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NEXT Oncology and MediLink Therapeutics Take “Team Approach” to Next Level on Phase 1 First in Human Clinical Trial in San Antonio

On October 9, 2023 MediLink Therapeutics reported the company and NEXT Oncology are collaborating on a Phase 1 First in Human Clinical trial for an antibody drug conjugate (ADC) that shows great promise to mitigate solid tumor cancer with an innovative approach to teamwork (Press release, MediLink Therapeutics, OCT 9, 2023, View Source [SID1234635728]).

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The Phase 1 study, which measures both dosing and safety, is examining MediLink’s YL201 ADC platform and its ability to reduce or stabilize tumors that have not responded to currently approved treatments.

With this cancer study, the two organizations are changing the way that sponsors and research organizations work together to intentionally maximize the benefits of collaboration and shorten drug development time to bring therapies to patients in need faster.

As the trial proceeds, the companies dialogue on patient progress and outcomes instantaneously, so there is a real time exchange of information and a collaboration that is atypical in most research / sponsor relationships. In addition, there is a "bench to bedside and back" approach using proprietary, curated technology, enabling both teams to shorten the timeline of drug development with real-time sharing of information.

MediLink’s YL201 ADC could hold the potential to improve the quality of life of patients, with a higher efficacy and fewer toxic side effects when compared to other therapeutics. The first in human trial kicked off in June, 2022 and NEXT Oncology has treated five patients so far. MediLink Therapeutics intends to expand its collaboration with NEXT Oncology as the company’s future drug TMALIN platforms are ready to come to clinic.

"We selected NEXT Oncology for our South Texas study because of their deep experience in ADCs, and capabilities with first in human Phase 1 trials," commented Sasha Stann, MediLink’s Senior Director of Clinical Operations and Project Management. "We are amazed with the way this program is unfolding. NEXT Oncology keeps us informed every step of the way and the collaboration is at a level we’ve rarely seen. With partners like NEXT, we will solve cancer together."

"We are on a mission to solve cancer, and when traditional therapies don’t provide results, we are the NEXT Option in care," Dr. Anthony Tolcher, NEXT Oncology’s CEO and Founder stated. "Having a hand in this promising drug platform, delivering this opportunity to patients and working with MediLink Therapeutics is the exemplification of our shared mission."

Coeptis Therapeutics to Participate in Panel at the BioFlorida Conference Discussing Emerging Cell and Gene Therapies

On October 9, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that Dan Yerace, Director and Vice President of Operations, will participate in a panel titled, "Ambitious Innovation: Emerging Cell and Gene Therapies," at the BioFlorida Conference on Thursday October 12th from 11:50 AM-12:50 PM (Press release, Coeptis Therapeutics, OCT 9, 2023, View Source [SID1234635727]).

Details of the panel discussion are as follows:

Event:

BioFlorida Conference

Date & Time:

October 12, 2023, at 11:50 AM, EDT

Panel Title

Ambitious Innovation: Emerging Cell and Gene Therapies

Location:

Sawgrass Marriott Golf Resort & Spa, Ponte Vedra Beach, FL

Coeptis Therapeutics to Participate in Panel at the BioFlorida Conference Discussing Emerging Cell and Gene Therapies

Details of the panel discussion are as follows:

Event:

BioFlorida Conference

Date & Time:

October 12, 2023, at 11:50 AM, EDT

Panel Title

Ambitious Innovation: Emerging Cell and Gene Therapies

Location:

Sawgrass Marriott Golf Resort & Spa, Ponte Vedra Beach, FL

TransThera announces two oral presentations of tinengotinib clinical data at 2023 ESMO and SABCS annual meetings

On October 9, 2023 TransThera Sciences (Nanjing) Inc., a clinical-stage biopharmaceutical company focused on inventing differentiated drugs for global patients, reported to deliver two oral presentations of tinengotinib clinical data in cholangiocarcinoma (CCA) at 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, and in breast cancer at 2023 San Antonio Breast Cancer Symposium (SABCS) annual meeting respectively (Press release, TransThera Biosciences, OCT 9, 2023, View Source [SID1234635725]). TransThera will also give a poster presentation of tinengotinib phase 1b/2 clinical data in Chinese patients at 2023 ESMO (Free ESMO Whitepaper).

2023 ESMO (Free ESMO Whitepaper), October 22-24, Madrid, Spain

Mini-Oral Presentation, Abstract #95MO
Title: Tinengotinib in Patients with Advanced, Fibroblast Growth Factor Receptor (FGFR) inhibitor Refractory/Relapsed Cholangiocarcinoma
Presenter: Meredith S Pelster, MD

Poster presentation, Abstract #670P
Title: Preliminary Efficacy and Safety of Tinengotinib (TT-00420) Monotherapy in Chinese Patients (pts) with Advanced Solid Tumors: Results from a Phase Ib/II Study
Presenter: Jean Fan, MD

2023 SABCS, December 5-9, San Antonio, TX, US.

Rapid-Fire Mini-Oral Presentation, Abstract #1572754
Title: The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2- breast cancer or TNBC

"We are thrilled that tinengotinib clinical data has been selected for multiple oral and poster presentations in these impactful global scientific meetings. " Commented Dr. Frank Wu, chairman and CEO of TransThera, "It is a strong recognition from the community to tinengotinib as a very novel compound in global phase 3 development, capable of demonstrating efficacy in a variety of solid tumors with significant unmet medical needs. The upcoming presentations mark the potential of tinengotinib in CCA and breast cancer. We look forward to more discussions next year in other indications!"

About tinengotinib

Tinengotinib is a global innovative clinical-stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan-Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China.

Hansa Biopharma announces encouraging high-level results for first-in-human trial of HNSA-5487

On October 9, 2023 Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, reported high-level results from NICE-01, the first-in-human trial for HNSA-5487 (Press release, Hansa Biopharma, OCT 9, 2023, View Source [SID1234635724]). Results showed the molecule was safe and well tolerated. Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects. Pharmacokinetics (PK) was in line with expectations and pharmacodynamics (PD) (efficacy on IgG cleavage) showed a fast and complete cleavage of IgG to F(ab’)2- and Fc-fragments with increasing doses.

NICE-01 is a double blind, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of HNSA-5487 administered as a single intravenous (IV) infusion. The trial included a total of 36 healthy male and female adult participants.

HNSA-5487 is the company’s lead candidate in the Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NiceR) program. The NiceR program aims to develop next-generation enzymes with lower immunogenicity that would potentially allow for repeat dosing in a range of indications including IgG-driven autoimmune diseases where patients experience flares, transplantation where repeat dosing would be beneficial, gene therapy and oncology.

Søren Tulstrup, President and CEO, Hansa Biopharma said, "This is encouraging data as we continue to explore the potential for HNSA-5487 and better understand how this powerful, new enzyme could benefit patients and clinicians. An enzyme with lower immunogenicity would potentially enable repeat dosing, allowing a prolonged effect by flexibly extending the IgG-free window depending on the number of repeated infusions. This could enable innovative treatment approaches in a broad range of indications, and benefit patients with diseases where a prolonged IgG-free window is needed".

Analysis of additional exploratory endpoints on IgG recovery and immunogenicity is now being conducted, with follow up on all subjects for 12 months. This analysis will serve as key input in determining the further clinical development program, including selection of indications.