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Amphista Therapeutics announces FDA clearance of IND application for AMX-883, its lead Targeted Glue™ degrader for acute myeloid leukaemia

On June 8, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of next generation targeted protein degradation (TPD) medicines, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AMX-883, an orally available non-cereblon degrader of BRD9, for the treatment of acute myeloid leukaemia (AML). AMX-883 is expected to enter the clinic in H2 2026.

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IND clearance allows Amphista to start its Phase 1 monotherapy dose-escalation and optimisation clinical trial of AMX-883 in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome (MDS), a related bone marrow disorder that often progresses to AML. After establishing the monotherapy profile, the Company intends to explore AMX-883 in combination with venetoclax and azacitidine in early lines of therapy, where treatment resistance continues to pose a major clinical challenge.

Louise Modis, Chief Executive Officer at Amphista, said: "FDA clearance of our IND for AMX-883, our lead Targeted Glue, for acute myeloid leukaemia is a significant milestone as we transition into a clinical-stage company. AMX-883 is the only BRD9 degrader currently being developed and the compelling preclinical findings submitted to the FDA support its potential as a first-line treatment option in the earlier disease setting in one of the most aggressive blood cancers. We look forward to commencing the clinical trial in H2 2026."

Patrick Kelly, Chief Medical Officer at Amphista, added: "AML remains one of the most devastating blood cancers, with a 5-year survival rate of just 33%, and resistance to standard-of-care treatments like venetoclax a critical challenge. FDA clearance of our IND for AMX-883 supports the advancement of a differentiated therapeutic approach, with the potential to establish an important new treatment pathway for patients in urgent need of innovative therapies."

(Press release, Amphista Therapeutics, JUN 8, 2026, View Source [SID1234666481])

Alligator Bioscience comments on Henlius update on global phase 3 trial with HLX22

On June 8, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on a recent update regarding patient recruitment in the ongoing Phase 3 clinical trial of HLX22, developed by Shanghai Henlius Biotech, Inc.

According to communication shared by Henlius, the first patients have now been dosed in all regions participating in the global Phase 3 study of HLX22, including China, Japan, Korea, Latin America, Australia, the United States and Europe.

HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"The successful dosing of the first patients across all regions marks an important milestone, signaling the continued progress in the Phase 3 study with HLX22," said Søren Bregenholt, CEO of Alligator Bioscience. "The continued advancement also suggests sustained investigator interest in evaluating HLX22 as a potential treatment option for patients with gastric cancers."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, JUN 8, 2026, View Source [SID1234666480])

AIM ImmunoTech Reports Positive Mid-Year Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

On June 8, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive progress in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).

See: DURIPANC, 2026 Mid-Year Interim Clinical Progress Update

AIM recently announced enrollment of the final patient in the clinical trial, barring any disqualifying pre-treatment circumstances. The Company remains on track for a planned December 2026 evaluation of the clinical trial’s primary endpoint, Clinical Benefit Rate ("CBR"), defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.

DURIPANC is a follow-up to a 57-subject Named Patient Program ("NPP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.

AIM Chief Executive Officer Thomas Equels stated: "There is a clear need for an approved treatment that is both more effective and less toxic than what is currently available to people suffering with pancreatic cancer. Despite advances in chemotherapy, survival for these patients is too often short and agonizing. The published NPP data and the DURIPANC interim results support our belief that Ampligen has the potential to meaningfully extend survival and provide late-stage pancreatic cancer patients with a higher quality of life. For example, in the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, we saw overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. We are also diligently planning the next step in Ampligen’s development, with an eye toward a pivotal Phase 3 clinical trial evaluating the experimental drug in combination with a PD-1 inhibitor in an effort to demonstrate its value across multiple endpoints, most importantly overall survival and progression-free survival. If a Phase 3 clinical trial was able to pair significant survival results with AIM’s impressive safety and tolerability profile, then it could position AIM as a leader in pancreatic cancer research potentially translational to the patient as a standard of care."

The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

(Press release, AIM ImmunoTech, JUN 8, 2026, View Source [SID1234666479])

China NMPA Grants IND Clearance to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for the Treatment of Late-Stage Solid Tumors, Including Prostate Cancer

On June 8, 2026 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the China National Medical Products Administration (NMPA) has cleared Adcentrx’s Investigational New Drug (IND) application for ADRX-0405. The clearance enables the company to include China-based clinical centers to its ongoing Phase 1a/1b trial (NCT06710379) evaluating ADRX-0405 in patients with late-stage solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer.

ADRX-0405 is a potential first-in-class, next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is overexpressed in prostate cancer and certain other cancers, with limited expression in healthy tissue.

"NMPA’s clearance of the ADRX-0405 IND is another important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This clearance expands our ability to enroll patients in both the U.S. and China, broadening geographic representation and allowing us to generate clinical data across more diverse patient populations. This enables ADRX-0405 to address important unmet needs across multiple tumor types."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates completing the Phase 1a portion of the trial by the fourth quarter of 2026.

About ADRX-0405

ADRX-0405 is a clinical-stage ADC targeting STEAP1. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx’s innovative i-Conjugation technology platform, a core element of its ADC design. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

I-CONJUGATION is a trademark registered in China.

(Press release, Adcentrx Therapeutics, JUN 8, 2026, View Source [SID1234666478])

OriCell’s GPC3 CAR-T Receives NMPA Clearance for Confirmatory Phase II Trial in Late-Line Advanced Hepatocellular Carcinoma

On June 7, 2026 OriCell Therapeutics Holdings Limited ( The "Company" or "Oricell") , reported that its proprietary GPC3-targeted autologous CAR-T therapy, Ori-C101, has received clearance from China’s National Medical Products Administration (NMPA) to proceed into a confirmatory Phase II clinical trial in patients with GPC3-positive advanced hepatocellular carcinoma (HCC). The study is designed as a prospective, randomised, open-label, multi-centre registration trial evaluating the efficacy and safety of Ori-C101 in patients who have failed two or more prior lines of therapy.

This marks the first GPC3-directed immune cell therapy anywhere in the world to enter a confirmatory trial, and the first CAR-T product for a liver cancer indication to reach a Phase II randomised controlled study — a milestone that underscores China’s potential to lead the next wave of innovation in cell therapy for solid tumours.

HCC, a disease with few options at the late line

Hepatocellular carcinoma is among the most prevalent malignancies globally, with China alone accounting for roughly 410,000 new cases and 317,000 deaths each year. For patients whose disease has progressed through both immune checkpoint inhibitors (ICI) and tyrosine kinase inhibitors (TKI), options are essentially exhausted: existing second-line agents were developed for patients intolerant of, or progressing on, first-line sorafenib, and nothing has been approved beyond that point. The unmet need is acute.

Phase I data of Ori-C101: robust efficacy and manageable safety

Results from the Phase I BEACON study were featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which recently wrapped up in Chicago, drawing significant attention from the oncology community. All enrolled patients had failed at least two prior lines of therapy, including both TKI and ICI treatment.

Key results:

Objective response rate (ORR): 50% across the evaluable population; 66.7% in the recommended Phase II dose (RP2D) cohort; 100% in the highest dose cohort (DL4)

Speed of response: 89% of responders had already achieved objective response by their first post-infusion assessment, with marked tumour shrinkage

Overall survival (OS): Median OS of 21.4 months in the overall population; 12-month survival rate of 69.3% — more than double the roughly 10.6-month historical median seen with available second-line agents, heralding a potential new era of long-term survival for patients with advanced HCC

Safety: Cytokine release syndrome (CRS) was manageable; no immune effector cell-associated neurotoxicity syndrome (ICANS) or off-target toxicity was observed, and tolerability was favourable across the study population

Notable case: One patient achieved partial response at first assessment, progressed to complete response by month four, and remains in remission at 24 months

Mechanism and broader potential

GPC3 (Glypican-3) is overexpressed in more than 70% of hepatocellular carcinomas, as well as in gastric cancer, lung squamous cell carcinoma, and ovarian clear cell carcinoma — making it a highly specific and compelling target for cancer therapy. Ori-C101 is engineered to identify and eliminate GPC3-positive tumour cells with precision, drawing on two proprietary platforms: OriAb (AI-assisted antibody discovery and engineering) and OriArmoring (structure-enhanced cell platform).

Ori-C101’s profile has the potential to support use in earlier lines of treatment, and GPC3’s expression across multiple tumour types provides a strong scientific rationale for future indication expansion. As the confirmatory trial advances, the goal of treatment in advanced HCC has the potential to shift from controlling disease to achieving durable remission — or even cure.

Principal investigators

The confirmatory Phase II study is a nation-wide, multi-centre trial co-led by Professor Fan Jia (Academician of the Chinese Academy of Sciences and Honorary President of Zhongshan Hospital, Fudan University) and Professor Qin Shukui (Qiantang Scholar and Professor at Nanjing Tianyinshan Hospital, China Pharmaceutical University).

In a joint statement, the two investigators said: "In our earlier work on late-line advanced HCC, the BEACON study delivered important progress. GPC3 is specifically overexpressed in HCC and represents an ideal therapeutic target, yet GPC3-directed CAR-T approaches have historically been constrained by the immunosuppressive tumour microenvironment. BEACON was designed precisely to break through that barrier and find a new, accessible path for patients who have exhausted their options. The preliminary results from this novel ‘armoured’ GPC3 CAR-T construct — showing strong objective response rates with a manageable safety profile — not only address an evidence gap in late-line refractory HCC but offer broader lessons for innovative immune cell therapies in solid tumours. We look forward to the Phase II randomised controlled study, and to obtaining the expected results under rigorous scientific design, comprehensive management, and strict quality control."

OriCell co-founder, Chairman and Chief Executive Officer Dr. Yang Huanfeng commented: "We are deeply grateful to the NMPA Centre for Drug Evaluation and relevant government authorities for their strong support of innovative drug development, and to Academician Fan, Professor Qin and their teams for their trust and active participation. This approval validates the scientific soundness and feasibility of our technology platform and marks a new stage of growth for OriCell. With a clear regulatory pathway now in place, we will push forward with Ori-C101’s confirmatory clinical development, with the aim of bringing a genuinely new treatment option to patients as quickly as we can. We believe this progress will also underpin China’s strategy for taking innovative medicines global and competing actively in international markets."

(Press release, OriCell Therapeutics, JUN 7, 2026, View Source [SID1234666476])