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Aprea Therapeutics Announces Twice Daily (BID) Dosing of Patients in ABOYA-119 Clinical Trial of ATRN-119 to Potentially Optimize Clinical Outcomes and Strengthen Clinical Path Forward

On December 11, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision oncology company developing innovative therapies for cancers with specific genetic alterations to potentially minimize damage to healthy cells, reported that the first patient has been dosed at Dose Level 7, evaluating ATRN-119 550 mg twice daily, in the ongoing ABOYA-119 Phase 1/2a clinical trial (Press release, Aprea, DEC 11, 2024, View Source [SID1234649038]).

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The ABOYA-119 trial is evaluating ATRN-119 as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DNA damage response (DDR)-related genes. The study was initially designed to dose patients with ATRN-119 once daily and has tested doses of 50 to 800 mg to date. A protocol amendment allows for twice daily dosing, beginning with 550 mg twice daily (for a total daily dose of 1,100 mg). This strategic dose adjustment is driven by robust scientific evidence suggesting that more frequent dosing of ATRN-119 will maintain optimal therapeutic levels and potentially enhance the drug’s efficacy.

Twice daily dosing is expected to optimize ATRN-119’s activity across a 24-hour cycle thereby providing better target coverage and maximal benefit. This will increase the likelihood of achieving superior clinical outcomes and may potentially accelerate the path to regulatory approval and commercialization. It could also strengthen Aprea’s competitive positioning by addressing key pharmacokinetic and pharmacodynamic factors.

"The addition of twice daily dosing in the ABOYA-119 trial underscores Aprea’s commitment to delivering innovative treatments while continuously refining our approach based on the latest data and insights," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Twice daily dosing represents a proactive step to de-risk the trial, potentially increasing the probability of success. Importantly, it reflects our commitment to scientific excellence and we believe it positions the ATRN-119 program as a high-value asset that may be differentiated from other ATR inhibitors. To our knowledge, we believe ATRN-119 is the only ATR inhibitor in clinical development that is currently being tested as monotherapy on a continuous twice daily schedule. We believe this adjustment will further enhance shareholder value and support the long-term success of our mission."

Dr. Gilad added, "This approach not only enhances our development strategy but also creates new opportunities for partnership that could accelerate commercialization of ATRN-119 and expand patient access globally."

Anthony Tolcher, M.D., FRCPC, FACP, CEO of NEXT Oncology and Investigator in the ABOYA-119 trial commented, "Inhibition of ATR has emerged as a promising strategy for cancer treatment that exploits synthetic lethal interactions with proteins that are involved in DNA damage repair. This mechanism holds considerable promise for patients with difficult-to-treat cancers. We are pleased to continue to enroll our patients in this important study and recognize that a twice daily dosing regimen of ATRN-119 may allow us to maximize the therapeutic potential of the drug."

Dose escalation in the ABOYA-119 trial is expected to continue with both once-daily and the twice-daily dosing schedules, to be studied independently. The primary endpoint of the trial is the tolerability and pharmacokinetics of ATRN-119. Under the current updated protocol, Aprea anticipates the Phase 1 readout in the second half of 2025. For more information, please refer to clinicaltrials.gov NCT04905914.

About ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. Patients with DDR-related gene mutations have a poor prognosis and, currently, there are no effective therapies available for them.

Alpha Tau to Present at the 43rd Annual J.P. Morgan Healthcare Conference

On December 11, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 43rd Annual Healthcare Conference on Thursday, January 16, 2025 at 9:45am PT / 12:45pm ET, in San Francisco, CA, and will host institutional investor meetings at the event (Press release, Alpha Tau Medical, DEC 11, 2024, View Source [SID1234649037]).

Event: J.P. Morgan 43rd Annual Healthcare Conference
Format: Presentation and 1-on-1 Meetings
Date: January 16, 2025
Time: 9:45AM PT – 10:25AM PT
Location: Westin St. Francis, San Francisco, CA

Webcast: Link located on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source

Please reach out to your J.P. Morgan representative to schedule 1-on-1 meetings with Mr. Sofer and Mr. Levy.

Beroni Group Has Made Significant Progress in the Field of iNKT Cell Anti-tumor Therapy

On December 11, 2024 Beroni group reported that immune evasion has become one of the main obstacles in the development of tumor immunotherapy (Press release, Beroni Group, DEC 11, 2024, View Source [SID1234648997]). In the field of invariant natural killer T（iNKT） cell therapy, CD1d in cancer cells is the main tumor antigen presenting molecule that iNKT cells can recognize through its T cell receptor. The genetic and functional variability of CD1d in cancer cells has been considered an important factor in cancer immune evasion. In addition, the tumor specific proteins MUC4 and ITPRIPL1 expressed by refractory pancreatic cancer cells will also pose challenges such as protective immunity to iNKT cell therapy.

In order to unravel the problem of the molecular mechanism of immune evasion of cancer cells during the treatment using iNKT cells and improve the therapeutic effect of iNKT cells, the research team of Beroni Pharmaceutical (Guangdong) Co., Ltd. adopted an adeno-associated virus (AAV) adjuvant strategy to continuously target, identify and label pancreatic cancer cells to express exogenous CD1D-like molecules using our unique pancreatic cancer tropism AAV variant capsid and pancreatic cancer specific gene regulatory elements. By overcoming the challenge of immune evasion mechanism, this innovative AAV adjuvant strategy may significantly improve the effect of iNKT cell therapy and improve the prognosis of pancreatic cancer patients.

In addition, the research team also found that the persistence and recognition killing efficacy of iNKT cells in solid tumors are often constrained by weakened immune suppression mechanisms and unfavorable metabolic environments in the tumor microenvironment. To address this challenge, the research team has developed a metabolic reprogramming strategy for iNKT cells, which optimizes the metabolic health of iNKT cells to better alleviate the immunosuppressive effects of solid tumors caused by the tumor microenvironment. This groundbreaking approach is expected to revolutionize traditional solid tumor immune adoptive therapy by significantly enhancing the metabolic health and tumor killing persistence of iNKT cells.

The research team of Beroni Pharmaceutical (Guangdong) Co., Ltd. is seeking patents for both technologies mentioned above, which marks an important step forward for Beroni Group in developing and improving effective iNKT cell therapy. This marks an important milestone for Beroni Group to continuously expand upon our existing anti-cancer product line. The combination of these two cutting-edge technology is expected to create a new treatment option for advanced solid tumor patients.

Beroni Group will strive to promote clinical application of iNKT cell therapy through unremitting research and clinical development, ultimately to improve prognosis and quality of life bring in cancer patients.

Immutep Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer

On December 10, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the initiation of the pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC) (Press release, Immutep, DEC 10, 2024, View Source [SID1234649046]).

"The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company. This also represents a key step towards potentially establishing a new standard of care for patients with metastatic NSCLC. We are confident based on the strength of eftilagimod alfa’s data that it can make a meaningful difference in cancer patients’ lives, and we eagerly anticipate enrolling the first patient into this important study during the first quarter of 2025," said Marc Voigt, CEO of Immutep.

Immutep has successfully completed regulatory submissions to the vast majority of the more than 25 countries that will be part of the global TACTI-004 trial. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional approvals from multiple countries are expected in the weeks and months ahead.

The registrational TACTI-004 Phase III trial will evaluate eftilagimod alfa, a soluble LAG-3 protein that activates dendritic cells, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy compared to KEYTRUDA in combination with chemotherapy and placebo in ~750 metastatic 1L NSCLC patients, regardless of PD-L1 expression. The 1:1 randomized, double-blind, multinational, controlled study, with dual primary endpoints of progression-free survival and overall survival, will include over 150 clinical sites in over 25 countries across the globe.

The Company expects to enrol the first patient in Q1 of CY2025.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Orion Corporation Enters Collaboration With Evariste to Design Inhibitors of an Undisclosed Target

On December 10, 2024 Evariste, a TechBio using mathematics and AI to design small molecule therapeutics, reportedto have entered into a preclinical research agreement with Orion Corporation, a leading Finnish pharmaceutical company (Press release, Orion, DEC 10, 2024, View Source [SID1234649023]).

As part of the agreement, Evariste will use its innovative discovery platform, Frobenius Discovery, to design small molecule inhibitors for a target selected by Orion. The collaboration will deploy Frobenius Discovery’s full suite of proprietary machine learning algorithms, automated compound designers, and accelerated free energy calculations to deliver potential candidate molecules.

"We are excited to work together with Evariste in utilizing cutting-edge AI-driven molecular design and mathematical algorithms to accelerate our drug discovery process," said Emilia Väisänen, Head of Medicinal Chemistry at Orion.

Anna Hercot, CEO of Evariste, commented: "We are very excited to leverage the Frobenius Discovery platform and work with an outstanding team at Orion to help accelerate the delivery of new medicines to patients."