On May 16, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that the United States Patent and Trademark Office has issued U.S. Patent No. 11,648,235, titled "Treatment of Glioblastoma," with claims to a method of treating glioblastoma with azeliragon (Press release, Cantex, MAY 16, 2023, View Source [SID1234631790]). This patent will expire in 2042.

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Glioblastoma is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. Earlier this year, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon.

Stephen Marcus, MD, CEO of Cantex commented, "The issuance of this patent, expiring in 2042, adds to the already strong intellectual property protection provided by Cantex’ existing composition of matter patents and the regulatory exclusivity conferred by FDA orphan drug protection. Improved treatment of glioblastoma is greatly needed and the therapeutic effect of azeliragon will be evaluated in Cantex’ phase 2 glioblastoma clinical trials."

About Azeliragon

Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Azeliragon was originally under development for Alzheimer’s disease by the company from which Cantex licensed it. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex is also developing azeliragon for the treatment of brain metastasis, pancreatic cancer, and breast cancer, where RAGE has been implicated in disease progression and in complications of cancer treatment. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.

On May 16, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that the Company will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, June 2-6 (Press release, Triumvira Immunologics, MAY 16, 2023, View Source [SID1234631789]). The presentation by Benjamin L. Schlechter, MD, from Harvard Medical School and a Senior Physician in Gastrointestinal Oncology at the Dana-Farber Cancer Institute, will highlight updated clinical data from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) in patients with relapsed or refractory solid tumors.

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"We are excited to present the latest clinical data from our Phase I/II trial of TAC01-HER2 in refractory solid tumors at the upcoming ASCO (Free ASCO Whitepaper) meeting as a poster and a poster discussion. The availability of updated clinical data will offer remarkable insights into the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2 targeted therapies," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "We are committed to delivering innovative solutions for cancer patients and addressing critical unmet medical needs and look forward to sharing the updated findings with the oncology community at this prestigious scientific meeting."

ASCO Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)
Authors: Benjamin L. Schlechter, MD, Senior Physician, Instructor in Medicine, Harvard Medical School and Attending Physician, Medical Oncology, Dana-Farber Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00 AM-11:00 AM
Poster Discussion Session Date and Time: 6/3/2023, 3:00 PM-4:30 PM
Abstract Number: 2519

Abstract titles are currently available on the ASCO (Free ASCO Whitepaper) website. A copy of the presentations will be available after the closure of the meetings, under the Presentations & Publications tab of the News & Resources section of the Company’s website.

On May 16, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that about 30 accepted abstracts of clinical data from multiple trials in relation to TYVYT (sintilimab injection), olverembatinib (BCR-ABL TKI), IBI326 (equecabtagene autoleucel), IBI376 (parsaclisib), IBI110 (anti-LAG-3 monoclonal antibody), IBI939 (anti-TIGIT monoclonal antibody) and IBI351 (KRASG12C inhibitor) will be presented at the upcoming international medical conferences. A brief summary of the selected presentations is as follows (Press release, Innovent Biologics, MAY 16, 2023, View Source [SID1234631788]):

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AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING 2023 (Jun 2-6)

Topic: PD-1 blockade with sintilimab plus induction chemotherapy and concurrent chemoradiotherapy (IC-CCRT) versus IC-CCRT in locoregionally-advanced nasopharyngeal carcinoma (LANPC): A multicenter, phase 3, randomized controlled trial (CONTINUUM).[1]
Presentation Type: Oral Presentation
Presentation Time：June 5, 2023, 08:00 – 11:00 (GMT-5) Chicago, IL, U.S.
Abstract Number: LBA 6002
Main Researcher: Professor Jun Ma and Professor Liu Xu, Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: Updated results from a phase 1b study
Presentation Type: Poster Presentation
Abstract Number: 2576
Main Researchers: Professor Nong Xu and Professor Chenyu Mao, The First Affiliated Hospital, School of Medicine, Zhejiang University.

Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line of advanced hepatocellular carcinoma: preliminary results from a phase 1b study
Presentation Type: Poster Presentation
Abstract Number: 2577
Main Researcher: Professor Baocai Xing and Professor Ming Liu, Peking University Cancer Hospital & Institute.

Topic: Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: preliminary results from a pooled analysis of two phase 1 studies
Presentation Type: Poster Presentation
Abstract Number: 3586
Main Researcher: Professor Ying Yuan and Professor Kefeng Ding, The Second Affiliated Hospital, Zhejiang University School of Medicine.

Topic: CT103A, a novel fully human BCMA-targeting CAR-T therapy, in patients with relapsed/refractory multiple myeloma: updated long-term follow-up results of phase 1b/2 study (FUMANBA-1)
Presentation Type: Poster Presentation
Abstract Number: 8025
Main Researchers: Professor Chunrui Li, Department of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science; Professor Lugui Qiu, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.

Topic: Antitumor activity of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST)
Presentation Type: Poster Presentation
Abstract Number: 11540
Main Researcher: Professor Haibo Qiu, Sun Yat-sen University Cancer Center.

Topic: A study to evaluate the safety, tolerability and efficacy of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC): updated efficacy and safety results
Presentation Type: Online Publication
Abstract Number: e14578
Main Researcher: Professor Ying Cheng and Professor Chunjiao Wu, Jilin Cancer Hospital.

EUROPEAN HEMATOLOGY ASSOCIATION (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress (Jun 8-15)

Topic: CD47/PD-L1 bispecific antibody (IBI322) in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma: a Phase 1 study
Presentation Type: Oral Presentation
Presentation Time: June 11, 2023, 11:30 – 12:45 (CEST) Frankfurt, Germany
Abstract Number: S216
Main Researchers: Professor Ting Niu, West China Hospital of Sichuan University; Professor Huilai Zhang, Tianjin Medical University Cancer Institute & Hospital.

Topic: A phase 2, multicenter, single-arm study of parsaclisib, a PI3kδ inhibitor, in relapsed or refractory follicular lymphoma in China: updated results from the study
Presentation Type: Poster Presentation
Abstract Number: P1099
Main Researcher: Professor Weili Zhao and Professor Zhong Zheng, Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

Topic: Safety and efficacy of IBI346, a first-in-class BCMA-targeting modular CAR-T cell therapy, for patients with relapsed/refractory multiple myeloma (RR MM): preliminary results from two Phase 1 studies
Presentation Type: Poster Presentation
Abstract Number: P1406
Main Researcher: Professor Zhengzheng Fu and Professor Depei Wu, The First Affiliated Hospital of Soochow University; Professor Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

On May 16, 2023 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, reported the presentation of the trial in progress (TIP) FRIDA poster entitled Iadademstat in combination with gilteritinib for patients with mutated FLT3 relapsed/refractory acute myeloid leukemia at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, to be held in-person from June 2-6, 2023 at the McCormick Place in Chicago, Illinois (Press release, Oryzon, MAY 16, 2023, View Source;utm_medium=email&utm_campaign=NdP.11+17-05-2023+FRIDA-ASCO+ENG594 [SID1234631787]).

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Dr. Amir Fathi, Director of the Leukemia Program at Massachusetts General Hospital, is the Principal Investigator of the study and first author of the poster. He will be recording a brief video summarizing the poster information and study status.

Dr. Douglas V. Faller, Oryzon’s Global Chief Medical Officer, will attend the poster presentation, which will take place during the Poster Discussion Session on Monday June 5 from 8:00 AM-11:00 AM within the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Session.

FRIDA (NCT05546580) is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3·mutations. The trial’s primary objectives are to evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3mut+ R/R AML and to establish the Recommended Phase 2 Dose (RP2D) for this combination. Secondary objectives include evaluation of the treatment efficacy, measured as the rate of complete remission and complete remission with partial hematological recovery (CR/CRh), the duration of responses (DoR) and the assessment of measurable residual disease (MRD). FRIDA will be conducted in 10-15 sites in the US. The study will enroll up to approximately 45 patients and if successful, the Company and FDA have agreed to hold a meeting to discuss the best plan to further develop this combination in this much in need AML population.

Presentation materials will be available both on the ASCO (Free ASCO Whitepaper) website and on our website under the Events section following the session.

On May 16, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 1,408,384 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $0.945 per share (or common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules (Press release, OncoSec Medical, MAY 16, 2023, View Source [SID1234631786]). The Company has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 1,408,384 shares of common stock. The warrants will have an exercise price of $0.82 per share, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about May 18, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-260850) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 8, 2021, and declared effective on November 15, 2021. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a 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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.