Immutep Signs Exclusive License Agreement with Cardiff University for Next Generation Anti-LAG-3 Molecules for Cancer

On June 25, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, reported a License Agreement with Cardiff University granting the Company exclusive rights to develop and commercialise anti-LAG-3 small molecules (Press release, Immutep, JUN 25, 2024, View Source [SID1234644513]).

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A number of promising compounds that block LAG-3, an immune checkpoint known to reduce the immune system’s response to fight cancer, have been identified under Immutep’s collaboration with the world-leading scientists at Cardiff University. Led by Professor Andrew Godkin of Cardiff University, Professor Andrea Brancale (now of the University of Chemistry and Technology, Prague), and Dr Frédéric Triebel, Immutep CSO, the compounds were identified by chemical library screening, molecular modelling (virtual screening) and synthetic chemistry.

Professor Andrew Godkin of Cardiff University said: "Our collaboration with Immutep has been exciting and fruitful, resulting in a number of small molecules with the potential to fight cancer by blocking the interaction between LAG-3 on T cells and MHC Class II on antigen-presenting cells. Small molecules represent the next generation of anti-LAG-3 therapies and hold tremendous promise, as they can be given to cancer patients as a convenient oral pill."

To date, over a dozen companies have initiated clinical trials investigating antagonist or "blocking" LAG-3 antibodies including Bristol Myers Squibb’s relatlimab, which was approved by the FDA in 2022 as part of a fixed dose combination with nivolumab for the treatment of metastatic melanoma. This new combination, known as Opdualag, achieved commercial sales of US$252 million and US$627 million in 2022 and 2023, respectively. Immutep’s program aims to develop an orally-available small molecule anti-LAG-3 treatment for cancer patients at a lower cost compared with the anti-LAG-3 monoclonal and bi-specific antibodies that are commercially available or under clinical development today.

Dr. Frédéric Triebel, Immutep CSO, said: "With our first-in-class MHC Class II agonist, eftilagimod alfa, entering late-stage clinical trials in oncology and IMP761, the world’s first LAG-3 agonist antibody targeting the root cause of autoimmune diseases scheduled to enter the clinic by mid-year, the team at Immutep continues to build on its pioneering leadership position in the LAG-3 therapeutic landscape with this novel program. This License Agreement harnesses many years of collaborative work with the expert team at Cardiff University and enables us to advance the most promising preclinical compounds towards the next stage of development."

A joint patent application has been filed by Immutep S.A.S. and University College Cardiff Consultants Limited (a Cardiff University affiliate) to protect the new intellectual property. The License Agreement builds on Immutep’s collaboration with Cardiff University which commenced in 2019. University College Cardiff Consultants Limited will receive an upfront payment of £25,000 and a milestone payment upon first commercial sale of a licensed product, and is eligible to receive low single-digit sales based royalties.

Monopar Announces MNPR-101-RIT Abstract Accepted as a Top-Rated Oral Presentation at EANM’24

On June 25, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, reported that its abstract titled "Evaluation of Anti-uPAR Antibody as a Radiopharmaceutical for Imaging and Treatment of Solid Tumors" has been accepted as a "Top-Rated Oral Presentation" within the Scientific Program of the European Association of Nuclear Medicine (EANM) 2024 Annual Congress to be held on October 19-23, 2024 in Hamburg, Germany (Press release, Monopar Therapeutics, JUN 25, 2024, View Source [SID1234644531]).

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Monopar’s abstract details its MNPR-101-RIT, a novel first-in-class radio-immuno-therapeutic program that targets cancers expressing the urokinase plasminogen activator receptor (uPAR), including triple-negative breast, colorectal, and pancreatic cancers. The Company’s preclinical data demonstrate compelling and durable anti-tumor benefits with MNPR-101 conjugated to therapeutic radioisotopes, including lutetium-177 (Lu-177) and actinium-225 (Ac-225).

"We are honored by the recognition of our MNPR-101-RIT abstract at EANM’24," said Chandler Robinson, MD, CEO of Monopar Therapeutics. "This selection underscores the potential of our uPAR-targeted therapy and the interest around uPAR as a potential new target for radiopharma treatment."

Monopar recently initiated its MNPR-101-Zr first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients. Further information about this trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.

OSE Immunotherapeutics Announces Commercial and Revenue Sharing Agreement in the Field of CAR T-cell Therapies

On June 24, 2024 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported that the Company has entered into a commercial and revenue sharing agreement with leading global cancer center (Press release, OSE Immunotherapeutics, JUN 24, 2024, View Source [SID1234646936]).

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This exclusive and worldwide agreement with Memorial Sloan Kettering Cancer Center (MSK) covers OSE Immunotherapeutics’ patent rights and jointly owned OSE/MSK patent rights in the field of Chimeric Antigen Receptor (CAR) cell therapy for the treatment of Interleukin-7 Receptor (IL-7R) expressing cancers, in particular hematological tumors such as Acute Lymphoblastic Leukemia. As part of this agreement, MSK will lead the research, development, and commercialization efforts, and subsequently share potential future revenues with OSE Immunotherapeutics.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: "We are very pleased to reinforce our collaboration with one of the world’s most renowned US cancer hospitals in oncology and in particular in the field of CAR-T cell therapies. Based on their pioneering expertise in this area, we look forward to the clinical exploration of a potential breakthrough therapy option for IL-7R expressing cancer patients".

"I am excited for the next steps in translation of IL-7R targeted CARs to clinical trials treating IL-7R expressing tumor bearing patients at MSK," said Prasad S. Adusumilli, MD, FACS, Deputy Chief and Attending, Thoracic Service, and Vice Chair for Translational Research, Department of Surgery, at MSK. Dr. Adusumilli holds the Min H. & Yu-Fan C. Kao Chair in Thoracic Cancer at MSK. His laboratory team investigated and developed therapeutic strategies using IL-7R CAR T cells.

This new agreement is based on the initial multi-year research collaboration between MSK and OSE Immunotherapeutics to explore the preclinical potential of a non-antagonist IL-7R monoclonal antibody directed against the alpha chain of IL-7R used either as a therapeutic antibody or for the design of innovative CAR-T cells for cancer indications expressing high level of IL-7R.

G1 Therapeutics Provides Update on Phase 3 PRESERVE 2 Trial in Patients Receiving Trilaciclib Prior to First Line Chemotherapy in Metastatic Triple Negative Breast Cancer (mTNBC)

On June 24, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported topline results from the final OS analysis of its Phase 3 PRESERVE 2 trial evaluating the efficacy and safety of trilaciclib administered prior to chemotherapy (gemcitabine and carboplatin; GCb) in patients with metastatic TNBC (Press release, G1 Therapeutics, JUN 24, 2024, View Source [SID1234644498]).

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The study did not demonstrate a statistically significant treatment effect in the ITT population (n=187) with a hazard ratio (HR) of 0.91 (p=0.884). The median OS in the trilaciclib plus GCb arm was 17.4 months compared to 17.8 months in the control arm. Median OS numerically favored the trilaciclib arm in both PD-L1 subgroups (positive and negative), though neither achieved statistical significance. Varying effects were observed across regions and patients who received different types of subsequent therapies; these findings will be evaluated further. The safety profile of trilaciclib with GCb observed in the trial was consistent with prior studies, and no new safety signals were identified. Consistent with other trilaciclib studies, evidence of myeloprotection was observed, including a reduction in the occurrence of severe neutropenia, which occurred in 8% of patients who received trilaciclib compared to 29% of patients in the control arm. The Company will submit the results of this trial to a future medical conference.

"The unexpected results from PRESERVE 2 underscore the challenge of developing new therapies for triple negative breast cancer," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are disappointed that this trial did not deliver the benefit that we anticipated to people living with TNBC. We are also grateful to the patients who participated in this trial, their families, and their healthcare teams including the clinicians and their staff."

Mr. Bailey continued, "We will now further our focus on both accelerating and expanding the growth of the ES-SCLC business to achieve anticipated company profitability in the second half of 2025 and evaluating other myeloprotection uses for trilaciclib. We are also pursuing ex-US partners to expand the use of COSELA (trilaciclib) globally."

Financial Guidance

G1 today reaffirmed its full year 2024 COSELA net revenue guidance and updated its cash runway guidance. G1’s guidance is based on current expectations for continued sales growth of COSELA in the U.S. and achievement of its forecasts.

The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. Additionally, G1 plans to wind down the Phase 3 PRESERVE 2 trial, discontinue the anticipated hiring of staff and investment for a 1L TNBC indication and make targeted headcount reductions outside of the existing commercial organization to streamline the Company. These efforts are expected to provide sufficient cash runway to achieve anticipated company profitability in the second half of 2025.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to discuss PRESERVE 2. Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Merck Provides Update on Xevinapant Program in Locally Advanced Head and Neck Cancer

On June 24, 2024 Merck, a leading science and technology company, reported the discontinuation of the Phase III randomized TrilynX study evaluating xevinapant plus chemoradiotherapy (CRT) in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) (Press release, Merck KGaA, JUN 24, 2024, View Source [SID1234644514]). The decision follows a pre-planned interim analysis performed by the study’s Independent Data Monitoring Committee, which found that the trial would be unlikely to meet its primary objective of prolonging event-free survival. Top-line safety data were overall compatible with the chemo-radio sensitizing properties of xevinapant. The company will conduct an in-depth review of the data and will share the results in a peer-reviewed forum.

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LA SCCHN has proven to be a difficult-to-treat form of cancer. CRT has remained the standard of care for decades, despite multiple studies designed to improve outcomes with new treatment approaches, including multiple immunotherapy trials.

"We sincerely thank the patients, caregivers and clinical investigators who participated in this trial," said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. "While we are disappointed by these results, we remain steadfast in our commitment to develop transformative medicines within our oncology portfolio for areas of high unmet need."

Given the totality of the data, the company decided to also stop the Phase III clinical trial X-Ray Vision (xevinapant plus radiotherapy, compared to placebo plus radiotherapy) in patients who underwent resection of locally advanced head and neck cancer.

Merck is working to develop and deliver new treatment options that exploit the vulnerabilities of tumor cells. The company is exploring modalities including antibody drug conjugates (ADCs) and DNA damage response (DDR) inhibitors, across multiple tumor types, including many that have proven difficult to treat where there are significant unmet needs for patients. The company’s support for the head and neck cancer community remains steadfast with Erbitux, approved in combination with radiotherapy for the initial treatment of locally advanced SCCHN, and which continues to be studied in more than 200 active clinical trials, including at least 15 Phase III studies.