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Moderna Announces Phase 2 Data on mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, to be Presented at the 2023 ASCO Annual Meeting

On May 30, 2023 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that two abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6 in Chicago, IL (Press release, Moderna Therapeutics, MAY 30, 2023, View Source [SID1234632227]). mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

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The two abstract titles are:

Abstract #LBA9515: Minimal residual disease by circulating tumor DNA as a biomarker of recurrence free survival in resected high-risk melanoma patients treated with mRNA-4157/V940, a personalized cancer vaccine, and pembrolizumab
Poster Discussion Session S406; Saturday, June 3 at 4:30 PM – 6:00 PM CDT
Presenter: Matteo S. Carlino, PhD, MBBS, FRACP
Abstract #LBA9503: Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial
Melanoma/Skin Cancers Oral Abstract Session; Monday, June 5 at 3:00 – 6:00 PM CDT
Presenter: Muhammad Adnan Khattak, PhD, FRACP, MBBS
Moderna Investor Event

Moderna will host a live webcast on Monday, June 5 from 6:00 – 7:00pm CDT, which will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

About mRNA-4157 (V940)

mRNA-4157 (V940) is a novel investigational messenger ribonucleic acid (mRNA)-based individualized neoantigen therapy1 consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

Individualized neoantigen therapies are designed to prime the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature. mRNA-4157 (V940) is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Based on early clinical studies, combining mRNA-4157 (V940) with KEYTRUDA may potentially provide an additive benefit and enhance T cell-mediated destruction of tumor cells.

Mirati To Encore Compelling Clinical Data Demonstrating Adagrasib’s Potential as a Targeted Treatment for KRASG12C-Mutated Advanced Solid Tumors at 2023 ASCO Annual Meeting

On May 30, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported presentations and posters to be shared at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating the utility of adagrasib across multiple tumor types (Press release, Mirati, MAY 30, 2023, View Source [SID1234632226]).

The company will present encore data indicating adagrasib, a potent and selective KRASG12C inhibitor, is well tolerated and demonstrates meaningful clinical activity in patients with previously treated pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), and other solid tumors harboring a KRASG12C mutation. Phase 2 data from the KRYSTAL-1 study demonstrates the potential value of adagrasib monotherapy for patients with unresectable or metastatic KRASG12C-mutated solid tumors beyond non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Data was previously shared at the April ASCO (Free ASCO Whitepaper) Plenary Series and published in the Journal of Clinical Oncology as a Rapid Communication, reserved for publications deemed to provide timely and late breaking research that may have an immediate impact on patient care.

This encore presentation follows the recent inclusion of adagrasib in the National Comprehensive Center Network (NCCN) Guidelines for both PDAC and Central Nervous System (CNS) Cancers for patients living with previously treated KRASG12C-mutant PDAC and non-small cell lung cancer (NSCLC) with CNS metastases, respectively.

In addition, the company announced that it will present two posters which highlight real-world observations in patients living with metastatic NSCLC (mNSCLC). Full presentation details of all three presentations are below:

KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Advanced Solid Tumors Harboring a KRASG12C Mutation: Saturday, June 3, 2023 at 10:30-11:45 p.m. PT / 12:30-1:45 PM CT (Abstract #425082) during the ASCO (Free ASCO Whitepaper) Plenary Series: Rapid Abstract Updates Education Session. Full abstract can be found here.

Real-world study of treatment patterns and clinical outcomes in patients with mNSCLC post-approval of immunotherapy in the community oncology setting: Saturday, June 3, 2023 at 11:15 a.m. – 2:15 p.m. PT / 2:15-5:15 p.m. ET (Abstract 6629) during the Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Session. Full abstract can be found here.

Real-world outcomes of the first-line immune checkpoint inhibitors with or without chemotherapy in KRAS G12C altered NSCLC according to PD-L1 status: Sunday, June 4, 2023 at 6:00 a.m. PT / 9:00 a.m. ET – 12:00 p.m. (Abstract 9136) during the Lung Cancer – Non-Small Cell Metastatic Poster Session. Full abstract can be found here.
"We’re pleased to be back at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting to share meaningful clinical results demonstrating the efficacy of adagrasib in a range of tumor types beyond NSCLC and CRC, indicating a potential path to regulatory approval for adagrasib in additional indications," shared Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We are also eager to share the results of our real-world studies to demonstrate the continued unmet need within first-line NSCLC which continues to be an area of active study for adagrasib in combination with pembrolizumab with and without chemotherapy."

Morphogenesis, Inc. and CohBar, Inc. Announce Acceptance of Abstract for Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 30, 2023 Morphogenesis, Inc. ("Morphogenesis"), a privately-held Phase 2/3 clinical-stage biotechnology company developing novel personalized cancer vaccines and tumor microenvironment modulators to overcome resistance to current immunotherapies, and CohBar, Inc. (NASDAQ: CWBR) ("CohBar"), reported that Morphogenesis’ abstract has been accepted for poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023 in Chicago, IL (Press release, , MAY 30, 2023, View Source [SID1234632225]).

Details of the presentation are as follows:

Title: Phase 1b trial of IFx-Hu2.0, a novel personalized cancer vaccine, in checkpoint inhibitor resistant Merkel cell carcinoma and cutaneous squamous cell carcinoma
Abstract #: 9534
Presenter: Andrew Brohl, MD, H. Lee Moffitt Cancer Center and Research Institute
Session Title: Melanoma/Skin Cancers – Advanced/Metastatic Diseases
Session Date and Time: Saturday, June 3, 2023, 1:15 – 4:15 a.m. CT
Location: Hall A, Poster #297

Morphogenesis and CohBar recently announced that they have entered into a definitive merger agreement for an all-stock transaction to form a company combining expertise and resources to advance a late-stage oncology pipeline. The combined company will focus on advancing Morphogenesis’ two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market ("Nasdaq"). The transaction is expected to close in the third quarter of 2023.

TRACON Pharmaceuticals Announces Poster Presentations for Envafolimab and TRC102 at the 2023 ASCO Annual Meeting

On May 30, 2023 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with other life science companies to develop and commercialize innovative products in the United States, reported the presentation of two posters at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 annual meeting, being held June 2-6, 2023 (Press release, Tracon Pharmaceuticals, MAY 30, 2023, View Source [SID1234632224]).

Trials in Progress Poster Presentation:
Abstract Title: ENVASARC: A pivotal trial of envafolimab and envafolimab in combination with ipilimumab in patients with advanced or metastatic undifferentiated pleomorphic sarcoma or myxofibrosarcoma who have progressed on prior chemotherapy
Abstract Number: TPS11583
Poster Session: Sarcoma, Poster Board 515a
Session Start: June 3, 2023 1:15 PM CDT

Poster Presentation:
Abstract Title: Phase 2 trial of TRC102 (methoxyamine HCl) with temozolomide (TMZ) in patients with granulosa cell ovarian cancer
Abstract Number: 5564
Poster Session: Gynecologic Cancer, Poster Board 259
Session Start: June 5, 2023 1:15 PM CDT

The posters will be available on the publications page of the company’s website following presentation.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients as well as multiple Phase 1 and Phase 2 clinical trials in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

XENOTHERA publishes its results at the World Cancer Congress in Chicago (ASCO) June 2-6, 2023.

On May 30, 2023 XENOTHERA reported its participation in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) congress, where the world’s cancer experts gather each year to share the latest clinical trial data and innovations in cancer research and education (Press release, Xenothera, MAY 30, 2023, View Source [SID1234632223]). On this occasion, XENOTHERA (Nantes, France) publishes two abstracts demonstrating the value of its technology against cancers.

For nearly ten years, XENOTHERA has been developing innovative drugs based on its glycohumanized polyclonal antibody (GH-pAb) technology. XENOTHERA’s antibodies address major therapeutic needs in several therapeutic areas, including oncology, immunosuppression, viral and bacterial infections. XENOTHERA’s GMP platform allows for accelerated development thanks to its internal biomanufacturing facility, its clinical experience (400 patients exposed to GH-pAb), and its clinical and regulatory mastery. In less than 8 years, three of XENOTHERA’s GH-pAbs have been introduced in humans, in transplantation, Covid and infectious diseases. During clinical trials already conducted (phase I, phase II, phase III), GH-pAbs have demonstrated their safety and therapeutic potential.

At the ASCO (Free ASCO Whitepaper) congress, XENOTHERA details the properties of its fourth GH-pAb, XON7, active against solid tumors and in hematology, by publishing two abstracts. The first abstract (#421432) presents the anti-cancer activity of XON7 on more than 10 solid tumors including non-small cell lung (NSCL), pancreas, liver, colon, prostate, and several lymphomas, in vitro and in vivo. The second abstract (#421642) presents the synergy between XON7 and immune checkpoint inhibitors (ICIs) in vivo in non-small cell lung cancer.

XON7’s recognition of multiple solid tumors and its ability to act synergistically with ICIs confirms its status as a promising candidate for a new line of treatments for several cancers that affect millions of patients.

Based on fundamentally innovative and different mechanisms of action, XON7 is presented as "first in class", and limits the risk of tumor escape unfortunately observed with many treatments. The first clinical trial of XON7 is scheduled to start before the end of 2023.

XENOTHERA’s presence at ASCO (Free ASCO Whitepaper) 2023, an event known for highlighting new discoveries in optimizing patient care, improving access and developing new treatments, allows the company to raise awareness of its technology within the international medical community.