On September 6, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM") (Press release, Moleculin, SEP 6, 2022, View Source [SID1234619076]).

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"The receipt of Orphan Drug Designation represents an important milestone for our promising WP1122 development program," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Given the progress of our Phase 1 clinical trial in healthy volunteers, the strong preclinical data supporting GBM as one of many potential indications and the recent clearance by the FDA of IND status for WP1122 in GBM, we believe this designation further supports the potential of WP1122 and is another step forward in further validating our deep pipeline."

WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. Based on preclinical data indicating the potential for WP1122 as a treatment for GBM, Moleculin received Investigational New Drug status and is evaluating opportunities for collaboration in clinical development.

GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months.1 It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,2 and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.3 The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.4

The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides Moleculin certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

On September 6, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Dean Schorno, the company’s chief financial officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference at 2:00 p.m. ET on Tuesday, September 13, 2022, in New York, NY (Press release, Rigel, SEP 6, 2022, View Source [SID1234619075]).

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To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

On September 6, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company, reported early clinical findings from its ongoing TCR-T Library Phase 1/2 trial (Press release, Alaunos Therapeutics, SEP 6, 2022, View Source [SID1234619073]).

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"We are excited to announce early findings from our TCR-T Library trial. This is the first time that an objective clinical response has been observed in a solid tumor cancer in connection with non-viral TCR-T cell therapy," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We believe this reinforces our approach targeting shared tumor-specific hotspot mutations using our non-viral Sleeping Beauty technology. We look forward to presenting additional details at the CICON conference on September 30."

The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at The University of Texas MD Anderson Cancer Center. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR library. The first patient dosed was diagnosed with non-small cell lung cancer with a KRAS G12D mutation, matching one of the ten TCRs within the Company’s TCR library. The patient received TCR-T cells, which were produced using Sleeping Beauty at the Company’s in house cGMP manufacturing facility. The patient had a confirmed objective partial response. The Company has dosed a second patient in the study, diagnosed with colon cancer, who has been treated at the second dose level and has cleared the 28-day safety window.

"While cell therapies have demonstrated success in hematological cancers, there remains a significant unmet medical need for effective and cost-efficient cell therapies for patients with solid tumors, which account for nearly 90% of all cancer diagnoses. These early clinical findings show the potential for the first time that we may be able to use a non-viral TCR-T cell therapy to achieve measurable regression in solid tumors," added Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck Medical Oncology, Division of Cancer Medicine at MD Anderson. "We are encouraged by these findings, and we look forward to continuing enrollment in the study."

Data is scheduled to be presented during a proffered talk at CICON, which is being held in New York, NY from September 28 – October 1, 2022.

On September 6, 2022 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological, pulmonary, and musculoskeletal disorders with high unmet medical need, reported that Jasbir S. Seehra, Ph.D, President and Chief Executive Officer, and Keith Regnante, Chief Financial Officer, will participate in a fireside chat presentation at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 3:40 pm Eastern time (Press release, Keros Therapeutics, SEP 6, 2022, View Source [SID1234619072]).

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A live audio webcast of the fireside chat presentation will be available at View Source;tp_key=ccabae4d4a&tp_special=8 and an archived replay will be accessible in the Investors section of the Keros website at View Source for up to 90 days following the conclusion of the event.

On September 6, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of Master Key therapies, reported that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update on the Company’s progress at the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Black Diamond Therapeutics, SEP 6, 2022, View Source [SID1234619071]). The presentation will be available for on-demand viewing beginning Monday, September 12, 2022, starting at 7:00 AM ET.

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Black Diamond Therapeutics management will also participate in investor meetings at the Morgan Stanley 20th Annual Global Healthcare Conference being held from Monday, September 12th to Wednesday, September 14th, 2022, in New York, NY.

A webcast of the H.C. Wainwright presentation can be accessed by visiting the investors relations section of the Company’s website at: www.blackdiamondtherapeutics.com. A replay of the webcast will also be available and archived on for 90 days following the event.