On December 10, 2024 Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, and NeraCare, a leading developer of laboratory tests for the prognosis of melanoma, reported an exclusive global license agreement to develop and commercialize NeraCare’s Immunoprint test on Akoya’s multiplexed immunofluorescent platform (Press release, Akoya Biosciences, DEC 10, 2024, View Source [SID1234648972]). Building on the research collaboration between the companies announced earlier this year, the license agreement grants Akoya the exclusive right to develop, market and commercialize the test for clinical research, diagnostic development or, following regulatory approval, patient clinical testing as both a laboratory test or a distributable diagnostic on Akoya’s PhenoImager HT platform.

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!

Melanoma, the leading cause of skin cancer, sees over 235,000 new diagnoses every year, 80% of which are in early-stage disease (IA/IB/IIA). While these early-stage patients undergo surgery and subsequent monitoring, they are ineligible to receive effective adjuvant therapies approved for later stage melanoma. NeraCare’s Immunoprint assay addresses this critical unmet need by identifying early-stage melanoma patients at high risk of relapse, comparable to later-stage patients, making them ideally suited to potentially benefit from therapeutic options.

"The agreement builds on the complementary expertise of both companies: Akoya’s market-leading multiplex immunofluorescence technology and NeraCare’s innovative development and rigorous clinical validation of Immunoprint. Together, we aim to expand access to life-saving therapies for early-stage melanoma patients worldwide," said Friedrich Ackermann, Co-Founder of NeraCare.

"Our collaboration is a testament to the versatility of Akoya’s PhenoImager HT platform and the clinical impact spatial biology can deliver. Immunoprint has proven unparalleled in identifying high-risk melanoma patients through multiple clinical studies, and our partnership aims to offer a platform to address the unmet need for earlier therapeutic intervention," added Daniel von Janowski, Co-Founder of NeraCare.

"Our exclusive partnership with NeraCare for Immunoprint is a significant advancement of our clinical strategy providing Akoya and our pharmaceutical partners the opportunity to transform melanoma patient care We are honored to be partnering with NeraCare to help bring this test to market and serve a critical unmet need," said Brian McKelligon, CEO of Akoya Biosciences.

On December 10, 2024 Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported data from the TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) at the 66th ASH (Free ASH Whitepaper) annual meeting (Press release, Curis, DEC 10, 2024, View Source [SID1234648969]).

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!

The additional data presented include data for 21 patients with a FLT3 mutation (FLT3m) who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. This brings the total number of patients dosed at the RP2D from 12 to 21 patients.

Data show 10 objective responses in 19 response-evaluable patients: 6 complete remission (CR), 2 CR with either a complete remission with incomplete hematological recovery (CRi) or a partial hematological recovery (CRh) and 2 morphologic leukemia-free state (MLFS). Prior therapies of responders included Venetoclax (5/10), HMA (6/10), and FLT3i (6/10). Two of the 21 patients were treated, but discontinued treatment prior to first disease assessment (death occurred at Day 8 and Day 13, respectively), and were not included as response-evaluable patients.

Two patients who achieved a CR and CRi, respectively, proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 7 of 10 responses reported at the first assessment (Cycle 2 Day 1).

"We continue to be pleased with the monotherapy data in R/R AML patients with a FLT3 mutation," said James Dentzer, President and CEO of Curis, "and believe these data further support the exciting potential of emavusertib’s novel mechanism to address a significant unmet need in patients with AML."

On December 9, 2024 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, reported initial positive clinical data from the multi-center Phase 1-2 study of IMPT-314 in patients with large B-cell lymphoma that is being presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Lyell Immunopharma, DEC 10, 2024, View Source [SID1234648922]). IMPT-314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin lymphoma.

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!

As of October 22, 2024 (the data cutoff for the presentation), 23 patients with relapsed or refractory (R/R), CAR T-naive large B-cell lymphoma received IMPT-314. The efficacy evaluable population consisted of 17 patients. The ORR was 94% (16/17 patients), with 71% (12/17 patients) achieving a CR by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were in response at last follow-up). In the safety evaluable population of 23 patients, no Grade 3+ CRS was reported. Grade 3 ICANS was reported in 13% (3/23) of patients with a median time to complete ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy. In the efficacy evaluable set, 16 patients were evaluable for pharmacokinetics. IMPT-314 demonstrated robust expansion and peak cell expansion occurred between Days 7 – 28 post IMPT-314 infusion (median Tmax = 10 days). Additionally, the final drug product contained the desired naïve and central memory cell phenotype (median, 91%; range, 82 – 99%) that has been associated with improved overall survival in other CAR T cell clinical studies.

The data are being presented today at the 2024 ASH (Free ASH Whitepaper) Annual Meeting by Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, and the poster is available in the Investors’ section of the Company’s website.

"The high rate of complete responses with a favorable safety profile support the strong potential of IMPT-314, Lyell’s next-generation dual-targeting CAR T-cell therapy enriched for naïve and central memory T cells. This product candidate was designed to maximize durable responses by overcoming heterogeneous CD19 antigen density and antigen escape, enhance CAR T cell persistence, and reduce exhaustion," said Lynn Seely, M.D., Lyell’s President and Chief Executive Officer. "Based on these strong data, we remain on track to initiate a pivotal trial in 2025 of IMPT-314 in CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting and are continuing to evaluate IMPT-314 in the 2nd-line setting in the ongoing Phase 1-2 trial."

"The data presented today from IMPT-314 suggest the potent targeting of both CD19 and CD20 coupled with CD62L+ cell enrichment has the potential to provide differentiated benefit in objective and complete response rates over first-generation CD19 CAR therapies in patients with aggressive large B-cell lymphoma," stated Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA. "IMPT-314 incorporates the same CAR construct as CART19/20 which was evaluated in a Phase 1 trial at UCLA, and I am pleased that the IMPT-314 data are consistent with our experience at UCLA."

About IMPT-314

IMPT-314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the response as compared to the approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma.

IMPT-314 is designed with an ‘OR’ logic gate to target B cells that express either CD19, CD20 or both. IMPT-314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity.

IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma.

On December 9, 2024 GlyTherix and Nusano, a physics company transforming the production of radioisotopes, reported a supply agreement for non-carrier-added lutetium-177 (Lu-177) (Press release, Glytherix, DEC 10, 2024, View Source [SID1234648902]). The agreement also provides GlyTherix access to Nusano’s future actinium-225 (Ac-225) production, currently scheduled to begin in 2026, and planned future production of zirconium-89 (Zr-89), lead-212 (Pb-212) and terbium-161 (Tb-161).

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!

GlyTherix’s radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue.

Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma, esophageal and ovarian cancer. GlyTherix plans to use 177Lu-DOTAMiltuximab in its planned Australian Phase Ib in 2025, followed by US Phase II trials in 2026.

On December 9, 2024 Cimeio Therapeutics reported that it has entered a research collaboration with Kyowa Kirin Co., Ltd. (Kyowa Kirin) to develop a novel therapy for diseases with high unmet need (Press release, Cimeio Therapeutics, DEC 10, 2024, View Source [SID1234648894]).

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!

The partnership combines Cimeio’s proprietary Shielded Cell and Immunotherapy (SCIP) platform with Kyowa Kirin’s expertise in cellular therapies and underscores both companies’ commitment to using emerging cell and gene therapy technologies to develop new ways to treat patients. Under the terms of the agreement, Cimeio is eligible to receive an upfront payment and two years of research funding. Upon Kyowa Kirin’s exercise of a commercial license option, Cimeio will be eligible for development and commercial milestones as well as royalties on sales of potential products arising from the partnership. Further terms are not disclosed.

Cimeio’s SCIP platform is based on the development of novel immunotherapies enabled by epitope-shielded cells. These cells contain modified variants of naturally occurring cell surface proteins that maintain their function but are resistant to depletion by the paired immunotherapy. These shielded cells enable the development of powerful therapeutics for previously undruggable targets, targeted conditioning for HSC transplant, and immune system reset amongst other applications.

"We are thrilled to collaborate with Kyowa Kirin, a company with a rich history of investing in innovative technologies that have the potential to significantly improve outcomes for patients with serious conditions," said Dr. Stefanie Urlinger CSO of Cimeio. "This partnership represents a significant step forward for our company and mission."

"Kyowa Kirin and Cimeio share the vision for the potential of therapeutics enabled by epitope-shielded cells," said Yoshifumi Torii, Ph.D, Executive Officer, Senior Vice President, Head of Research Division of Kyowa Kirin. "With this partnership we believe we can develop a safe and effective therapy for diseases that in the past have been incredibly difficult to treat, and we’re looking forward to working with the talented team at Cimeio."