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First Prospective Clinical Validation of Allarity’s DRP® Companion Diagnostic to be Presented at 2023 ASCO Annual Meeting

On May 30, 2023 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported the results of a prospective Phase 2 clinical study of the Company’s proprietary DRP technology that will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2023 (Press release, Allarity Therapeutics, MAY 30, 2023, View Source [SID1234632228]).

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In the Phase 1/2 study, researchers analyzed the transcriptomic profiles of 37 evaluable metastatic breast cancer (mBC) patients and, based on analysis of biomarkers comprised within a DRP signature, assigned response likelihood scores (DRP 0-100) of patient tumors to a targeted, liposomal form of cisplatin (LiPlaCis). Data from the poster presentation will show that the cisplatin-DRP identified all four mBC patients who demonstrated a partial response (PR) in the trial as likely responders to the LiPlaCis treatment regimen using a DRP80+ score as a cut-off for likely responders. In addition, the cisplatin-DRP also identified mBC patients demonstrating other efficacy signals, including improved progression-free survival. Based on these data, researchers concluded that the cisplatin-DRP companion diagnostic can differentiate, in a statistically significant way, clinical responders and non-responders to cisplatin administered as LiPlaCis.

"While our proprietary DRP companion diagnostics have been extensively validated in numerous retrospective analyses across multiple forms of cancer and many drug types, these data represent the first prospective clinical study showing that our technology can predict actual patient responses ahead of potential treatment," said James G. Cullem, Chief Executive Officer of Allarity Therapeutics. "The ability to differentiate likely responders to a specific drug regimen prior to treatment has the potential to provide improved patient benefits and potential clinical trial efficiencies, and we are excited that these data will be shared with our colleagues at this year’s ASCO (Free ASCO Whitepaper) meeting."

Using a proprietary systems biology algorithm, Allarity’s DRP technology analyzes transcriptomic differences between cell lines that are sensitive and resistant to provide a biomarker signature of drug response and resistance. The DRP platform further refines the predictive signature through a clinical relevance filter (created from more than 3,000 actual tumor biopsy samples from a broad range of cancer drug clinical trials) to eliminate unnecessary biomarkers. By remaining agnostic to what influences tumor response or resistance to a drug, DRP enables the identification of unknown biomarkers crucial to drug response or resistance.

Allarity conducted the study in collaboration with investigators at hospitals in Denmark and its CRO Smerud Medical Research International AS. The LiPlaCis program is currently licensed to CHOSA Oncology AB for further clinical development.

The poster presentation details are as follows:

Poster Title: "Predictive biomarker for cisplatin in prospective phase 2 of liposomal cisplatin in metastatic breast cancer."
Authors: Nielsen, D., Jakobsen, E,H., Langkjer, S.T., Danoe, H., Balslev, E., Knoop, A., … Lassen, U.N.
Abstract Number: 3130
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: 6/3/2023, 8:00 AM-11:00 AM local time

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.

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.