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AbCellera Reports Q1 2026 Business Results & Announces Positive Interim Phase 1 Clinical Data for ABCL635

On May 11, 2026 AbCellera (Nasdaq: ABCL) reported financial results for the first quarter of 2026 and positive interim results from the Phase 1 portion of its ongoing Phase 1/2 clinical trial of ABCL635. ABCL635 is a potential first-in-class antibody targeting the neurokinin 3 receptor (NK3R) for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We are excited to share interim Phase 1 data that show ABCL635 achieved robust NK3R target engagement at doses that were well-tolerated in healthy volunteers and a pharmacokinetic profile that may support a once monthly dosing regimen. We look forward to the efficacy readout from the Phase 2 data in Q3, which we believe will be highly de-risking for the program," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Through 2026 we are focused on delivering data readouts for our clinical programs, advancing ABCL688 and ABCL386 into IND-enabling studies, and selecting at least one additional development candidate. We continue to maintain our strong cash position, ending the quarter with approximately $655 million dollars in available liquidity to execute on our strategy."

Q1 2026 Business Summary and Program Updates

ABCL635 and ABCL575 continued to progress through clinical trials.
ABCL386 and ABCL688 are progressing through IND-enabling activities.
Generated a net loss of $43.2 million, compared to a net loss of $45.6 million in Q1 2025.
Ended the quarter with approximately $655 million in total available liquidity to execute on our strategy.
Clinical Update: ABCL635 Interim Phase 1 Data

Study Design

The Phase 1 trial of ABCL635 (NCT07118891) is a randomized, double-blind, placebo-controlled study designed to evaluate single and multiple doses of ABCL635 in healthy volunteers. A total of 40 healthy men and postmenopausal women were enrolled in the single ascending dose (SAD) part and treated with single doses ranging from 30 mg to 900 mg. The multiple ascending dose (MAD) part enrolled a total of 16 postmenopausal women who received multiple once monthly doses ranging from 300 mg to 600 mg.

Study Results

The interim Phase 1 data supported advancing ABCL635 into Phase 2. Data from the MAD part remain blinded, with safety follow-up visits ongoing. The unblinded interim data from the SAD part demonstrated the following:

A favorable tolerability profile: ABCL635 was well-tolerated across all doses, with no serious adverse events or elevations in liver enzymes. Treatment-emergent adverse events were generally mild and transient.
A pharmacokinetic profile that supports monthly dosing: ABCL635 exhibited an estimated half-life of ~24 days, supporting the potential for a once monthly subcutaneous dose.
Strong suppression of biomarkers of target engagement: To confirm target engagement of NK3R on kisspeptin, neurokinin B, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus, testosterone, a clinically validated surrogate biomarker of NK3R antagonism, was measured in male volunteers. ABCL635 demonstrated sustained and dose-dependent suppression of testosterone over a four-week period.
Based on these data, AbCellera advanced ABCL635 into a Phase 2 study, as announced earlier this year. The Phase 2 is a multicenter, randomized, double-blind, placebo-controlled trial with approximately 80 postmenopausal women designed to evaluate the efficacy of ABCL635 in reducing the frequency and severity of moderate-to-severe VMS.

Business Metrics

December 31, 2025

March 31, 2026

Partner-led programs with downstreams

In the clinic

In discovery or preclinical development

Molecules in the clinic with downstreams

Beginning in Q1 2026, AbCellera is reporting new business metrics to focus on programs and molecules with downstream participation which are believed to be progressing. At the end of Q1 2026, partners led 40 programs which AbCellera believes to be progressing and where AbCellera holds a downstream stake (down from 44 on December 31, 2025). In total, AbCellera held downstream stakes in 14 molecules in the clinic understood to be progressing on March 31, 2026.

Discussion of Q1 2026 Financial Results

Revenue – Total revenue was $8.3 million, compared to $4.2 million in Q1 2025.
Research & Development (R&D) Expenses – R&D expenses were $46.7 million, compared to $42.5 million in Q1 2025.
Sales, General, & Administrative (SG&A) Expenses – SG&A expenses were $12.3 million, compared to $19.1 million in Q1 2025.
Net Loss – Net loss of $43.2 million, or $(0.14) per share on a basic and diluted basis, compared to net loss of $45.6 million, or $(0.15) per share on a basic and diluted basis, in Q1 2025.
Liquidity – $531 million of total cash, cash equivalents, and marketable securities and approximately $124 million in available non-dilutive government funding, bringing total available liquidity to approximately $655 million to execute on AbCellera’s strategy.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

About ABCL635

ABCL635 is a potential first-in-class antibody drug for the non-hormonal treatment of moderate-to-severe VMS, commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G protein-coupled receptor (GPCR) expressed on KNDy neurons in the infundibular nucleus of the hypothalamus. ABCL635 is the first program from AbCellera’s GPCR and ion channel platform to advance into the pipeline, entering the clinic in July 2025. Additional details are available at www.abcellera.com/pipeline.

(Press release, AbCellera, MAY 11, 2026, View Source [SID1234665463])

Hokkaido University Leverages BostonGene’s AI-powered Platform to Advance Precision Oncology

On May 11, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported the expanded strategic research collaboration with Hokkaido University. This multi-year initiative is designed to produce actionable, high-quality, clinically relevant data that support the development of precision therapies and ultimately improve outcomes for cancer patients in Japan.

In collaboration with Hokkaido University, BostonGene will conduct next-generation sequencing and perform integrated analysis of DNA, RNA and immune system profiling using its proprietary AI-powered platform to analyze genomic and immune profiles from tumor samples across more than 20 cancer types. These analyses will help identify patient-specific disease drivers, profile underlying immune signatures, and guide optimal therapeutic decision-making.

"BostonGene’s AI-powered platform gives us the advanced analytics needed to turn clinical data into actionable insights," said Dr. Ichiro Kinoshita, Principal Investigator and Professor at the Division of Clinical Cancer Genomics/Department of Medical Oncology at Hokkaido University, and Dr. Yutaka Hatanaka, Associate Professor at the Center for Development of Advanced Diagnostics (C-DAD), Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital. "By contributing our scientific expertise and patient samples, we’re driving a more personalized, effective approach to oncology for Japanese patients.

"This partnership exemplifies how BostonGene’s AI-driven insights translate complex patient data into meaningful advances in drug development and clinical care, while reinforcing our commitment to advancing translational oncology in Japan, where there is significant and urgent clinical need," said Yukimasa Shiotsu, President and Representative Director of BostonGene Japan.

(Press release, BostonGene, MAY 11, 2026, View Source [SID1234665462])

ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness

On May 11, 2026 ProBio Inc. and Curocell reported to have achieved a significant milestone with the BLA regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01). This next-generation CD19-targeted CAR-T cell therapy is developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval not only highlights Korea’s growing innovation in advanced therapies but also marks a critical step towards bringing transformative treatment options to patients. To learn more about ProBio’s contributions to advanced therapeutic manufacturing, visit www.probiocdmo.com.

Clinical data from Phase 1/2 studies has demonstrated compelling efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy also exhibited a manageable safety profile, with the most commonly reported grade 3/4 adverse events including neutropenia, anemia, and thrombocytopenia.

A key differentiating feature of CRC01 lies in Curocell’s proprietary OVIS platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This innovative mechanism is designed to address immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to conventional CAR-T approaches.

As a strategic partner of Curocell, Probio has supported the journey from post-IND supplier change to BLA application and commercial production. We partnered closely with the client to manage complex change control activities and secure rapid regulatory approval for major process and site changes. With deep expertise in lentiviral vector manufacturing, we completed process characterization within four months, defined critical process parameters, implemented a robust control strategy, and achieved first‑pass success across all three validation batches. Our strong performance during the MFDS pre‑approval inspection, from audit readiness to real‑time responses, was recognized by both regulators and the client. We successfully obtained MFDS GMP certification, representing the first GMP approval for a lentiviral vector manufacturing facility in Korea and reinforcing our role as a pioneer in the local cell and gene therapy supply chain.

The program has now progressed into the commercial manufacturing phase. ProBio remains committed to delivering high-quality plasmid and viral products, supporting the broader adoption of CAR-T therapy, enabling patient access. "We are thrilled to witness this landmark achievement by Curocell," said Allen GUO, CEO from ProBio. "This approval not only represents a major step forward for patients in Korea but also reinforces the global potential of innovative CAR-T therapies. At ProBio, we remain committed to empowering our partners with integrated CDMO solutions to accelerate the development and commercialization of advanced therapies worldwide."

"The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea’s first CAR-T therapy," said Kim Gun-soo, CEO of Curocell. "ProBio has played a key role throughout the entire process, from the clinical stage to process development, quality management, regulatory response, and preparation for commercial production, serving as an important partner in supporting the successful approval and laying the foundation for commercialization." He added, "Moving forward, Curocell plans to improve treatment access for patients in Korea based on a stable global supply chain and quality competitiveness, while continuing to expand into global markets and advance the development of next-generation CAR-T therapies."

(Press release, ProBio, MAY 11, 2026, View Source [SID1234665461])

Inhibrx Reports Interim Phase 2 Data for INBRX-106 in First-Line HNSCC; Initial Results Demonstrate Potential Costimulatory Benefit Over PD-1 Monotherapy

On May 11, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone. A clear signal of added benefit in this study design would support INBRX-106’s potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications.

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments. The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update.

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes.

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone. The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator.

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

"We are greatly encouraged by these early clinical results," said Mark Lappe, Chief Executive Officer of Inhibrx. "These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism."

Next Steps

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter. The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027. Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. To date, over 175 patients have been treated with INBRX-106.

(Press release, Inhibrx, MAY 11, 2026, View Source [SID1234665460])

Anixa Biosciences Reports Updated Positive Survival Observations from Ongoing Phase 1 Trial of Lira-cel Ovarian Cancer CAR-T Therapy

On May 11, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the Company’s follicle-stimulating hormone receptor ("FSHR")-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer.

Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy ("ISCT") 2026 Annual Meeting by Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center. The presentation, titled "A Phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer," reviewed the trial design, objectives and current clinical status of Anixa’s ongoing Phase 1 trial of lira-cel.

Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive.

Preliminary safety observations presented at ISCT include:

No dose-limiting toxicities ("DLTs") have been encountered in the first three dose cohorts.
All doses have been administered successfully by the intraperitoneal ("IP") route.
There have been no observations of Immune Effector Cell-Associated Neurotoxicity Syndrome ("ICANS") or significant Cytokine Release Syndrome ("CRS").
All significant adverse events observed to date have been unrelated to lira-cel administration.
Dr. Amit Kumar, Chairman and Chief Executive Officer of Anixa, stated, "The updated survival observations from this ongoing Phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer. While this remains an early-stage study, lira-cel has continued to demonstrate a favorable preliminary safety profile, with no dose-limiting toxicities, ICANS or CRS observed in the first three dose cohorts. We believe these findings support continued dose escalation and clinical evaluation."

Dr. Kumar continued, "We look forward to treating patients in the next dose cohort, which is expected to evaluate a dose approximately three times higher than the previous cohort and to include lymphodepletion with cyclophosphamide and fludarabine. This approach may create a more favorable environment for CAR-T cell expansion, persistence and activity."

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, is Anixa’s investigational autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor ("FSHR"), which Anixa believes represents a unique CAR-T target in ovarian cancer. FSHR is selectively expressed on ovarian cells, tumor vasculature and certain cancer cells, but not in most healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.

(Press release, Anixa Biosciences, MAY 11, 2026, View Source [SID1234665459])