On October 7, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported seven oral and poster presentations will be featured at the 2024 AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics ("Triple Meeting"). The conference is being held October 23-25, 2024 in Barcelona, Spain (Press release, Revolution Medicines, OCT 7, 2024, View Source [SID1234647062]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Two late-breaking presentations will feature new clinical data from patients treated for PDAC, including updated safety and efficacy data from the ongoing RMC-6236 monotherapy study and initial safety and antitumor activity data from the first-in-human monotherapy study of RMC-9805.

Details of the presentations are listed below:

Revolution Medicines Late Breaking Presentations:

Title: Updated safety and efficacy from a Phase 1 study of RMC-6236, a RAS(ON) multi-selective, tri-complex inhibitor, in patients with RAS mutant pancreatic ductal adenocarcinoma (PDAC)
Presenter: Brian Wolpin, M.D., M.P.H., Dana-Farber Cancer Institute
Abstract Number: 514LBA
Session: Late Breaking Posters
Date/Time: 12:00 p.m. – 7:00 p.m. CEST on October 23, 2024
9:00 a.m. – 5:30 p.m. CEST on October 24, 2024
9:00 a.m. – 3:00 p.m. CEST on October 25, 2024

Title: Preliminary safety, pharmacokinetics, and antitumor activity of RMC-9805, an oral, RAS(ON) G12D-selective, tri-complex inhibitor in patients with KRAS G12D pancreatic ductal
adenocarcinoma (PDAC) from a Phase 1 study in advanced solid tumors
Presenter: David S. Hong, M.D., MD Anderson Cancer Center
Abstract Number: 502LBA
Session: Late Breaking Abstracts and Proffered Papers: Novel discoveries in drug development
Date/Time 4:12 – 4:24 p.m. CEST on October 25, 2024

Additional Revolution Medicines Presentations:

Title: Selective Inhibition of Active KRAS G13C with RMC-8839 Reveals an Increased Dependence of Codon-13 KRAS-Mutant Cancers on Wild-Type RAS Isoforms
Presenter: Kyle Seamon, Ph.D.
Abstract Number: 92
Session: Molecular Targeted Agents
Date/Time: 12:00 p.m. – 7:00 p.m. CEST on Wednesday, October 23

Title: The RAS(ON) Multi-Selective Inhibitor RMC-6236 Synergizes with T Cell-Directed Immunotherapies to Extend Durability of Antitumor Activity in Preclinical RAS-Driven Cancer Models
Presenter: Elsa Quintana, Pharm.D., Ph.D.
Abstract Number: 307
Session: Translational Studies
Date/Time 9:00 a.m. – 5:30 p.m. CEST on Thursday, October 24

Title: Combination of RAS(ON) Multi-Selective and G12D-Selective Inhibitors Improves Antitumor Activity and Enhances Antitumor Immunity in Preclinical Models of KRAS G12D-Driven Cancers
Presenter: Mallika Singh, Ph.D.
Abstract Number: 300
Session: Translational Studies
Date/Time: 9:00 a.m. – 5:30 p.m. CEST on Thursday, October 24

Collaborator Presentations:

Title: Preclinical Evaluation of RMC-7977, a Multi-Selective RAS(ON) Inhibitor, as a Therapeutic Strategy for KRAS-Mutant Cholangiocarcinoma
Presenter: Rodrigo Entrialgo-Cadierno, M.D., Universidad de Navarra
Abstract Number: 297
Session: Translational Studies
Date/Time 9:00 a.m. – 5:30 p.m. CEST on Thursday, October 24, 2024

Title: Targeting KRAS codon 13 mutations using direct combination approaches in non-small cell lung cancer
Presenter: Dr. Helen Adderley, The University of Manchester and The Christie NHS Foundation Trust
Abstract Number: 113
Session: New Drugs
Date/Time: 12:00 p.m. – 7:00 p.m. CEST on October 23, 2024

Investor Webcast
Revolution Medicines will host an investor webcast focused on PDAC data from the RMC-6236 and RMC-9805 monotherapy studies on Friday, October 25, 2024, following the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium’s Late-Breaking Session. Details for the webcast will be forthcoming and available on the Investors section of the Revolution Medicines website at View Source

Additional updates on the company’s three RAS(ON) inhibitor clinical development programs will be provided later in the quarter.

On October 7, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported three upcoming poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place November 6-10, 2024 in Houston (Press release, Mural Oncology, OCT 7, 2024, View Source [SID1234647060]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company will present tumor microenvironment pharmacodynamic data from the phase 1/2 ARTISTRY-3 study, an evaluation of less frequent dosing of nemvaleukin, Mural’s engineered interleukin-2 (IL-2). Additionally, Mural will share data from its two preclinical research programs in IL-18 and IL-12, including new preclinical efficacy data for IL-18. The details are as follows.

Title: Tumor microenvironment pharmacodynamic effect of nemvaleukin less frequent intravenous dosing in multiple solid tumors: results from the phase 1/2 ARTISTRY-3 study
Abstract Number: 217
Presentation Date: Friday, Nov. 8

Title: Preclinical efficacy and immune activity of half-life extended IL-18 fusion proteins resistant to IL-18BP suppression
Abstract Number: 1340
Presentation Date: Saturday, Nov. 9

Title: Modulation of IL-12p70 exposure and activity following sequential administration of tumor targeted self-assembling split IL-12 subunits
Abstract Number: 1300
Presentation Date: Saturday, Nov. 9

On October 7, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, reported that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers (Press release, Monopar Therapeutics, OCT 7, 2024, View Source [SID1234647059]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial.

MNPR-101 is Monopar’s proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical (link) and preclinical (link) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101-Zr (MNPR-101 conjugated to zirconium-89).

"We are very encouraged by the recently released human clinical data and preclinical efficacy results (link), and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

"We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial," commented Andrew Cittadine, Monopar’s Chief Operating Officer. "Our goal is to light up the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu."

Further information about the MNPR-101-Lu trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Details about the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial are available at www.ClinicalTrials.gov under study identifier NCT06337084.

On October 7, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it will host a Virtual Acute Myeloid Leukemia KOL event on Monday, October 14th from 11:00 AM – 1:00 PM ET (Press release, Moleculin, OCT 7, 2024, View Source [SID1234647058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For the event, Walter Klemp, Chairman and Chief Executive Officer, and Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin will be joined by key opinion leaders: Michael Andreef, MD, PhD, Professor of Medicine, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center; Dr. Giovanni Martinelli, Associate Professor; Department of Medical and Surgical Sciences, Bologna University; and Mohamad Cherry, MD, Medical Director of Hematology at Atlantic Health System.

As part of the event, the members of the Moleculin Management team and participating KOLs will provide an overview of Annamycin, discuss the use of anthracyclines, how Annamycin could significantly change the AML treatment landscape, and the Company’s recently announced global Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the "MIRACLE" trial).

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. A live video webcast of the event will be available on the Events page under the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days.

On October 7, 2024 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that the first patient has been dosed in its advanced melanoma (MELODY-1) trial (Press release, Microbiotica, OCT 7, 2024, View Source [SID1234647057]). This international trial is due to recruit up to 40 patients at clinical centres in the UK, France, Italy and Spain. Initial data readouts are expected by the end of 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Melanoma is a life-threatening skin cancer that can spread to other parts of the body in its advanced stages. PD-1 inhibitor immunotherapies have revolutionised cancer treatment and are now commonly used to treat melanoma. However new treatment options are still needed to extend the benefit to patients for whom immunotherapies do not work (treatment-resistant patients). This can be up to 50% of all advanced melanoma patients.

MB097 is a once daily, orally administered LBP consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors (ICIs). The MELODY-1 study will investigate the safety, tolerability, and initial signals of efficacy of MB097 in advanced (metastatic) melanoma, in combination with KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD will supply KEYTRUDA (study identifiers NCT06540391; MSD KEYNOTE-E75; 023-507377-17).

This is a Phase 1b, first-in-human, randomised open-label clinical trial with all patients receiving MB097 and pembrolizumab for up to six months. Half of the participants will also receive vancomycin before starting the co-therapy to determine whether it helps the bacterial strains in MB097 embed and grow in the gut more efficiently. Participants benefiting from the treatment at the end of the initial six-month period may continue to receive pembrolizumab for up to an additional 18 months (approximately 24 months total). There will be up to 18 sites taking part in the study across the four countries.

As well as assessing the safety and tolerability of the co-therapy, the trial will measure standard oncology treatment efficacy including imaging measurements of tumour response. In addition, it will measure the engraftment of the strains being dosed, and changes in several immune biomarkers.

The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma, including the MELRESIST study carried out with the company’s collaborators at Cambridge University Hospitals, UK. Collectively, the MB097 bacterial consortium provides microbiome signalling that appears to be needed for ICI response. Pre-clinical studies demonstrate that MB097 activates core pathways of the immune system including Cytotoxic T Lymphocytes and Natural Killer cells to enable them to kill tumour cells. Research to understand the mechanism of action of the nine bacterial strains has indicated that in addition to this immune-activating effect, the bacteria in MB097 produce metabolites that act directly at the site of the tumour.

Ron Carter, Microbiotica’s Chief Medical Officer, said, "The gut microbiome, the community of bacteria in the gut, plays a crucial role in digesting food and protecting people from infections, but it also interacts very closely with the immune system. In cancer patients, the bacteria in MB097 appear to be associated with better response rates to immune checkpoint inhibitor therapies, such as anti PD-1 drugs. MB097, with its precisely selected microbes based on data from responsive patients, in combination with ICIs, could therefore activate a therapeutic benefit for non-responding patients with advanced melanoma. Moreover, as the MB097 bacteria are found in healthy subjects as well as in patients who responded to ICIs, we anticipate a favourable safety profile."

Professor Paolo A. Ascierto, Director of the Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, National Tumor Institute Fondazione G. Pascale, Naples, Italy where the first patient has been dosed said, "Combining beneficial microbes with immune checkpoint inhibitors to increase the number of patients who could benefit from these life-saving therapies is a cutting-edge modality that could change the medical paradigm for advanced melanoma patients. With more than half of patients with melanoma being treated with anti PD-1 drugs either not responding or relapsing, I have great hope that the addition of a MB097 precision microbiome therapy such to the treatment regime can improve the outcome for many more patients."

Pippa Corrie, PhD, FRCP, Affiliated Associate Professor of Medical Oncology, University of Cambridge, leading the UK arm of the study, said, "Our MELRESIST study has been fundamental in identifying precisely those gut bacteria that are associated with positive outcomes for melanoma patients on ICIs. The microbial signature comprising a small group of bacteria that were consistently raised in abundance in responding patients across multiple independent cohorts, which gives confidence that MB097 has real potential to increase the number of patients who can benefit from these ICI treatments by optimising the patient’s gut microbiome."