On April 13, 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 data from the planned interim futility analysis of its pivotal, randomized Phase 2 ALPHA3 trial in first-line (1L) consolidation large B-cell lymphoma (LBCL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the protocol-defined data cutoff, which was triggered when the 24th patient completed Day 45 MRD assessment, 58.3% (7/12) of patients in the cemacabtagene ansegedleucel (cema-cel) arm achieved minimal residual disease (MRD) negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Based on literature,1 2 3 a difference in percentage points of 25-30% in the MRD clearance could translate into meaningful clinical benefit at study completion. In addition, at the first MRD assessment (Day 45), plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm. The Company believes these interim data provide initial support for cema-cel’s potential as a novel strategy for treating high-risk patients at the end of first-line treatment.

MRD status post-treatment has emerged as a strong predictor of relapse in LBCL, creating a potential opportunity to intervene earlier in the course of disease, when disease burden is low, but the risk of progression remains high.4 5 The ALPHA3 trial is the first randomized study in LBCL designed to assess whether MRD-guided intervention before relapse can eliminate residual disease and potentially prevent recurrence. The study identifies high-risk patients using Natera’s CLARITY MRD assay which is powered by its phased variant MRD technology. Patients with LBCL who have completed curative-intent treatment in both front-line and later line settings, including autologous CAR T therapy, and who achieve MRD negative status by technology have demonstrated improved progression-free survival (PFS) and EFS compared to those who do not attain MRD-negative status.6 7

"Early MRD clearance in this setting is encouraging and supports the potential for cema-cel to change how we approach high-risk LBCL at the end of first-line therapy," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer of Allogene. "These interim data suggest that an off-the-shelf CAR T may be able to intervene during that important window before clinical relapse to eliminate residual disease and make earlier intervention feasible in routine clinical practice. We look forward to the next study milestones as the trial continues to further define the potential of cema-cel."

"Our goal has always been to move CAR T from a bespoke procedure available at a limited number of centers to a scalable therapy that can reach patients more broadly," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Although still early, the ALPHA3 results show encouraging MRD clearance and a favorable safety profile. Combined with the advantages of an off-the-shelf CAR T platform—rapid availability, operational simplicity, and potential for outpatient use—cema-cel, if approved, could leapfrog existing options and enable earlier intervention in the disease course."

SAFETY & HOSPITALIZATION
Cema-cel has been generally well-tolerated as of the data cutoff with no serious adverse events related to treatment. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD) in the Treatment Emergent Adverse Events (TEAEs) of Special Interest category, which captures adverse events associated with CAR T.

TEAEs of Special Interest Cema-cel Arm (N=12)
n (%) Observation Arm (N=12)
n (%)
CRS (Any Grade) 0 -
ICANS (Any Grade) 0 -
GvHD (Any Grade) 0 -
Infection* 2 (16.7%) 2 (16.7%)
Infection (Grade ≥3) 0 0
Other Neurologic Events** 6 (50.0%) 1 (8.3%)
Other Neurologic Events (Grade ≥3) 0 0

*Infection events were low grade and limited to urinary tract infection, subcutaneous abscess, COVID19, and skin infection
**Other neurologic events were low grade and limited to headache, dizziness, numbness or tingling in the hands or feet, and altered taste

No Hospitalizations for Treatment Related Adverse Events: Ten of 12 patients who received cema-cel were managed entirely outpatient post-infusion. The remaining two patients were briefly hospitalized for events deemed unrelated to cema-cel treatment (atrial fibrillation and non-cardiac chest pain). One patient in the observation arm was hospitalized for febrile neutropenia. This contrasts with the broader CAR T experience where hospitalization for toxicity management remains common, even in outpatient programs, with approximately 70–90% of patients requiring admission and roughly 75% hospitalized for adverse events within 30 days.8

"The early safety profile, characterized by an absence of CRS and ICANS, is encouraging given its potential to enable safe outpatient management," said Nancy L. Bartlett, M.D., Professor of Medicine, Division of Oncology, Washington University School of Medicine in St. Louis and a Siteman Cancer Center physician. "When considered alongside the availability of an off-the-shelf product, these findings suggest the possibility of overcoming key logistical barriers that have historically limited broader use of CAR T, particularly in earlier lines of therapy. Coupled with the encouraging MRD clearance data, this approach may represent an important step toward improving outcomes while expanding patient access."

REAL-WORLD FEASIBILITY AND COMMUNITY USE
At the time of the interim futility analysis, community cancer centers accounted for approximately 33% of screening activity and cema-cel infusions, including several sites with little to no prior CAR T experience. Participation from these centers, where most patients receive care, underscores the feasibility of offering cema-cel in these settings and supports potential for broader adoption.

"In busy community practices, the goal is simple: bring the therapy to the patient, not the patient to the therapy," said Jeff Sharman, M.D., Chair, Lymphoma Research Executive Committees, SCRI at Willamette Valley Cancer Institute & Research Center. "Historically, CAR T has largely been out of reach for community practices. The ability to deliver an off-the-shelf CAR T safely in the community setting, potentially outpatient, could address far more patients and extend treatment reach across the communities we serve."

PATIENT CHARACTERISTICS
Both study arms consisted of patients with high-risk, aggressive lymphomas. Although limited by the small sample size, baseline characteristics show that a numerically greater number of patients in the cema-cel arm had more aggressive disease features, specifically stage III-IV disease and higher IPI scores, compared to the observation arm.

At Original Diagnosis Cema-cel Arm (N=12)
n (%) Observation Arm (N=12)
n (%)
History of Bone Marrow Involvement 4 (33.3%) 3 (25.0%)
Disease Stage
I – II 0 2 (16.7%)
III – IV 12 (100%) 10 (83.3%)
IPI Score
0 to 1 0 4 (33.3%)
2 to 3 7 (58.3%) 5 (41.7%)
4 to 5 5 (41.7%) 2 (16.7%)
Unknown 0 1 (8.3%)
Gene Alterations/Over Expression
Double Hit 6 (50.0%) 2 (16.7%)
Triple Hit 0 2 (16.7%)
Double Expressor 2 (16.7%) 0

First-Line Regimens and PET/CT Response to the 1L Regimen: A high-intensity variant of R-CHOP, DA-EPOCH-R, was the most commonly administered 1L therapy across both arms, with a slightly higher proportion of patients in the cema-cel arm receiving this first line treatment regimen (58.3% vs. 41.7%). Twenty-five percent of patients in each arm entered the study after achieving a partial remission to 1L therapy.

Cema-cel Arm (N=12)
n (%) Observation Arm (N=12)
n (%)
First-Line Treatment
R-CHOP 2 (16.7%) 3 (25.0%)
R-Pola-CHP 2 (16.7%) 2 (16.7%)
DA-EPOCH-R 7 (58.3%) 5 (41.7%)
R-miniCHOP 1 ( 8.3%) 2 (16.7%)
Most Recent PET/CT Response Before Randomization
CR 9 (75.0%) 9 (75.0%)
PR 3 (25.0%) 3 (25.0%)

ALPHA3 TRIAL AND TIMELINE
This interim futility analysis was based on the first 24 patients randomized (12 in the cema-cel arm and 12 in the observation arm) and followed for post-treatment MRD assessment. MRD is assessed on Day 45, Month 3, and every 3 months during the first year of follow-up. The primary endpoint of EFS, along with key secondary endpoints of PFS and overall survival (OS), remains blinded. The study is enrolling across more than 60 sites, with additional sites coming online, and is expected to enroll approximately 220 patients. Study accrual is anticipated to be complete by the end of 2027. The study is powered to detect a 50% reduction in the risk of EFS events. EFS events include the initiation of new anti-lymphoma therapy, disease progression, or death. The Company anticipates an interim EFS analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, these results could support a Biologics License Application (BLA) submission.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. PT / 8:30 a.m. ET to discuss the interim futility analysis. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. Please use this link to register for the listen-only webcast. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, APR 13, 2026, View Source [SID1234664313])

On April 13, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO) reported that it intends to offer and sell, in an underwritten public offering and subject to market and other conditions, $175 million of shares of its common stock. All of the shares are being offered by Allogene. In addition, Allogene intends to grant the underwriters for the offering a 30-day option to purchase up to an additional $26.25 million of the shares of its common stock offered in the public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Allogene expects to use the net proceeds from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, general and administrative expenses, and capital expenditures.

Goldman Sachs & Co. LLC, Jefferies and TD Cowen are acting as the joint book-running managers for the offering. TPG Capital BD, LLC is acting as co-manager for the offering.

The shares of common stock described above are being offered by Allogene pursuant to a shelf registration statement filed by Allogene with the Securities and Exchange Commission (SEC) that was declared effective on April 25, 2024. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, or by telephone at (877) 821-7388, or by emailing [email protected]; or from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Allogene, APR 13, 2026, View Source [SID1234664312])

On April 13, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and Children’s Hospital of Philadelphia (CHOP), the nation’s first pediatric hospital, reported a strategic collaboration to accelerate the discovery, development and nationwide availability of specialized pediatric diagnostics. By combining CHOP’s pediatric research and clinical expertise with Labcorp’s national diagnostic infrastructure, scientific capabilities and commercialization expertise, the collaboration aims to expand access to advanced diagnostic testing for children and families across the country.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our shared aim to improve children’s health makes this collaboration so powerful," said Stephen R. Master, M.D., Ph.D., division chief and director of metabolic and advanced diagnostics at Children’s Hospital of Philadelphia. "By pairing CHOP’s pediatric leadership with Labcorp’s nationwide reach, we seek to deliver important new and specialized tests to children and their families more efficiently and at greater scale."

Innovation Pipeline to Advance Pediatric Diagnostic Development
At the core of the collaboration is the creation of a joint pediatric diagnostics innovation pipeline where CHOP and Labcorp will team up to identify, develop and expand new tests and technologies with a goal of streamlining the path from discovery to national availability. Pediatric-specific diagnostics deliver more accurate, age-appropriate insights for children by accounting for their unique biology, developmental stages and physiological ranges—factors that traditional adult-oriented tests often overlook. The collaboration will make novel diagnostics available nationwide across key clinical areas, such as oncology, metabolic disease and autoimmune conditions.

Expanding Nationwide Access to Advanced Pediatric Testing
Together, the organizations will provide clinicians and health systems with cutting-edge pediatric testing—bringing breakthrough diagnostics in cancer, genetics, immune disorders and rare diseases to patients sooner and enabling earlier, more precise diagnoses.

"Labcorp and CHOP share a commitment to advancing pediatric care. By combining CHOP’s deep pediatric expertise with Labcorp’s scientific capabilities and national reach, we can bring pediatric diagnostic innovations to patients faster and make advanced testing accessible to many more families," said Bryan Vaughn, executive vice president, Diagnostics at Labcorp.

"Today’s announcement marks an important milestone at the intersection of scientific research and collaboration," said Joseph Mitchell, M.D., president at Children’s Hospital of Philadelphia. "Our commitment to innovation has always been driven by one goal: improving the lives of children. By working closely with Labcorp, we can create the breakthroughs that children and families need – today and in the years to come."

(Press release, LabCorp, APR 13, 2026, View Source [SID1234664311])

On April 13, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the completion of patient randomization in the Phase 2 part of the Phase 1/2 clinical trial evaluating TG4050, an individualized neoantigen therapeutic vaccine (INTV) developed from Transgene’s myvac platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

38 patients have been randomized in the Phase 2 part of the Phase 1/2 trial for adjuvant treatment of head and neck cancer (HNSCC1). With the primary endpoint of the trial being 2-year disease-free survival (DFS), Transgene is advancing the study and expects to communicate top line results by the end of Q1 2028.

TG4050 is designed to stimulate a strong and individualized immune response aimed at preventing relapse in patients following surgery and adjuvant (chemo)radiotherapy.

Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented: "Completing randomization in the Phase 2 part of the study is an important milestone for TG4050 and for our myvac platform and confirms the expected readout timing of the primary endpoint of the Phase 1/2 trial by the end of Q1 2028, while we plan to release first immunological data in H2 2026. We are grateful to the patients, investigators and site personnel who contribute to advancing this promising, individualized immunotherapy. We look forward to the upcoming analyses as we continue our efforts to provide an innovative individualized treatment option for patients diagnosed with operable squamous head and neck cancer."

The primary objective of the randomized multicenter Phase 1/2 trial (NCT04183166) is to compare the efficacy of TG4050 as a single agent versus watchful waiting in the adjuvant treatment of locoregionally advanced HPV-negative head and neck cancer (HNSCC).

The primary endpoint of the trial is 2-year disease-free survival (DFS) and is expected to read out as soon as all patients from the Phase 2 part achieve 2-year follow-up from randomization unless an event (relapse, death) occurs earlier, with results anticipated by the end of Q1 2028.

Data from patients in the Phase 1 part of the trial have already shown that multiple subcutaneous injections of TG4050 were well-tolerated with no unexpected safety signals.
3-year DFS follow-up of Phase 1 patients is expected in Q2/Q3 2026.

TG4050, as a monotherapy, met all trial endpoints in the Phase 1 part of the trial and induced long-lasting immune responses to vaccine neoantigens that were sustained for up to two years after treatment initiation. All patients treated with TG4050 were disease-free at 2-years (median follow-up: 30 months), confirming robust clinical proof of principle.

The positive clinical and translational data2 suggest that individualized treatment with TG4050 has the potential to prevent cancer relapses when administered as monotherapy in an adjuvant treatment regimen in patients with high risk, resected, locally advanced HPV-negative HNSCC.

(Press release, Transgene, APR 13, 2026, View Source [SID1234664310])

On April 13, 2026 AnBogen Therapeutics, a clinical-stage biotechnology company focused on precision oncology, reported that two key research abstracts regarding its lead compound, Imofinostat (ABT-301), have been selected for poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data demonstrate ABT-301’s superior performance in enhancing immunotherapy for colorectal cancer (CRC) and reveal a novel mechanism for overcoming chemotherapy resistance in pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AnBogen will present these breakthroughs during the session "PO.ET09.01 – Epigenetic Modulators 1" on Tuesday, April 21, 2026, from 9:00 AM to 12:00 PM (Local Time) in San Diego.

1. Strengthening Immune Response: New Evidence in Colorectal Cancer (CRC)

Abstract Title: Imofinostat in combination with immune checkpoint inhibitors enhances anti-tumor activity in colorectal cancer
Abstract Number: 4496 (Section 14, Poster 15)
Key Breakthrough: Preclinical data confirms that Imofinostat, acting as an HDAC inhibitor, effectively modulates the tumor microenvironment (TME). By synergizing with immune checkpoint inhibitors and anti-angiogenic agents, it converts "cold tumors" into "hot tumors," significantly enhancing the immune system’s ability to recognize and eliminate cancer cells. This provides a robust scientific foundation for AnBogen’s ongoing global clinical trials.
2. Breaking the Defense: Targeting the HDAC3-NRF2 Pathway in Pancreatic Cancer

Abstract Title: Imofinostat enhances chemotherapy response in KRAS-mutant pancreatic ductal adenocarcinoma (PDAC) by targeting the HDAC3-NRF2 pathway
Abstract Number: 4497 (Section 14, Poster 16)
Key Breakthrough: For highly challenging KRAS-mutant pancreatic cancer, the study reveals that Imofinostat precisely regulates the HDAC3-NRF2 signaling pathway—a key driver of chemo-resistance. By intervening in this pathway, Imofinostat significantly boosts tumor sensitivity to chemotherapy, offering a promising new therapeutic strategy for patients with this aggressive malignancy.
Triple Combination Strategy for Advanced CRC

Based on the strong scientific evidence presented at AACR (Free AACR Whitepaper), AnBogen is actively advancing a Phase 1/2 global multi-center clinical trial (NCT07244705) for Imofinostat in combination with Tislelizumab (an anti-PD-1 monoclonal antibody provided by BeOne Medicines under a clinical drug supply agreement) and an anti-angiogenic agent for advanced CRC.

This triple combination strategy leverages ABT-301’s capacity to reshape the tumor microenvironment and lift immune suppression, which in turn unlocks the therapeutic potential of the PD-1 inhibitor. Through a synergistic interplay with anti-angiogenic agents, the treatment collectively promotes the normalization of tumor vasculature and optimization of the microenvironment. This integrated action effectively dismantles drug delivery barriers, allowing immune cells to penetrate deeper into the tumor core for maximum anti-cancer synergy.

"The two abstracts presented at AACR (Free AACR Whitepaper) this year represent international academic recognition of ABT-301’s innovative mechanism," said John Hsu, CEO of AnBogen Therapeutics. "We are accelerating the translation of these findings into clinical results. Furthermore, our recent successful Series B funding and upcoming plans for an Emerging Stock Market listing will provide the resources needed to drive our trials forward and address significant unmet medical needs."

About Imofinostat (ABT-301) Imofinostat is a small-molecule Histone Deacetylase inhibitor (HDACi). It reactivates tumor suppressor genes silenced by cancer cells, inducing apoptosis and inhibiting tumor growth. In Phase 1 monotherapy trials, ABT-301 demonstrated excellent safety and competitive advantages across various solid tumors.

Currently, a global multi-center Phase 1/2 clinical trial (NCT07244705) is underway to evaluate the safety and efficacy of Imofinostat in combination with Tevimbra (Tislelizumab) and Bevacizumab. This study focuses on patients with proficient mismatch repair (pMMR) or non-high microsatellite instability (Non-MSI-H) metastatic colorectal cancer (mCRC).

(Press release, Anbogen Therapeutics, APR 13, 2026, View Source [SID1234664308])