On September 14, 2023 Curasight A/S reported that the previously announced results from the investigator-initiated phase II study using uPAR-PET (uTRACE) in primary brain cancer have been presented in an oral presentation at the World Molecular Imaging Congress (WMIC) 2023 in Prague (Press release, Curasight, SEP 14, 2023, View Source [SID1234635173]).

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The oral presentation expanded on the topline results released earlier this year on June 29th and were presented in the session "Prospective Phase II Trial of [68Ga-NOTA-AE105] uPAR-PET/MRI in Patients with Primary Gliomas: Prognostic Value and Implications for uPAR-Targeted Radionuclide Therapy" by Dr. Aleena Azam from Rigshospitalet and University of Copenhagen. The abstract of the presentation will, together with the other abstracts presented at the WMIC, be published in an upcoming issue of the medical journal Molecular Imaging and Biology (Springer Publisher).

The Phase II study was carried out in 24 glioma patients, 22 with high-grade gliomas and 2 with low-grade gliomas. Of the high-grade gliomas, 16 were grade IV (Glioblastomas). All 24 patients underwent a uPAR-PET scan with 68Ga-NOTA-AE105 (uTRACE), and tumor uptake was evaluated as SUV values. The patients were followed over time to assess progression-free survival (PFS) and overall survival (OS). Patients were divided into high and low uPAR groups. Of the Glioblastomas 94% (15 of 16) were uPAR-PET positive. uPAR-PET was highly prognostic, and the high uptake group compared to the low uptake group had a more than 10-fold poorer prognosis (hazard ratio).

"We are proud that the investigator-initiated phase II trial in brain cancer was selected for an oral presentation at the World Molecular Imaging Congress in Prague. We believe this Phase II clinical data supports our focus on brain cancer and we will make every effort to move our theranostic strategy with uTRACE and uTREAT in these patients forward. The current poor prognosis in these patients and the need for better therapies make us committed to bring our technology fast forward to we hopefully will be able to help the patients to a better outlook and life.", said Ulrich Krasilnikoff, CEO of Curasight.

About high grade glioma and glioblastoma

Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. Curasight’s research and development efforts aim to address this challenge and improve the lives of patients facing aggressive brain cancer. Glioblastoma is the first indication for uTREAT, but uTREAT has also potential in several other cancer types expressing the biomarker uPAR. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed with the aggressive form, glioblastoma, annually in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive.

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."