ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference

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])

Whitehawk Therapeutics Advances to Clinical Stage with IND Clearance for HWK-007 and Announces IND Submission for HWK-016

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])

Osel Enters Agreement with SWOG Cancer Research Network for First-Ever Pivotal Trial of a Microbiome-Based Therapy in Oncology

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])

Cellectis Announces 2026 Strategy and Catalysts

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])

KAHR Bio Announces Strong Topline Phase 2 Results for DSP107 in Combination with Anti-PD-L1 Therapy in Colorectal Cancer

On January 8, 2026 KAHR Bio (KAHR or the Company), a clinical-stage biotechnology company developing DSP107, a first-in-class, bispecific 4-1BB–targeted, next-generation T-cell engager, reported topline results from its Phase 2a dose-expansion cohort in late-line metastatic microsatellite stable colorectal cancer (MSS-CRC). DSP107 was evaluated in combination with atezolizumab (Tecentriq), an anti–PD-L1 therapy. The combination demonstrated favorable safety, clinical evidence of antitumor activity, and extended survival, including in patients with liver metastases.

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KAHR also announced the closing of a $22 million round in equity financing. The equity investment was led by Flerie AB, Peregrine Ventures, Oriella Ltd. of the Consensus Business Group, aMoon Growth Fund, and the Cancer Focus Fund, with participation from certain additional existing investors and new investors including SPRIM Global Investments. The proceeds are expected to fully fund KAHR’s randomized, controlled Phase 2b trial of DSP107 in combination with atezolizumab versus fruquintinib (Fruzaqla) in fourth-line metastatic MSS-CRC. The trial was initiated in December 2025 following the U.S. Food and Drug Administration (FDA) investigational new drug (IND) clearance. In addition to the equity financing, KAHR has entered into a $10 million on-demand debt facility with SPRIM Global Investments, which the Company can draw down based on eligible research and development (R&D) activity under the Australian Government’s R&D tax rebate scheme. Additional equity commitments are under discussion as the Company continues to attract new investor interest.

The topline Phase 2a (NCT04440735) data demonstrated a median overall survival of 17.5 months, exceeding outcomes reported for currently approved therapies in this setting (6.4–10.8 months). Notably, approximately 75% of enrolled patients had liver metastases, a population historically refractory to immunotherapy. Across more than 130 patients treated with DSP107 to date in a variety of solid tumors and hematological malignancies, the therapy continues to demonstrate a favorable safety and tolerability profile.

Based on these encouraging results, KAHR has initiated a randomized, controlled, multicenter Phase 2b clinical trial in fourth-line metastatic, chemo-refractory MSS-CRC. The trial is expected to enroll at 18 sites across Australia and the United States, with the first patient having been enrolled in December 2025. Interim results are expected in late 2026, with topline data anticipated in the second half of 2027. Additional information about the study is available at clinicaltrials.gov (NCT07235293).

Anwaar Saeed, M.D., Chief of GI Oncology at the University of Pittsburgh and Co-Leader of the Cancer Therapeutics Program at UPMC Hillman Cancer Center, who co-led the Phase 2a trial said, "Observing efficacy with an immunotherapy approach in late line MSS-CRC patients with liver metastases is unexpected. DSP107’s mechanism is particularly suited to this setting as it utilizes CD47 overexpression on cancer cells to anchor a 4-1BB ligand to those cells, thereby attracting and activating T cells. CD47 expression increases in liver metastases following chemotherapy, creating a therapeutic window uniquely addressable by DSP107."

"Following these compelling topline results demonstrating anti-tumor activity and meaningful survival outcomes in heavily pretreated MSS-CRC patients, including those with liver metastases, we have made MSS-CRC our primary development focus and look forward to advancing the Phase 2b trial," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR.

Dr. Pereg added, "We highly appreciate the continued support from our existing and new investors. Their commitment reflects confidence in the clinical potential of DSP107 and the opportunity to meaningfully improve outcomes in MSS-CRC, a disease with a significant unmet medical need, and in our team’s ability to execute as we move toward our next milestones."

About DSP107
DSP107, KAHR Bio’s lead drug candidate, is a first-in-class, bispecific CD47×4-1BB targeting, next-generation T-cell engager. DSP107 utilizes tumor-expressed CD47 as an anchor, selectively binding CD47 on cancer cells while sparing red blood cells, thereby overcoming the safety challenges previously seen with other CD47-directed agents. Once bound, DSP107 converts the tumor’s immune-evasion signal into a potent 4-1BB co-stimulatory activation signal, recruiting and activating CD8 cytotoxic T cells and orchestrating engagement of both the innate and adaptive immune systems to generate a coordinated anti-tumor response. This approach is particularly relevant in colorectal cancer, where more than 70% of metastatic patients develop liver metastases that commonly upregulate CD47 following earlier-line chemotherapy. Unlike prior immunotherapy approaches in MSS-CRC, which have demonstrated limited benefit due to poor immune cell infiltration and low immunogenicity, DSP107 is designed to leverage tumor CD47 overexpression to enhance immune engagement within the tumor microenvironment, transforming it from immunosuppressive to immune-responsive and enabling productive anti-tumor immunity.

About Microsatellite Stable Metastatic Colorectal Cancer
Colorectal cancer (CRC) is one of the most common cancers worldwide and a leading cause of cancer mortality. Globally, CRC ranks among the top three most frequently diagnosed cancers, with approximately 1.9 million new cases and nearly 900,000 deaths annually, making it the second leading cause of cancer-related death and the third most common cancer overall. Among metastatic colorectal cancer (mCRC) cases, approximately 85–90 % are microsatellite stable (MSS). MSS-CRC is characterized by low tumor mutational burden and limited inherent immune activation, and as a result, tumors are typically unresponsive to current immunotherapies, including immune checkpoint inhibitors. Standard treatment for MSS-CRC continues to rely on cytotoxic chemotherapy, targeted agents, and VEGF inhibition. Despite advances in systemic therapy, there remains a significant unmet medical need for more effective treatment options, and ongoing research is focused on novel approaches, including immune-based and mechanism-driven combination strategies, to improve outcomes for patients with this challenging disease.

(Press release, KAHR Medical, JAN 8, 2026, View Source [SID1234661864])