On September 24, 2026 Elephas Biosciences Corporation, developer of a functional precision medicine platform for oncology therapy response measurement, reported a collaboration with Italy-based Tes Pharma to evaluate TES-4207, a first-in-class investigational therapy targeting NR2F6 for treatment of non-small cell lung cancer (NSCLC). Through the collaboration, Elephas’ elive platform will characterize functional response to TES-4207 in live human NSCLC tumor tissue, as a monotherapy and in combination therapy.

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As Tes Pharma integrates the ex vivo elive platform with their TES-4207 small molecule program, researchers will use functional data from live human NSCLC tumor tissue to characterize response phenotypes and inform continued translational and clinical development. The data will provide additional functional insights to support ongoing evaluation and development of the molecule.

"As we continue advancing TES-4207, understanding functional response in live human tumor tissue provides an important layer of information to support our first-in-class development program," shared Francesco Greco, Project Leader at Tes Pharma. "The insights generated through this collaboration will help us better understand the potential of TES-4207, alone and in combination with other therapies, as we determine the best path forward."

Elephas’ elive platform keeps tumor tissue alive and preserves the native tumor microenvironment, measuring therapeutic response directly rather than inferring it. For pharma partners, this generates functional human response data that can inform mechanism of action, combination therapy evaluation, and responder and non-responder profiling as programs move through translational and clinical development.

"We are pleased to collaborate with Tes Pharma and apply our elive platform to the development of TES-4207," shared Erika von Euw, PhD, MBA, Vice President, Scientific Affairs at Elephas. "Evaluating TES-4207 directly in live tumor tissue, both as a monotherapy and in combination with PD-1 blockade, allows us to capture tissue-specific functional responses while preserving the complexity of the tumor microenvironment. These insights can help inform clinical development and support a more precise approach to identifying groups most likely to benefit."

(Press release, Tes Pharma, SEP 24, 2026, View Source [SID1234671061])

On September 24, 2026 Sanyou Biopharmaceuticals Co., Ltd. ("Sanyou Bio") and NovoCodex Biopharmaceuticals Co., Ltd. ("NovoCodex") reported that the two companies have formally entered into a strategic collaboration agreement. The partnership will focus on the joint development of innovative antibody-drug conjugates (ADCs), leveraging Sanyou Bio’s strengths in innovative ADC discovery powered by its AI-Super trillion antibody/molecule libraries (AI-STAL) and Sanyou AI-Drug Accelerator (SAI-DA), together with NovoCodex’s extensive expertise in site-specific conjugation technology using unnatural amino acids. Through this collaboration, the two companies will jointly advance the development of innovative ADC therapeutics and work to deliver therapies with greater clinical value to cancer patients worldwide.

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The core competitiveness of ADC therapeutics begins with the precision of antibody targeting and is realized through stable and controllable conjugation processes. NovoCodex’s proprietary site-specific conjugation technology platform, NovoCode, precisely incorporates unnatural amino acids into antibodies to achieve defined and controllable conjugation sites, ensuring a highly homogeneous ADC product rather than the heterogeneous mixtures generated by traditional random conjugation approaches. This technology has been validated in the pivotal Phase III clinical trial of ARX788, and has supported ARX305 in demonstrating a favorable safety window and durable antitumor activity in patients with advanced renal cancer with high CD70 expression.

Sanyou Bio’s innovative ADC discovery platform was established in 2020 and has extensive experience in project design and process development, having successfully delivered more than 800 ADC conjugation projects. Particularly in the development of novel ADC molecular formats, Sanyou Bio has established capabilities in the discovery and design of dual-target ADCs and dual-payload ADCs. Dual-target ADCs enhance tumor selectivity by targeting two distinct antigen epitopes, while dual-payload ADCs expand the therapeutic window and help overcome drug resistance by incorporating two payloads with different mechanisms of action. These two innovative molecular formats are particularly well suited to have their design potential fully unlocked through NovoCodex’s NovoCode platform.

The two companies’ synergistic exploration in this area is expected to open up new technological possibilities for the development of next-generation ADC therapeutics.

The strategic collaboration will focus on the following key areas:

Integration of Antibody Discovery and Site-Specific Conjugation:
Sanyou Bio will leverage the AI-STAL platform to screen antibody candidates with high internalization efficiency and high target specificity, while NovoCodex will use the NovoCode platform to develop site-specific conjugation processes, establishing a coordinated evaluation of antibody characteristics and conjugation strategies from the outset.

Joint Exploration of Dual-Target and Dual-Payload ADCs:
Combining Sanyou Bio’s molecular design capabilities with NovoCodex’s site-specific conjugation platform, the two companies will advance the evaluation of target combinations for dual-target ADCs, the screening of payload pairs for dual-payload ADCs, and preclinical proof-of-concept studies.

Building a Closed-Loop R&D Workflow:
The two companies will establish joint project teams to integrate the entire development process, from target research and antibody screening through conjugation process development and in vitro and in vivo evaluation, thereby accelerating the development of ADC candidates.
Dr. Xuejun Liang, Chairman and CEO of NovoCodex, said:
"The success of an ADC therapeutic depends, to a significant extent, on the degree of compatibility between the antibody molecule and the conjugation strategy. Sanyou Bio’s AI-STAL and SAI-DA platforms can rapidly identify high-quality antibody candidates from massive molecular libraries, providing critical support for us to move upstream from process development toward the molecular design stage. At the same time, Sanyou Bio’s capabilities in dual-target ADCs and dual-payload ADCs represent major directions in the development of innovative ADCs today. Through this collaboration, we look forward to jointly developing innovative ADC therapeutics with a wider safety window and more durable efficacy."

Dr. Guojun Lang, Founder and CEO of Sanyou Bio, said:
"NovoCodex’s site-specific conjugation technology based on unnatural amino acids has been extensively validated in clinical development. NovoCodex’s unnatural amino acid-based site-specific conjugation platform, NovoCode, offers the key advantages of precise control over conjugation sites and a high degree of molecular homogeneity. The value of this collaboration lies in enabling Sanyou Bio’s molecular discovery capabilities and innovative ADC R&D capabilities to directly serve an ADC technology platform already validated in clinical development. This means that we can rapidly translate the value of dual-payload ADC engineering into therapeutic candidates within a more predictable conjugation system. It represents an efficient integration of ‘innovation at the source’ and ‘process validation,’ and we look forward to the opportunities this collaboration will bring."

This strategic partnership marks a key milestone for Sanyou as it deepens industry-wide collaboration across the ADC landscape. Drawing on each party’s complementary strengths in novel ADC development, Sanyou Bio and NovoCodex aim to streamline development of next-generation ADCs and build source-level innovation advantages for ADC drug discovery.

(Press release, Sanyou Biopharmaceuticals, SEP 24, 2026, View Source;sanyou-bio-and-novocodex-partner-to-co-develop-innovative-dual-payload-adcs-302888906.html [SID1234671060])

On September 24, 2026 Amberstone Biosciences, Inc., a preclinical-stage oncology company developing pH-gated, tumor-activated T-cell engagers (TCEs), reported a collaboration and license agreement with Shanghai Henlius Biotech, Inc., a commercial-stage biopharmaceutical company (2696.HK). Under the agreement, Amberstone will work with Henlius to apply its proprietary T-MATE (Tumor Microenvironment Activated ThErapeutics) platform technology to generate preclinical candidates against up to two targets selected by Henlius. Henlius will lead subsequent research, development, manufacturing, and commercialization activities worldwide.

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T-cell engagers redirect a patient’s T cells to kill cancer cells, but their development in solid tumors has been constrained by cytokine release syndrome and on-target, off-tumor toxicity. T-MATE is designed to address these limitations through reversible pH gating, reducing T-cell activation in the circulation and healthy tissues while retaining therapeutic activity across a broad range of pH conditions found in solid tumors. Preclinical studies have shown potent tumor-cell killing under tumor-like pH conditions with markedly reduced activity at physiological pH. Amberstone’s self-developed lead T-MATE TCE asset is expected to enter clinical development in the first half of 2027.

Under the agreement, Amberstone will receive an upfront payment and research funding, and is eligible to receive up to US$440 million in potential development, regulatory, and sales milestones for each target, plus tiered royalties on net sales.

(Press release, Amberstone Biosciences, SEP 24, 2026, View Source [SID1234671059])

On September 24, 2026 Earendil Labs, an AI-powered biotechnology company advancing next-generation biologics, reported a research collaboration with Genentech, a member of the Roche Group, to discover and develop multiple therapeutic bispecific antibody programs in oncology.

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Under the collaboration, Earendil Labs will lead antibody discovery and research through the early clinical development stage for antibody programs directed to certain pre-agreed target combinations. Genentech will assume responsibility for subsequent global clinical development and commercialization of such antibody programs arising from the collaboration. The transaction is subject to customary closing conditions.

As part of the agreement:

Earendil Labs will receive a $55 million upfront payment
The total potential value of the collaboration, including upfront, development, regulatory and sales milestone payments, is in excess of $1.5 billion.
Earendil Labs is also eligible to receive tiered royalties on net product sales.
Jian Peng, PhD, CEO of Earendil Labs, said: "Genentech is a pioneer in defining modern biologics cancer medicine. Earendil Labs is building an AI-driven high-throughput biology platform that effectively integrates AI directly into biologics research and development—from predictive protein modeling and generative protein design to rapid experimental validation. By combining our platform with Genentech’s deep expertise in oncology drug development, we aim to accelerate the creation of differentiated bispecific antibodies and translate them into new medicines."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added: "Despite many major advances in targeted cancer therapies and immunotherapies, there still exists a significant unmet medical need as many cancer patients develop drug resistance or relapse. Tumor growth and metastasis depend on multiple and interactive biological pathways, making it especially challenging for therapies directed at a single mechanism to achieve durable benefit. Bispecific antibodies offer the potential to address complementary disease biology within a single medicine. Through this strategic collaboration, we strive to discover and advance meaningful new treatment options for patients expeditiously."

"Bispecific antibodies have reframed how we approach treatment precision in oncology," said Boris L. Zaïtra, Head of Roche Corporate Business Development. "In cancers where patients face high relapse rates and limited options, bispecific antibodies support our commitment to delivering innovative, targeted therapies. Partnering with companies such as Earendil Labs allows us to push the boundaries of scientific innovation to meet patients’ critical unmet needs in oncology."

(Press release, Earendil Labs, SEP 24, 2026, View Source [SID1234671058])

On September 24, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2026.

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Tumor HI

upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.
Enrollment is in progress and topline results are expected before the end of 2026.
In June 2026, the Company shared positive interim data from the upLIFT study, announcing that of the 8 participants enrolled, 6 had already met the responder criterion for the study’s primary endpoint within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. Since the time of this announcement, the seventh participant has also met the responder criterion for the study’s primary endpoint.
One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.
In June 2026 at the Annual Meeting of the Endocrine Society (ENDO), Rezolute delivered a poster presentation highlighting favorable outcomes from a case series report of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor HI), demonstrating that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.
The outcomes of this case series were also recently published in manuscript form in The Journal of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia due to malignant insulin-secreting tumors.

Congenital HI

In September 2026, the Company provided an update that data from the Phase 3 sunRIZE study in congenital HI, which did not meet its primary endpoint, remains under review with the U.S. Food and Drug Administration (FDA or Agency).
In June 2026, the Company provided additional study data for the Agency’s independent review, including source and analysis datasets and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring (CGM) based glucose outcomes from the pivotal portion of the study.
The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.
Rezolute will continue to await feedback and reserves the ability to request a formal meeting under a regulatory timeline, as needed.
In June 2026 at ENDO, Rezolute delivered three data presentations focused on congenital HI.
In an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study, reviewed previously reported results from the study.
Two poster presentations highlighted results from systematic analyses of natural history and adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis of the literature as well as a claims-based approach to quantifying congenital HI complications, respectively.

Fourth Quarter and Full Year Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.9 million for the fourth quarter of fiscal 2026, compared with $20.9 million for the same period a year ago. Full fiscal year 2026 R&D expenses were $53.8 million, compared to $61.5 million in fiscal year 2025. The decrease from fiscal year 2025 to fiscal year 2026 was primarily due to decreased manufacturing costs for ersodetug, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $6.5 million of share-based compensation expense for the fiscal year 2026, compared with $3.5 million for fiscal year 2025.

General and administrative (G&A) expenses were $6.7 million for the fourth quarter of fiscal 2026, compared with $5.0 million for the same period a year ago. Full fiscal year 2026 G&A expenses were $29.2 million, compared to $18.4 million in fiscal year 2025. The increase was primarily attributable to increased employee-related stock-based compensation expense, and an increase in professional fees in preparation for future ersodetug commercial activities. G&A expenses include $8.0 million of share-based compensation expense for fiscal 2026, compared with $3.6 million for fiscal year 2025.

Net loss was $20.5 million for the fourth quarter of fiscal 2026 compared with a net loss of $24.4 million for the same period a year ago. Full year fiscal 2026 net loss was $77.6 million compared to net loss of $74.4 million for the fiscal year 2025.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

(Press release, Rezolute, SEP 24, 2026, View Source [SID1234671057])