2012; Malard et al. 2016).

Flow cytometry studies indicate peripheral NKT expansion at Day 28 in patients receiving clinical benefit from RGI- 2001.The mean levels of absolute Tregs at Day 42, 1 week following the last dose of RGI-2001, were higher in subjects who were alive and had not developed Grade II-IV aGVHD by Day 180 compared with those who had died and/or did develop aGVHD. A large percentage of activated Tregs were proliferating, with activated Tregs proliferating to a greater extent compared with nonactivated Tregs. The proliferation was greater in after- treatment compared to baseline samples. This effect was also observed in the single-dose study (Phase 1/2a RGI-2001-002). The results from exploratory correlative analyses are consistent with the proposed mechanism of action of RGI-2001. RGI-2001 may induce activation and proliferation of NKT cells, leading to a reduction in aGVHD through increasing the proliferation of activated Tregs.

"Our data suggest that RGI-2001 prevents acute GVHD through NKT and Treg cells without compromising general immune function and has the potential to become a best-in-class drug for preventing acute GVHD," said Kenzo Kosuda, CEO of REGiMMUNE. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT.

Dr Jack Bui,MD,Ph.D. from University of California, San Diego, is the presenter for this important poster for RGI-2001. Details of presentation, please see RGI-2001 AACR (Free AACR Whitepaper) Poster Presentation.

Title: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood.
Authors: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3;
Session Title: PO.CT02.02 – Phase II Clinical Trials 2
Session Date and Time: April 8th 2024, 1:30 PM – 5:00 PM

On April 11, 2024, Rigel Pharmaceuticals, Inc. ("Rigel") reported to have entered into Amendment No. 4 (the "Amendment") to that certain Credit and Security Agreement, dated as of September 27, 2019 (as further amended, supplemented or otherwise modified from time to time prior to the Amendment, the "Existing Credit Agreement," and as amended by the Amendment, the "Amended Credit Agreement") with Midcap Financial Trust ("MidCap"), as administrative agent, and the lenders party thereto ("Lenders"), pursuant to which MidCap and the Lenders agreed to amend the Existing Credit Agreement to, among other things, (i) extend the maturity date for the term loans to September 1, 2027 (the "Maturity Date"), (ii) extend the interest only period for the term loans to October 1, 2025, (iii) reset the prepayment fee applicable to the term loans, (iv) increase the exit fee payable on the term loans, (v) revise the interest rate payable on the term loans, and (vi) update certain financial covenants in connection with the new maturity date (Filing, 8-K, Rigel, APR 11, 2024, View Source [SID1234642036]).

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The term loans under the Amended Credit Agreement may be prepaid in full or in part through September 30, 2025 with payment of a 1.5% prepayment premium, and thereafter they may be prepaid in full or in part through the date immediately prior to the Maturity Date with payment of a 1.0% prepayment premium.

The interest rate applicable to the term loans under the Amended Credit Agreement is the secured overnight financing rate ("SOFR") (as defined in the Existing Credit Agreement) plus 6.50%, subject to a SOFR floor of 4.00%. The amortization payments on the term loans under the Amended Credit Agreement start on October 1, 2025. All unpaid principal and accrued interest is due and payable in full no later than the Maturity Date.

The Amended Credit Agreement requires that (i) Rigel maintains Borrower Unrestricted Cash of at least $10.0 million at all times, and (ii) upon Borrower Unrestricted Cash falling below 1.25x of the term loans outstanding, Rigel maintains TAVALISSE Net Revenue in the U.S. (with capitalized terms as defined in the Amended Credit Agreement).

The foregoing description of the Amendment in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which will be included as an exhibit to Rigel’s Quarterly Report on Form 10-Q for the fiscal period ending March 31, 2024, to be filed with the U.S. Securities and Exchange Commission.