First‑in‑Human STC‑1010 Data Show Favorable Safety and Early Immune Engagement in Metastatic MSS Colorectal Cancer

On April 14, 2026 Brenus Pharma reported that new first‑in‑human data will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026 (April 17–22, San Diego, California). The company continues to advance its lead candidate, STC-1010, a next generation in vivo allogeneic immunotherapy built on the Stimulated Ghost Cells (SGC) technology.

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The poster will provide a translational overview demonstrating how STC-1010 is administrated in microsatellite‑stable colorectal cancer (MSS CRC), a setting resistant to standards immunotherapy.

Clinical findings from BreAK CRC001 (NCT06934538), Phase I/IIa first‑in‑human evaluation of STC‑1010 in unresectable metastatic MSS CRC, first-line setting (n=6; median follow‑up: 6 months) show :

Favorable safety with no dose‑limiting toxicities (DLTs) observed.
Promising early efficacy, including 100% disease control rate (DCR) in RECIST.
Evidence of immune activation, including delayed‑type hypersensitivity (DTH) responses.
Exploratory analyses are ongoing to further characterize tumor–immune dynamics and identify predictive biomarkers supporting subsequent stages of clinical development.

Together, these results support continued advancement of STC‑1010 toward later‑stage evaluation and validate the SGC technology as a scalable, "off-the-shelf" approach for high unmet-need solid tumors.

Poster Details

Poster Title: "From preclinical models to first‑in‑human evaluation of STC‑1010 immunotherapy in unresectable advanced colorectal cancer"
Session: First‑in‑Human Phase I Clinical Trials
Date & Time: April 20, 2026 | 9:00 AM – 12:00 PM
Location: Poster Section 50
Poster Board Number: 11
Abstract Number: CT051

(Press release, Brenus Pharma, APR 14, 2026, View Source [SID1234664372])

Senhwa Biosciences Secures Strategic Backing from Global Investor GEM with Up to NT$500 Million to Accelerate AI-Driven Drug Development

On April 14, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company reported the signing of a Memorandum of Understanding (MOU) with GEM YIELD BAHAMAS LIMITED, an affiliate of the global investment firm Global Emerging Markets (GEM). Under the agreement, GEM intends to provide up to NT$500 million in terms of strategic funding to support Senhwa’s advancing pipeline, AI-enabled drug discovery initiatives, and global expansion strategy.

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This partnership highlights growing international investors’ confidence in Senhwa’s innovative R&D capabilities and its differentiated approach to integrating artificial intelligence into the development of its core assets. In addition to its ongoing focus on cancer immunotherapy, Senhwa has been actively building an AI-driven discovery platform. Through strategic collaboration with Y combinator backed AI Native company such as CellType, the Company is leveraging next-generation C2S (cell-to-sentence) technology to deepen mechanistic insights and systematically identify potential combination therapy in treating different types of cancers.

AI-enabled validation has demonstrated that Senhwa’s lead candidates possess promising immunomodulatory potential under specific tumor microenvironment conditions. These findings support the Company’s "cold-to-hot tumor" strategy, positioning Senhwa to capture opportunities in the next wave of immuno-oncology (IO 2.0). Mechanism-driven, AI-assisted drug development is rapidly emerging as a key investment theme across global pharmaceutical and capital markets.

Global Emerging Markets (GEM), headquartered in Luxembourg with offices in Paris, New York and Nassau (Bahamas), is a leading alternative investment group focused on emerging markets. GEM has completed over 590 transactions across 75 countries. Each investment vehicle has a different degree of operational control, risk-adjusted return, and liquidity profiles. Its family of funds and investment vehicles provide GEM and its partners with exposure to Small-Mid Cap Management Buyouts, Private Investments in Public Equities and select venture investments.

Senhwa believes this strategic capital commitment will enable the Company to advance its clinical programs in parallel with its AI-driven discovery platform, further strengthening its competitive position within the global biopharmaceutical ecosystem. The partnership also lays a solid foundation for future international collaborations and potential commercialization opportunities.

(Press release, Senhwa Biosciences, APR 14, 2026, View Source [SID1234664371])

PanGIA Biotech Non-Invasive Cancer Detection Abstracts Accepted for Presentation at AACR Annual Meeting 2026

On April 14, 2026 PanGIA Biotech, Inc. ("PanGIA Biotech" or "Company") reported that two research abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026, taking place April 17–22 in San Diego, California. Both abstracts highlight ongoing development of the Company’s PanGIA Analysis System ("PAS"), a machine learning platform designed to support non-invasive cancer detection through advanced biomarker analysis.

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Reflecting the Company’s continuing research into expanding the capabilities of the PAS across early detection applications, the accepted abstracts include:

"Our mission is to enable earlier detection to help facilitate better patient outcomes, reducing patient mortality. The acceptance of these abstracts is a step in that direction," said Holly Magliochetti, CEO and Co-Founder of PanGIA Biotech. "Opportunities like presenting at AACR (Free AACR Whitepaper) allow us to contribute to the broader conversation shaping the future of cancer diagnostics."

As one of the world’s leading scientific forums for cancer research, the AACR (Free AACR Whitepaper) Annual Meeting brings together clinicians, researchers, and industry leaders to share advances in oncology and translational medicine.

The Company’s research builds on ongoing work to expand the analytical capabilities of the PAS platform and support multi-cancer early detection approaches.

"Presenting this work at AACR (Free AACR Whitepaper) provides an opportunity to share how PanGIA Biotech’s research and development applies machine learning to complex biomolecular signals in non-invasive samples," said Obdulio Piloto, PhD, co-founder and Chief Scientific Officer of PanGIA Biotech and co-author of the studies. "Our research continues to explore how these analytical approaches may support earlier and more scalable cancer detection."

(Press release, PanGIA Biotech, APR 14, 2026, View Source [SID1234664370])

GlycoNex Receives PMDA Approval in Japan to Initiate First-in-Human Phase 1 Trial of GNX1021 in Gastrointestinal Cancers

On April 14, 2026 GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.

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This milestone marks GlycoNex’s transition into clinical-stage development for its proprietary glycan-targeting ADC platform and represents a significant step toward addressing high unmet need in gastric and other gastrointestinal malignancies.

The multi-center, multinational Phase 1 study in patients with advanced gastrointestinal cancers is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNX1021 and to establish a recommended dose range for subsequent clinical development. The first phase of the trial will be conducted in Japan and Taiwan. Patient enrollment in Japan is expected to begin in June 2026. GlycoNex plans to submit an Investigational New Drug (IND) application in Taiwan in June 2026, with enrollment anticipated to begin in the third quarter of 2026.

"PMDA approval to initiate our first-in-human study is a defining milestone for GlycoNex and a critical validation of our glycan-targeting platform," said Dr. Mei-Chun Yang, Chief Executive Officer of GlycoNex. "GNX1021 represents a differentiated approach to ADC development, designed to address tumor heterogeneity by targeting glycan structures broadly expressed across multiple cancer-associated proteins. We believe this unique mechanism, combined with the selective expression of the bLeB/Y antigen in gastrointestinal tumors, positions GNX1021 to potentially deliver meaningful clinical benefit, particularly in gastric cancer where new treatment options are urgently needed."

GNX1021 is an innovative ADC designed to target branched glycan antigens that are abnormally overexpressed on tumor cell surfaces. Unlike conventional targeted therapies that recognize a single protein epitope, GNX1021 exploits aberrant glycan structures across multiple tumor-associated membrane proteins, enabling multi-target engagement and potentially overcoming a key limitation of existing precision oncology agents.

GNX1021 targets the bLeB/Y antigen, which is highly expressed in epithelial tumors—including gastric, pancreatic, and colorectal cancers—while showing minimal expression in healthy human tissues. This unique targeting mechanism enables GNX1021 to identify cancer cells with high specificity, significantly improving the therapeutic index and patient safety.

In preclinical safety assessments, GNX1021 demonstrated a controlled and predictable safety profile in toxicology studies involving rats and cynomolgus monkeys. Results indicated a stable metabolic process with no significant drug accumulation or unanticipated damage to major organs. These findings not only validate the biosafety of GNX1021 but also provide robust scientific evidence to support its transition into human clinical trials.

Dr. Yang concluded: "We are encouraged by continued global interest in novel ADCs with differentiated targets. As GNX1021 advances through clinical development, we believe it has the potential to generate significant strategic partnering interest while, more importantly, advancing a new therapeutic approach for patients with difficult-to-treat cancers. Reflecting on recent global ADC licensing trends, drugs with unique targets that have reached Phase 1 clinical trials often command total deal values ranging from several hundred million to over a billion USD."

(Press release, GlycoNex, APR 14, 2026, View Source [SID1234664369])

Phrontline Biopharma Presents Preclinical Data for TJ106, a Biparatopic HER2 Dual-Payload ADC, at American Association for Cancer Research Annual Meeting 2026

On April 14, 2026 Phrontline Biopharma reported the presentation of preclinical data for TJ106, a next-generation biparatopic HER2-targeting antibody-drug conjugate (ADC) with a dual-payload platform, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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The data demonstrate robust antitumor activity across HER2-expressing tumor models, including those with low or heterogeneous HER2 expression and models resistant to prior HER2-targeted therapies and antibody-drug conjugates, including Trastuzumab deruxtecan. These findings support the continued development of TJ106 as a potential treatment option for patients with HER2-expressing cancers who have progressed on existing therapies.

TJ106 is engineered with a biparatopic HER2 antibody designed to bind two distinct epitopes, promoting receptor clustering and enhancing internalization. This approach is intended to improve intracellular delivery of cytotoxic payloads and address limitations associated with heterogeneous HER2 expression and suboptimal uptake observed with earlier HER2-targeted therapies.

The molecule incorporates a dual-payload design combining a topoisomerase I inhibitor and a microtubule inhibitor. These payloads provide complementary and non-overlapping mechanisms of action, enabling sustained cytotoxic activity and the potential to overcome resistance associated with single-payload ADCs. In preclinical studies, TJ106 demonstrated consistent tumor growth inhibition across multiple models, including those previously exposed to HER2-directed therapies.

TJ106 also incorporates an optimized linker system designed to balance plasma stability with efficient intracellular payload release, supporting a favorable therapeutic window in preclinical evaluations.

"The data presented at AACR (Free AACR Whitepaper) highlight the potential of TJ106 to address key challenges in HER2-targeted therapy, including resistance and tumor heterogeneity," said Martin S. Olivo, M.D., M.Sc., Chief Medical Officer of Phrontline Biopharma. "By combining biparatopic targeting with a dual-payload approach, TJ106 is designed to enhance tumor delivery and provide durable antitumor activity while maintaining an acceptable safety profile."

Phrontline plans to advance TJ106 into IND-enabling studies with an anticipated Investigational New Drug (IND) submission in early 2027. A global Phase I clinical trial is expected to evaluate TJ106 in patients with HER2-expressing solid tumors, including breast and gastric cancers, with a focus on patients previously treated with HER2-targeted therapies, including ADCs. The clinical program is expected to incorporate dose optimization principles aligned with U.S. Food and Drug Administration Project Optimus, including evaluation of exposure–response relationships and multi-cycle tolerability.

About TJ106

TJ106 is an investigational biparatopic HER2-targeting antibody-drug conjugate (ADC) incorporating a dual-payload platform consisting of a topoisomerase I inhibitor and an eribulin-based microtubule inhibitor. The molecule is designed to enhance tumor targeting, internalization, and intracellular drug delivery to address resistance mechanisms in HER2-expressing cancers.

(Press release, Phrontline Biopharma, APR 14, 2026, View Source [SID1234664368])