ConcertAI and NeoGenomics Announce Collaboration to Advance Population-Scale, Definitive Hematological Research & Generative AI Solutions at 2024 JP Morgan Conference

On January 8, 2024 ConcertAI, LLC, a leading oncology real-world evidence data and AI technology company, and NeoGenomics, Inc., a leading oncology testing services company, reported a broad collaboration to advance large-scale hematological research solution to investigate real-world clinical practice and outcomes in hematological malignancies (Press release, NeoGenomics Laboratories, JAN 8, 2024, View Source;generative-ai-solutions-at-ash-2023-302028062.html [SID1234639118]).

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Few diseases are as complex as hematological malignancies. The number of alternative treatments considered for patients at different points throughout their care is more varied and individualized than what is seen in diagnosis and management of solid tumors. Hematological malignancies require surveillance of patients over multiple time periods with numerous clinical and diagnostic measures to assess sustained response to treatment or relapse.

Combining ConcertAI’s longitudinal clinical data with NeoGenomics’ comprehensive biomarkers derived from hundreds of hematological tests, we are able to establish a robust and definitive real-world evidence (RWE) hematology solution. The collaboration advances molecular and genetic data solutions for the entire drug development lifecycle, from early clinical development planning to post-approval epidemiological studies. The scale and volume of the combined dataset, which covers over one million patient lives across over 1,000 oncology clinics, provides coverage of key biomarkers throughout the entire patient treatment journey and across multiple lines of therapy, which enables high-value research and quality of care insights. This is the first population-scale hematology data set, which is both large and broad enough to minimize selection bias, to offer an actionable representation of the hematological prevalent disease in the US. The multi-modal combination of Electronic Medical Record (EMR) and rich biomarker data allows for the latest causal inference methodologies, increasingly preferred by the U.S. FDA and other regulatory bodies, and clinical AI methodologies with assurance of high representativeness and generalizability.

"ConcertAI has spent the last three years with biopharma researchers, medical societies, patient advocacy groups, and academic teams to define requirements for truly definitive, insight-enabling research solutions for hematological malignancies," said Jeff Elton, PhD, CEO of ConcertAI. "We did this with the collective goal of having a decade or more of data, richness, consistency in biomarker coverage and the ability to integrate across clinical data and diagnostic modalities. NeoGenomics captures the majority of all U.S. hematologic malignancy testing being sent out to a reference laboratory. It was obvious to both teams that combining our data and capabilities could solve the legacy challenges of depth, breadth, and limited longitudinality."

With rich cytogenetics, morphology, flow cytometry, FISH, and molecular hematological data, this collaboration now has the potential to apply the latest Generative Artificial Intelligence and other complementary approaches that are historically limited by data set sizes and lack of standardization. Hematological diseases can be stable under treatment for years and then enter a period of non-response and relapse. New AI approaches offer the potential to define predictable patterns linked to specific biomarker patterns, aligned to different treatment approaches, and directly associated with outcomes, which can inform new therapeutic programs, clinical trial designs, and treatment strategies.

"We are excited to see the collaboration produce a rich and meaningful dataset to fuel life science research, clinical trial planning and real-world data application," said Lindsey Gasparini, Vice President of Informatics at NeoGenomics. "Our expansive footprint in hematologic testing will enable an important view into clinical work up, diagnosis, and monitoring through longitudinal and multi-modal testing for the community oncologist. ConcertAI has an impressive collection of research-grade clinical data in oncology and hematology, and the power in linking that with the depth and breadth of NeoGenomics data is transformational," Gasparini continued.

The companies will be launching a hematology-focused collaborative version of ConcertAI’s Clinical Trial Optimization solution later in Q1, supporting study design and optimizing all aspects of trial planning, with multiple clinical development initiatives planned.

Abbisko Therapeutic announces that EMA has granted orphan drug designation for its CSF-1R inhibitor Pimicotinib

On January 8, 2024 Abbisko Therapeutics (HKEX code: 02256) reported that its investigational innovative CSF-1R inhibitor pimicotinib(ABSK021) has been granted orphan drug designation(ODD) by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT) (Press release, Abbisko Therapeutics, JAN 8, 2024, View Source [SID1234639117]).

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Following the successful ODD granted by the EMA, the product will benefit from incentives, including protocol assistance, fee reductions, procedural advantages for market authorization, and market exclusivity and so on. In addition to the above-mentioned benefits within the European Union, member states may also offer specific stimuli for orphan drugs.

Previously, in June 2023, pimicotinib was granted the Priority Medicines(PRIME) designation by the EMA, which aims to expedite the review process for promising medicines in areas of unmet medical needs.

In early December 2023, Abbisko entered into an agreement with Merck that granted it an exclusive license to commercialize pimicotinib for all indications in the Chinese mainland, Hong Kong, Macau, and Taiwan. Merck also obtained an exclusive option for global commercial rights of pimicotinib, subject to the terms and conditions as agreed between the parties. Pursuant to the terms of the license agreement, Abbisko will receive a one-time, non-refundable down payment of US$ 70 million. In the event that Merck exercises the global commercialization option, Merck will pay Abbisko an additional option exercising fee. The aggregate amounts of upfront payment, option exercising payment, and payment for development and commercialization milestones will total US$ 605.5 million. Abbisko will also receive double-digit percentage (%) royalties on annual net sales.

Pimicotinib is a novel, orally available, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. It has been granted the Break Through Designation(BTD) and PRIME designation by China NMPA, U.S. FDA, and EMA for the treatment of TGCT patients who are not amenable to surgery. The study is the first global Phase III clinical trial of TGCT conducted simultaneously in China, the U.S., Canada and Europe.

Upon 1-year follow-up in a Phase 1b trial for TGCT, pimicotinib demonstrated an ORR of 87.5% (28/32, including 3 CR) in the 50 mg QD cohort,which was presented at the 2023 CTOS. Pimicotinib has completed a Phase I dose-escalation trial in the U.S. In December this year, it was granted Fast Track Designation (FTD) by the U.S. FDA for the treatment of unresectable TGCT .

In addition to TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other indications including many types of solid tumors in clinic, and it has obtained approval from China NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer. Up until today, no highly selective CSF-1R inhibitors have been approved in China.

Orion and Glykos announce research collaboration and licensing agreement to develop next-generation ADCs

On January 8, 2024 Orion Corporation and Glykos Finland Oy reported that they have entered into a research collaboration and licensing agreement to develop next-generation antibody-drug conjugates (ADCs) (Press release, Orion, JAN 8, 2024, View Source [SID1234639115]).

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Under the agreement, Orion gains access to Glykos’ proprietary ADC technologies, initiating an ADC program with the potential for expansion into two additional programs in the future. Orion will be responsible for the target selection, research, development, and commercialization of up to three next-generation ADCs, with a focus on solid tumors.

Glykos is eligible for milestone payments related to signing of the agreement, target selection and sales milestones. Glykos is also entitled to receive royalties on commercial sales generated from the three ADC programs.

Outi Vaarala, Senior Vice President, Innovative Medicines and R&D, Orion, said: "Collaboration with Glykos and possibility to utilize their ADC technology complements nicely our research portfolio in oncology and is yet another demonstration of our will to develop new treatment options for cancer patients with unmet needs."

Juhani Saarinen, CEO of Glykos, said: "The acknowledgment of our ADC technology by an esteemed pharmaceutical company like Orion is a strong statement to the transformative potential of these technologies in enhancing the therapeutic index of ADCs. We look forward to partnering with Orion and believe that with their expertise on cancer therapies and robust clinical pipeline, this partnership can deliver innovative medicines for cancer patients."

Immunome Exclusively Licenses Zentalis ROR1 Antibody-Drug Conjugate and Proprietary Technology Platform

On January 8, 2024 Immunome, Inc. (Nasdaq: IMNM) and Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), reported that they have entered into an exclusive, worldwide license agreement under which Immunome has licensed from Zentalis ZPC-21, a preclinical ROR1 antibody-drug conjugate (ADC) with best-in-class potential on track for IND submission in 1Q 2025, and Zentalis’ proprietary ADC platform technology (Press release, Zentalis Pharmaceuticals, JAN 8, 2024, View Source [SID1234639114]).

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"This agreement strengthens Immunome’s pipeline while expanding our ADC toolbox," said Clay B. Siegall, Ph.D., Chairman and Chief Executive Officer of Immunome. "ZPC-21’s preclinical activity across multiple models suggest best-in-class potential against ROR1, a clinically validated target that is relevant to both solid tumors and hematological malignancies. We intend to efficiently advance ZPC-21 through IND and into clinical development."

Dr. Siegall continued: "The next generation of transformative ADCs will be built through combining rigorously selected targets with innovative linker-payload platforms. We believe that the linker-payload technology that underlies ZPC-21 may compare favorably to the platforms of successful ADC franchises— a testament to Zentalis’ deep understanding of medicinal chemistry and cancer biology. Immunome will now evaluate and advance Zentalis’ platform technology in the context of our multiple discovery-stage ADC programs against undisclosed targets."

Under the terms of the deal, Zentalis will receive an up-front payment of $35 million in cash and Immunome common stock. Zentalis will be eligible to receive up to $275 million of milestone payments for ZPC-21 and the platform technology in addition to mid-to-high single-digit royalties.

"Immunome’s leadership team’s track record of advancing paradigm-changing ADCs, along with Zentalis’ commitment to apply cutting-edge medicinal chemistry to anti-cancer agents, makes Immunome the ideal partner to advance our ADC platform," said Cam Gallagher, President of Zentalis. "This transaction realizes immediate value for our shareholders while enabling the Zentalis team to focus on advancing azenosertib, our oral WEE1 inhibitor with first-in-class and best-in-class potential, through multiple ongoing clinical studies in tumor types with high unmet need."

Leerink Partners is acting as exclusive financial advisor to Zentalis

Advancing Novel treatments for the Hematological Malignancies

On January 8, 2024 Syros presented its corporate presentation (Presentation, Syros Pharmaceuticals, JAN 8, 2024, View Source [SID1234639113]).

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