On November 2, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will host a conference call and live webcast on Wednesday, November 9, 2022 at 8:30 am ET (5:30 am PT) to report third quarter 2022 financial results and provide recent corporate updates (Press release, Aadi Bioscience, NOV 2, 2022, View Source [SID1234622843]).

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Conference Call Information

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this Conference Registration (vevent.com). Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the website for at least 30 days.

On November 2, 2022 QuantuMDx Group Limited ("QuantuMDx"), a UK-based developer of transformational Point-of-Need molecular diagnostics, and A.Menarini Diagnostics S.r.I. (Menarini), reported an exclusive distribution agreement for QuantuMDx’s Q-POC platform in the UK and France (Press release, QuantuMDx, NOV 2, 2022, View Source [SID1234622842]).

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Under the terms of the agreement, Menarini will market, sell and service Q-POC, QuantuMDx’s SARS- CoV-2 assay and its new SARS-CoV-2, Flu A/B, RSV Respiratory Panel test which the Company launched earlier this year. The [five-year] agreement will initially cover distribution to the UK and France, with the scope to expand to other markets.

Jonathan O’Halloran, Chief Executive Officer, QuantuMDx, said: "This agreement with Menarini is a significant commercial step for QuantuMDx. Not only does Menarini have a vast global network, but their specific in-country knowledge and presence across Europe, and beyond, means they are an excellent partner for us. The agreement will allow us to further accelerate commercial sales of Q- POC, bringing our Point-of-Need multiplex molecular diagnostics platform to clinical and non-clinical settings in a host of new markets. I look forward to working closely with Menarini on what I am confident will be a very successful partnership."

Fabio Piazzalunga, Global Head, Menarini Diagnostics S.r.I., commented: "The recent pandemic has highlighted the importance of being able to accurately, and rapidly, diagnose infectious diseases. QuantuMDx’s Q-POC platform, which can provide results in approximately 30 minutes, will allow healthcare professionals to make informed treatment decisions and slow the risk of transmission. Menarini is a pioneer in decentralising diagnostics routines and developed core competencies and technologies in doing so. We are extremely happy to be able to start providing such an innovative platform to laboratories in the UK and France."

On November 2, 2022 PACT Pharma, Inc., a privately held biopharmaceutical company developing transformational personalized neoantigen-specific and off-the-shelf T cell receptor (TCR) T cell therapies for the eradication of solid tumors, reported that new data highlighting its first-of-its-kind adoptive T cell therapy platform will be featured in multiple presentations at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022) (Press release, PACT Pharma, NOV 2, 2022, View Source [SID1234622841]). The company, along with academic research collaborators, will deliver oral and poster presentations, including a late-breaking oral presentation, providing the latest clinical and preclinical findings from its pioneering research in the field of personalized neoantigen TCR T cell therapies. SITC (Free SITC Whitepaper) 2022 is being held November 8-12, 2022, in Boston, Massachusetts.

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Details of the company’s presentations at SITC (Free SITC Whitepaper) 2022 are as follows:

Late Breaking Oral Presentation #1478 (With Accompanying Poster):

Title: A Phase I Study of Personalized Adoptive TCR T Cell Therapy in Patients with Solid Tumors: Safety, Efficacy, and T Cell Trafficking to Tumors of Non-virally Gene Edited T Cells
Presenting Author: Stefanie Mandl, Ph.D., chief scientific officer, PACT Pharma
Category/Session: Late Breaking Abstract Session 103
Date/Time: Thursday, November 10, 2022, 11:10 a.m. – 11:40 a.m. Eastern
Location: Hall B2
Oral Presentation #123:

Title: Landscape Analysis of the Neoepitope-specific T Cell Responses in Patients with and without Clinical Benefit from Immune Checkpoint Blockade Therapy
Presenting Author: Cristina Puig Saus, Ph.D., adjunct assistant professor, University of California, Los Angeles
Category/Session: Rapid Oral Abstracts – Basic Science Session 104
Date/Time: Thursday, November 10, 2022, 12:25 – 12:33 p.m. Eastern
Location: 253ABC
Poster Presentation #320:

Title: Rapid Identification of a TCR Library Targeting the HPV E6/E7 Oncoproteins to Enable Multi-TCR T-Cell Therapies for Patients with HPV16+ Epithelial Cancers
Presenting Author: Stefanie Mandl, Ph.D., chief scientific officer, PACT Pharma
Category/Session: Cellular Therapies Poster Session
Date: Friday, November 11, 2022
Location: Poster Hall C
Poster Presentation #712:

Title: Retrospective Tumor Microenvironment Analysis from a Personalized neoTCR-T Cell Therapy Clinical Trial and Its Potential Applications for Off-the-Shelf HPV TCR T Cell therapies
Presenting Author: Chad Smith, Ph.D., associate director, bioinformatics, PACT Pharma
Category/Session: Clinical Trials in Progress Poster Session
Date: Friday, November 11, 2022
Location: Poster Hall C
Additional information on the 37th Annual Meeting of SITC (Free SITC Whitepaper) is available through the conference website at: View Source

On November 2, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported the first patient in Europe has been enrolled and dosed in France in the Company’s ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer (Press release, CNS Pharmaceuticals, NOV 2, 2022, View Source [SID1234622840]).

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The Company has opened 29 clinical trial sites of the 68 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

"Our team has worked tirelessly to expand the presence of our clinical trial for Berubicin on a global scale. To have enrolled and dosed our first patient in France shortly after the opening the site is a noteworthy accomplishment and a testament to our team’s dedication to drive the program forward. I am pleased with the progress made and remain committed to building on this momentum. We expect to enroll and dose additional patients across our clinical trial sites in Europe and advance toward the much-anticipated inflection point which is the interim analysis," commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process. Additionally, the Company has also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On November 2, 2022 Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to serve genetically defined patients suffering from cancer and autoimmune diseases, reported that Syed Kazmi, Chief Executive Officer, will be making a business update presentation and meeting with institutional investors at the following conferences in November 2022 (Press release, Jubilant Therapeutics, NOV 2, 2022, View Source [SID1234622839]):

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