On October 9, 2023 Ossium Health reported that Kevin Caldwell, CEO, Co-Founder & President, will present at the annual Cell & Gene Meeting on the Mesa to be held October 10-12 in Carlsbad, California and live streamed globally (Press release, Ossium Health, OCT 9, 2023, View Source [SID1234635731]).

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Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.

Kevin will provide attendees with a first glimpse inside Ossium’s landmark clinical study recently launched in collaboration with the National Marrow Donor Program (NMDP) / Be The Match. This study’s initiation serves as a major milestone for the blood cancer community as it will provide safety and efficacy data on Ossium’s bone marrow and unlock a new source of on-demand bone marrow for patients. In addition, Kevin will provide an update on Ossium’s phase 1 study of allogeneic bone marrow-derived cell therapy for the treatment of steroid-refractory acute graft versus host disease and Ossium’s upcoming launch of OssiGraft, a next-generation viable bone allograft.

The following are specific details regarding Ossium Health’s presentation at the conference:

Event: 2023 Cell & Gene Meeting on the Mesa

Date: Wednesday, October 11, 2023

Time: 5:15 – 5:30 pm Pacific Time

Location: Ecolab Life Sciences Ballroom
Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011

Virtual attendance is available which includes a livestream of Ossium Health’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Savannah Bryant at [email protected] and interested media should contact Stephen Majors at [email protected].

On October 9, 2023 Circle Pharma, a biopharmaceutical company advancing the discovery and development of intrinsically cell-permeable macrocycles, reported an upcoming poster presentation 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), taking place from October 11-15, 2023, in Boston, MA (Press release, Circle Pharma, OCT 9, 2023, View Source [SID1234635730]).

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Details of the presentation are as follows:
Title:

Novel orally bioavailable macrocycles that target cyclin A and B elicit antitumor activity in breast cancer patient-derived xenograft models

Presenter:

Mariana Paes Dias, Vall d’Hebron Institute of Oncology, Barcelona, Spain

Abstract Number:

LB_C04

Session:

Poster Session C

Date/Time:

Saturday, Oct. 14, 12:30-4:00 p.m.

ABOUT CIRCLE PHARMA’S CYCLIN A/B INHIBITOR PROGRAM

Circle Pharma has developed an orally bioavailable macrocycle with dual cyclin A and B inhibitory activity that drives synthetic lethality in multiple tumor types. In biochemical and cellular studies, Circle’s cyclin A/B inhibitor has been shown to potently and selectively disrupt the protein-protein interaction between Cyclins A and B and their key substrates, including E2F (a substrate of Cyclin A) and Myt1 (a substrate of Cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B inhibitors to cause pronounced tumor regression in multiple xenograft models. Circle Pharma plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for its clinical candidate, CID-078, and initiate clinical development in 2024.

On October 9, 2023 Foundation Medicine Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options (Press release, Foundation Medicine, OCT 9, 2023, View Source [SID1234635729]).

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This announcement marks Foundation Medicine’s fifth pan-tumor approval in the U.S. for FoundationOne CDx, the only tissue test with multiple biomarkers approved as a tumor agnostic companion diagnostic in the U.S., including TMB and NTRK1/2/3. It also marks Foundation Medicine’s ninth approved companion diagnostic indication across 7 different fusion genes (ALK, ROS1, NTRK1, NTRK2, NTRK3, FGFR2, and now RET.)

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor, which allows a tailored treatment approach and will determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, which occur in less than two percent of solid tumors1. The test currently has over 30 companion diagnostic indications, ranging from lung, breast, prostate, colon, and other solid malignancies.

"With a growing need for solutions for patients with rare fusions, high-quality companion diagnostics provide critical information to support oncologists in the development of personalized treatment plans," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "With our experience successfully navigating the complexities of a pan-tumor approval, we’re proud to have another companion diagnostic for our FDA-approved tissue test that can help enable broader access to an important therapy option for RET-fusion positive solid tumors. We appreciate this meaningful collaboration with Lilly to help bring more treatment options to patients facing a cancer diagnosis."

"One of our top priorities is helping people living with lung cancer access the best treatment possible and this approval marks a milestone on the path to developing highly personalized care for them," said GO2 for Lung Cancer President & CEO Laurie Ambrose. "We are encouraged by the expanded access and options they will receive and are confident this will positively impact the lives of people living with cancer and their loved ones."

Foundation Medicine is the global leader in companion diagnostic approvals. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing. This companion diagnostic approval is the latest in a series of collaborative efforts between Foundation Medicine and Lilly.

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

Retevmo is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

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."

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]).

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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