On July 6, 2021 Gadeta B.V., a clinical-stage company developing innovative, gamma delta (γδ) T-cell receptor (TCR)-based immunotherapies for cancer patients, reported the dosing of the first patient with GDT-002 (formerly labelled TEG002), a potential first-in-class cellular immunotherapy for the treatment of cancer (Press release, Gadeta, JUL 6, 2021, View Source [SID1234584635]).

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The multicenter phase 1/2 study in collaboration with the Dana-Farber Cancer Institute, Mass General Brigham Cancer Care and Beth Israel Deaconess Medical Center, is evaluating safety, tolerability and preliminary efficacy of GDT-002 for the treatment of multiple myeloma (MM).

"The initiation of our phase 1/2 trial of GDT-002 and the dosing of our first patient are a transformational milestone for Gadeta in its mission to provide novel treatments to patients with cancer, including MM," said Dr Marco Londei, Chief Executive Officer of Gadeta. "Despite the successes with CAR-T and related therapies, patients often develop resistance to currently approved treatments. We believe GDT-002 offers potential as a possible new treatment option for patients with multiple myeloma and potentially other liquid and solid cancers."

GDT-002 is a cell therapy product utilizing specific γδ TCR for the treatment of a wide range of cancers. The target recognized by GDT-002 is upregulated in a wide range of liquid and solid tumors, presenting great therapeutic potential. Preclinical studies have shown that GDT-002 selectively kills primary naïve and relapsed/refractory MM cells and has an activity comparable, in MM animal models, to that of BCMA CAR-T. Importantly, a broad spectrum of liquid and solid tumors is recognized by GDT-002.

Gadeta is developing a pipeline of cell therapies, utilizing tumor specific γδ TCRs. Gadeta aims to bring its novel pipeline of selected, γδ TCR-based products to the clinic, with a focus on solid tumors.

More details of the trial can be found at clinicaltrials.gov NCT04688853.

On July 6, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its second-quarter 2021 financial results on Tuesday, Aug. 3, 2021 (Press release, Bausch Health, JUL 6, 2021, View Source [SID1234584634]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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On July 6, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported it will report its second quarter 2021 financial results and operational highlights on Thursday, August 5, 2021, following the close of U.S. financial markets (Press release, Novavax, JUL 6, 2021, https://www.prnewswire.com/news-releases/novavax-to-host-conference-call-to-discuss-second-quarter-financial-results-and-operational-highlights-on-august-5-2021-301325648.html [SID1234584633]). Details of the event and replay are as follows:

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On July 6, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing antibody drugs with independent intellectual property rights, reported that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for YH001 (anti-CTLA-4) and YH003 (anti-CD40) in the United States (Press release, Eucure, JUL 6, 2021, View Source [SID1234584632]).

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A phase II, non-randomized, multi-center clinical study will evaluate the use of YH001 in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody (Toripalimab) for the treatment of advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). A phase II, open-label, multi-center study will evaluate the safety and efficacy of YH003 combined with Toripalimab for the treatment of PD-1-resistant unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC). Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China. The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approvals signify "a milestone" for Eucure Biopharma. "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials. This is not only an affirmation of the clinical safety and preliminary efficacy of these two products, but also an affirmation of Biocytogen’s drug discovery platform and in vivo drug efficacy screening model. I am very pleased to see that the Eucure team was able to advance clinical development so efficiently. We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world. With our RenMice HiTS Platform, Eucure’s clinical pipeline will continue to expand with potentially novel best-in-class and first-in-class mAbs for oncologic, viral and autoimmune diseases."

About YH001

YH001 is a humanized IgG1 monoclonal antibody targeting CTLA-4. YH001 enhances the immune response against tumor cells and promotes removal of regulatory T cells from the tumor microenvironment. In phase I first-in-human dose-escalation studies in patients with advanced solid tumors conducted in Australia and China, YH001 has shown best-in-class potential with an improved safety profile compared to Ipilimumab (Yervoy), and promising preliminary efficacy when used in combination with Toripalimab.

About YH003

YH003 is a humanized IgG2 agonistic antibody targeting CD40, a receptor that promotes the activation of antigen-presenting cells and the effector activity of anti-tumor T cells. CD40 activation is a key regulatory point in tumor immunotherapy, effectively transforming cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Available clinical data from the YH003 phase I dose-escalation trial indicates a desirable safety profile when combined with Toripalimab, and a potential breakthrough treatment for PD-1-refractory melanoma.

On July 6, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUL 6, 2021, View Source [SID1234584631]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $12 million of shares of its common stock. 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.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under the Company’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and 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. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.