On September 14, 2023 Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company will present at the Pareto Securities Healthcare Conference, Today, September 14, at 12.55 CET (Press release, Medivir, SEP 14, 2023, View Source [SID1234635172]).

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CEO Jens Lindberg will give an updated presentation of the company following the recently presented promising interim results from the ongoing phase 1b/2a combination study with fostrox + Lenvima in primary liver cancer (HCC).

The presentation will be available after the meeting on Medivirs website; www.medivir.com.

On September 14, 2023 Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting edge antibody technology innovation and provider of integrated antibody discovery and development solutions from "Idea to IND" (I to I), reported an agreement with BeiGene, Ltd. to expand the companies’ discovery strategic collaboration leveraging Nona’s proprietary Harbour Mice platform (Press release, Nona Biosciences, SEP 14, 2023, View Source [SID1234635171]).

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Through the collaboration, BeiGene will be granted access to Nona Biosciences’ proprietary fully human transgenic mice platform Harbour Mice. Previously, in 2018, BeiGene obtained rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programs. This expanded collaboration between Nona and BeiGene will extend to the Harbour Mice HCAb (heavy chain only antibody format) platform to further improve therapeutic antibody discovery efficiency and flexibility.

"We are delighted to broaden our collaboration with BeiGene on antibody discovery. Our platform has enabled biotechnology and pharmaceutical companies as well as academia to accelerate innovative drug discovery for more than a decade. BeiGene has been a long-term partner for us, and partnership expansion is emblematic of Nona’s accumulated knowledge and expertise in drug discovery," said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences.

On September 14, 2023 Dizal reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for golidocitinib for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (Press release, Dizal Pharma, SEP 14, 2023, View Source [SID1234635170]).

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"We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023," said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile. We believe it will provide a much-needed treatment option for patients with this challenging disease. At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases."

The JAK/STAT signaling pathway plays a vital role in the pathogenesis and progression of various hematologic malignancies, including T-cell malignancies. Golidocitinib, as the first and currently the only JAK1-only inhibitor in the NDA stage for r/r PTCL, shows promising potential in inhibiting tumor growth and proliferation by targeting the JAK/STAT pathway.

The NDA submission for golidocitinib is supported by data from the JACKPOT8 PARTB study, a multinational, pivotal study to evaluate the efficacy and safety of golidocitinib in patients with r/r PTCL. The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%. Anti-tumor efficacy was observed across different PTCL subtypes and irrespective of the patients’ prior treatment history. The majority of treatment-related adverse events (TRAEs) could be monitored and well managed in the clinic. These findings highlight the superior efficacy and safety of golidocitinib, positioning it as a potential breakthrough therapy for patients with r/r PTCL. Furthermore, the clinical significance of golidocitinib has been widely acknowledged at prestigious conferences such as ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper), ICML, and ASH (Free ASH Whitepaper) with five oral presentations for four consecutive years. Recently, the Phase I clinical data of golidocitinib for the treatment of r/rPTCL (JACKPOT8 PARTA) was published in the esteemed peer-reviewed journal, Annals of Oncology (Impact Factor: 51.8).

About golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3% and a CRR of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).

On September 14, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported a safety and patient dosing update from two Phase 1 clinical trials investigating DVX201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection (Press release, Coeptis Pharmaceuticals, SEP 14, 2023, View Source [SID1234635169]). DVX201 is a novel allogeneic, unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells.

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Interim data from both trials involving 16 patients and 23 infusions of DVX201 indicate that the NK cell therapy is well-tolerated with no dose limiting toxicities (DLTs), cytokine release syndrome (CRS) or infusion toxicities observed thus far through the highest dose level. The Phase 1 clinical trial investigating DVX201 in patients with hospitalized COVID-19 infection (NCT04900454) has completed the three dosing cohorts (3+3 design), enrolling a total of nine patients each receiving a single infusion. DVX201 was tolerated at all dosing levels.

The Phase 1 trial investigating DVX201 in relapsed/refractory AML or high-risk MDS (NCT04901416) has safely dosed a total of seven subjects each receiving two infusions (14 total). The trial is expected to enroll three to five additional patients who will be infused at the highest dosing level. Coeptis expects to report topline safety and efficacy data from the full patient population in the first quarter of 2024.

"The excellent safety results to date for DVX201 across two trials with distinct patient populations, including 16 patients and 23 infusions, is extremely encouraging and represents a major step for this first in-human use of an allogeneic NK cell therapy derived from pooled donor CD34+ HSPCs," said Colleen Delaney, MD, Chief Scientific and Medical Officer. "DVX201, a pooled donor product, represents a truly novel manufacturing platform, and these preliminary safety results give us confidence as we continue enrolling the highest dose cohort, which should total seven subjects for 14 infusions for the remaining portion of the Phase 1 trial in relapsed/refractory AML and high risk MDS. We anticipate receiving top line data for this trial in 1Q24."

On September 14, 2023 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that Ryvu’s licensee, the Menarini Group, will expand development of MEN1703 (SEL24) by initiating a new Phase II study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in addition to continued translational work in other hematologic indications (Press release, Ryvu Therapeutics, SEP 14, 2023, View Source [SID1234635168]).

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"We are excited to begin this Phase II study with our partner Menarini to address the critical unmet need in DLBCL," said Pawel Przewiezlikowski, co-founder, largest shareholder, and CEO of Ryvu Therapeutics. "The extensive preclinical evidence of MEN1703 activity in multiple types of lymphomas sets a promising foundation for evaluating the molecule’s potential in DLBCL, and we look forward to seeing this program continue to advance in the clinic."

The Phase II study, which will explore the activity of MEN1703 in combination with standard-of-care therapy in DLBCL and as a single agent, is being initiated based on strong preclinical activity of MEN1703 in lymphoma. MEN1703 has completed Phase II studies in relapsed/refractory AML, including an expansion cohort in IDH-mutated AML. The studies demonstrated an acceptable safety profile and early signs of single agent activity. Based on these data, development of MEN1703 will continue with focus on DLBCL and potentially other indications. AML will be deprioritized given the existing data and competitive landscape.

Under the terms of the license agreement executed in 2017, Menarini is the global development and commercial licensee. Ryvu remains a strategic partner through the existing Joint Steering Committee and will become an operational partner as part of an amended agreement to enable Ryvu to execute clinical studies on behalf of Menarini. Menarini will continue to be responsible for all research and development costs, including full reimbursement to Ryvu for study execution; the license and financial terms of the original agreement remain unchanged.

"DLBCL is an aggressive and difficult-to-treat type of non-Hodgkin lymphoma, and these patients have limited therapeutic options and face challenges in achieving sustained remissions," said Elcin Barker Ergun, CEO of the Menarini Group. "We are pleased to advance MEN1703 into clinical development and look forward to exploring its therapeutic potential in DLBCL as well as evaluating it in other promising indications."

About MEN1703 (SEL24)

MEN1703 (SEL24) is a clinical-stage program discovered and developed by Ryvu Therapeutics and licensed to the Menarini Group. MEN1703 is a first-in-class, dual PIM/FLT3 kinase inhibitor with a unique activity profile. By design, this profile may provide responses to treatment that are more durable than current options and address a disease that has progressed following FLT3 inhibition. Preclinical data suggests therapeutic potential in both hematological malignancies and in solid tumors. Ryvu has granted the Menarini Group an exclusive worldwide license to further research, develop, manufacture and commercialize MEN1703 (SEL24).

More information on the study at: View Source