On January 10, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its updated strategy for company growth (Press release, Innate Pharma, JAN 10, 2025, View Source [SID1234649612]). This comprehensive plan is anchored in three key pillars designed to drive sustainable growth, foster innovation, and deliver transformative therapies to patients worldwide.

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"Our updated strategy underscores Innate Pharma’s unwavering dedication to innovation, collaboration, and delivering transformative therapies for patients worldwide," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "With a focus on our ANKET platform and ADC programs, we are poised to redefine the landscape of immunotherapy, addressing unmet needs in oncology and autoimmune diseases. This roadmap reflects our steadfast commitment to advancing science, strengthening partnerships, and maximizing value for patients and shareholders alike as we look toward a brighter future in immuno-oncology."

Three Pillars of Growth

Drive innovation with first-in-class ANKET Platform: A new era in NK cell therapeutics is at the heart of Innate Pharma’s strategy, based around its validated, proprietary Antibody-based NK Cell Engager Therapeutics (ANKET) platform. This cutting-edge technology with anticipated applications in hematologic malignancies, solid tumors, and autoimmune diseases leverages the advantages of harnessing NK cell effector functions and can create proliferation of NK cells. By advancing its clinical pipeline, Innate aims to exploit therapeutic possibilities in oncology and autoimmune diseases. IPH6501, Innate’s proprietary ANKET is currently being investigated in a Phase 1/2 study in patients with CD20-expressing non-Hodgkin’s Lymphoma.

Accelerate development of differentiated Antibody-Drug Conjugates (ADCs): Innate Pharma is advancing its ADC programs to develop differentiated and highly targeted treatments that combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs. IPH4502, Innate’s lead ADC, a novel and differentiated topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4, is being investigated in a Phase 1 trial in patients with advanced solid tumors.

Advance current late-stage assets through partnerships: Partnerships will continue to play a critical role in the Company’s strategy, for broader impact with Innate’s established antibody assets, including lacutamab and monalizumab. Innate is actively seeking a partner to progress lacutamab for patients with advanced forms of T cell lymphomas. Monalizumab, currently in a Phase 3 trial PACIFIC-9 led by AstraZeneca in non-small cell lung cancer, will see readouts by end of 2026. By entrusting these promising therapies to strategic partners, Innate ensures their ongoing development and potential commercialization, maximizing their therapeutic potential and reach.

With this multi-faceted strategy, Innate Pharma believes it is positioned to accelerate its growth trajectory and reinforce its leadership in the immuno-oncology space. The Company’s robust scientific expertise, strategic collaborations, and focus on patient outcomes create a strong foundation for success.

On January 10, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC) a Canadian biopharmaceutical company developing radiopharmaceuticals and ADC products using its proprietary platform and drug delivery technologies in addition to novel immune-oncology vaccines, reported its participation to the Biotech ShowcaseTM conference next week in San Francisco during the J.P. Morgan Healthcare Conference to meet with industry leaders, partners and potential investors (Press release, Defence Therapeutics, JAN 10, 2025, View Source;utm_medium=rss&utm_campaign=defence-to-connect-with-industry-leaders-and-potential-partners-during-the-jp-morgan-healthcare-conference-in-san-francisco-plans-to-expand-the-next-generation-of-radio-immuno-conjugates-in-2025 [SID1234649649]).

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The Biotech Showcase is a premier investor conference committed to creating a platform for biotech companies, offering them a unique opportunity to showcase their innovation and engage one-to-one with investors and biopharmaceuticals executives. The life science conference is taking place from January 13-16 in San Francisco during the JP Morgan Healthcare Conference which is the premier healthcare investment symposium attracting thousands of industry leaders and investors.

"Our CSO, Dr. Maxime Parisotto, and I will be actively participating in the healthcare conference and meetings related in San Francisco to meet with global industry leaders, potential partners and investors to reinforce our network in the US ecosystem and more importantly to clearly demonstrate the strength and importance of our proprietary Accum technology platform in the US life science market. The Accum technology platform has a great potential to play a pivotal role to improve ADCs and in the development of targeted radiopharmaceutical therapies, which we are fully dedicated to expanding in 2025" says Mr. Plouffe, CEO and president of Defence Therapeutics.

The Company is also pleased to announce the closing of the 1st tranche of its previously announced non-brokered private placement (the "Offering") of units of the Company (the "Units") at a price of $0.60 per Unit for aggregate gross proceeds of $300,000 (the "Closing"). Each Unit consists of one common share in the capital of the Company (each, a "Share") and one common share purchase warrant (each whole, a "Warrant"). Each Warrant is exercisable to acquire one additional Share at an exercise price of $0.75 per Share for a period of 24 months from the date of the Closing (the "Warrant Expiry Date").

In connection with the Closing, the Company paid a cash finder’s fee of $24,000 and issued 40,000 finder’s warrants (the "Finder’s Warrants") to certain qualified arm’s length finder. Each Finder’s Warrant is exercisable into one Share at an exercise price of $0.75 per Share on or before the Warrant Expiry Date.

The Company intends to use the net proceeds of the Offering to advance its preclinical and clinical programs and for general working capital. All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day from their date of issue in accordance with applicable securities legislation.

On January 10, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers (Press release, NextCure, JAN 10, 2025, View Source [SID1234649597]).

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"Dosing the first patient in the LNCB74 Phase 1 study is a significant milestone for NextCure as we continue to advance our B7-H4 ADC program," said Udayan Guha, M.D., Ph.D., NextCure’s Senior Vice President, Clinical & Translational Development. "We look forward to establishing the safety, tolerability, and preliminary anti-tumor activity of LNCB74. We believe this novel ADC could potentially transform treatment options for multiple cancers."

In December 2024, NextCure announced that the U.S. Food and Drug Administration had cleared its Investigational New Drug application for LNCB74.

LNCB74 is being developed in partnership with LigaChem Biosciences as part of a collaboration agreement.

On January 10, 2025 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported the expanded commercial availability of the NavDx test for Molecular Residual Disease (MRD) detection in anal squamous cell carcinoma (ASCC) patients (Press release, Naveris, JAN 10, 2025, View Source [SID1234649613]). NavDx, Naveris’ proprietary flagship blood test, is the first and only clinically validated circulating tumor TTMV-HPV DNA blood test that provides a non-invasive and precise method that can detect MRD before there is clinical or radiographic evidence of cancer recurrence.

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The commercial expansion coincides with the publication of clinical validity and utility data in the journal Cancers1 that demonstrates the NavDx test’s ability to accurately and reliably detect MRD in HPV-positive anal cancer patients in a multi-center, real-world cohort.

Dr. Barry M. Berger, Chief Medical Officer of Naveris, commented: "With an impressive per-test positive predictive value (PPV) of 98% and a negative predictive value (NPV) of 95%, the NavDx test demonstrates exceptional clinical value in detecting and ruling out disease recurrence in ASCC patients. This offers real utility for physicians, allowing them to accurately assess whether a patient has residual disease and implementing the most appropriate course of care without unnecessary delays. This expanded use of NavDx represents a critical step forward in advancing both precision medicine and the overall management of HPV-related anal cancer."

This new data further reinforces the clinical value of TTMV-HPV DNA testing in HPV-positive cancers, as supported by more than 30 peer reviewed publications validating use of the NavDx test in head and neck cancers.

The expansion of the NavDx test in HPV-positive anal cancer patients also reflects Naveris’ commitment to increasing access to high-quality care. As a blood test, the NavDx test offers a simpler, non-invasive, and more accessible compliment to traditional institution-based surveillance methods and is anticipated to increase healthcare access for those who face challenges in receiving timely, effective cancer care.

"Certain populations, notably those living with HIV and of lower socioeconomic status, are much more likely to develop anal cancer. These populations often face barriers to accessing care under current recurrence surveillance protocols," noted Alice L. Pomponio, Managing Director of the American Cancer Society’s BrightEdge impact investing arm and a Naveris Board Observer. "By bringing the NavDx test to clinic for anal cancer MRD testing, Naveris is addressing an urgent need for early cancer detection solutions and providing health equity for individuals that face challenges to accessing care. Our shared mission of impact investing, leveraging innovation to improve care for underserved populations, can be achieved through a test that will improve clinical care for all patients."

On January 10, 2025 Pfizer Inc. (NYSE: PFE) reported positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) (Press release, Seagen, JAN 10, 2025, View Source [SID1234649598]). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance).

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"Patients with BCG-naïve high-risk non-muscle invasive bladder cancer have high rates of recurrence and progression," said Neal Shore, M.D., FACS, Medical Director for the Carolina Urologic Research Center, and lead investigator for the CREST trial. "These study results demonstrate the potential for sasanlimab in combination with BCG to redefine the treatment paradigm for patients living with BCG-naïve, high-risk non-muscle invasive bladder cancer, including patients with carcinoma in-situ (CIS), providing prolonged event-free survival which may delay or reduce the need for more aggressive treatment options. Administered subcutaneously every four weeks, sasanlimab, if approved, could also help lower the treatment burden on both patients and healthcare systems."

Each year, approximately 100,000 people globally are diagnosed with high-risk NMIBC.3 Induction therapy with BCG followed by maintenance has been the standard of care for patients with high-risk NMIBC for decades.4 40-50% of patients experience recurrent disease, often requiring radical cystectomy,5,6,7 which is associated with significant risks8,9,10 and bladder-sparing treatment options are still limited.11,12

"The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years," said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. "These results reinforce Pfizer’s leadership in genitourinary cancer research and development, demonstrating our ongoing commitment to deliver new treatment options for patients with bladder cancer."

The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors.

Results will be submitted for presentation at an upcoming medical congress. Pfizer plans to discuss these data with global health authorities to support potential regulatory filings. Sasanlimab also continues to be investigated in combination with Pfizer’s antibody drug conjugate (ADC) portfolio in advanced solid tumors.

About CREST

The CREST trial is a Phase 3, multinational, randomized, open-label, three parallel-arm study of sasanlimab, an anti-PD-1 mAb, in combination with BCG (BCG induction with or without BCG maintenance) versus BCG (induction and maintenance) in participants with BCG-naïve, high-risk NMIBC. Patients were randomized to receive sasanlimab 300 mg by subcutaneous (SC) injection every four weeks up to cycle 25 (cycle = four weeks), in combination with BCG once weekly for six consecutive weeks (induction period) followed (Arm A) or not (Arm B) by maintenance with BCG, or BCG induction and maintenance up to cycle 25 (Arm C). The primary endpoint is EFS as assessed by the investigator, between Arm A and C, defined as the time from randomization to the earliest of recurrence of high-grade disease, progression of disease, persistence of CIS, or death. Key secondary endpoints include EFS as assessed by the investigator between Arm B and Arm C.

About Sasanlimab

Sasanlimab is a humanized immunoglobulin G4 mAb that binds to human programmed death-1 (PD-1) to block its interaction with PD-1 and PD-L1/PD-L2. PD-1 is a protein expressed on T cells, dendritic cells, natural killer cells, macrophages, and B cells, that functions as an immune checkpoint that negatively regulates T-cell activation and effector function when activated by its ligands and may play an important role in tumor evasion from host immunity. It can be administered through a once every four weeks subcutaneous injection by prefilled syringe (2mL).

In early-stage clinical studies, sasanlimab administered at 300 mg SC every four weeks showed clinical efficacy in advanced solid tumors and advanced urothelial cancer. In addition to NMIBC, sasanlimab is being evaluated in several ongoing clinical trials with other novel combinations.