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ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004

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 that the first patient has been dosed in the Company’s Phase 2 ASPEN-09-Breast trial evaluating its investigational CD47-inhibitor evorpacept. This trial will evaluate the combination of evorpacept with trastuzumab and physicians’ choice of chemotherapy in patients with HER2-positive metastatic breast cancer whose disease has progressed after ENHERTU (T-DXd).

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Additionally, after successfully clearing the second dose cohort, the Phase 1 trial evaluating the Company’s epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) ALX2004 for the treatment of EGFR-expressing solid tumors has begun enrolling patients in the third dose cohort at 4mg/kg. No dose-limiting toxicities were observed in the prior two dose cohorts.

"We are extremely pleased with the progress we are making on these clinical trials," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We believe both evorpacept and ALX2004 have the potential to fill significant gaps in the standard of care for many types of cancer."

Evorpacept is the first CD47 inhibitor to show substantial tumor response and a well-tolerated safety profile in a randomized trial. Data from this prior gastric cancer trial, ASPEN-06, show that evorpacept demonstrated benefit across all efficacy parameters in patients with HER2-positive disease and high CD47 expression levels. Research has demonstrated that increased CD47 expression is correlated with poor patient outcomes in many tumor types, including breast cancer.

The Phase 2 ASPEN-09-Breast clinical trial (NCT07007559) is a single-arm, open-label, multicenter study evaluating evorpacept plus trastuzumab and physicians’ choice of chemotherapy in 80 patients with HER2-positive breast cancer previously treated with ENHERTU (fam-trastuzumab deruxtecan-nxki), which was recently approved as first-line therapy. The trial will utilize participants’ CD47 expression levels as a biomarker to assess responses.

The primary endpoint of the trial is overall response rate (ORR) in patients who are confirmed HER2 positive by circulating tumor DNA (ctDNA). Key secondary endpoints are ORR in the HER2 ctDNA+ subpopulation by level of CD47 expression, clinical benefit rate (CBR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS), and safety. ORR in the HER2 ctDNA-negative subpopulation is an exploratory endpoint. ALX Oncology anticipates sharing interim data from the trial in Q3 2026.

The ALX2004 Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label, multicenter trial evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by optional dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC).

"Preclinical data suggest that ALX2004 has the potential to overcome the toxicity challenges associated with earlier generation EGFR-targeted ADCs," said Lettmann. "It is encouraging that, after clearing the second dose cohort in our Phase 1 trial at 2mg/kg, we are able to double the dosage to 4mg/kg in the third cohort."

ALX Oncology expects to provide an initial safety update from the Phase 1 ALX2004 trial during 1H 2026.

(Press release, ALX Oncology, JAN 8, 2026, View Source [SID1234661846])

Allogene Therapeutics Positions 2026 as a Program-Defining Year for Scalable, Real-World Allogeneic CAR T

On January 8, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease.

After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, Allogene has built an off-the-shelf CAR T platform designed to deliver clinical utility, broad patient access, predictable manufacturing, and scalable economics which are core requirements for cell therapy to move beyond a bespoke process toward routine medical practice.

"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene with value-defining readouts and clinical maturity unmatched in the allogeneic field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "With multiple first-half clinical milestones, we aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."

A Biologic-Like CAR T Platform Built for Real-World Demand
The Company’s off-the-shelf approach is purpose-built seeking to deliver the attributes required for sustainable growth and broad patient access, including:

Rapid, on-demand availability
Consistent, predictable product performance
Simplified administration compatible with outpatient use and deployment beyond academic centers into community settings
Manufacturing scalability of approximately 30,000 – 60,000+ doses annually
Efficient cost-of-goods profile (<$10K – 20K/dose)

Together, these attributes will position Allogene’s platform to support broad deployment across hematologic malignancies, autoimmune disease, and solid tumors – enabling CAR T therapy to reach patients earlier, more reliably, and in care settings where most patients are treated.

Cema-Cel: Giving LBCL Patients a Second Chance at First-Line Success
Allogene’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL).

ALPHA3 seamlessly integrates cema-cel as a "7th cycle" of first-line therapy, without altering existing first-line treatment workflows, enabling early, MRD-guided treatment intervention for patients at high risk of relapse. The trial is enrolling patients across both academic and community cancer centers to improve patient access as the majority of LBCL patients are treated in the community cancer setting in the US.

An early Q2 2026 interim futility analysis focused on MRD clearance represents the first program-defining test of whether early, MRD-guided allogeneic CAR T can prevent recurrence of lymphoma. A 25–30% improvement in MRD clearance versus observation could signal one of the most meaningful advances in LBCL since the introduction of rituximab, based on historical benchmarks and growing data linking MRD clearance to long-term outcomes.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease with Built-In Lymphodepletion
ALLO-329 is a next-generation dual-targeted CD19/CD70 AlloCAR T incorporating Allogene’s proprietary Dagger technology, which provides built-in, targeted lymphodepletion by selectively depleting cells in the patient that are responsible for rejecting AlloCAR T products: activated CD70-positive T cells.

This approach could reduce or eliminate the need for conventional cytotoxic lymphodepletion and significantly expand access, especially for:

Younger patients and women of child-bearing age for whom cytotoxic lymphodepletion is problematic
Settings where rheumatologists, not oncologists, are the primary treating physicians
Patients with moderate disease where a streamlined treatment could improve adoption

The Phase 1 RESOLUTION trial, a 3+3 dose escalation study, is enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The trial plans to test up to four cell dose levels from a starting cell dose of 20 million CAR T cells in two parallel cohorts (one with a low intensity lymphodepletion and one with no lymphodepletion).

Initial proof-of-concept data are expected by the end of 1H 2026. Expected to be included in the initial data release are early clinical outcome and supporting translational data covering disease-related biomarkers, CAR T expansion, and immune reconstitution from the first dose level (20 million CAR T cells) cohorts.

If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, reduced toxicity, and accessibility to rheumatologists become critical competitive differentiators.

ALLO-316: TRAVERSE Trial Establishes CAR T Potential in Solid Tumors
ALLO-316 has demonstrated early, durable responses in heavily pretreated patients with renal cell carcinoma (RCC), representing one of the first credible signals that CAR T – autologous or allogeneic – may deliver meaningful benefit in solid tumors. The Phase 1 trial demonstrated:

Robust CAR T cell expansion following standard Flu/Cy-based lymphodepletion, providing proof-of-concept for the Dagger technology platform
31% confirmed ORR with a single ALLO-316 dose1 in patients with high CD70 expression, which represents ~2/3 of clear cell RCC
All responses were durable beyond 6 months after ALLO-316 with no further treatment2
The Company continues pathway exploration for its continued development

"Each of our programs represents a different frontier where our products can change the trajectory of disease," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer. "Cema-cel has the potential to reshape first-line lymphoma treatment by reaching patients destined to suffer a cancer recurrence before they relapse. ALLO-329 is designed to bring CAR T into the autoimmune setting with a therapy that is scalable, precise, and potentially deliverable without traditional lymphodepletion. And ALLO-316 has shown promising activity in a metastatic solid tumor context – something many considered unattainable for cell therapy. What these programs collectively demonstrate is that allogeneic CAR T is no longer a theoretical platform. It is a clinical reality advancing across multiple major therapeutic areas."

Cash Runway into 2H 2027
The Company continues to expect its cash runway to extend into the second half of 2027, excluding any impact from potential business development activities.

Together, these catalysts position Allogene to enter 2026 with an increasingly differentiated platform, strengthening fundamentals and the potential to reshape multiple high-value therapeutic categories through scalable, real-world allogeneic CAR T.

(Press release, Allogene, JAN 8, 2026, View Source [SID1234661845])

Akari Therapeutics to Present at the 2026 Biotech Showcase

On January 8, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, reported that Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics will present at the 2026 Biotech Showcase being held from January 12-14, 2026 in San Francisco, CA.

Presentation details are as follows:

Date/Time: Tuesday, January 13, 2026 at 9:30 AM PST

Location: Yosemite A (Ballroom Level)

In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

(Press release, Akari Therapeutics, JAN 8, 2026, View Source [SID1234661843])

ADC Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Revenue and Cash Estimates and Recent Corporate Updates

On January 8, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported corporate updates and highlights from its ZYNLONTA clinical program.

"During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This year, we look forward to multiple clinical catalysts including full results from our LOTIS-5 and LOTIS-7 2L+ DLBCL trials, as well as potentially from the ongoing Phase 2 indolent lymphoma IITs. Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow. Taken together, we anticipate we will see an acceleration in net product revenue growth beginning in 2027."

Recent Highlights and Developments

Preliminary unaudited 2025 selected financial results. ZYNLONTA net product revenue is expected to be approximately $73 million for full year 2025 compared with $69.3 million for full year 2024. Fourth quarter 2025 ZYNLONTA net product revenue is expected to be approximately $22 million, as compared to $16.4 million in the fourth quarter of 2024, primarily reflecting variability in customer ordering. Underlying demand for ZYNLONTA in the current 3L/3L+ DLBCL indication remained broadly stable year-over-year. The Company ended 2025 with cash and cash equivalents of approximately $261 million which, based on current plans, is expected to provide a cash runway at least to 2028.

Reported updated data from LOTIS-7 in December 2025. Updated data from the LOTIS-7 Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) demonstrated an 89.8% best overall response rate (ORR) and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of 6 months follow-up. Enrollment in the LOTIS-7 trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 µg/kg dose expected during the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. In addition, the Company plans to assess regulatory and compendia strategies in the first half of 2027.

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of approximately 262 progression-free survival (PFS) events is reached and data are available. Publication of the full results is anticipated by the end of 2026. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.

Investigator-initiated trials (IITs) of ZYNLONTA in indolent lymphomas ongoing. Initial data from the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) and the Phase 2, single-arm, open-label, multicenter trial of ZYNLONTA to treat r/r marginal zone lymphoma (MZL) led by the Sylvester Comprehensive Cancer Center at University of Miami have shown promising efficacy and manageable safety results. The Company anticipates publication of both data sets as early as the end of 2026. Assuming positive data, the Company plans to assess regulatory and compendia strategies.

IND-enabling activities completed for PSMA-targeting ADC. IND-enabling activities for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC were completed at the end of 2025. The Company continues to explore partnership opportunities.

(Press release, ADC Therapeutics, JAN 8, 2026, View Source [SID1234661842])

Terns Pharmaceuticals to Highlight 2026 Priorities and Program Milestones at the 44th Annual J.P. Morgan Healthcare Conference

On January 7, 2026 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported that management will provide an update on 2026 priorities and program milestones during the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 12th, 2026 at 3:45pm in San Francisco, CA.

"Last year was transformative for Terns as we completed our transition to an oncology company anchored by our allosteric BCR-ABL inhibitor, TERN-701, for CML. Following compelling TERN-701 data at ASH (Free ASH Whitepaper) in December, and our subsequent capital raise, we are in a strong position to advance TERN-701 towards pivotal trial initiation. Based on accelerating momentum in our CARDINAL trial, our goal for pivotal trials is to enroll patients more quickly than historical precedents in CML and to generate data that further strengthen the position of TERN-701 as a potential best-in-disease therapy across all lines of CML treatment," said Amy Burroughs, chief executive officer of Terns. "We believe that reaffirming clinical differentiation and advancing to product launch rapidly will be key factors to maximize the therapeutic and commercial potential of TERN-701," added Ms. Burroughs.

Anticipated 2026 Priorities and Key Milestones

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Anticipated 2026 milestones for TERN-701 include:

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Selection of pivotal dose in mid-2026

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End of Phase 2 regulatory interaction with U.S. FDA in mid-2026

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Updated and expanded CARDINAL data by second half of 2026

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Initiation of first pivotal trial (2L+ population) in late 2026 / early 2027

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Preliminary study design anticipates evaluation of TERN-701 vs control arm of investigator’s choice 2 nd generation TKI (dasatinib, nilotinib, bosutinib) with major molecular response (MMR) at six months as the primary endpoint

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New cohort added to the ongoing CARDINAL Phase 1/2 study to evaluate TERN-701 500mg QD in approximately 20 patients with BCR-ABL resistance mutations including T315I, M244V, F359I/C/V and others

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At the 67th ASH (Free ASH Whitepaper) Annual Meeting in December 2025, Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, presented unprecedented safety and efficacy data from the CARDINAL trial

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CARDINAL enrolled a predominantly 3L+ patient population with 38% of patients having received prior asciminib of whom 75% discontinued due to lack of efficacy

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TERN-701 showed an encouraging safety profile (N=63)

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87% (55/63) of patients remained on treatment as of the data cutoff

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No dose-limiting toxicities were observed in dose escalation, and a maximum tolerated dose was not reached

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The majority of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship

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Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (8%) and thrombocytopenia (8%)

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Unprecedented efficacy with MMR achievement rate by 24 weeks of 75% (18/24) in evaluable patients enrolled at the recommended phase 2 dose range of >320mg QD, trending 2-3X higher than asciminib in Phase 1 and Phase 3 studies evaluating a 3L+ patient population

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Deep molecular response (DMR) achievement rate by 24 weeks of 36% (10/28)

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Encouraging MMR rates in patients with prior asciminib (n=10)

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Overall MMR rate of 60% (6/10), with 43% (3/7) achieving MMR and 100% (3/3) maintaining MMR

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Enrollment has accelerated with 85+ patients enrolled as of December 8, 2025

Other Pipeline Programs

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Discovery efforts are underway on undisclosed targets for oncology indications

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Terns is seeking a strategic partner to advance the TERN-501 and TERN-801 legacy metabolic programs

Corporate Updates

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In December 2025, Terns completed an upsized public offering of 18,687,500 shares of its common stock, generating gross proceeds of approximately $747.5 million before deducting underwriting discounts and commissions and other offering expenses

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Unaudited cash, cash equivalents and marketable securities for the year ended December 31, 2025, of approximately $1.0 billion expected to provide cash runway into 2031, including the first potential approval and launch of TERN-701

A live webcast of the Company’s J.P. Morgan Healthcare Conference presentation will be available on the investor relations page of Terns’ website at View Source A replay of the webcast will be archived on Terns’ website for at least 30 days following the presentation.

(Press release, Terns Pharmaceuticals, JAN 7, 2026, View Source [SID1234661903])