On September 21, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported it will hold a formal presentation on Sept. 28 at the Cantor Fitzgerald Global Healthcare Conference in New York (Press release, Elevar Therapeutics, SEP 21, 2023, View Source [SID1234635307]).

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The presentation details are as follows:
Date/Time: Sept. 28 from 3-3:30 p.m. ET
Presenters: Saeho Chong, chief executive officer; Paul Friel, chief commercial officer; Wade Smith, chief financial officer

"The recent months have been very busy at Elevar as we bring our lead development drug, rivoceranib, through the final stages of clinical development as a potential treatment option for those confronted with unresectable hepatocellular carcinoma (uHCC)," said Chong. "We look forward to updating our peers at the Cantor Fitzgerald Global Healthcare Conference about this effort and our broader clinical and commercial development plans."

Supported by its Phase 3 CARES-310 results, Elevar in May submitted a new drug application to the U.S. Food and Drug Administration (FDA) for rivoceranib plus camrelizumab as a first-line treatment option for uHCC. Jiangsu Hengrui Pharmaceuticals Co., Ltd., the developer of camrelizumab, submitted a biologics license application. The FDA granted a May 2024 Prescription Drug User Fee Act date for the combination.

Elevar’s presentation will examine continued development opportunities for rivoceranib; the drug’s positioning in the market and commercialization plans; the CARES-310 trial outcomes and subgroup analysis; and Elevar’s worldwide rights for rivoceranib, which exclude China, where rivoceranib has been approved as a single agent for the treatment of gastric cancer since 2014 and as a first-line treatment in combination with camrelizumab for uHCC since January 2023.

On September 21, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a panel presentation at the Cantor Global Healthcare Conference on Thursday, September 28, 2023, at 10:20 a.m. ET in New York City (Press release, Checkpoint Therapeutics, SEP 21, 2023, View Source [SID1234635306]). The Company will also attend in-person one-on-one meetings during the conference.

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A webcast of the presentation will be available on the News & Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days after the meeting.

On September 21, 2023 Akari Therapeutics, Plc (Nasdaq: AKTX) ("Akari" or the "Company"), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that it has entered into definitive purchase agreements with certain existing investors, including Akari Chairman Dr. Ray Prudo and President and CEO Rachelle Jacques, for a private placement of its equity securities that is expected to result in gross proceeds of approximately $2 million (Press release, Akari Therapeutics, SEP 21, 2023, View Source [SID1234635304]). Akari also announced receipt of a United Kingdom (U.K.) research and development (R&D) tax credit in the amount of $2.5 million.

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In connection with the private placement financing, the Company will issue unregistered American Depository Shares ("ADSs"), each representing 2,000 of the Company’s ordinary shares, at a purchase price of $3.30 per ADS (or ADS equivalents in lieu thereof). The closing of the financing is expected to take place September 22, 2023, subject to the satisfaction of customary closing conditions.

Paulson Investment Company, LLC, is acting as the exclusive placement agent in connection with this financing.

The ADSs 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 have not been registered under the Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

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

On September 20, 2023 LIXTE Biotechnology reported a Phase 1b collaborative clinical trial to assess whether adding Lixte’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC) (Press release, Lixte Biotechnology, SEP 20, 2023, View Source [SID1234637965]). The clinical trial is sponsored by The University of Texas – MD Anderson Cancer Center and will be conducted at MD Anderson and will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. LIXTE will provide LB-100; GSK will provide dostarlimab and financial support for the clinical trial.

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The clinical trial is based on the observation of longer survival of patients with OCCC treated with immunotherapy whose cancer cells have an acquired gene mutation resulting in a reduction in PP2A. This finding was reported by the lead clinical investigators of this new trial1: Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH, Assistant Professor of Obstetrics and Gynecology at Northwestern University Feinberg School of Medicine. The observation by Drs. Jazaeri and Hinchcliff, that a genetically acquired reduction in PP2A enhances sensitivity to immunotherapy, raises the possibility that reducing PP2A pharmacologically with LB-100 will enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody dostarlimab in patients with OCCC lacking the genetic reduction in PP2A.

John S. Kovach, M.D., LIXTE’s founder and Chief Executive Officer, said, "Preclinical data supports the idea that LB-100 enhances the efficacy of PD-1 therapy.1 Clinical data also supports this idea, in that patients with ovarian clear cell carcinoma with dysfunctional PP2A due to somatic mutations in PPP2R1A have shown dramatically longer survival after treatment with immune checkpoint blockers."

Dr. Hinchcliff, said, "OCCC is a comparatively chemotherapy resistant disease and therefore has very limited options for treatment. This clinical trial is an exciting alternative approach that leverages the potential synergy between these two agents and is aiming to improve the impact immunotherapy may have for these patients."

On September 20, 2023 RefleXion Medical, Inc., a therapeutic oncology company and 3B Pharmaceuticals (3BP) GmbH, a biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for cancer detection and treatment, reported an exclusive licensing agreement for RefleXion to develop and commercialize a specific 3BP molecule to direct its SCINTIX biology-guided radiotherapy (Press release, 3B Pharmaceuticals, SEP 20, 2023, View Source [SID1234635302]). This molecule may significantly expand the patient population eligible for SCINTIX therapy to patients with solid tumor cancers of any stage in a manner that may improve both outcomes and procedural workflow.

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The proprietary molecule, termed RXM-4768, targets fibroblast activation protein (FAP) found in nearly all solid tumor types. Using its technology platform, 3BP has discovered and characterized a large portfolio of FAP-targeting molecules as potential diagnostic and therapeutic radiopharmaceuticals. Together the companies selected one molecule optimized for utility with RefleXion’s SCINTIX radiotherapy that expands the role of FAP-targeting molecules to now include directing external-beam radiotherapy delivery in real time.

"This molecule has the potential to light up most solid tumor types in the body, thus demonstrating the power of radiopharmaceuticals by enabling SCINTIX therapy to reach patients with metastatic cancers that currently have dismal outcomes," said Thorsten Melcher, Ph.D., chief business officer at RefleXion.

"Our partnership with 3BP is as unprecedented in the external-beam radiotherapy industry as our SCINTIX therapy is for cancer treatment. We are excited, in collaboration with 3BP and others, to advance this molecule through clinical testing to commercialization." Overcoming the hurdles of targeting and motion management, especially for multiple tumors, is the core challenge in external beam radiotherapy. SCINTIX therapy, delivered by the RefleXion X1, uses emissions from cancer cells created by injecting the patient with a radiopharmaceutical to deliver a radiation dose that continuously and autonomously targets the cancer itself.

"We designed RXM-4768 with the unique requirements for SCINTIX therapy in mind, and our preclinical data demonstrated its potential as an effective biology guide for potentially most solid tumor cancer types," said Dr. Ulrich Reineke, founder & managing director of 3B Pharmaceuticals. "We look forward to working with RefleXion and their collaborator network to bring this project to fruition."

RXM-4768 was previously known as 3BP-4768 and is part of the rights retained by 3BP under the Global Exclusive Licensing Agreement for 3BP’s FAP-targeting peptide technology with Novartis Innovative Therapies AG. Under the terms of the agreement, RefleXion has worldwide, exclusive and sublicensable rights to continue development and subsequent commercialization of RXM-4768 for use with SCINTIX biology-guided radiotherapy. Terms of the transaction also include upfront and annual license payments to 3BP. Upon achievement of certain regulatory and commercial milestones, additional payments and commercial royalties would be due to 3BP. Further terms of the agreement were not disclosed.

RefleXion recently announced completion of the world’s first SCINTIX treatment in a patient with a recurrent lung tumor at Stanford Medicine Cancer Center. This milestone ushers in a new era of autonomous radiotherapy where the biology of the tumor directs where to deliver the radiation dose.