On November 5, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, hematologic malignancies and solid tumors, reported financial results and operational highlights for the third quarter ended September 30, 2026.

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"The growing body of evidence for prula-cel continues to strengthen our conviction in its potential to generate meaningful, lasting remissions for patients living with SLE, including those with LN and extra renal SLE. The compelling efficacy observed following complete discontinuation of immunosuppressants, together with evidence of a deep immune reset and a favorable safety profile supporting outpatient administration, reinforce the potential for prula-cel to meaningfully change the treatment paradigm for lupus patients," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "With pivotal study startup activities underway in LN and planned FDA discussions regarding potential pivotal expansion to include lupus patients without nephritis, we look forward to providing a regulatory update and additional 12-month follow-up data from approximately 22 patients in the first quarter of 2027 followed by clinical data from our systemic sclerosis cohort in the second quarter. Together with continued progress on ADI-212 and our in vivo CAR-T pipeline, we believe 2027 will be a catalyst-rich year for Adicet."

Third Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Prula-cel demonstrated positive safety and efficacy data in Phase 1 trial of patients with SLE with or without LN. In September 2026, the Company announced updated safety and efficacy data from its ongoing Phase 1 study evaluating prula-cel in patients with SLE, with or without LN. As of the August 28, 2026 data cutoff, 22 efficacy-evaluable patients (16 with LN and 6 with extra-renal SLE) had 6 to 21 months of follow-up, including 13 patients with at least 12 months of follow-up. Prula-cel continued to demonstrate positive clinical responses and a favorable safety profile in this heavily pretreated population. At 12 months, 50% of evaluable LN patients achieved a complete renal response and 54% of evaluable patients achieved Definition of Remission in Systemic lupus (DORIS) remission. Patients also demonstrated rapid and sustained reductions in mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Physician’s Global Assessment (PGA). All patients discontinued immunosuppressants, and all but one tapered background steroids to 5 mg or less of prednisone equivalent. Prula-cel was generally well tolerated, with no Grade > 2 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), no immune effector cell-associated hemophagocytic syndrome (IEC-HS), and no graft-versus-host disease (GvHD) observed, supporting the potential for outpatient administration. Biomarker analyses further demonstrated evidence of immune reset, including complete CD19+ B-cell depletion, naïve-dominant B-cell reconstitution, reductions in anti-dsDNA antibodies, and complement recovery.
Prula-cel pivotal LN study start-up activities underway; FDA meeting planned in 4Q/2026 regarding potential pivotal expansion beyond LN; regulatory update and additional 12-month clinical data expected in 1Q/2027. The Company has initiated start-up activities for a pivotal study in LN. The single-arm study is expected to enroll a double-digit number of patients, with complete renal response at 12 months as the primary efficacy endpoint. Given the high DORIS remission rates reported in the September 2026 clinical data update, the Company plans to engage with the FDA in the fourth quarter of 2026 regarding the potential expansion of its pivotal development program to include lupus patients without nephritis. The Company expects to provide an update on these discussions, as well as additional clinical data from approximately 22 patients with at least 12 months of follow-up, in the first quarter of 2027.
Phase 1 readout of prula-cel in systemic sclerosis (SSc) expected in the second quarter of 2027. The Company expects to report clinical data evaluating prula-cel in SSc in the second quarter of 2027.
Solid tumor indications

Phase 1 startup activities underway for ADI-212 in mCRPC following FDA IND clearance and FTD. In August 2026, the FDA cleared the Company’s IND application for ADI-212 in mCRPC, followed by the granting of FTD in September 2026. Phase 1 startup activities are underway, with patient enrollment in mCRPC anticipated in the first quarter of 2027. ADI-212 is designed as an off-the-shelf therapy, featuring multiple platform enhancements by incorporating gene-editing and expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of the tumor microenvironment.
In Vivo CAR-T Program and Pipeline

Progressing a differentiated portfolio of in vivo CAR-T programs designed to address significant unmet needs in both hematologic malignancies and solid tumors. The Company is advancing its in vivo CAR-T platform and pipeline designed to optimize in vivo T-cell transduction and generate highly cytolytic CAR-T therapy. Ongoing preclinical activities include programs targeting multiple myeloma, non-Hodgkin’s lymphoma, and solid tumor indications. Based on progress to date, The Company plans to initiate its first in vivo CAR-T program in the second half of 2027.
Financial Results for Third Quarter 2026:

Research and Development (R&D) Expenses: R&D expenses were $15.6 million for the three months ended September 30, 2026, compared to $22.9 million during the same period in 2025. Non-cash stock-based compensation expense included in R&D expense was $0.8 million for the third quarter of 2026.
General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the three months ended September 30, 2026, compared to $5.1 million during the same period in 2025. Non-cash stock-based compensation expense included in G&A expense was $0.7 million for the third quarter of 2026.
Net Loss: Net loss was $18.9 million, or a net loss of $1.76 per basic and diluted share for the three months ended September 30, 2026. This net loss includes non-cash charges of $2.7 million that consisted primarily of share-based compensation, depreciation expenses, and noncash lease expense.
Cash Position: Cash, cash equivalents and short-term investments were $100.9 million as of September 30, 2026. The Company expects that current cash, cash equivalents and short-term investments as of September 30, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, NOV 5, 2026, View Source [SID1234674359])

On November 5, 2026 Acepodia (6976: TT), a clinical-stage biotechnology company developing next-generation cell therapies and antibody-drug conjugates, reported that the first patient has been dosed in its Phase 1 trial of ACE723 in unresectable or metastatic hepatocellular carcinoma (HCC). The patient was dosed at a clinical trial site in China.

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ACE723 is a GPC3-targeted dual-payload antibody-drug conjugate (ADC) and the first candidate from Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform to reach the clinic.

"Dosing the first patient with ACE723 is an important moment for Acepodia. It is the first time a molecule from our AD2C platform has been given to a patient," said Sonny Hsiao, Ph.D., Chief Executive Officer and Chairman of Acepodia. "We are grateful to the patients, investigators and site teams who made this possible, and we look forward to sharing updates as the study progresses."

ACE723 pairs a GPC3-targeting antibody with two cytotoxic payloads that kill tumor cells through different mechanisms. This design is intended to address tumor heterogeneity and the resistance that can limit single-payload ADCs. GPC3 is frequently expressed in HCC, making it an attractive target for delivering payloads directly to tumor cells.

The Phase 1 study will assess the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity of ACE723. The dose-escalation portion is designed to define a recommended dose for later-stage development and potential expansion cohorts.

ACE723 received IND clearance from the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) in September 2026, followed by IND approval from the Taiwan Food and Drug Administration (TFDA) in October 2026, supporting clinical development across the United States, China and Taiwan.

HCC accounts for more than 70% of liver cancer cases worldwide. While immunotherapy-based combinations have improved first-line treatment for advanced disease, many patients eventually progress or develop resistance and have few effective options afterward. New therapies with differentiated mechanisms are urgently needed.

(Press release, Acepodia, NOV 5, 2026, View Source [SID1234674358])

On November 5, 2026 Mondego Bio reported the initiation of a first-in-human Phase 1 clinical study of MB‑388, an oral dual PTPN2/PTPN1 inhibitor designed to overcome resistance to cancer immunotherapy by acting in both tumor cells and immune cells.

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The randomized, double-blind, placebo-controlled Phase 1a study will evaluate single and multiple ascending doses of MB‑388 in healthy volunteers. It will assess safety and tolerability, characterize pharmacokinetics (PK) and measure target engagement using blood-based pharmacodynamic (PD) biomarkers.

MB‑388 was designed to address a central limitation of this inhibitor class: achieving sustained target coverage with an oral molecule while preserving a therapeutic window broad enough for combination with checkpoint inhibitors. In head-to-head preclinical studies against osunprotafib, the leading clinical-stage PTPN2/PTPN1 inhibitor, MB‑388 showed a substantially higher unbound fraction in human plasma, higher oral exposure and longer target coverage. MB‑388 also showed more than 1,000-fold selectivity over unrelated targets and favorable exposure margins in rodent and non-rodent safety studies.

In preclinical tumor models that respond to or resist PD‑1 blockade, MB‑388 was active both as monotherapy and in combination with anti-PD‑1 treatment. Treatment increased intratumoral CD8-positive T cells and granzyme B, consistent with the intended immune-mediated mechanism.

"Starting the first clinical study of MB‑388 is an important milestone for Mondego," said Nikolay Savchuk, PhD, Chief Executive Officer of Mondego Bio. "The Phase 1a study will define the relationship between exposure, pathway engagement and tolerability, giving us the data to move efficiently into our planned study in patients with cancer."

Mondego plans to begin a Phase 1b study in January 2027 in patients with advanced solid tumors who have progressed on or after standard therapy, including patients previously treated with checkpoint inhibitors. The study will first evaluate MB‑388 as monotherapy, then add a combination run-in with PD‑(L)1 blockade once initial monotherapy dose levels have been cleared. The combination program will include both checkpoint-refractory and checkpoint-naive patients.

Initial human PK and PD data are expected in December 2026, and a readout from combination dose escalation is planned for December 2027.

(Press release, Mondego Bio, NOV 5, 2026, View Source [SID1234674357])

On November 5, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that the European Patent Office has granted European Patent No. EP 4454709, titled "Fibroblast Delivery of Tumor Inhibitory Agents." The patent covers methods of preparing fibroblasts as anti-cancer delivery compositions by modifying the cells to improve their ability to home to cancer cells and loading them with one or more tumor inhibitory agents, including an oncolytic virus.

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Cancer is still one of the most difficult diseases in medicine. Many of the most promising anti-cancer agents, including oncolytic viruses, cytokines, and suicide genes, do their best work inside a tumor. The hard part is getting enough of them there without harming healthy tissue. Fibroblasts have a natural tendency to migrate toward tumors, where they are recruited into the surrounding stroma. The patent builds on that tendency and turns the fibroblast into a delivery vehicle.

The newly granted patent describes methods in which fibroblasts are modified to enhance their homing activity toward cancer cells or cancerous tissue. The claimed tumor inhibitory agent comprises an oncolytic virus, such as vaccinia virus. In data described in the patent, fibroblasts carrying Newcastle disease virus significantly inhibited tumor growth in a mouse melanoma model, while the virus given on its own, even at high doses, did not affect tumor growth.

Coverage and strength of the patent include:

The independent claim covers the core method of preparing tumor-homing fibroblasts loaded with an oncolytic virus and conditioned under hypoxia, whether the homing step is performed before, after, or at the same time as the loading step. Other claims add specific homing receptors (CXCR4, CXCL16, and CCL9), vaccinia virus as the oncolytic virus, and additional payloads delivered by vector, including TNF-alpha, TRAIL, suicide genes, the interleukins IL-2, IL-12, IL-18, and IL-23, interferons, and bispecific antibodies.

Additional claims cover modified fibroblasts for use in treating cancer in individuals who have cancer or are at risk for it, alongside surgery, chemotherapy, radiation, hormone therapy, or immunotherapy. The patent protects the engineered cells as they would be used in a patient, not only the way they are made.
"We filed the first application behind this patent when very few people were thinking about fibroblasts as a way to carry a cancer-killing virus into a tumor," said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. "Fibroblasts are abundant, they are easy to grow, and they already know how to find a tumor. Our job is to give them something useful to carry when they get there. This patent gives us a long runway in Europe to do that work. Cancer is a long game, and we are building for it."

About the Technology

Fibroblasts are the most common cell type found in connective tissue and play a central role in tissue repair. Tumors actively recruit fibroblasts into the surrounding stroma, and FibroBiologics’ patented approach puts that behavior to work. The cells are modified in culture to strengthen their homing activity toward cancer cells, conditioned under hypoxia, and loaded with one or more tumor inhibitory agents, such as an oncolytic virus or a vector encoding an anti-cancer protein. Once administered, the fibroblasts are intended to carry their payload into the tumor and release it where it is needed, with the goal of concentrating the treatment at the cancer and limiting exposure to healthy tissue.

(Press release, FibroBiologics, NOV 5, 2026, View Source [SID1234674356])

On November 5, 2026 Dizal (SSE: 688192), a biopharmaceutical company dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of oncology and hematological diseases, reported that it will present its latest clinical results from its hematological disease portfolio with three oral and five poster presentations, at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The oral sessions will feature clinical studies evaluating golidocitinib and birelentinib in lymphoma and hematologic immune diseases. The clinical data for GW5282 in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) will be presented for the first time.

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Dr. Xiaolin Zhang, CEO of Dizal, said: "Dizal has a globally competitive hematological disease portfolio. Our robust presence at ASH (Free ASH Whitepaper) 2026 reflects the exciting advancement of our differentiated portfolio in T-cell and B-cell lymphomas, as well as autoimmune diseases. We believe these programs will bring the next generation of novel therapies to patients globally."

Golidocitinib in PTCL and HLH

Golidocitinib is the world’s first and only Janus kinase 1 (JAK1) inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). It has shown promising preliminary efficacy across T-cell lymphoma subtypes and selected hematologic immune diseases.

An oral presentation will feature updated data in adults with secondary hemophagocytic lymphohistiocytosis (HLH), extending the previous findings reported at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026 (Abstract #PF700). The results demonstrate that golidocitinib, as a single agent, can achieve high and durable response rates with a manageable safety profile, supporting further development of the drug in this devastating disease.
New data of golidocitinib with CHOP as first-line treatment show promising antitumor activity and a manageable safety profile. These findings support its potential as a frontline treatment option.
Two real-world retrospective studies of golidocitinib in r/r cutaneous T-cell lymphoma (CTCL) and mycosis fungoides (MF) exhibit robust and durable antitumor activity with a manageable safety profile.
A preliminary study evaluating golidocitinib combined with PD-1 blockade and asparaginase-containing immunochemotherapy demonstrates encouraging efficacy and a favorable tolerability profile for newly diagnosed and high risk advanced extranodal NK/T-cell lymphoma (ENKTL).
Birelentinib: in 1st line CLL/SLL as a single agent and in combination with a BCL2 inhibitor

Birelentinib is an innovative dual inhibitor of Lyn and BTK, designed to simultaneously inhibit both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways. Two oral presentations will report data from birelentinib, as a monotherapy or in combination with venetoclax, in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL).

Birelentinib monotherapy has demonstrated robust antitumor activity, durable responses and favorable tolerability in patients with treatment-naïve and heavily pre-treated CLL/SLL. A global, randomized Phase 3 study is ongoing to compare the efficacy and safety of birelentinib versus investigator’s choice of treatment in relapsed or refractory CLL/SLL.
Birelentinib in combination with venetoclax in treatment-naïve CLL/SLL shows encouraging efficacy and a well-tolerated safety profile, regardless of high-risk genetic features.
GW5282: Preliminary Clinical Evaluation in r/r NHL

GW5282 is a next-generation EZH1/2 dual inhibitor designed to simultaneously inhibit both EZH1 and EZH2 with equal potency, thereby preventing the tumor escape due to compensatory activation of EZH1. GW5282 showed much improved drug-like properties, with high oral bioavailability, longer half-life, reasonable daily dose, and much improved bone marrow safety.

The emerging clinical data for GW5282 demonstrate an encouraging safety profile and clinical efficacy across multiple r/r non-Hodgkin lymphoma (NHL) subtypes.

Details of the respective presentations are summarized below:

Lead Author

Abstract Title

Presentation Details

Prof. Zhao Wang

Golidocitinib monotherapy for adult hemophagocytic
lymphohistiocytosis: Interim efficacy and safety results
from a prospective single-arm trial (JACKPOT11)

Abstract Number: 515
Oral Presentation

10:30 AM – 10:45 AM CST, Dec 13, 2026

Prof. Ting Niu

Multicenter phase II study (TAI-SHAN10): Combination of
birelentinib and venetoclax in treatment-naïve CLL/SLL
patients

Abstract Number: 256

Oral Presentation

2:45 PM – 3:00 PM CST, Dec 12, 2026

Prof. Jianyong Li

Phase 2 study of birelentinib (DZD8586) monotherapy for
treatment-Naïve and relapsed/refractory patients with
CLL/SLL (TAI-SHAN8)

Abstract Number: 107

Oral Presentation

10:30 AM – 10:45 AM CST, Dec 12, 2026

Prof. Ting Niu

Updated safety and efficacy of golidocitinib plus CHOP as
first-line treatment for peripheral T-cell lymphoma in the
phase I/II study (JACKPOT52)

Abstract Number: 1855

Poster Session

5:30 PM – 7:30 PM CST, Dec 12, 2026

Prof. Huiqiang Huang

Real-world study of golidocitinib monotherapy in
relapsed/refractory cutaneous T-cell lymphoma (R/R
CTCL): A multicenter retrospective analysis

Abstract Number: 1844

Poster Session

5:30 PM – 7:30 PM CST, Dec 12, 2026

Prof. Liqun Zou

Real-World Efficacy and Safety of Golidocitinib in
Relapsed/Refractory Mycosis Fungoides: Promising
Activity in High-Risk Subtypes and Combination Regimens

Abstract Number: 5361

Poster Session

6:00 PM – 8:00 PM CST, Dec 14, 2026

Prof. Liqun Zou

Frontline Golidocitinib Plus PD-1 Blockade, Gemcitabine,
and Pegaspargase for Advanced Extranodal NK/T-Cell
Lymphoma: Preliminary Results of a Prospective Phase 2
Study

Abstract Number: 3601

Poster Session

6:00 PM – 8:00 PM CST, Dec 13, 2026

Prof. Huilai Zhang

A phase I/II study of GW5282, a selective EZH1/2 dual
inhibitor, in refractory or relapsed non-Hodgkin lymphomas
(BEI-DOU1)

Abstract Number: 5415

Poster Session

6:00 PM – 8:00 PM CST, Dec 14, 2026

About Golidocitinib

Golidocitinib is the world’s first and only Janus kinase 1 (JAK1) inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with r/r PTCL.

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About Birelentinib

Two resistance mechanisms have been found in patients whose diseases have progressed on a BTK inhibitor treatment: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed to treat both BTK-dependent and BTK-independent B-cell non-Hodgkin lymphoma (B-NHL).

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

About GW5282

GW5282 is a next-generation EZH1/2 (Enhancer of Zeste Homolog 1 and 2) dual inhibitor, preventing EZH1 compensatory activation as a resistance mechanism.

While EZH2 is a clinically validated target for multiple hematological and solid tumors, translational science evidence indicates that inhibiting EZH2 alone often leads to incomplete pathway blockade due to compensatory activation of EZH1. Furthermore, approved EZH2-only inhibitors are limited by a short plasma half-life. Consequently, much higher dosing regimens are required to cover the target, leading to high pill burden-related gastrointestinal adverse reactions and dose-limiting bone marrow toxicities.

GW5282 is designed to address these critical limitations. Available clinical data showed much improved drug-like properties, with high oral bioavailability, longer half-life, reasonable daily dose, and much improved bone marrow safety.

(Press release, Dizal Pharma, NOV 5, 2026, View Source [SID1234674355])