On August 17, 2023 QiLu Pharmaceutical’s reported that iruplinalkib’s phase III clinical trial (INSPIRE) results were chosen for oral presentation at the 2023 World Conference on Lung Cancer (WCLC) (Press release, Qilu Pharmaceutical, AUG 17, 2023, View Source [SID1234634489]).

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The iruplinalkib INSPIRE study is a randomized, open, multi-center phase III clinical trial, designed to evaluate the efficacy and safety of Iruplinalkib (oral 180 mg, once daily; 60 mg once daily for the 7-day lead-in phase) versus crizotinib (oral 250 mg, twice daily) in patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have not previously received ALK TKI treatment. The primary endpoint is progression-free survival (PFS), as assessed by an Independent Review Committee (IRC). The leading investigator of the study is Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences. The study was carried out across 40 hospitals in China.

Between September 4, 2019, and December 2, 2020, a total of 292 patients were enrolled and randomized to treatment (iruplinalkib group 143; crizotinib group 149). The published results were based on an interim analysis of the study, reviewed by the Independent Data Monitoring Committee (IDMC) (data cut-off date: November 13, 2022). The median follow-up time for the iruplinalkib and crizotinib groups was 23.98 months and 24.54 months, respectively. The results showed that the primary endpoint PFS (per RECIST v1.1 by IRC) met the pre-defined criteria, and the PFS in iruplinalkib group was significantly improved compared to the crizotinib group, with median PFS of 27.70 months and 14.62 months, respectively (hazard ratio, 0.344 [98.02% confidence interval 0.226-0.523]). In terms of secondary endpoints such as duration of response (DoR) and control of intracranial disease, the results in iruplinalkib group were also superior to those from the crizotinib group. In this study, the safety of Iruplinalkib was consistent with the safety profile of previous studies. Iruplinalkib showed a good safety profile and no increased safety risk compared to crizotinib.

On June 28, 2023, the China National Medical Products Administration approved iruplinalkib tablets for market launch, for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have progressed or are intolerant to crizotinib. Currently, the new drug application for iruplinalkib as a first-line treatment for ALK-positive, advanced NSCLC patients has been submitted and accepted by China CDE. Iruplinalkib may be a new treatment option for patients.

On August 17, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that it has completed the exclusive license of key assets from Deverra Therapeutics Inc. ("Deverra") related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages (Press release, Deverra Therapeutics, AUG 17, 2023, View Source [SID1234634488]). The transaction enables Coeptis to further build its pipeline by adding a patented, elegant, and scalable allogeneic immune cell manufacturing platform that aligns with its existing SNAP-CAR and GEAR technologies, increasing the potential for accelerated product development.

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As a result of the transaction, Coeptis acquires exclusive rights to two Investigational New Drug (IND) applications and two assets in the Phase 1 clinical trial stage (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections. In addition, Coeptis augments its existing portfolio of cell therapy product candidates with a distinctly scalable allogeneic cellular immunotherapy platform that is being developed to generate and deliver off-the-shelf (no HLA matching), cost effective, on-demand cell therapies to a broad patient population.

In addition to the Phase 1 assets, this transaction equips Coeptis to begin infusing its existing pipeline assets with allogeneic technologies that are clinical stage-ready, helping to accelerate development efforts on targeted novel products, including potentially the development of allogeneic engineered NK and MAC cell therapies.

"Finalizing this transaction represents a pivotal transition of Coeptis into a clinical stage company with novel, synergistic and differentiated cell therapy pipeline candidates," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "As we move forward, I am excited to work with Colleen Delaney, MD, a visionary scientist whose career has been dedicated to researching and advancing all aspects of cell therapy product development. A true leader in the field, Colleen’s experience and leadership will be invaluable as we progress our expanded pipeline towards our ultimate goal of bringing improved treatments to patients in need."

Under the transaction, Coeptis paid to Deverra approximately $570,000 in cash and issued to Deverra 4,000,000 shares of Coeptis’ common stock.

On August 17, 2023 Immutep presented its investor presentation (Press release, Immutep, AUG 17, 2023, View Source [SID1234634486]).

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On August 17, 2023 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), reported that an abstract regarding tumor tissue analysis data from a clinical trial of MN-166 (ibudilast) in glioblastoma has been selected for poster presentation at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) to be held November 15 – 19, 2023 in Vancouver, British Columbia, Canada (Press release, MediciNova, AUG 17, 2023, View Source [SID1234634485]). The poster will be presented by MediciNova’s collaborator, Dr. Justin Lathia, Vice Chair in the Department of Cardiovascular and Metabolic Sciences and Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at the Lerner Research Institute at Cleveland Clinic; Professor, Department of Molecular Medicine at Case Western Reserve University School of Medicine; and Co-Leader, Molecular Oncology Program, Case Comprehensive Cancer Center.

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The presentation details are as follows:

Title: Immunohistochemistry evaluation on pre-treatment tumor tissue predicts treatment response to MN-166 (ibudilast) and Temozolomide combination therapy in glioblastoma patients
Session Name: Poster Session
Session Date: Friday November 17, 2023
Session Time: 7:30 PM – 9:30 PM

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On August 17, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported the publication of a peer-reviewed research paper in Science (Press release, Revolution Medicines, AUG 17, 2023, View Source [SID1234634484]). This original research was led by scientists at Revolution Medicines and conducted in collaboration with researchers from Memorial Sloan Kettering Cancer Center.

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The paper describes the Revolution Medicines tri-complex inhibitor approach to developing novel small molecules with high affinity and selectivity for the active state of mutant RAS, or RAS(ON), proteins that are common causes of human cancer and were previously considered undruggable. Specifically, it describes the creation of innovative, natural product-inspired, orally bioavailable small molecules, including the tool compound RMC-4998 and the clinical candidate RMC-6291. These compounds are shown to remodel the surface of the cellular chaperone cyclophilin A (CYPA) to create a neomorphic interface with affinity for active KRAS and achieve high selectivity for mutant KRASG12C via covalent, irreversible binding to the cysteine residue in the active state of this variant RAS protein that often drives formation of lung and colorectal cancers. KRASG12C(ON) trapped in these tri-complexes is sterically blocked from interacting with downstream effectors that transmit cancer-causing signals. Both RMC-4998 and RMC-6291 inactivate oncogenic signaling in KRASG12C-dependent tumor cells and drive deep and durable tumor regressions in human xenograft models of these cancers.

"This research serves as preclinical validation of our tri-complex RAS(ON) inhibitor platform and confirms our ability to design potent, selective small molecules that target KRAS mutations in their active or ON state," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "These data provide the rationale for the RMC-6291 clinical program, our first mutant-selective RAS(ON) inhibitor to enter clinical development, which is currently underway. We look forward to sharing a preliminary report of the clinical profile for RMC-6291 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Triple Meeting) in October 2023."

The investigational agent RMC-6291, an oral, selective, covalent inhibitor of KRASG12C(ON) designed to treat patients with cancers driven by the KRASG12C variant, is the first of the company’s mutant-selective RAS(ON) inhibitors to enter clinical development and the first reported clinical-stage inhibitor of KRASG12C that uses this highly differentiated mechanism of action. Revolution Medicines is currently evaluating RMC-6291 as monotherapy in a Phase 1/1b trial in patients with advanced KRASG12C mutant solid tumors (NCT05462717).

The manuscript published In Science is entitled, "Chemical remodeling of a cellular chaperone to target the active state of mutant KRAS" and can be accessed at View Source