On May 30, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the Company will present at several healthcare industry conferences in June 2023 (Press release, Carisma Therapeutics, MAY 30, 2023, View Source [SID1234632230]). These conferences include:

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2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Yara Abdou, MD, will present trials in progress poster during the meeting:
A phase 1, first-in-human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2-overexpressing solid tumors
Saturday, June 3, 2023, at 8:00 am CT
Chicago, Illinois

2023 Fierce Biotech Next Gen Virtual Event

Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer will give a presentation on Carisma’s revolutionary CAR-M approach.
Tuesday, June 13, 2023 at 10:00 am ET
Virtual
Register to view webcast here.

CHI’s Immuno-Oncology Summit Europe

Tom Wilton, Chief Business Officer, will give a presentation titled "CAR-M: Driving Anti-Tumor Immunity with Chimeric Antigen Receptor Macrophages."
Wednesday, June 21, 2023, at 5:10 pm BST
London, United Kingdom

The Cell and Gene Therapy Conference

Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer will give a presentation titled "Development of CAR macrophages – a novel approach for solid tumor immunotherapy."
Saturday, June 24, 2023 at 2:30 pm ET
King of Prussia, Pennsylvania
A replay of webcasts, when available, will be posted and archived at Carisma’s Investor Events webpage for a limited time following the event.

On May 30, 2023 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended olverembatinib (HQP1351), Ascentage Pharma’s lead novel drug candidate, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment (Press release, Ascentage Pharma, MAY 30, 2023, View Source [SID1234632229]).

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This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). A New Drug Application (NDA) for this indication was accepted by the NMPA in July 2022 and subsequently granted a BTD that will support a full approval of olverembatinib. To date, olverembatinib has been granted two Priority Review Designations that underscored the drug’s promising therapeutic utility.

BTDs are commonly granted to innovative drugs and modified novel drugs that are intended for the prevention or treatment of serious life-threatening diseases and/or conditions that severely impact the quality of life for which there is no existing treatment or where sufficient evidence indicates advantages over currently available treatment options. Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress. Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA). In conclusion, granting of BTDs effectively accelerates development and review of innovative drugs and modified novel drugs presenting significant clinical value or addressing urgent unmet clinical needs.

GIST is a type of malignancy that arises in mesenchymal tissues of the gastrointestinal tract, and most patients with GIST harbor KIT or PDGFRA mutations. The introduction of TKIs has significantly improved the prognosis of these patients. However, patients with SHD-deficient GIST, a rare subtype of GIST, still have considerable unmet medical needs. It is known to the research community that patients with SDH-deficient GIST are commonly insensitive to existing TKIs. Although patients with early-stage localized disease can benefit from surgical treatment, most of them eventually experience relapse[1]-[5]. At present, there is no standard of care for patients with relapsed or advanced SDH-deficient GIST, whose 5-year event-free survival (EFS) is only 24%[1]-[5].

Olverembatinib, a third-generation TKI being jointly commercialized in China by Ascentage Pharma and Innovent Biologics, is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation. While being clinically developed and adopted for the treatment of hematologic malignancies, olverembatinib also showed potent antitumor activity against GIST in preclinical models and early clinical studies, including particularly promising efficacy in patients with SDH-deficient GIST. Results from an ongoing Phase Ib/II study of olverembatinib in China showed an impressive clinical benefit rate (CBR) of 93.8% in patients with this subtype of GIST[6]. Based on these promising results, the study was selected for presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for two consecutive years. (Olverembatinib is an investigational drug that has not been approved for any indication in the US.)

"We are highly appreciative of the regulator’s recognition of olverembatinib’s clinical potential," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This BTD indicates olverembatinib’s promising therapeutic utility in SDH-deficient GIST, marking a major milestone in its clinical development for nonhematologic indications. Moving forward, we will maintain close contact with the CDE to expedite the clinical development program in China and allow patients to benefit from this novel therapeutic as soon as possible."

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

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.

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]).

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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."