On April 7, 2022 Tvardi Therapeutics, Inc. ("Tvardi"), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported its collaborators will present preclinical data demonstrating TTI-101 overcomes palbociclib resistance in metastatic breast cancer murine models at the upcoming 2022 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans, LA, from April 8th – 13th, 2022 (Press release, Tvardi Therapeutics, APR 7, 2022, View Source [SID1234611596]). The study was led by Khandan Keyomarsi, PhD, Professor of Experimental Radiation Oncology at The University of Texas MD Anderson Cancer Center.

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 studies to be presented demonstrate that the upregulation of the IL-6 / STAT3 pathway plays a critical role in palbociclib (CDK 4/6) resistance in hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer. Inhibition of STAT3 with TTI-101 overcomes this resistance. Further, the studies demonstrate that the combination of TTI-101 with palbociclib is synergistic in arresting tumor growth in murine models derived from metastatic breast cancer patients who had developed resistance to palbociclib.

"Palbociclib has proved successful in delaying progression in HR+/HER2- metastatic breast cancer patients; however, ~70% will develop resistance and progress within 1-2 years of treatment. There is a significant unmet need for safe and effective options for those patients who become resistant to palbociclib," said Imran Alibhai, PhD, CEO of Tvardi Therapeutics. "The work by Dr. Keyomarsi and her collaborators builds on their previous publications demonstrating the central role of STAT3 in this patient population and paves the way for clinical studies to investigate TTI-101 in combination with palbociclib."

Details of the presentation are as follows:
Circulating IL-6, an early biomarker in HR+, Her2- metastatic breast cancer patients progressing on CDK4/6 inhibitors
Session and Poster: PO.ET03.04 – Breast Cancer Drug Resistance and Novel Targets: 1774 / 3
Presenter: Nicole Kettner, PhD
Date and Time: Monday, April 11th, 2022, 1:30 – 5:00 PM CT

About TTI-101
TTI-101 is an orally delivered small-molecule that directly binds and subsequently blocks the activation of the STAT3 protein. TTI-101, as a single agent, is currently being studied in a multicenter Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 has been well-tolerated and has demonstrated clinical activity across a broad range of tumors including multiple durable radiographic objective responses. For more information on this ongoing clinical trial of TTI-101, please visit Clinical Trials.

On April 7, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported the details of its webcast to discuss updated clinical data from the ongoing monotherapy Phase 1 arm of the Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors and relapsed/refractory acute myeloid leukemia on April 8, 2022, at 1:15 p.m. ET (Press release, Rubius Therapeutics, APR 7, 2022, View Source [SID1234611595]).

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!

In addition to members of the Rubius management team, Alexander I. Spira, M.D., Ph.D., FACP​, Co-Director, Virginia Cancer Specialists Research Institute, Director, Thoracic and Phase 1 Program and RTX-240 clinical investigator, will join the webcast to discuss the evolving oncology therapeutics landscape and clinical development opportunities for RTX-240.

The audio webcast will be available on the Events and Presentations page within the Investors and Media section of the Rubius Therapeutics website. The update may also be accessed by dialing (800) 289-0045 (domestic) or (615) 622-8086 (international) five minutes prior to the start of the call. The conference ID is 7865329. An archived webcast will be accessible for 90 days after the event.

On April 7, 2022 Propella Therapeutics, Inc. ("Propella"), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm), a research-based pharmaceutical enterprise and leading manufacturer in PPI and oncology medications, reported that the companies have entered into an exclusive licensing agreement for CGS-200-5, a clinical-stage topical treatment that is being developed for the treatment of pain in patients with moderate to severe osteoarthritis (OA) of the knee (Press release, Propella Therapeutics, APR 7, 2022, View Source [SID1234611594]). Under the terms of the agreement, ASK Pharm will have exclusive rights to develop, manufacture and commercialize CGS-200-05 for the Greater China region. As part of the agreement, Propella will receive an upfront payment and is entitled to receive regulatory and sales milestones, as well as royalties on future product sales. In a prior Phase 2 study (NCT#:03528369), four once-daily applications of CGS-200-5 reduced pain by 50% for 90 days in patients with moderate to severe OA of the knee.

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!

"We are pleased to enter this licensing agreement with Jiangsu Aosaikang Pharmaceutical," said William Moore, Ph.D., President and CEO of Propella Therapeutics. "Today’s announcement reflects our strategy to partner non-oncology pipeline assets with leading companies who have the expertise to maximize their value in select territories. Such agreements also provide Propella with an important source of non-dilutive capital that will help us advance our oncology pipeline, including our lead clinical-stage oncology asset, PRL-02, which is being developed for the treatment of advanced prostate cancer."

"Chronic disease therapeutics are one of ASK‘s four strategic focuses. We are very pleased to have reached this cooperation with Propella," said Mrs. Tingting Song, Chief Strategy Officer of ASK Pharm. "(OA) is one of the most prevalent conditions resulting to disability, particularly in the elderly population in China. CGS-200-5 meets the significant unmet medical need and market demand for topical long-lasting pain relief for knee osteoarthritis (OA). We will work closely with our partner to accelerate the development and commercialization process of CGS-200-5 and provide more effective medicines to patients as soon as possible."

Yafo Capital (Shanghai) acted as sole advisor to Propella on this transaction.

About CGS-200-5

There are currently no approved therapies that effectively manage moderate to severe OA knee pain without significant concerns related to efficacy, tolerability, safety, or addiction potential. Topical CGS-200-5 has clinically been shown to significantly reduce OA knee pain. In a Phase 2 study, CGS-200-5 reduced pain by 50% (based on WOMAC pain score) while demonstrating good safety and tolerability. CGS-200-5 also demonstrated highly durable pain relief. Patients on average reported diminished pain through 90 days, the final time point of the Phase 2 study, following just four consecutive days of topical treatment at study start. Acknowledging the therapeutic potential of topical high-concentration capsaicin, the American College of Rheumatology recently revised its OA treatment guideline to conditionally recommend topical capsaicin for knee OA pain.

On April 7, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported the initiation of a Phase 2a clinical trial[1] sponsored by AP-HP[2], evaluating MaaT013, MaaT Pharma’s lead Microbiome Ecosystem Therapy candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo), which are standard first line treatments for patients with metastatic melanoma (Press release, MaaT Pharma, APR 7, 2022, View Source [SID1234611593]).

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 2a clinical trial is coordinated by Professor Franck Carbonnel, MD, Professor of Gastroenterology at the Kremlin-Bicêtre Hospital in Villejuif, France, and is being carried out in collaboration with INRAE[3] and Institut Gustave Roussy. The trial is a randomized, placebo-controlled study and is expected to enroll 60 patients in France. The primary endpoint is safety, while the secondary endpoint will evaluate MaaT013’s potential to improve the response to ICI therapies, as a consequence of MaaT013’s impact on the patient’s gut microbiome. Patients will be randomized to receive either MaaT013 in combination with both ICIs or a placebo with both ICIs. MaaT Pharma will provide MaaT013 drug candidate and the placebo for this study as well as perform the microbiome profiling of patients using its proprietary gutPrint platform. This clinical trial is registered on clinicaltrials.gov.

Several studies have suggested that gut microbiota diversity and richness are predictors of response to ICI treatment[4] in patients with solid tumors. Notably, in two recent studies conducted in melanoma patients[5], fecal microbiota transfer from ICI therapy responders could overcome resistance to that same therapy in non-responders.

[1] NCT04988841: Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD1 inhibitors.
[2] AP-HP: Assistance Publique – Hôpitaux de Paris
[3] INRAE: Institut national de recherche pour l’agriculture, l’alimentation et l’environnement
[4] Routy B. et al, Science 2018, Matson et al, Science 2018, Gopalakrishnan V. et al, Science, 2018
[5] Davar D. et al, Science, 2021 ; Baruch E.N. et al, Science, 2021
About MaaT013

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, Microbiome Ecosystem Therapy. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for acute Graft-versus-Host Disease (aGvHD) and is currently being evaluated in a Phase 3 clinical trial. MaaT Pharma has obtained positive safety and efficiency clinical data for 76 patients with aGvHD (Phase 2 clinical trial and Early Access Program in France).

On April 7, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, has scheduled a conference call for Tuesday, May 3, 2022, at 8 a.m. (ET) reported its first quarter 2022 financial results for the period ending April 1, 2022 (Press release, Leidos, APR 7, 2022, View Source [SID1234611592]). The company plans to issue its quarterly earnings press release before the conference call on May 3, 2022.

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 offers a live and replay audio broadcast of the conference call with corresponding supplemental information at View Source

A telephone playback of the first quarter 2022 earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on May 3, 2022, through 11:59 p.m. (ET) on May 10, 2022. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415) and entering conference ID 13728784.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source