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."

On June 20, 2024 Jazz Pharmaceuticals plc reported top-line results from the Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET) (Press release, Jazz Pharmaceuticals, JUN 20, 2024, View Source [SID1234644460]). Suvecaltamide did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score and key secondary endpoint of Clinical Global Impression-Severity (CGI-S) scale.

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While not statistically significant, numeric improvements were observed on the primary endpoint and key secondary endpoint at 30mg versus placebo. The improvement in placebo from baseline to week 12 also exceeded the Company’s expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.

"We are disappointed that the trial did not meet its primary endpoint. We recognize the significant unmet need for people living with ET, and we are grateful to the patients, their families and the investigators that participated in the trial," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "We are evaluating the data to better understand the trial results and await the results of the suvecaltamide trial in Parkinson’s disease tremor to determine next steps for the program. The Phase 2 Parkinson’s disease tremor trial is ongoing with results expected first quarter 2025."

Suvecaltamide was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed. The most common treatment-emergent adverse events (TEAEs) were dizziness, headache, paresthesia, diarrhea and insomnia. These were predominately mild to moderate in severity. One participant experienced a serious adverse event considered treatment related by the investigator.

About the Phase 2b Trial
The Phase 2b clinical trial (NCT05122650) is a 12-week, multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of suvecaltamide in a once-daily oral dose of 10, 20 and 30mg or placebo. The primary endpoint (modified TETRAS composite outcome score) represents items 1-11 from the TETRAS-ADL combined with items 6+7 (spiral and handwriting assessments, respectively) from the TETRAS-PS with scoring modifications. The key secondary endpoint in the trial measured the percentage of participants with ≥1 point improvement on CGI-S. The trial randomized 420 participants from four countries.

About Suvecaltamide
Suvecaltamide (JZP385) is an investigational, highly selective and state-dependent modulator of T-type calcium channels (Cav3). T-type calcium channels play a role in the brain’s control of muscle movement.1 Suvecaltamide preferentially binds to stabilize a specific conformation of the channel and reduce activity. The suvecaltamide Phase 2 proof-of-concept trial in Parkinson’s disease tremor is ongoing (NCT05642442).

On June 20, 2024 Kanvas Biosciences, a full-stack spatial biology company, reported its newest drug candidate in its Immuno-oncology Program: KAN-003 (Press release, Kanvas Bioscience, JUN 20, 2024, View Source [SID1234644459]). The Kanvas platform provides the unique ability to map host-microbiome interactions and leverage the resulting data to design live biotherapeutic products (LBPs), which can be used to create novel microbiome-based therapies that complement existing therapies and provide a safe method for targeting underlying disease processes with greater efficacy. The company’s lead drug candidate, KAN-001, is an LBP demonstrating significant potential to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs). KAN-003 will be a consistent dose regimen that cancer patients can take just before and with ICI treatment.

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ICI treatment is a type of immunotherapy that can help fight a variety of cancers, including malignant melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and renal cell carcinoma. ICIs block checkpoint proteins from binding with their partners, which prevents the "off" signal from being sent to T cells and allows T cells to kill cancer cells. However, only 20 – 40% of patients respond to ICI therapy. For patients whose cancers don’t respond to ICI treatment, intervening with a fecal microbiota transplant (FMT) is an alternative option. FMTs involve transferring a microbial ecosystem from a healthy individual into another person, often by colonoscopy. Still, FMT treatments are not commercially scalable, risk the transfer of pathogens and in most cases provide only a single dose.

To improve upon the effectiveness of FMTs, Kanvas has developed its own microbiome-based drug pipeline. With KAN-003, the company’s goal is to dramatically increase the percentage of patients who respond to ICI therapy across all ICI-approved cancer types. Both KAN-001 and KAN-003 are currently undergoing preclinical studies in collaboration with The University of Texas MD Anderson Cancer Center and the institution’s Platform for Innovative Microbiome and Translational Research (PRIME-TR). While KAN-003 is different from KAN-001 in terms of donor source and the microbial ecosystem, the two candidates’ manufacturing strategies are identical, allowing Kanvas to synergize its learnings and scale to drug production quickly.

"As we’ve learned time and again, there’s no single cure for cancer, but every cancer patient deserves safe and effective options. Designed as an earlier treatment option, KAN-003 may generate an earlier response and the chance to stabilize or send cancers into remission for ICI-naive patients," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "We believe that the complex interaction of the gut microbiome with human health can be unlocked with a series of discrete, solvable steps, and FMT treatments have already revealed what’s possible for microbiome-based therapeutics. With KAN-001 and now KAN-003, we’re working to transform Immuno-oncology and patient lives."

Kanvas is currently preparing a pre-Investigational New Drug (IND) filing for KAN-003 for Q3 of 2025 and actively seeking additional partners interested in supporting rigorous clinical studies over the next few years. To learn more, contact the company directly.