On November 29, 2023 Celdara Medical and Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) reported the signing of a Memorandum of Understanding (MOU) aimed at identifying and advancing promising new therapeutics in areas of high unmet medical need (Press release, Celdara Medical, NOV 29, 2023, View Source [SID1234638039]). Under the terms of this agreement, both organizations look to expand opportunities to provide financial support for the development of early-stage therapeutics by exchanging non-competitive information submitted in academic funding proposals.

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Since its founding in 2008, Celdara Medical has built a robust pipeline of potential therapeutics for diseases with unmet needs, sourced from across the nation and globally. Many of these pipeline opportunities align with TRxA’s strategic objectives, as does the shared focus on and primacy of patient need and experience.

Launched in June 2022, TRxA is a global drug discovery and development accelerator focused on supporting academic scientists in defining optimal strategies for advancing new, cutting-edge small molecule therapeutics from the lab to patients. TRxA leverages C-Path’s expertise in translational and regulatory science to provide vital funding and drug development expertise to support its grantees in developing comprehensive data packages for potential drug candidates, a key to garnering interest from biotechnology and pharmaceutical companies to invest in clinical trials.

Dr. Jake Reder, Co-founder, and Chief Executive Officer of Celdara Medical, expressed his enthusiasm for the collaboration, stating, "At Celdara Medical, we advance therapies with the potential to make a meaningful difference in the lives of patients. This collaboration with TRxA will improve the efficiency of both organizations, expanding complementary access to our respective innovation pipelines."

Dr. Julie Coleman, Director at Celdara Medical, added, "This MOU reflects our shared commitment to breaking down barriers in drug development. By sharing resources and expertise with TRxA, we are poised to make significant strides in identifying important inventions and advancing treatments for patients with urgent medical needs."

Dr. Maaike Everts, Executive Director of C-Path’s TRxA, also shared her perspective on the collaboration, stating, "Drug discovery and development is a team sport; many types of expertise, funding models and organizations need to come together to mature an idea coming out of an academic institution into a therapy available to patients. I am very excited to work together with Celdara Medical to find the best environment and expertise needed to ensure our best and brightest ideas get nurtured into new medicines. The exchange of information under this MOU will be a great benefit to the scientists who approach us with their ideas for novel drugs."

The MOU between Celdara Medical and C-Path highlights the significance of collaboration and information sharing in delivering innovative therapies to patients. Together, the two organizations are committed to improving healthcare worldwide.

On November 29, 2023 Biolexis Therapeutics, Inc., a clinical stage AI-driven drug discovery company, reported the successful closure of a $10 million Series A funding round (Press release, Biolexis Therapeutics, NOV 29, 2023, View Source [SID1234638038]). The investment was led by Clarke Capital, a prominent institutional investor and alternative investment firm.

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The new funding will advance Biolexis’ development pipeline which includes a range of promising metabolic drug candidates. These drugs have the potential to tackle various metabolic disorders that affect millions of people worldwide and are linked to significant health complications such as obesity and diabetes.

"This financial backing from Clarke Capital is a testament to the potential of our metabolic drug portfolio," said David Bearss, CEO of Biolexis. "Our science is on point and our team is ready to tackle the unmet needs within the metabolic disorder spectrum. With Clarke Capital’s support, we’re in a strong position to accelerate our drug development pipeline and move closer to bringing our solutions to patients."

The Series A funding marks a significant milestone for Biolexis but also marks Clarke’s return to partner with Drs. Bearss and Vankayalapati, having been a major investor in their first company, Montigen Pharmaceuticals, a decade and a half ago before it was sold to a publicly traded company. The reteaming will allow the company to expand its operations and accelerate the clinical development of its key drug candidates. With the prevalence of metabolic diseases on the rise and current treatments in limited supply, the need for new and effective treatment options is more urgent than ever.

"At Clarke Capital, we’re committed to investing in companies poised to make a significant impact on healthcare," said James Clarke, CEO of Clarke Capital. "Biolexis’ impressive approach to addressing metabolic disorders and other treatment-resistant conditions has the potential to change lives. We are overjoyed to support their mission and look forward to seeing the results of their groundbreaking work."

To date, Drs. Bearss and Vankayalapati have filed more than 20 Investigational New Drugs (INDs) and have secured more than 100 patents. Using its unique AI-driven MolecuLern process, Biolexis has 40 active programs in discovery and 10 pipeline programs in the IND-enabling stages of development. The process, which targets any class of protein to identify novel chemical entities (NCEs) with drug-like characteristics and real wet-lab data validation, reduces the discovery and development timeline from years to months.

On November 29, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that it will host an Investor Event at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego and via webcast at 8:00 PM PST on December 10, 2023 (Press release, BeiGene, NOV 29, 2023, View Source [SID1234638037]). This event will cover BeiGene’s R&D progress and broad hematology portfolio, with invited speakers presenting key data from the ASH (Free ASH Whitepaper) 2023.

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A live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source Archived replays will be available for 90 days following the event.

On November 29, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported positive new data for tabelecleucel (tab-cel or EBVALLO) in patients with relapsed or refractory (r/r) or treatment-naïve Epstein-Barr virus-positive post-transplant lymphoproliferative disease involving the central nervous system (CNS) (EBV+ CNS PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) (Press release, Atara Biotherapeutics, NOV 29, 2023, View Source [SID1234638036]). These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.

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The clinical experience from this combined analysis of four single-arm, open-label studies, including the multicohort Phase 2 EBVision trial (NCT04554914, n=4) expands on previous data from two single-center, Phase 2 studies (NCT00002663, n=10; NCT01498484, n=2), and multicenter, expanded-access protocol (NCT02822495, n=2).

"EBV+ CNS PTLD is a rare but extremely serious disease, and patients often face a poor prognosis that underscores the urgent medical need," said AJ Joshi, M.D., Executive Vice President, Chief Medical Officer at Atara. "We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting. Tab-cel shows a strong objective response rate in these high-risk patients with a favorable safety profile for patients with EBV-driven diseases."

In this pooled analysis, a total of 18 patients, including one previously untreated patient, with EBV+ CNS PTLD received cycles of three weekly infusions of tab-cel at ~2×106 cells/kg. Key endpoints were objective response rate (ORR), overall survival (OS), and safety parameters. Patients received a median (range) of 1 (0 to 5) lines of prior therapy.

An ORR of 77.8% (14/18) was observed in all patients (95% CI: 52.4, 93.6), with a best overall response of Complete Response (CR; 38.9%; n=7) or Partial Response (PR; 38.9%; n=7). The median time to response (TTR) in all patients was 1.8 months (range: 0.7–6.4).

The estimated one-year overall survival (OS) rate was 70.6% (95% CI: 43.0, 86.6) for all patients. The one-year OS rate for responders was 85.7% versus 0% for non-responders.

Tab-cel was well-tolerated. No reports of serious treatment-emergent adverse events, including neurotoxicity, organ rejection, graft versus host disease, or tumor flare reaction of any grade, were identified related to tab-cel.

Detailed results on baseline demographics, disease characteristics, best overall response, OS, and additional safety data including tab-cel exposure details, will be presented on December 7 in the Proffered Paper Session 2.

Oral Presentation Details:
Title: Clinical Experience of Tabelecleucel in Epstein-Barr Virus-Positive Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Involving the Central Nervous System
Presenting Author: John Patton, M.D., Ph.D., James Comprehensive Cancer Center, The Ohio State University, Columbus, OH
Date & Time: December 7, 2023, at 2:15 – 3:45 p.m. CET / 5:15 – 6:45 a.m. PST
Presentation Number: 49O
Session: Proffered Paper Session 2
Location: Palexpo Congress Centre, Room B

On November 28, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the successful completion of the first stage of cohort 3 of the Phase I/IIa theranostic trial, SECuRE, evaluating 64Cu/67Cu-SAR-bisPSMA in patients with mCRPC where 3 participants have been treated at the highest dose level of 12GBq of 67Cu-SAR-bisPSMA (Press release, Clarity Pharmaceuticals, NOV 29, 2023, View Source [SID1234638003]). No adverse events were reported in relation to 64Cu-SAR-bisPSMA. Only 1 adverse event was reported and related to the 12GBq cycle of 67Cu-SAR-bisPSMA in 1 of the 3 participants, which was a grade 1 decrease in neutrophil count, and the patient has fully recovered. No ongoing adverse events and no DLTs have been reported and the SRC has recommended the trial progresses with the 3 additional participants as planned in cohort 3.

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

Cohort 3 of the trial has a 3+3 study design with the intent to gather and analyse data from the first 3 participants before progressing with an additional 3 participants. The initial data is very encouraging with no DLTs observed at the highest dose of 67Cu-SAR-bisPSMA (12GBq) and the SRC, responsible for assessing safety of participants and overseeing the general progress of the trial, has assessed the data and recommended the trial continues.

Cohort 3 is the last to assess single doses of 67Cu-SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation. The initial 3 participants in cohort 3 were heavily pre-treated prior to entering the trial, having received multiple lines of therapy including other investigational products, radioligand therapy and chemotherapy. They continue to be monitored by their physicians for safety and treatment response as per the trial protocol. All 3 participants in cohort 3 remain on the trial following their recent administration of 12GBq of 67Cu-SAR-bisPSMA, with 2 demonstrating a PSA reduction within weeks of dosing, one of which is greater than 90% reduction and the second approximately 40% reduction to date.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are excited by the PSA declines seen in almost all patients to date in cohorts 2 and 3 from just a single cycle. This result is also seen in patients that have been heavily pre-treated and have failed many other therapies that are either commercial or investigational. Moreover, the safety profile is very favorable and there have been no DLTs reported to date.

"SAR-bisPSMA was designed to be a best-in-class PSMA product as, unlike all other PSMA products in the market, it has dual targeting. The product was optimised to address the challenges of low uptake and retention in lesions that the first generation of PSMA products suffer from, and in both pre-clinical and clinical development to date we have observed two to three times the uptake of SAR-bisPSMA in lesions, followed by retention in lesions out to at least 96 hours. So far, the higher uptake and retention of product, coupled with the advantageous properties of copper-67, has shown quite impressive responses measured by PSA reductions in patients from single cycles of product to date.

"A number of patients from the SECuRE trial have either received, or will soon receive, additional doses of 67Cu-SAR-bisPSMA under the US Food and Drug Administration’s (FDA) Expanded Access Program (EAP). This demonstrates the initial clinical benefit observed in such patients after the administration of a single cycle of the product during the trial.

"As we have seen PSA reductions in the majority of patients after a single cycle of 67Cu-SAR-bisPSMA across all dose levels, which is known to be an independent prognostic indicator of improved overall survival following radio-ligand therapy2,3, we hope to achieve long-term and durable responses once we progress to the multi-dose cohorts of the trial. Furthermore, with commercial quantities of the 67Cu radioisotope now being routinely produced domestically in the US, we see a clear path to commercialisation as we can resolve the supply and manufacturing issues which have plagued the commercial launch of first-generation products. We look forward to sharing more data along with any further updates from patients who may receive single or multiple cycles of 67Cu-SAR-bisPSMA in our programs and bringing this product to the greater prostate cancer patient population," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide4. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease5.