On January 8, 2026 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported a strategic collaboration with Ottimo Pharma Limited ("Ottimo"), an innovative, clinical-stage biotech company developing one-of-a-kind PD-1/VEGFR2 dual paratopic antibodies to extend the lives of patients living with cancer. The partnership will utilize BostonGene’s advanced artificial intelligence (AI) platform to apply multiomic analytics and expedite the clinical development of Ottimo’s novel therapeutic candidate, OTP-01. OTP-01 is a first-in-class, bifunctional, dual paratopic antibody therapeutic that maintains a conventional IgG architecture while being engineered to simultaneously inhibit two critical signaling pathways, PD-1 and VEGFR2, with the goal of enhancing anti-tumor immunity and overcoming both primary and acquired resistance that limit the effectiveness of current immuno-oncology approaches.

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"The challenge of immune resistance in cancer treatment requires clinically precise solutions that address not only immune suppression, but also immune exclusion," said Robert Tighe, SVP Preclinical and Translational Sciences at Ottimo Pharma. "OTP-01’s novel dual mechanism is designed to address both by combining immune checkpoint blockade with VEGFR2-targeted vascular normalizing activity to improve immune cell access and enable more effective antitumor immune responses. Our collaboration with BostonGene provides a promising opportunity to establish a robust, data-driven development blueprint by helping us identify the patients most likely to benefit from this differentiated therapy."

Under the collaboration, BostonGene will synthesize preclinical datasets, early clinical signals, multiomic analyses, and tumor microenvironment insights to generate foundational biological hypotheses, define optimal first-in-man strategies, refine translational and correlative elements, and develop patient selection approaches that directly support Phase I/IIA progress. This analysis is intended to support early clinical decision-making and significantly de-risk and accelerate the path to market.

"Ottimo is at the forefront of engineering next-generation I-O molecules, and OTP-01 represents a significant advancement," said Ferran Prat, PhD, JD, Chief Commercial Officer at BostonGene. "Our powerful analytical engine is ideally suited to process the complexity of multiomic data generated by a dual-mechanism drug like OTP-01. By leveraging our AI foundation model, we will deliver the precision insights necessary for optimal patient stratification and clinical execution, ensuring this highly promising therapy reaches patients as efficiently as possible."

The agreement reflects a strong alignment of interests, featuring a shared-upside structure tied to clinical, regulatory, and commercial milestones.

(Press release, BostonGene, JAN 8, 2026, View Source [SID1234661878])

On January 8, 2026 ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Chief Executive Officer Jason Lettmann and Chief Medical Officer Barbara Klencke will deliver a corporate presentation on Thursday, January 15, 2026, at 12:00 p.m. Pacific Time.

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The live webcast of the J.P. Morgan fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

(Press release, ALX Oncology, JAN 8, 2026, View Source [SID1234661847])

On January 8, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HWK-007, its PTK7-targeted ADC. Whitehawk’s Phase 1 trial for HWK-007 is now actively recruiting and will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.

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The company also announced the submission of an IND for HWK-016, its MUC16-targeted ADC, to the FDA in December 2025. A Phase 1 trial is anticipated to start recruiting this quarter and is expected to initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

Both next-generation ADC programs leverage Whitehawk’s advanced ADC technology platform consisting of a highly stable yet cleavable linker that delivers a DNA Topoisomerase I (TOP1) inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.

"These are important regulatory and execution milestones, underscoring the strength of our preclinical data and our ability to advance multiple programs in parallel," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "At Whitehawk, we are taking a unique approach to the development of next-generation ADCs, combining validated tumor biology with a differentiated ADC architecture. Our platform’s design features are intended to maximize tumor targeting while minimizing off-target toxicity, enabled by highly selective antibodies, a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing, and controlled delivery of a potent TOP1 inhibitor payload. As our lead programs enter the clinic, our focus will be on efficient clinical execution to generate data that validates this approach with meaningful outcomes for patients."

About HWK-007
HWK-007 is a differentiated next-generation ADC targeting Protein Tyrosine Kinase 7 (PTK7). PTK7 is an oncofetal transmembrane pseudokinase that drives early embryonic development, has restricted expression in adult tissues and frequent overexpression in a wide range of cancers. PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. There are no approved PTK7-directed ADCs.

HWK-007-101 is a Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

About HWK-016
HWK-016 is a differentiated next-generation ADC targeting the membrane-bound portion of Mucin 16 (MUC16). MUC16 is a glycoprotein with low level of expression in normal adult tissues, and broad overexpression in gynecological tumors including ovarian, cervical and endometrial. In ovarian cancer, for example, MUC16 is present at rates up to 3-10 times higher than clinically validated and emerging ADC targets.

Shed MUC16 (CA125) is a validated biomarker for cancer screening and disease monitoring in gynecologic cancers. When ADCs bind to this cleaved portion of the MUC16 protein in circulation, it is cleared from the patient systemically rather than reaching the tumor. HWK-016 is designed to overcome this by directly targeting the membrane-bound, non-shed portion of MUC16.

HWK-016-101 is a planned Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HWK-016 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

(Press release, Whitehawk Therapeutics, JAN 8, 2026, View Source [SID1234661863])

On January 8, 2026 Osel Inc., a clinical-stage biopharma company pioneering live biotherapeutic products (LBPs), reported a clinical trial agreement with SWOG Cancer Research Network for a pivotal Phase 3 clinical trial of its lead oncology candidate, MO-03, in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma (mRCC). This marks the first-ever pivotal trial of a microbiome-based oral therapy in oncology.

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The BIOFRONT trial will build on promising results from two prior clinical studies led by Dr. Sumanta Kumar Pal, MD, FASCO at City of Hope. In those studies, prior formulations of the product were added to nivolumab and ipilimumab or to cabozantinib and nivolumab and showed statistically significant improvements in response rates and progression free survival, without added toxicity.1,2 A recent dose-escalation study confirmed favorable safety across higher dose levels, with no increase in immune-related adverse events, leading to a new high-potency capsule formulation, MO-03, specific for oncology.

"The study represents a major advance for patients with advanced RCC," said Dr. Pal. "While other combination approaches in the front-line setting add significant toxicity, MO-03 could possibly augment the efficacy of immunotherapy-based regimens without compromising quality of life."

The Phase 3 randomized, double-blind study will enroll approximately 700 patients across up to 150 SWOG sites in the United States, comparing MO-03 plus approved IO therapy versus placebo plus IO. The trial is supported by the National Cancer Institute (NCI), part of the National Institutes of Health. Trial initiation is slated for Q1 2026.

MO-03 is a high-potency capsule formulation of Clostridium butyricum Miyairi 588 (CBM588), developed specifically for oncology by Osel and Japan’s Miyarisan Pharmaceutical Co., which will supply the GMP product. Osel holds the Investigational New Drug applications (INDs) for CBM588 and MO-03 in the United States and has exclusive marketing rights to CBM588 and MO-03 pharmaceutical products in the United States, Canada, and Europe.

"We appreciate the investment that SWOG/NCI is making in this pivotal trial, which will position MO-03 as a first-in-class LBP in oncology," said Peter P. Lee, MD, Chairman of Osel. "We are actively working with Miyarisan to engage partners who are interested in commercializing MO-03, pending positive Phase 3 results. Recent market research among US oncologists and payers shows strong interest in MO-03 and a high likelihood of coverage in the mRCC setting."

The BIOFRONT trial, formally titled "S2419, Phase III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic CBM588 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma," is led by Principal Investigator (PI) Pedro C. Barata, MD, MSc, at University Hospitals Seidman Cancer Center. Co-PIs are Ulka Vaishampayan, MD, at University of Michigan Rogel Cancer Center, and Sumanta K. Pal, MD, at City of Hope.

Osel holds the exclusive worldwide intellectual property rights for the use of Clostridium butyricum in oncology in combination with immune checkpoint inhibitors (ICIs) including the PD-1, PD-L1 and CTLA-4 inhibitors nivolumab, ipilimumab, pembrolizumab, cemiplimab, durvalumab, daclizumab, avelumab, or atezolizumab. The allowed claims specifically cover Clostridium butyricum as the sole live biotherapeutic product in combination regimens with ICIs and other anti-cancer agents. The intellectual property includes not only renal cell cancer but also extends to other major malignancies and microsatellite-instability high (MSI-H) cancers, including non-small cell lung cancer, melanoma, sarcoma, lymphoma, breast cancer, bladder cancer, cervical cancer, colon cancer, head and neck cancer, liver cancer, stomach cancer, or rectal cancer, supporting the broad clinical potential of MO-03.

(Press release, Osel, JAN 8, 2026, View Source [SID1234661879])

On January 8, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported its strategic priorities and key catalysts expected for 2026.

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"2025 was a transformational year for Cellectis, as we transitioned to a late-stage development allogeneic CAR-T company with the initiation of a pivotal Phase 2 trial for lasme-cel." said André Choulika, Ph.D., Chief Executive Officer of Cellectis. "As we enter 2026, we remain fully committed to executing our pivotal Phase 2 BALLI-01 trial for lasme-cel in ALL, with interim data expected in Q4, presenting the full Phase 1 data of the NATHALI-01 trial for eti-cel in NHL, and leveraging the momentum of our strategic partnership with AstraZeneca."

Allogeneic CAR-T Pipeline

Lasme-cel in r/r B-ALL (BALLI-01)

Following the initiation of the pivotal Phase 2 BALLI-01 clinical trial in October 2025, Cellectis expects to complete the first interim analysis in Q4 2026. This upcoming milestone (n=40) builds upon the encouraging Phase 1 clinical data presented at the Cellectis’ R&D Day, which highlighted:

Strong Efficacy: 68% overall response rate (ORR) with lasme-cel Process 2 (n=22), 83% at the recommended Phase 2 dose (RP2D) (n=12) and 100% in the target Phase 2 population (n=9). 56% complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate with ~80% of these patients achieving minimal residual disease (MRD)-negative status in the target Phase 2 population. 60% MRD- negative CR/CRi rate achieved in patients who relapsed following a prior CD22 targeted therapy.
Strong Survival Benefit: 14.8 months median overall survival (OS) in patients who achieved MRD-negative CR/CRi.
Favorable Safety Profile: lasme-cel was generally well tolerated, with a single case of grade 2 immune effector cell–associated hemophagocytic syndrome (IEC-HS), which resolved.
Eti-cel in r/r NHL (NATHALI-01)

Building on the preliminary Phase 1 data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025, Cellectis is focused on maximizing the clinical impact of its dual-target CAR-T candidate:

Phase 1 interim Results: The NATHALI-01 clinical trial demonstrated an encouraging ORR of 88% and a CR rate of 63% at the current dose level, showcasing the potential of eti-cel in r/r NHL patients who have relapsed following multiple lines of therapy including, for most patients, an autologous CD19 CAR-T.
Q1 2026: Initiation of patient enrollment in the cohort with low dose interleukin-2 (IL-2) support to evaluate the potential to further enhance the already high response rates and durability of response in patients with r/r NHL.
Q4 2026: The Company expects to report the full Phase 1 dataset, including results from the IL-2 combination.
Strategic Partnerships

AstraZeneca

Activities are progressing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.
Servier / Allogene

CD19: Servier’s sublicensee Allogene announced that the H1 2026 interim futility analysis from the pivotal Phase 2 ALPHA3 Trial with cema-cel in first-line consolidation large B-cell lymphoma remains on track. Under the Servier agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales.
CD70: Allogene announced that the TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients, and that plans are ongoing to determine the next phase of the program.
Iovance

Iovance announced that clinical results for IOV-4001, a PD-1 inactivated tumor- infiltrating lymphocyte (TIL) cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026, and that other potential indications for IOV-4001 are also in development.
Cash Runway

Cellectis believes its cash, cash equivalents, and fixed-term deposits will be sufficient to fund its operations into H2 2027.
J.P. Morgan Healthcare Conference

Cellectis management will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, and will be available for one-on-one investor meetings. To schedule a meeting, please contact Cellectis Investor Relations at [email protected]

(Press release, Cellectis, JAN 8, 2026, View Source [SID1234661848])