On December 8, 2025 Agora Open Science Trust reported the nomination of M4K2009 as the lead development candidate for its M4K Pharma program, which applies open science to drive the development of an affordable treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare and devastating pediatric brain cancer. Nominating a lead development candidate marks the point where a discovery program selects a single molecule with the highest potential to advance further towards human clinical trials. The selection of M4K2009 represents a significant scientific and organizational milestone.

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The nomination follows an extensive, multi-year research collaboration with several academic and industry partners worldwide. Among the hundreds of compounds designed and evaluated, M4K2009 demonstrated excellent potency, selectivity, brain penetration, and tolerability in preclinical models, establishing it as a strong candidate for further development.

"Our nomination of M4K2009 represents an important milestone for open science drug discovery," said Max Morgan, CEO of Agora Open Science Trust. "By pooling resources, foregoing patents and secrecy, and instead working openly and collaboratively across institutions with complementary capabilities and expertise, our team has now shown that open science is capable of delivering high-quality, clinically viable candidates, particularly in areas of market failure underserved by traditional proprietary approaches."

With financial and in-kind support from the Krembil Foundation, Conscience’s Developing Medicines through Open Science (DMOS) program, OICR’s Cancer Therapeutics Innovation Pipeline (CTIP), Charles River Laboratories, Structural Genomics Consortium, Institute of Cancer Research, University of Pennsylvania, Montreal Children’s Hospital/McGill University, CAMH, Children’s Cancer Institute, Sant Joan de Deu Hospital, Reaction Biology, GL Chemtec and The Brain Tumour Charity, M4K Pharma has made critical strides toward realizing an affordable, first-in-class therapy for children affected by DIPG.

Conscience’s DMOS program, which is supported by a grant from the Government of Canada’s Strategic Innovation Fund, enables collaborative preclinical drug discovery in areas where open sharing and collaboration are key to advancement towards accessible treatments, such as rare and neglected diseases. Participating projects which include at least one Canadian SME, use an open science approach as they foster collaboration for pre-clinical work, demonstrate early proof-of-concept research, and ultimately translate innovation into affordable medicine and better health outcomes globally. The inaugural round of the program launched in February 2025, with the Agora Open Science Trust as one of the recipients.

"M4K Pharma’s lead development candidate nomination represents a significant step in advancing the program toward the clinical stage and demonstrates that an open science approach can bring us closer to meaningful treatments for rare diseases like DIPG," says Anne Fortier, VP drug discovery and development at Conscience. "Through the DMOS program, we’re proud to support rigorous, collaborative work that helps make therapies more accessible and affordable, particularly in areas where few solutions currently exist."

"Canada is proud to support open science collaborations that deliver real hope for children and families facing rare diseases like DIPG. The nomination of M4K2009 as a lead candidate reflects the power of Canadian innovation and partnership. By accelerating the development of affordable and accessible therapies, we are not only advancing research, but strengthening our position as a global leader in health innovation for the benefit of all Canadians," said The Honourable Mélanie Joly, Minister of Industry and Minister responsible for Canada Economic Development for Quebec Regions.

By sharing data and results with the research community and firmly committing to Agora’s charitable mission of achieving affordable access for affected children, the M4K Pharma program has been successful in motivating and aligning a broad range of contributors. The program has crowdsourced inputs from leading experts and reduced costs and duplication of effort across ALK2 drug discovery research for DIPG, and demonstrated that open science can achieve breakthroughs in areas that traditional, closed models often overlook.

(Press release, M4K Pharma, DEC 8, 2025, View Source [SID1234661302])

On December 8, 2025 Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, reported interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart (ABC008) in patients with T cell large granular lymphocytic leukemia (T-LGLL) with anemia and/or neutropenia, in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025 in Orlando, Florida.

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Ulviprubart is a potentially first-in-class, potent, monoclonal antibody targeting KLRG1, a novel mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. Ulviprubart was designed to target KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

"The data presented at ASH (Free ASH Whitepaper) continue to support the potential of ulviprubart to selectively target and deplete highly differentiated T cells that drive debilitating diseases like T-LGLL. At the interim analysis, ulviprubart had an acceptable safety profile and was generally well tolerated across ascending doses, further supporting ulviprubart’s potential in treating patients with T-LGLL," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro.

T-LGLL is a hematological cancer driven by pathogenic expansion of immune cells that are frequently KLRG1+, resulting in neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one-third of patients.

Key Highlights from Oral Presentation:

The Phase 1/2 clinical trial (NCT05532722) is an open label, ascending dose study of ulviprubart patients with T-LGLL. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluating initial efficacy and pharmacokinetic/pharmacodynamic (PK/PD) profile of ulviprubart.

As of the data cut-off date of November 15, 2025:

21 patients were enrolled and evaluable for safety. 95% (n=20) of patients had neutropenia and 57% (n=12) of patients had anemia at baseline.
62% (n=13) of patients achieved >12 weeks of Q4W dosing on ulviprubart.
Among evaluable patients, seven experienced sustained depletions of >50% of CD8+ CD57+ KLRG1+ T cells at two or more consecutive visits. Three patients experienced sustained depletions of >90% of both CD8+ CD57+ KLRG1+ T cells and the CD8+ CD57+ parent population.
Among evaluable patients, all had neutropenia and nine patients had anemia at baseline.
With treatment, seven patients had a neutropenia response, defined as an absolute neutrophil count (ANC) increase of ≥50% from baseline for ≥4 weeks or ANC levels ≥1000 cells/µL for ≥4 weeks.
With treatment, two patients had an anemia response, defined as hemoglobin increased ≥1 g/dL for ≥4 weeks and not attributable to transfusion or growth factor.
Overall, ulviprubart was well tolerated at increasing doses and had an acceptable safety profile. Most treatment-related treatment-emergent adverse events (TEAE) were mild or moderate in severity. One patient experienced a Grade 3 infusion-related reaction, the only serious treatment-related TEAE observed on therapy.

About Ulviprubart
Ulviprubart (ABC008) is potentially a first-in-class, potent, monoclonal antibody targeting KLRG1, a novel proposed mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. KLRG1 is a cell surface receptor predominantly expressed on highly differentiated T cells, while moderately or minimally expressed on other immune cells. Ulviprubart was designed to selectively deplete KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

(Press release, Abcuro, DEC 8, 2025, View Source [SID1234661301])

On December 8, 2025 Cellarity, a clinical-stage biotechnology company developing Cell State-Correcting therapies through integrated multi-omics and AI modeling, reported the presentation of new preclinical data on investigational programs for sickle cell disease (SCD) and myelofibrosis (MF) during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Cellarity has created a novel approach to drug discovery that focuses on understanding the holistic cell state. The Company’s advanced platform leverages high-dimensional transcriptomics and AI predictive algorithms to discover new biological pathways and to create novel, oral therapeutics that can effectively and safely switch disease mechanisms to healthy cell function, termed as "Cell State-Correcting." This has resulted in a growing pipeline of differentiated drug candidates, with the first now in clinical development for sickle cell disease.

"Cellarity’s novel platform is fueling meaningful progress, enabling us to explore a broad set of indications across several therapeutic areas. We are advancing our lead asset in sickle cell disease, CLY-124, currently in phase 1 clinical development, while also progressing a second hematology program focused on myelofibrosis in the preclinical stage," said Ted Myles, Chief Executive Officer of Cellarity. "Together, these efforts reinforce the strength of our platform approach and commitment to delivering highly innovative, novel therapies to patients."

"The presentations at ASH (Free ASH Whitepaper) underscore the power of Cellarity’s novel pipeline of potentially transformative programs in hematology, addressing significant unmet medical need in sickle cell disease and myelofibrosis. CLY-124 has the potential to transform the standard of care in sickle cell disease, as we believe it may induce fetal hemoglobin through a pathway that avoids cytotoxicity that limits other approaches," said Cameron Trenor, M.D., Chief Medical Officer of Cellarity. "In myelofibrosis, we have identified new candidates that are highly selective in targeting pathways implicated in mutant JAK2 signaling, which may result in the avoidance of anemia that is a common side effect associated with other therapies."

CLY-124: A first-in-class, oral globin-switching therapy for sickle cell disease
SCD is a devastating inherited disease involving sickle-shaped red blood cells that block blood vessels. Research has demonstrated that increasing fetal hemoglobin (HbF) reduces vaso-occlusive crises (VOCs), pain and organ damage, yet most compounds that increase HbF are limited by cytotoxicity and highly variable patient response. Using its integrated discovery platform, Cellarity evaluated hemoglobin regulation through erythropoiesis to predict chemical compounds that could enrich fetal hemoglobin, identifying high levels of HbF induction associated with neddylation inhibition. This led to the identification of Defective in Cullin Neddylation 1 (DCN1) – a previously unexplored target for globin gene switching. Knockout of DCN1 in vitro led to increased expression of gamma globin genes (HBG1/2) and a higher ratio of fetal vs total globin gene expression with no evidence of cytotoxicity, illustrating a potentially safer globin-switching mechanism.

CLY-124 is being developed as a potent DCN1 inhibitor with optimized pharmacology and pharmacokinetic properties. Preclinical evaluation of CLY-124 demonstrated superiority to hydroxyurea in both fetal hemoglobin protein and globin gene ratios (HBG1/2 over total beta-like globin transcripts), approaching levels reported for recent gene therapy programs. Further, pre-clinical combination studies demonstrated robust synergistic effects when combining CLY-124 with hydroxyurea and with no dose-limiting toxicities. CLY-124 is currently progressing through a phase 1 dose escalating study in healthy volunteers and adults with sickle cell disease.

Selective targeting of mutant JAK2 to address myelofibrosis
Myelofibrosis is a blood cancer caused by mutated gene called JAK2V617F (JAK2) in stem cells within the bone marrow, causing fibrosis, inflammation, and dysfunctional blood cells that lead to anemia, enlargement of the spleen and eventual bone marrow failure. Current JAK2 inhibitor therapies like ruxolitinib manage disease symptoms but are limited by dose because they inhibit both healthy and mutant JAK2 signaling resulting in cytopenias.

Cellarity leveraged high-dimensional transcriptomics from patient samples to map gene signatures uniquely associated with JAK2-mutant hematopoietic stem cells. Through its AI-powered, transcriptomic-driven discovery platform and iPSC (induced pluripotent stem cell)-based disease models, the company identified a novel, druggable biological target and small molecule interventions that selectively suppress the JAK2-mutant clone while sparing normal hematopoiesis.

(Press release, Cellarity, DEC 8, 2025, View Source [SID1234661300])

On December 8, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported positive new data from its pipeline of allogeneic T-cell immunotherapies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Orca-Q with and Without the Use of GvHD Prophylaxis

A subset of the multi-center Phase 1 clinical trial evaluated Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelofibrosis (MF), myelodysplastic syndrome (MDS) and mixed phenotype acute leukemia (MPAL) with HLA-matched related and unrelated donors. New data evaluating Orca-Q with and without the use of pharmacological graft versus host disease (GvHD) prophylaxis showed encouraging outcomes including rapid neutrophil recovery and low rates of acute and chronic GvHD, relapse and non-relapse mortality (NRM).

"Controlling alloreactivity and reducing GvHD following a conventional stem cell transplant typically requires multi-agent immunosuppression. However, this can impair immune reconstitution and increase the risk of organ toxicity, infection and relapse," said presenting author Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. "In these new findings, Orca-Q demonstrated encouraging outcomes even without the use of any pharmacological GvHD prophylaxis. While ongoing enrollment is important to further validate these results, the data suggest that Orca-Q may be able to control alloreactivity and potentially offer a platform to improve transplant outcomes through controlling GvHD and infection and reducing non-relapse mortality without increasing the risk of relapse."

Patients on Arm A received Orca-Q and single-agent tacrolimus (tac, n=18) while patients on Arm C received Orca-Q and no immune suppression (n=26). Median time to neutrophil engraftment was 15 days for patients who received tac and 11 days for patients who did not. Orca-Q was well-tolerated with 94% overall survival (OS) at one year for patients with tac and 87% for patients without tac. At one year, GvHD-and-relapse-free survival (GRFS) was 77% with tac and 79% without tac, and NRM was 6% and 0% with tac and without tac, respectively. Relapse-free survival (RFS) at one year was 88% with tac and 87% without tac. At Day 180, moderate-to-severe chronic GvHD was 12% with tac and 0% without tac. Grade 3-4 acute GvHD was 8% and 6% with and without tac, respectively.

Importantly, Orca-Q patients treated without GvHD prophylaxis demonstrated more rapid immune reconstitution and improved control of infections. Specifically, BMT CTN Grade 2+ infections at one year were 33% with tac and 17% without tac.

Orca-T and CAR-T Combination Treatment Versus Autologous CAR-T

A second oral presentation compared the results from two separate Phase 1 trials in adults with high-risk relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). The first trial evaluated OrCAR-T (n=16), a treatment that combines Orca-T and allogeneic CD19/CD22 CAR-T cells, and the second trial evaluated an autologous CD19/22 (n=17). At 18 months, progression-free survival (PFS) and OS were 100% and 100% with OrCAR-T, and 38.5% and 77% in the autologous cohort. Toxicities were mild across both cohorts, with no grade 3-4 CAR-related toxicities reported. At a median follow-up of 2.5 years, there were no relapses or patient deaths with OrCAR-T and seven deaths with autologous, six from refractory B-ALL.

"Among adults with B-ALL, CAR-T therapy is often followed by a consolidative allogeneic transplant to achieve long-term remission," said Lori Muffly, M.D., associate professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Health Care. "Emerging data showing improved progression-free survival in patients with a prior transplant has prompted interest in exploring whether combining a high-precision allogeneic therapy like Orca-T with CAR-T cells could provide a feasible, all-in-one treatment. While these findings are early, they suggest this approach has the potential to benefit patients across a range of hematologic diseases."

"Our team is encouraged by these new findings from our broader pipeline programs, including results that highlight the potential to eliminate the need for GvHD prophylaxis while preserving immune reconstitution with Orca-Q," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "The durability of Orca-T when combined with CAR-T therapy exemplifies how our high-precision approach may be applied to expand treatment options both within and beyond hematologic malignancies. Overall, these results reinforce our continued focus on advancing our pipeline to bring this high- precision platform to more patients who could potentially benefit."

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, DEC 8, 2025, View Source [SID1234661299])

On December 8, 2025 Qihan Biotech, a clinical-stage biotechnology company developing off-the-shelf cell therapies for autoimmune diseases and cancer, including allogeneic CAR-T and in vivo CAR-T therapies, reported an oral and several poster presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data included encouraging clinical results with the company’s allogeneic CAR-T program and foundational preclinical work supporting its emerging in vivo CAR-T program.

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Qihan’s oral presentation highlighted clinical data from 20 patients enrolled in three investigator-initiated trials evaluating QT-019B in multiple autoimmune diseases. Treatment was well tolerated, with no events exceeding Grade 1 CRS and no reported ICANS or serious infections.

Across multiple severe autoimmune indications, QT-019B demonstrated clinical benefit in patients dosed at therapeutically relevant levels (n=19), with one subtherapeutic-dose patient excluded from the efficacy summary.

SLE-ITP (n=6): 5 complete responses (CR) with normalized platelet counts and 1 partial response (PR)
APS-associated ITP (n=5): 4 CR with normalized platelet counts
AIHA (n=3): 2 CR with normalized hemoglobin
SLE (n=2): 1 DORIS remission and 1 SRI-4 response at Month 2
Neurological autoimmune diseases (NMOSD and MS; n=3): 2 EDSS stabilization; 1 too soon to assess
Pharmacokinetic and pharmacodynamic readouts reinforce the potential of Qihan’s immune-privileged platform to deliver durable, systemic immune reset.

Robust expansion of allogeneic CAR-T cells observed in 17 of 19 patients treated at therapeutic dose levels
Deep and sustained depletion of pathogenic autoantibodies, consistent with the intended immune-reset mechanism
In MS, early CSF analyses showed rapid and durable clearance of oligoclonal bands (OCB) and kappa free light chains (kFLC)
Qihan’s QT-019B program is supported by IND clearance for rSLE from both the US FDA and the China NMPA. The FDA has also granted Fast Track Designation for the SLE-ITP indication. Phase 1 enrollment is actively underway.

Qihan’s unique "immune-privileged" platform – built on the company’s world-leading capabilities in multiplexable gene editing and deep understanding of transplantation immunology – enables creation of next-generation cells capable of evading immune attack. The platform is uniquely designed to address the biological and translational barriers that have limited progress across the CAR-T field. A primary barrier is immune rejection, where host T and NK cells rapidly eliminate donor cells, limiting expansion and persistence, and preventing cells from surviving long enough to achieve durable clinical benefit. Another major challenge is the need for lymphodepletion, which is associated with organ damage and broad toxicities. Qihan is developing the next generation product QT-019C, which aims to overcome both immune rejection and the dependence on lymphodepletion. Across its oral and poster sessions, the company has demonstrated scientific rigor, clinical relevance, and platform scalability that collectively address these critical obstacles.

"Autologous therapies have shown what cell therapy can achieve, but they are not scalable for autoimmune disease. Efforts to develop off-the-shelf allogeneic approaches have been challenging due to immune rejection, limited expansion and persistence, and the need for lymphodepletion. Our data show a different path," said Luhan Yang, Ph.D., Chief Executive Officer of Qihan Biotech. "Our first-generation program demonstrates strong safety, robust in vivo expansion, meaningful efficacy, and evidence of immune reset. Our next-generation product, which is now in human testing in an IIT, goes further. By driving deeper hypoimmunity and enhanced expansion and persistence, it provides the possibility to eliminate lymphodepletion. We believe we are overcoming the key barriers that have constrained the field and opening the door to broadly accessible, off-the-shelf cell therapies."

Details of the oral and posters being presented are as follows:

Designing immune-evasive UCAR-T cells to overcome allogeneic barriers and advance off-the-shelf immunotherapy
Publication Number: 1045 (Oral Session)
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Refining CAR-T Cells and Engineered HSPCs; New Approaches to HSPC mobilization
Session Date & Time: December 8, 2025, at 4:30PM – 4:45 PM EST

Engineering Quiescent Viral Entry Pathways for in Vivo CAR-T Generation via Binder-Fusogen Combinatorics
Publication Number: 2404
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster I
Session Date & Time: December 6, 2025, at 5:30PM – 7:30 PM EST

Cytokine receptor armored CAR-T cells enable robust T cell expansion and function in the absence of lymphodepletion
Publication Number: 4104
Session Title: 702. CAR-T Cell Therapies: Basic and Translational: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Enhanced vsvg variants for binder‑dependent and high‑specificity transduction of primary T cells
Publication Number: 4181
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Rapid normalization of platelet counts in patients with refractory thrombocytopenia associated with systemic lupus erythematosus (SLE) following treatment with allogeneic dual-target CD19/BCMA CAR T-cell therapy (QT-019B)
Publication Number: 3031
Session Title: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Allogeneic Dual-Target CD19/BCMA CAR T-Cell Therapy (QT-019B) for Refractory Autoimmune Hemolytic Anemia
Publication Number: 5922
Session Title: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Session Date & Time: December 8, 2025, at 6:00PM – 8:00 PM EST

About QT-019B
QT-019B is Qihan Biotech’s first-generation allogeneic CAR-T therapy designed to treat severe autoimmune diseases. Engineered using Qihan’s immune-privileged platform, QT-019B incorporates multiplex gene edits to enhance expansion, persistence, and resistance to immune rejection. QT-019B has demonstrated encouraging safety and clinical activity in multiple investigator-initiated trials and has been cleared by US FDA and China NMPA for further clinical development. QT-019B has received FDA Fast Track Designation for SLE-ITP.

QT-019B has been evaluated in the following autoimmune diseases:
SLE: Systemic Lupus Erythematosus
SLE-ITP: Systemic Lupus Erythematosus–associated Immune Thrombocytopenia
APS-ITP: Antiphospholipid Syndrome–associated Immune Thrombocytopenia
AIHA: Autoimmune Hemolytic Anemia
MS: Multiple Sclerosis
NMOSD: Neuromyelitis Optica Spectrum Disorder

(Press release, Qihan Biotech, DEC 8, 2025, View Source [SID1234661298])