On March 14, 2023 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that two abstracts on mRNA-4157/V940 an investigational mRNA personalized cancer vaccine, have been accepted for presentation at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-19 in Orlando, FL (Press release, Moderna Therapeutics, MAR 14, 2023, View Source [SID1234628702]). mRNA-4157/V940 is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

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The two abstract titles are:

Presentation #CT001: A personalized cancer vaccine, mRNA-4157, combined with pembrolizumab versus pembrolizumab in patients with resected high-risk melanoma: Efficacy and safety results from the randomized, open- label Phase 2 mRNA-4157-P201/Keynote-942 trial. Harnessing the Immune System in the Clinic.
Session: Clinical Trials Plenary; Sunday, April 16 at 1:00-3:00 PM ET.
Presenter: Dr. Jeffrey S. Weber
Poster Session #CT224: Evaluation of minimal residual disease as a predictive biomarker of recurrence free survival in high-risk melanoma patients treated with a combination of mRNA-4157, a personalized cancer vaccine, and pembrolizumab.
Session: Phase II Clinical Trials 2; Tuesday, April 18 at 9:00 AM – 12:30 PM ET.
Author: Dr. Ryan J. Sullivan
AACR will post the text of late-breaking and clinical trials abstracts in the AACR (Free AACR Whitepaper) Annual Meeting online itinerary planner and Annual Meeting app on April 14, 2023 at 12:00 PM ET.

Moderna’s exhibit booth at the AACR (Free AACR Whitepaper) Annual Meeting is booth #2664.

About mRNA-4157/V940

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient’s tumor. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

mRNA-4157/V940 is being developed in combination with KEYTRUDA. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

Moderna and Merck plan to initiate a Phase 3 study in adjuvant melanoma in 2023 and expect to rapidly expand to additional tumor types, including non-small cell lung cancer.

On March 14, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in Orlando from April 14-19, 2023 (Press release, Kura Oncology, MAR 14, 2023, View Source [SID1234628701]).

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"We look forward to presenting preclinical data supporting the combination of farnesyl transferase inhibitors (FTIs) with KRASG12C inhibitors and tyrosine kinase inhibitors at this year’s AACR (Free AACR Whitepaper) Annual Meeting," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "These data add to the emerging body of evidence supporting the potential to use FTIs as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy. We recently announced FDA clearance of the Investigational New Drug application for our next-generation farnesyl transferase inhibitor, KO-2806, which was designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates, and we look forward to initiating our FIT-001 Phase 1 trial with KO-2806 later this year."

Session titles and information for the two abstracts are listed below and are now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Combination of tipifarnib with KRASG12C inhibitors to prevent adaptive resistance 
Session Category / Title: Clinical Research Excluding Trials / Precision Molecular Subtyping and Therapeutic Development
Session Date and Time: Sunday, April 16, 2023; 1:30 PM – 5:00 PM ET
Location: Orange County Convention Center, Poster Section 43
Abstract / Poster: 1079 / 23

Tipifarnib synergizes with TKIs in clear cell renal cell carcinoma models
Session Category / Title: Clinical Research Excluding Trials / Precision Molecular Subtyping and Therapeutic Development
Session Date and Time: Sunday, April 16, 2023; 1:30 PM – 5:00 PM ET
Location: Orange County Convention Center, Poster Section 43
Abstract / Poster: 1071 / 15

Copies of the presentations will be available on Kura’s website at View Source following presentation at the meeting.

On March 14, 2023 ImCheck Therapeutics reported that it will present data from its Phase I/IIa clinical trial EVICTION-2 in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, ImCheck Therapeutics, MAR 14, 2023, View Source [SID1234628700]). The EVICTION-2 trial is evaluating the combination of ImCheck’s lead program, ICT01, a γ9δ2 T cell-activating monoclonal antibody targeting BTN3A, combined with low dose IL-2, to selectively expand the number of γ9δ2 T cells in relapsed/refractory patients with solid tumors. The conference will be held in Orlando, Florida, from April 14 to 19, 2023, and clinical trial abstracts will be posted online on April 14.

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Details of the poster presentation are:

Abstract title: "First-in-Human Study of ICT01, an Anti-BTN3A Activating Monoclonal Antibody in Combination with Low Dose IL-2 in Patients with Advanced Solid Tumors (EVICTION-2 Study)"
Session title: First-in-Human Phase I Clinical Trials 2
Abstract number: CT179
Authors: Johann de Bono, Stéphane Champiat, Francois-Xavier Danlos, Martin Wermke, Volker Kunzmann, Aude De Gassart, Emmanuel Valentin, Marina Iché, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Aurélien Marabelle, Daniel Olive, Paul Frohna
Date/Time: Tuesday Apr 18, 2023 9:00 AM – 12:30 PM Eastern Time
Location: Poster Section 45
Poster Board Number: 11

On March 14, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported that Beyond Cancer, Ltd. will present two posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, which is scheduled to be held April 14-19 in Orlando, Florida (Press release, Beyond Air, MAR 14, 2023, View Source [SID1234628699]).

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Details of the poster presentations are as follows:

Title: Intratumoral administration of ultra-high concentration nitric oxide (UNO) is more efficacious than anti-PD1 therapy in 4T1 tumor-bearing mice
Session Category: Immunology
Session Title: Anticancer Immunotherapeutics
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM – 12:30 PM EDT
Location: Orange County Convention Center, Poster Section 22
Poster Board Number: 3
Abstract Number: 6327
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer, Ltd.

Title: Short-term exposure of cancer cells to ultra-high concentrations of nitric oxide (UNO) induces PD-L1 upregulation
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM – 12:30 PM EDT
Location: Orange County Convention Center, Poster Section 23
Poster Board Number: 7
Abstract Number: 6363
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer, Ltd.

Please note that the proffered abstracts accepted for presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2023 were released publicly at 4:30 PM EDT today, March 14, 2023.

About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.

On March 14, 2023 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), reported its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients (Press release, Bellicum Pharmaceuticals, MAR 14, 2023, View Source [SID1234628698]). The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid.

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The most recent patient treated in the Phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer (mCRPC) experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome (CRS), the second dose-limiting toxicity observed in this cohort of dose escalation. The company paused enrollment in its clinical studies and conducted a thorough review of the risk/benefit observed to date. While clinically meaningful efficacy has been observed—including 5 of 9 mCRPC patients treated achieving PSA50 response, 4 of whom achieved PSA90 response—the Company believes it does not have the necessary resources to optimize either the clinical dose and schedule of BPX-601 cells and the activating agent rimiducid, or the design of the BPX-601 cell construct to achieve a favorable risk/benefit profile.

The Company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the Company’s strategic alternatives is underway.

More information about Bellicum can be found at www.bellicum.com.