On September 6, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer will participate in two upcoming investor conferences (Press release, Candel Therapeutics, SEP 6, 2022, View Source [SID1234619078]).

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Citi’s 17th Annual BioPharma Conference
Format: Investor meetings
Date: Wednesday, September 7
Location: Boston, MA

H.C. Wainwright 24th Annual Global Investment Conference
Format: Webcast company presentation
Date: Monday, September 12
Time: 7:00 AM Eastern Time
Location: Virtual
Webcast link: Available here

A live webcast of the H.C. Wainwright company presentation is available here and can be accessed by visiting the Investors section of Candel Therapeutics’ website at www.ir.candeltx.com and selecting Events and Presentations under the News & Events tab. A replay of the webcast will be archived for up to 90 days following the presentation date.

On September 6, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported a summary of its Type C Clinical meeting minutes with the U.S. Food and Drug Administration (FDA) relating to its lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with recurrent glioblastoma (GBM) (Press release, PLUS THERAPEUTICS, SEP 6, 2022, View Source [SID1234619077]).

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The FDA and Plus Therapeutics agreed that the ReSPECT-GBM clinical trial should proceed to the planned Phase 2. The key focus areas of clinical investigation of the Phase 2 trial will be: 1) further dose exploration, including both increased dosing and multiple doses, and 2) collecting additional safety and efficacy data to inform the design of the future registrational trial. Furthermore, there was agreement that in a planned future registrational trial, overall survival should be used as the primary endpoint. The Company and the FDA also agreed to hold future meeting(s) to consider the use of external data to augment the control arm in the registrational trial.

"Our first formal FDA clinical meeting after in-licensing the Rhenium NanoLiposome radiotherapeutic platform was an important milestone for us," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We received clear feedback and, as a result, we intend to begin the ReSPECT-GBM Phase 2 trial utilizing our cGMP 186RNL drug, which should begin later this year. We will provide more details in our moderated oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress later this month."

In August 2022, the Company reported FDA feedback on its Chemistry, Manufacturing and Controls (CMC) focused Type C meeting. Planned cGMP production of 186RNL targeted radiotherapeutic is expected to begin in the second half of 2022 to support the ReSPECT Phase 2 clinical trial. On September 9, 2022, the ReSPECT-GBM trial principal investigator, Andrew Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio, will provide a full update on the Phase 1 trial and discuss the clinical development overview during the ESMO (Free ESMO Whitepaper) Congress.

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.