Merck to Participate in the Leerink Partners Global Biopharma Conference 2024

On March 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024, at 12:40 p.m. ET (Press release, Merck & Co, MAR 4, 2024, View Source [SID1234640733]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer

On March 4, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC) (Press release, Iovance Biotherapeutics, MAR 4, 2024, View Source [SID1234640731]). In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety and monitoring measures. Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202.

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The IOV-LUN-202 trial is investigating LN-145 in patients with advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations who were previously treated with chemotherapy and anti-PD-1 therapy and at least one line of an approved targeted therapy if indicated by other actionable tumor mutations. Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025.

Preliminary data from the IOV-LUN-202 trial support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Initial preliminary data were reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial.

For more information about the IOV-LUN-202 trial please visit www.lungcelltherapy.com.

PR: Heidelberg Pharma Announces Royalty Financing Agreement with HealthCare Royalty for up to USD 115 million

On March 4, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) reported that they have signed a royalty financing agreement (Press release, Heidelberg Pharma, MAR 4, 2024, View Source [SID1234640730]). Formal closing conditions that are expected to be fulfilled in a timely manner must still be met. Heidelberg Pharma is eligible to receive up to USD 115 million from the sale of its future royalties from worldwide sales of ZircaixTM (TLX250-CDx), a microdose radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and follow up of clear cell renal cancer.

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ZircaixTM is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. ZircaixTM also has potential as a PET diagnostic imaging agent for other tumor types. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian company based in Melbourne, Australia, in 2017.

Telix completed the Phase III ZIRCON trial for ZircaixTM in the third quarter of 2022. A rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) was announced by Telix in December 2023.

Key terms of the agreement between Heidelberg Pharma and HCRx:

Heidelberg Pharma will receive a USD 25 million upfront payment at closing
Heidelberg Pharma will receive a maximum of USD 75 million payment upon FDA approval of ZircaixTM
Heidelberg Pharma will receive a USD 15 million milestone payment if calendar year 2025 worldwide net product sales of ZircaixTM exceed a certain level
Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: "We are delighted to partner with HealthCare Royalty. This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM. The anticipated financial inflow will extend our cash reach substantially. We are well-positioned to accelerate and expand development of our proprietary pipeline candidates and ADC technologies."

"With this investment, we further pursue the goal of supporting innovative biopharmaceutical companies that will generate long-term value. We strongly believe in the potential of ZircaixTM to deliver value for patients worldwide and are pleased to partner with Heidelberg Pharma on this transaction." added Clarke Futch, founder, Chairman and Chief Executive Officer of HCRx.

Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction. Goodwin Procter LLP and Görg Partnerschaft von Rechtsanwälten mbB acted as legal advisors to Heidelberg Pharma. McDermott Will & Emery LLP acted as legal advisors to HCRx.

Conference Call

Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report. At the financial results press conference the transaction will be explained in more detail and there will be an opportunity to ask questions.

Defence Therapeutics Awarded Broad U.S. Patent Covering Its Pioneering Cancer-Killing Accutox® Technology

On March 4, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, reported the granting of US patent no. 11,890,350 (‘350) by the United States Patent and Trademark Office (USPTO), broadly covering its breakthrough AccuTOX technology (Press release, Defence Therapeutics, MAR 4, 2024, https://defencetherapeutics.com/defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology/?utm_source=rss&utm_medium=rss&utm_campaign=defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology [SID1234640729]). The ‘350 patent, which includes valuable composition-of-matter claims covering a portfolio of therapeutically-active molecules making up the AccuTOX platform, provides Defence with potential market exclusivity until late 2042.

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The AccuTOX platform is based on the discovery that certain bile acid-peptide conjugates, in their free forms, induce cancer cell death by triggering heightened metabolic stress and the production of reactive oxygen species. The ‘350 patent demonstrates that the bile acid-peptide conjugates, when used past cytotoxic threshold concentrations, can potently induce cell death in multiple tumor cells in vitro, including lung, breast, colon, melanoma, and lymphoma cancer cells, and can dramatically reduce lymphoma tumor volumes and enhance survival in vivo in treated mice compared to controls.

Defence’s ‘350 patent was issued with broad claims encompassing a plurality of AccuTOX molecules having cytotoxic or cytostatic activity, either as a monotherapy or in combination with other therapeutics. The granted claims also cover AccuTOX molecules releasably conjugated to a variety of carrier molecules, such as cancer-specific antibodies, where AccuTOX effectively plays the role of a cytotoxic drug, thereby pioneering a potentially new class of next-generation antibody-drug conjugates (ADCs).

Stemming from the data published in the ‘350 patent, pre-clinical and GLP studies for AccuTOX, either alone or in combination with immune checkpoint inhibitors such as anti-PD-1 and anti-LAG3, were undergone, and have shown that the compound is safe and well tolerated using both rodents and canine animal models, and have also demonstrated significant solid tumor growth reductions. Subsequently, Defence has now received FDA approval to commence its Phase I clinical trial to evaluate the effect of intratumoral administration of AccuTOX as a monotherapy, as well as in combination with Opdualag (fixed IV doses), in patients with unresectable stage IIIB to IV melanoma refractory to or relapse from standard therapy.

"The rapid granting of the broad ‘350 patent by the USPTO affirms the innovative and groundbreaking potential of AccuTOX as a leading cancer therapeutic, and also importantly provides a long patent runway and period of market exclusivity for Defence to fully explore the commercial potential of the AccuTOX platform and maximize the benefit to our partners and investors," says Mr. Plouffe, CEO and president of Defence.

This patent marks the fourth granted US patent in Defence’s ever-growing patent portfolio, which currently incudes seven published patent families.

The TG01 IND application by Circio’s partner IOVaxis Therapeutics has been approved by the Chinese regulatory authorities

On March 4, 2024 Circio Holding ASA (OSE: CRNA) reported that the TG01 investigational new drug (IND) application filed by partner IOVaxis Therapeutics of Nantong, China, has been approved by the Chinese National Medical Products Administration (NMPA) (Press release, Circio, MAR 4, 2024, View Source [SID1234640728]). Following this acceptance by the NMPA, IOVaxis has the necessary regulatory approval to initiate TG01 clinical development in China.

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Under the parties´ agreement, IOVaxis has an exclusive option to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to the partnership announcement here and the IND-filing here. Within two weeks of the TG01 IND approval by the NMPA, IOVaxis may elect to exercise its license option and trigger a USD 3m milestone payment to Circio.