On Decemebr 1, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases , reported that their first in class new drug Pidnarulex (CX-5461) , has been successfully selected to the anticancer pipeline of NIH-sponsored NExT Program (NCI Experimental Therapeutics Program), which will foster the exploration of its therapeutic potential in unmet medical needs and advancement to market (Press release, Senhwa Biosciences, DEC 1, 2022, View Source [SID1234624712]).

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The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancers by supporting the most promising new drug discovery and development projects. "The NExT Program does not directly fund but guide the project to its success ; applications with exceptional science cannot be accepted unless a clear path to the clinical practice or potential benefit to patients is identified. Senhwa is honored and will partner with the NCI to facilitate the milestone-driven progression of Pidnarulex (CX-5461) towards clinical evaluation and registration," said Dr. Jin-Ding Huang, the Chief Executive Officer of Senhwa Biosciences,.

Although Awardees will not necessarily receive direct funding; rather, the NCI may allocate various collaborations and grant resources toward the implementation and development of the awarded projects. NCI operates the program very much like a small pharmaceutical or biotechnology company by working with external investigators and top scientific experts to advance promising or novel therapies from the earliest stages of research to human clinical trials.

About Pidnarulex (CX-5461)

Specific mutations within the HR pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.

On December 1, 2022 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in a fireside chat presentation and host one-on-one meetings with investors at the JMP Securities Hematology and Oncology Summit, a virtual investor event taking place December 6-7, 2022 (Press release, Protagonist, DEC 1, 2022, View Source [SID1234624711]).

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Presentation Details:
Date: December 6, 2022
Time: 11:40 a.m. ET / 8:40 a.m. PT

A webcast of the event will be available for 90 days on the Investors section of the Protagonist Therapeutics website at View Source

On December 1, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) (Press release, Citius Pharmaceuticals, DEC 1, 2022, View Source [SID1234624710]). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).

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"The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options," stated Leonard Mazur, Chairman and CEO of Citius.

About I/ONTAK

I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for the treatment of PTCL and CTCL, respectively.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

On December 1, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it intends to offer and sell, subject to market and other conditions American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase ADSs (the "Warrants") in an underwritten public offering (Press release, RedHill Biopharma, DEC 1, 2022, View Source [SID1234624709]). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. The Company expects to grant the underwriter a 30-day option to purchase additional ADSs and/or Warrants at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by RedHill.

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Aegis Capital Corp. is acting as sole book-running manager for the proposed public offering.

The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

RedHill intends to use the net proceeds of the offering for working capital, acquisitions and general corporate purposes.

The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-258259) declared effective by the Securities and Exchange Commission (the "SEC") on August 9, 2021.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 1, 2022 Jacobio Pharma (1167.HK) reported that it will present the results of KRAS G12C inhibitor JAB-21822 as a single agent or in combination with SHP2 inhibitor JAB-3312 in preclinical cancer models in a poster session during the 2022 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ASIA (ESMO ASIA) Congress from December 2, 2022 to December 4, 2022 (Press release, Jacobio Pharmaceuticals, DEC 1, 2022, View Source [SID1234624708]).

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The results of preclinical study showed that JAB-21822 in combination with JAB-3312 could synergistically inhibit tumor growth in multiple KRAS G12C inhibitor-resistant models, suggesting that the combination of JAB-21822 and JAB-3312 may overcome adaptive resistance to KRAS G12C inhibitor in cancer patients. Jacobio is currently conducting a clinical trial of JAB-21822 in combination with JAB-3312 (ClinicalTrials.gov Identifier: NCT05288205).

About the Abstract:

Track: Developmental therapeutics
Title: Investigation of KRAS G12C inhibitor JAB-21822 as a single agent and in combination with SHP2 inhibitor JAB-3312 in preclinical cancer models
Format: Poster presentation
Abstract Number: 30P
Time: December 3, 2022
Please visit the official website of ESMO (Free ESMO Whitepaper) ASIA for more information: View Source

About JAB-21822

JAB-21822 is an oral, small molecule KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients harbouring KRAS G12C mutation with advanced solid tumors, including pivotal clinical trial to treat non-small cell lung cancer in China; monotherapy for STK11 co-mutated non-small cell lung cancer in the front-line setting; combination therapy with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and cetuximab.

About JAB-3312

JAB-3312 is a high-selective SHP2 allosteric inhibitor. Jacobio is currently conducting clinical trials of JAB-3312 in China and the United States, and JAB-3312 has been granted orphan drug designation for esophageal cancer (including esophageal squamous cell carcinoma) by the U.S. Food and Drug Administration (FDA). Jacobio has signed a global, strategic collaboration agreement to develop and commercialise SHP2 inhibitors with AbbVie on June 1, 2020.