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 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 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that Chief Executive Officer Vlad Vitoc, M.D. will present at the Biotech Showcase 2025 investor conference taking place in San Francisco, California January 13-15, 2025 (Press release, MAIA Biotechnology, JAN 10, 2025, View Source [SID1234649611]). Dr. Vitoc will also host one-on-one meetings with investors throughout the 3-day event. The live event will be followed by a virtual 2-day event on January 21-22, 2025.

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At the conference, Dr. Vitoc will discuss MAIA’s recent clinical developments and targeted value-driving milestones for 2025 and beyond, including:

Expansion of MAIA’s THIO-101 pivotal Phase 2 clinical trial to further assess the efficacy of telomere-targeting agent THIO in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy.
Multiple THIO trials planned for additional cancer indications.
Significant market opportunity for THIO in the top tumor types globally.
Biotech Showcase conference details:

Dates:

Live event January 13-15, 2025; Digital event January 21-22, 2025

MAIA presentation:

03:00PM PST on Monday, January 13, 2025*

Conference registration:

All-access and Digital passes available on the conference website

One-on-One Meetings:

Bookings available on the conference website

Webcast:

Join here for live presentation and virtual event streaming

On-demand playback:

Available here 2 hours after the presentation, accessible for 6 months

*Please note that the presentation date and time are subject to change. Attendees can refer to the program agenda for conference updates.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

On January 10, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that Chief Executive Officer Vlad Vitoc, M.D. will present at the Biotech Showcase 2025 investor conference taking place in San Francisco, California January 13-15, 2025 (Press release, MAIA Biotechnology, JAN 10, 2025, View Source [SID1234649611]). Dr. Vitoc will also host one-on-one meetings with investors throughout the 3-day event. The live event will be followed by a virtual 2-day event on January 21-22, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the conference, Dr. Vitoc will discuss MAIA’s recent clinical developments and targeted value-driving milestones for 2025 and beyond, including:

Expansion of MAIA’s THIO-101 pivotal Phase 2 clinical trial to further assess the efficacy of telomere-targeting agent THIO in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy.
Multiple THIO trials planned for additional cancer indications.
Significant market opportunity for THIO in the top tumor types globally.
Biotech Showcase conference details:

Dates:

Live event January 13-15, 2025; Digital event January 21-22, 2025

MAIA presentation:

03:00PM PST on Monday, January 13, 2025*

Conference registration:

All-access and Digital passes available on the conference website

One-on-One Meetings:

Bookings available on the conference website

Webcast:

Join here for live presentation and virtual event streaming

On-demand playback:

Available here 2 hours after the presentation, accessible for 6 months

*Please note that the presentation date and time are subject to change. Attendees can refer to the program agenda for conference updates.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

On January 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial (Press release, Verismo Therapeutics, JAN 10, 2025, View Source [SID1234649610]). The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

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CELESTIAL-301 aims to assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory (r/r) B cell Non-Hodgkin Lymphomas (B cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial is enrolling patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy.

CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are due in part to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.

SynKIR-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas.

"The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected," according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. "SynKIR-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients."

"We are thrilled to administer this promising therapy," said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. "Emerging treatments like SynKIR-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials."

Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR-310. SynKIR-310 is Verismo’s second clinical pipeline following SynKIR-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265.