On October 4, 2024 Oxcia reported that it has chosen to re-prioritize the clinical development of OXC-101 from solid tumors to hematological cancers, specifically acute myeloid leukemia (AML) (Press release, Oxcia, OCT 4, 2024, View Source;utm_medium=rss&utm_campaign=oxcia-is-focusing-the-development-of-oxc-101-on-hematological-cancers [SID1234647036]). The preclinical program for OXC-101 has shown good results in both AML and other forms of hematological cancers, and data to date from the phase I/II study MAATEO confirm the previous results. Oxcia has initiated an expansion part of the MAATEO study in patients with refractory/relapsed AML (R/R AML), where OXC-101 is administered in combination with idarubicin (an anthracycline).

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– The first AML patient to be treated with OXC-101 in an innovative combination treatment has recently been recruited, which is very exciting, says Oxcia’s CEO Ulrika Warpman Berglund. We aim to accelerate patient recruitment, for instance by including more study centers in AML, e.g. Rigshospitalet in Copenhagen. We are also working on an ODD (Orphan Drug Designation) application.

Biostock has today published an article describing Oxcia’s investment in AML and IPF, see Oxcias vd om satsningen på AML och lungfibros – BioStock (Oxcia’s CEO on the investment in AML and pulmonary fibrosis – BioStock – only available in Swedish)

Until now, OXC-101 has also been evaluated in the MASTIFF study, a phase I/II study in severely ill patients with an expansion group focused on advanced ovarian cancer and prostate cancer. OXC-101 demonstrated a clear clinically relevant effect, halting cancer growth in a majority of patients. At the same time, some patients suffered dose-limiting side effects in the form of neutropenia.

– Neutropenia means a decrease in neutrophil granulocytes, a type of white blood cell that is important for the immune system. We are now conducting preclinical studies to better understand these mechanisms. Next, we will investigate which doses, indications and patient groups we could proceed with in solid tumors. However, the focus of Oxcia’s development is on AML emphasizes CEO Ulrika Warpman Berglund.

On October 4, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, reported it will deliver an oral and a poster presentation on the company’s Immuno-STAT clinical assets CUE-101 and CUE-102, representative of the CUE-100 series, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 39th Annual Meeting (SITC 2024) (Press release, Cue Biopharma, OCT 4, 2024, View Source [SID1234647037]). The conference will be held in Houston, Texas, on November 6-10, 2024.

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Presentation Details
Title: A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer
Abstract Number: 649
Presenter: Dr. Christine Chung, Department Chair, Head and Neck Oncology, Moffitt Cancer Center
Session: Rapid Oral-Clinical 1
Date and Time: Friday, November 8, 2024, 12:30 p.m.–1:30 p.m. CST

Title: A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers
Abstract Number: 636
Presenter: Dr. Dae Won Kim, Moffitt Cancer Center
Session: Poster Session, Exhibit Halls A B George R. Brown Convention Center
Date and Time: Saturday, November 9, 2024, 9:00 a.m.–8:30 p.m. CST

All posters will be available to conference attendees as virtual e-posters on the virtual meeting platform on November 7, 2024, at 9 a.m. CST through January 7, 2025. The oral presentation and poster will also be available on November 8, 2024, in the Investor & Media section of the Company’s website at www.cuebiopharma.com, under Scientific Publications and Presentations.

On October 3, 2024 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported it will participate in Oppenheimer & Co. Inc.’s Targeted Radiopharmaceutical Therapies in Oncology Summit being held in New York City on Tuesday, October 8th, 2024 (Press release, NorthStar Medical Radiostopes, OCT 3, 2024, View Source [SID1234647021]). The meeting, Oppenheimer’s second annual event focused on issues, innovations and trends related to development and use of radiopharmaceuticals for treatment of cancer, will consist of topical panels, company presentations, opportunity for various one-on-one meetings and networking.

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Frank Scholz, Ph.D., President and Chief Executive Officer of NorthStar will take part, serving as an expert panelist in the session focused on "Supply Chain Challenges and Controversies – Ac-225 Availability, Pb-212 Logistics, The Last Mile" along with representatives from PharmaLogic, SpectronRx, and Perspective Therapeutics.

On October 3, 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 patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial (Press release, Immutep, OCT 3, 2024, View Source [SID1234647006]).

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The Phase II enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha ("efti") in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative.

Further updates will be provided after data collection, data cleaning, and analysis. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).

On October 3, 2024 OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, reported that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) has completed their final radiographical evaluation at 52 weeks and the treatment period for the clinical trial has now ended (Press release, OS Therapies, OCT 3, 2024, View Source [SID1234647022]). The Company is preparing to request a Type C Meeting with the U.S. Food & Drug Administration (FDA) and to make any protocol adjustments based on FDA’s recommendations. Following those adjustments, the Company will lock the clinical trial database in preparation for data analysis and topline data readout, expected to be announced in the fourth quarter of 2024.

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Concurrent with this announcement the Company announces that it will be ringing the closing bell at the New York Stock Exchange today. Company President and CEO Paul Romness is scheduled to give two interviews live on national television networks:

"B" Block in Market Movers on Fintech.TV at 9:10am on Thursday, October 3, 2024
Trading 360 on the Schwab Network at 11:30am on Thursday, October 3, 2024
OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with Osteosarcoma. The AOST-2121 Phase 2b clinical trial of 41 patients treated with OST-HER2 at 21 clinical trial sites across the United States is designed to demonstrate efficacy in patients who have already had recurrent metastatic disease to the lungs and are highly likely to continue to recur. A total of 16 OST-HER2 doses were administered once every three weeks, with a follow-up approximately four weeks after the final dose was administered, for a total of 52 weeks on study. Radiographic evaluation of recurrence occurred throughout the treatment period. The primary endpoints for the AOST-2121 study are Event Free Survival ("EFS"), defined as absence of recurrence of primary tumor or metastasis) at 12 months and Overall Survival (OS) at 36 months, with interim OS endpoints at 12 months, 18 months and 24 months. Topline EFS data, interim OS data, as well as additional secondary data analyses are expected to be reported in the fourth quarter of 2024.

The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T-cells that can eliminate or slow potential micro-metastases that can grow into recurrent Osteosarcoma. T-cell responses target HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent Osteosarcoma in the United States. There have not been any novel therapeutic interventions approved by the FDA in over 40 years.