On March 21, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of SNS-101, a conditionally active VISTA-blocking antibody, in patients with solid tumors (Press release, Sensei Biotherapeutics, MAR 21, 2023, View Source [SID1234629104]).

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SNS-101 is a conditionally active, human monoclonal IgG1 antibody designed to selectively block the VISTA checkpoint in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1. Preclinical studies have demonstrated SNS-101’s potential to inhibit tumor growth as monotherapy, significantly enhance the anti-tumor effects of PD-1 blockade, avoid poor pharmacokinetics from target-mediated drug disposition and lower the risk of cytokine release syndrome. Sensei plans to evaluate SNS-101 as a novel treatment for patients with solid cancers, as both a monotherapy and in combination with other therapies.

On March 21, 2023 Prestige Biopharma reported that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), in the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy (Press release, Prestige BioPharma, MAR 21, 2023, View Source [SID1234629103]).

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PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. PAUF overexpression promotes key cellular functions, including proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to chemotherapeutic agents. PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer

By effectively inhibiting the tumorigenic effects of PAUF overexpression in preclinical models, PBP1510 represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic

The first-in-human Phase 1/2a study is an open-label, multicentre, two-part study in patients with advanced/metastatic pancreatic cancer. Phase 1 is a dose-escalation phase, wherein PBP1510 will be administered, either as monotherapy or in combination with gemcitabine, in two separate dose-escalation cohorts. From Phase 1 part of the study a recommended Phase 2a dose (RP2D) will be determined based on the analysis of pharmacokinetics, safety, and efficacy data. Phase 2 is a dose-expansion phase, wherein PBP1510 at the RP2D in combination with gemcitabine will be administered to evaluate efficacy and safety of PBP1510

Overall, the Phase 1/2a study aims to collect important safety data on the use of PBP1510 as a monotherapy or in combination with gemcitabine and explore the efficacy of a combined PBP1510 and gemcitabine regimen. The study will substantiate the preclinical findings of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity, as anticipated from their distinct mechanisms of action

With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer. Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need.

On March 21, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Stifel 2023 CNS Days at 12:30 p.m. Eastern Time on Tuesday, March 28, 2023 (Press release, Neurocrine Biosciences, MAR 21, 2023, View Source [SID1234629102]). Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will participate at the conference.

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(PRNewsfoto/Neurocrine Biosciences, Inc.)

The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On March 21, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that an abstract regarding the Company’s next-generation anthracycline, Annamycin, has been selected for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL (Press release, Moleculin, MAR 21, 2023, View Source [SID1234629101]).

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Details of the presentation are as follows:

Title: Exploration of Annamycin Organotropism to Target Primary and Metastatic Liver Cancers
Track: Experimental and Molecular Therapeutics
Session: PO.ET09.10 – Novel Antitumor Agents, PI3K/AKT Inhibitors, Proteasome Inhibitors, and Topoisomerases
Abstract Number: 4947 / 25
Presenter: Rafal Zielinski, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center
Date and Time: April 18, 2023, 1:30 p.m. – 5:00 p.m. ET
Location: Section 15

For more and to view the abstract, visit the AACR (Free AACR Whitepaper) Annual Meeting website.

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple early-stage human clinical trials, including ongoing trials for the treatment of acute myeloid leukemia (AML) and STS lung metastases. For that reason, although additional data will be necessary, the Company believes Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently approved anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes the drug may have the potential to treat additional indications.

On March 21, 2023 Imunon, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Compensation Committee of the Company’s Board of Directors approved the grant of (i) inducement stock options (the "Inducement Option Grants") to purchase a total of 5,250 shares of common stock and (ii) restricted stock grants (the "Inducement Stock Grants") totaling 1,100 shares of common stock as a material inducement to the employment to two individuals hired by Imunon during the first quarter of 2023 (Press release, IMUNON, MAR 21, 2023, View Source [SID1234629099]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Inducement Option Grants have an exercise price per share equal to $1.32, which is equal to the closing price of Imunon’s common stock as reported by Nasdaq on March 17, 2023. The Inducement Option Grants vest in quarters over four years with the vesting starting on the one-year anniversary of each employee’s first day of employment with the Company and thereafter vest in three additional installments so all Inducement Option Grants will be fully vested and exercisable as of March 17, 2027, subject to each employee’s continued service relationship with the Company on each such date. Each Inducement Option Grant has a ten-year term.

Each of the Inducement Stock Grants will vest on the one-year anniversary of each employee’s first date of employment with the Company and are subject to each such employee’s continued service relationship with the Company on such vesting date.