On October 4, 2024 Kineta, Inc. (OTC Pink: KANT) , a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that its abstract on the KVA12123 clinical program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting to be held November 6-10, 2024, in Houston, Texas and virtually (Press release, Kineta, OCT 4, 2024, View Source;utm_medium=rss&utm_campaign=kineta-announces-kva12123-abstract-accepted-for-poster-presentation-at-society-for-immunotherapy-of-cancer-sitc-2024 [SID1234647029]).

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Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, has announced that on November 8, 2024 Jason Henry M.D., Associate Director, Drug Development at Sarah Cannon Research Institute, Denver Colorado will be presenting the poster with new clinical data from an ongoing Phase 1/2 clinical trial on KVA12123, Kineta’s VISTA blocking immunotherapy, alone and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors.

Presentation Details:

Title: A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors

Authors: Jason T Henry, MD1, Manish R. Patel, MD2, Paul L Swiecicki, MD3, Ida Micaily, MD4, Benjamin Garmezy, MD5, Kalyan Banda, MD6, Marya F Chaney, PhD7, Julia Cohen, MD7, Vinny Hayreh, MD8, Kurt Lustig, BS8, Yulia Ovechkina, PhD8, Evan Y Yu, MD6, Shawn P ladonato, PhD8, Thierry Guillaudeux, PhD8 and Lee Rosen, MD9,
(1) Sarah Cannon Research Institute at HealthONE, Denver, CO, (2) Florida Cancer Specialists, Sarasota, FL, (3) University of Michigan Rogel Cancer Center, Ann Arbor, MI, (4) Thomas Jefferson University, Philadelphia, PA, (5) Sarah Cannon Research Institute, Nashville, TN, (6) Fred Hutchinson Cancer Center, Seattle, WA, (7) Merck & Co., Inc., Rahway, NJ, (8) Kineta, Inc., Seattle, WA, (9) UCLA Medical Center, Los Angeles, CA.

Abstract Number: 625

Date / Time: Friday, November 8 at 9:00 A.M. – 7:00 P.M. Central Time

Location: Exhibit Halls AB – George R. Brown Convention Center, Houston, Texas

Abstract titles are now available on the SITC (Free SITC Whitepaper) website. Posters will be made available on the Kineta website following presentations at the conference.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On October 4, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a late-breaking oral presentation of the Phase 1 expansion results of IDE397, a first-in-class, oral, MAT2A inhibitor in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients at the 36th edition of the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place on October 23 to 25, 2024, in Barcelona, Spain (Press release, Ideaya Biosciences, OCT 4, 2024, View Source [SID1234647030]). In addition, IDEAYA will also have additional poster presentations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium highlighting preclinical data for the MAT2A and PARG programs.

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Details for the oral presentation are as follows:

Presenter: Dr. Benjamin Herzberg, MD, Assistant Professor, Columbia University

Title: Phase 1 expansion results of IDE397, a first-in-class, oral, MAT2A inhibitor (MAT2Ai) in MTAP deleted(del) non-small cell lung cancer (NSCLC) and urothelial cancer (UC)

Abstract #: 501 LBA

Session: Plenary Session 7, Late Breaking Abstracts and Proffered Papers: Novel discoveries in drug development

Date and Time: Friday, October 25, 2024 at 3:00pm CEST

Poster presentation details are below:

Author: Garbett, D. et al.

Title: The mechanistic basis of both deep and durable antitumor activity by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors

Poster Number: PB204

Session Title: Combination Therapies

Date and Time: Thursday, October 24, 2024, 9:00am – 5:30pm CEST, Exhibition Hall

Author: Munoz, D. et al.

Title: IDE161, a potential first-in-class clinical candidate PARG inhibitor, selectively targets solid tumors with replication stress and DNA repair vulnerabilities

Poster Number: PB337

Session Title: DNA Repair Modulation (e.g. PARP, CHK, ATR, ATM)

Date and Time: Friday, October 25, 2024, 9:00am – 3:00pm CEST, Exhibition Hall

The oral presentation and posters will be available online at View Source following the presentations.

On October 4, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported upcoming oral and poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Houston, Texas from November 6 – 10, 2024 (Press release, Immatics, OCT 4, 2024, View Source [SID1234647028]).

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Full abstracts will be available on November 5, 2024, at 9:00 am EST in the JITC Supplement.

Oral Presentations

Date / Time: November 8, 2024 / 3:50 – 5:25 pm Central Standard Time
Session: Oral Abstract Session 1
Abstract Number: 687
Title: ACTengine IMA203 TCR-T targeting PRAME shows deep and durable anti-tumor activity in heavily pretreated solid cancer patients
Presenter: Martin Wermke, M.D. (University Hospital Dresden, Germany)

Date / Time: November 9, 2024 / 12:30 PM – 1:30 pm Central Standard Time
Session: Rapid Oral – Clinical 2
Abstract Number: 661
Title: Enhanced pharmacology data of next-generation IMA203CD8 TCR-T monotherapy targeting PRAME
Presenter: Dejka M. Araujo, M.D. (MD Anderson Cancer Center, Houston, Texas, USA)

Poster Presentations

Date: November 8, 2024
Poster Number: 355
Title: An approach to bridging starting materials to monitor T cell persistence in adoptive T cell therapy
Presenter: Jourdan Andersson, Ph.D. (Immatics)

Date: November 9, 2024
Poster Number: 226
Title: An effective donor screening program for manufacturing of allogeneic γδ T cell products
Presenter: Inbar Azoulay Alfaguter, Ph.D. (Immatics)

Date: November 9, 2024
Poster Number: 228
Title: Optimizing and streamlining the manufacturing of Vγ9Vδ2 γδ T cells for allogeneic therapy
Presenter: Pooja Mehta, Ph.D. (Immatics)

Date: November 9, 2024
Abstract Number: 360
Title: Combination of a TCR-engineered autologous PRAME-targeting T cell therapy with a PRAME-encoding mRNA for the treatment of solid tumors
Presenter: Fabian Brunk, Ph.D. (Immatics)

Date: November 9, 2024
Poster Number: 372
Title: TCR-engineered T cells exhibit enhanced persistence and serial killing ability when armored with membrane-bound IL-15
Presenter: Justin Gunesch, Ph.D. (Immatics)

About IMA203 and Target PRAME
ACTengine IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203.

ACTengine IMA203 TCR-T is currently being evaluated in Phase 1 IMA203 monotherapy, and IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

On October 4, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus test, the company’s next generation multitarget stool DNA test (Press release, Exact Sciences, OCT 4, 2024, View Source [SID1234647027]). The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

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FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy. 1 * Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT**) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity. 2

"To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer," said Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study. "The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients."

"Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients," said Kevin Conroy, Chairman and CEO of Exact Sciences. "Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening."

CRC is often considered the most preventable, yet least prevented form of cancer. 3 It remains the second deadliest cancer in the United States. 4 The Cologuard Plus test will build on the success of the Cologuard test, which has been used more than 17 million times and helped meaningfully improve national CRC screening rates in the United States. 5,6 Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences’ commercial organization and industry-leading ExactNexus technology platform, making ordering and resulting seamless for more than 350 health systems. The innovative, non-invasive test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce (USPSTF) guidelines, and included within quality measures.

*The Cologuard Plus test demonstrates 91% specificity including non-advanced findings, 93% specificity including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.

**Refers to the commercially available Polymedco OC-Auto Micro 80iFOB Test

About the BLUE-C Study

BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of the Cologuard Plus test (multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based colorectal cancer screening test. Using colonoscopy as a reference method, the robust study design directly compared the Cologuard Plus test and an independent fecal immunochemical test (FIT*). The BLUE-C study cohort is diverse and reflective of the U.S. population. About 40% of all participants identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. This enrollment diversity helps ensure that the BLUE-C findings and the Cologuard Plus test are relevant for all screen-eligible individuals, regardless of race or ethnicity. 2

About the Cologuard Plus test

Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences’ lab and increase the valid result rate. Exact Sciences is preparing for the commercialization of the Cologuard Plus test.

About the Cologuard test

The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).

The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal DeeP-C study. The Cologuard test is easy to use, can be completed at home, and does not require any time off or special preparation.

On October 4, 2024 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it has engaged Syneos Health as the contract research organization ("CRO") for its upcoming Phase II oncology trial (Press release, CytoDyn, OCT 4, 2024, View Source [SID1234647025]). The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer ("CRC").

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Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers in accelerating the delivery of life-saving therapies to market. Syneos Health leverages advanced data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization. Syneos Health has helped to develop or commercialize 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.

"Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health. With this expanded mandate, we expect to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab," said Dr. Jacob Lalezari, CEO.

As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.