On June 20, 2024 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the presentation of preclinical data from the Company’s highly differentiated mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) program at the 4th American Association for Cancer Research (AACR) (Free AACR Whitepaper) International Meeting: Advances in Malignant Lymphoma (Press release, HotSpot Therapeutics, JUN 20, 2024, View Source [SID1234644465]).

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MALT1 is a component of the CARD11-BCL10-MALT1 (CBM) protein complex, which serves as a key regulator of NF-kB signaling in cells, including B and T cells. MALT1 is implicated in a range of hematological malignancies, including Non-Hodgkin’s lymphoma, as well as other lymphomas and selected solid tumors. Leveraging the Company’s proprietary Smart AllosteryTM platform, HotSpot has developed a potential first-in-class small molecule designed to selectively inhibit the scaffolding function of MALT1, a dominant driver of the NF-kB pathway, while sparing MALT1’s protease function.

"Given the NF-kB pathway’s role as an oncogenic driver in a range of hematological and solid tumors, the scaffolding function of MALT1, a key activator of the pathway, represents an attractive therapeutic target," said Geraldine Harriman, Co-Founder and Chief Scientific Officer of HotSpot. "At HotSpot, we’ve utilized our Smart AllosteryTM platform to develop HST-1021, a potentially first-in-class MALT1 scaffolding inhibitor. These preclinical data support the highly differentiated profile of HST-1021, demonstrating its broad and potent inhibitory activity with no observed adverse effects on T cells."

The presentation describes preclinical data for HST-1021, HotSpot’s MALT1 scaffolding inhibitor development candidate:

HST-1021 demonstrated potent inhibition of NF-kB and AP1 activity in vitro, two key markers of MALT1 scaffolding activity.
In contrast to MALT1 protease inhibitors, HST-1021 had no observed effect on MALT1 protease activity or T-cell function, and HST-1021 did not deplete Treg cells in vivo. HotSpot believes this supports the potential for mitigation of the risk of autoimmune disease resulting from chronic MALT1 protease function inhibition and could allow for broad combination use.
HST-1021 demonstrated more significant and broader anti-tumor activity as compared to a MALT1 protease inhibitor.

On June 20, 2024 Escend Pharmaceuticals, Inc., a privately held oncology company, reported a poster presentation with initial data from the Australasian Leukaemia and Lymphoma Group’s (ALLG) investigator-initiated Phase I/II platform study (MYDAS-T MDS05 domain 1) evaluating ES-3000 alone and in combination with ASTX727 at European Hematology Association (EHA) (Free EHA Whitepaper) (EHS) in Madrid, Spain (Press release, Escend Pharmaceuticals, JUN 20, 2024, View Source [SID1234644464]).

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The poster is entitled, ‘Combining oral Wnt/β catenin/inflammasome pathway inhibitor, a bis-benzylisoquinoline alkaloid (ES-3000) with oral decitabine/cedazuridine (ASTX727)* as a treatment strategy for myelodysplasia’. The primary objectives of the initial phase of the trial are to assess the safety profile of ES-3000 and determine the recommended phase 2 dose and dosing schedule of ES-3000 in combination with fixed-dose decitabine/cedazuridine (ASTX727). The results indicate a response in 40% of evaluable patients who received ES-3000 as a single agent. The dose-limiting toxicities as per BION modeling allowed the study to dose escalate.

A copy of the poster is available at Escend Pharmaceuticals’ website

About ES-3000

ES-3000 is a small molecule, oral investigational product that reduces leukemic stem cells by β-catenin and Calmodulin protein-dependent kinase II gamma (CamKIIγ). ES-3000 is being developed for the treatment of myeloid malignancies including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and myelodysplastic syndrome (MDS).

On June 20, 2024 Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, reported that it has closed on $4.3 million in a financing led by CJC Investment Trust, an entity controlled by board member Christopher Calise (Press release, Coeptis Therapeutics, JUN 20, 2024, View Source [SID1234644463]).

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Under the terms of the financing, the Series A Preferred is convertible into shares of the Company’s common stock at a price of $0.40 per share, subject to limitations. The investors also received in the aggregate a 6.45% equity interest in two of the Company’s newly formed subsidiaries, SNAP Biosciences Inc. and GEAR Therapeutics Inc.

Dave Mehalick, President and CEO of Coeptis Therapeutics said, "We are grateful for the continued support from our investors, particularly in these transformative times for Coeptis Therapeutics. These individuals share our passion and long-term vision for Coeptis, and their support goes beyond investment, reflecting a focus on the Company’s future."

"This financing comes at an opportune moment as we are anticipating several significant near-term milestones. The commitment from our investors not only strengthens our balance sheet but also bolsters our innovative cell therapy platforms and long-term growth prospects."

Proceeds from this financing will be allocated towards repayment of outstanding obligations, working capital, and general corporate purposes.

On June 21, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that the agreed equity investment by Takeda has been closed on June 20, 2024, with all proceeds already received (Press release, Ascentage Pharma, JUN 20, 2024, View Source [SID1234644462]). Pursuant to the terms of the Agreement, Ascentage Pharma has allotted and issued an aggregate of 24,307,322 subscription shares to Takeda International at the share purchase price of HK$24.09850 (equivalent to approximately US$3.08549).

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On June 20, 2024 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported that it has closed an EUR80 million Series B financing (Press release, iOnctura, JUN 20, 2024, View Source [SID1234644461]). The funding round was led by new investor Syncona Limited with participation by the EIC Fund, the venture arm of the European Innovation Council (EIC), as well as existing investors M Ventures, Inkef Capital, VI Partners, Schroders Capital and 3B Future Health Fund.

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iOnctura is developing a portfolio of precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. The Company has progressed two therapeutic candidates into mid-stage clinical development.

Lead asset roginolisib is the first allosteric modulator of PI3Kδ, with a unique chemical structure and binding mode. It is being developed for indications burdened by immune mediated resistance and a high expression of PI3Kδ in cancer cells and tumor-infiltrating immune cells. Roginolisib has potential to become the first successful, clinically meaningful therapy to target the critical PI3Kδ cancer pathway. It has demonstrated an unprecedented and first-in-class clinical profile in solid and hematological malignancies, with over 48 patients treated to date.

The financing will be used to accelerate development of roginolisib for the treatment of uveal melanoma (UM), a rare cancer of the eye with few available treatments. Eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032[1] . In a Phase Ib clinical trial, roginolisib demonstrated long-term safety and promising efficacy in UM with sustained clinical activity over many months. Full results will be announced in the coming months.

The successful UM data reported so far, combined with a rich preclinical data package, supports the rationale to expand into other indications. iOnctura plans to commence trials in other cancer indications, including non-small cell lung cancer and primary myelofibrosis, later in 2024.

iOnctura’s second clinical asset, cambritaxestat, is the only autotaxin inhibitor in clinical development to treat cancer. It has excellent potency and specificity, and is being developed for highly fibrotic tumors that overexpress autotaxin. A Phase Ib study of cambritaxestat in combination with chemotherapy in metastatic pancreatic cancer is ongoing.

Catherine Pickering, Chief Executive Officer, iOnctura, said: "This financing is validation of iOnctura’s approach to developing precision cancer treatments with maximum clinical impact. These therapies have the potential to significantly prolong the healthspan of patients suffering with neglected cancer types, such as uveal melanoma. We are pleased to welcome our new investors Syncona and the EIC Fund alongside our existing strong syndicate. Their experience will be invaluable as we look to advance our pipeline and take iOnctura to its next stage of growth."

Roel Bulthuis, Managing Partner and Head of Investments at Syncona and Board member of iOnctura, added: "iOnctura represents a compelling opportunity to invest in line with our strategy and capital allocation focus in a clinical-stage company, and take a promising lead programme through to late-stage development. To date, no company has been able to successfully target this well-known cancer pathway with sufficient precision. By allosterically modulating PI3Kδ, iOnctura has achieved a new level of precision and could be the first company to develop a clinically meaningful medicine targeting this pathway. Its programmes have potential utility across a range of cancers, which we are supporting the company to unlock through a refined clinical strategy."