One biologic, three mechanisms under investigation, an unmet need in oncology
Chemotherapy, targeted therapy, and immunotherapy each face drug resistance, treatment toxicity, immune suppression, and tumor fibrosis. Pancreatic cancer is where those limitations are most acute, and where the mechanisms under investigation for HHP appear to align most directly with the disease. The Company is investigating whether a single agent may address all four.
Dose-dependent killing of solid tumor cells has been observed in vitro, including pancreatic cancer lines (IC50 ~4.5 nM in the prostate-cancer potency assay; PDAC lines 13.3–22.3 µg/mL), with tumor growth inhibition observed in human PDAC patient-derived xenograft models. These are preclinical findings obtained with native, tissue-derived HHP.
Anti-inflammatory and anti-fibrotic activity that may normalize the tumor microenvironment — a possible path toward converting "cold" tumors "hot" for checkpoint inhibitor therapy.
Non-opioid suppression of peripheral and central pain sensitization has been observed in vitro and in animal models, including PDAC-associated pain — a prespecified secondary endpoint in the planned Phase 1/2a trial. Two primary papers and one review have been published from this work (Cells 2024; eLife 2024; J Transl Med 2026).
Synthetic HC-HA/PTX3 (HHP)
HHP is a biologically active extracellular matrix complex originally identified in the human amniotic membrane and umbilical cord of birth tissue, studied for more than 25 years under BioTissue Holdings, partly with NIH support. Since January 2026, Synvexon has achieved simplified, reproducible, higher-potency synthetic manufacturing, resolving the supply constraint that historically limited native-tissue-derived HHP — and has engaged EirGenix, a Taiwan-based GMP CDMO, to scale production for clinical trials.
More than two decades of research behind the platform
HHP was first identified in human birth tissue and studied for more than 25 years under BioTissue Holdings, Inc. — much of that work supported by NIH research grants, including an R01 award (2020–2025) studying birth-tissue products for non-opioid pain treatment, and a follow-on joint R01 grant submitted in 2026 to study HHP's suppression of cancer pain.
Synvexon Therapeutics, Inc., founded in December 2025, has licensed this platform technology from BioTissue Holdings, Inc. Since then, the Company has achieved a manufacturing breakthrough — simplified, reproducible, higher-potency synthetic production of HHP — resolving the supply constraint that had historically limited development of native-tissue-derived HHP.
He S-Q, Zhang C, Wang X-W, et al. “HC-HA/PTX3 from human amniotic membrane induced differential gene expressions in DRG neurons: insights into the modulation of pain.” Cells 2024;13(22):1887.
Zhang C, Huang Q, Ford NC, et al. “Human birth tissue products as a non-opioid medicine to inhibit post-surgical pain.” eLife 2024;13:RP101269.
Zhang C, Lin Q, Huang Q, et al. “Human birth tissue products for pathological pain: mechanisms, evidence, and translational outlook.” Journal of Translational Medicine 2026;24:798.
Two primary papers and one review, generated with the Johns Hopkins Pain Center under NIH R01 NS117761 (2020–2025). Two further manuscripts on HHP in pancreatic cancer have been prepared with China Medical University (Sher et al., in submission; a PDX companion in preparation), with National Taiwan University and Academia Sinica BioTReC as potential collaborators. All efficacy and safety data generated to date were obtained with native, tissue-derived HHP; comparability of synthetic HHP will be established through analytical characterization and a defined bridging package.
Five developments converged inside twelve months
A simplified, reproducible synthetic route and improved purification, completed in H1 2026 ahead of schedule. The process has since been run three times independently, with yield varying by about 6% between runs. The quantity constraint on twenty-five years of HHP research is resolved.
Synthetic HHP exceeds native, tissue-derived HHP in the Company's in vitro assays against the current reference material — a candidate improvement on the native material, not only a substitute for it. Confirmation against a re-established reference material is in progress.
EirGenix is producing recombinant PTX3 and TSG-6; the technology-transfer package is complete in draft and in internal review, and the process is being prepared for manufacture at GMP scale.
A worldwide exclusive license was executed in June 2026. Company-owned filings covering the synthetic process and batch-release assays will follow GMP manufacture.
Locally advanced PDAC — the only pathway with in vivo data in a human patient-derived xenograft model and a second, NIH-supported dataset in cancer pain.
The work now in front of the Company is execution — technology transfer, GMP manufacture, and establishing the comparability of synthetic material to the native complex on which the existing data were generated.
Locally advanced pancreatic cancer — the intended lead indication, with or without cancer pain
PDAC is the indication in which HHP's mechanism and the disease biology align most directly. Desmoplasia — the dense fibrotic, immunosuppressive stroma that shields the tumor — is the defining feature of the pancreatic microenvironment and the specific target of HHP's anti-fibrotic activity. It is also the only pathway for which the Company holds in vivo evidence in a human patient-derived xenograft model. HHP may also engage the disease’s central oncogenic driver: in PDAC cells it has been shown to reduce active KRAS-GTP — the driver mutated in more than 90% of PDAC and long considered “undruggable” — reinforcing its mechanistic relevance to the lead indication.
Locally advanced, unresectable PDAC without distant metastases, with an EUS-accessible target lesion — patients with or without cancer-associated pain. Roughly 30–40% of patients present at this stage.
EUS-guided intratumoral and peri-tumoral injection — the same access route already used for tissue diagnosis in PDAC, at the referral centers that would serve as trial sites.
Primary: safety, tolerability, and preliminary anti-tumor activity. Prespecified secondary: pain response and opioid use in patients with pain at baseline — one IND, one trial.
Dose-dependent killing of PDAC cell lines PANC-1 and PDAC-094LM in vitro (IC50 13.3–22.3 µg/mL; ~4.5 nM in the prostate-cancer potency assay), through membrane proteins distinct from CD44, plus tumor growth inhibition in human patient-derived xenografts after both intratumoral and peri-tumoral injection (native HHP; preliminary).
Eligible for Orphan Drug designation, with Fast Track and Breakthrough Therapy pursued as the data support. FDA pre-IND meeting Q3 2027, with the meeting request and briefing package submitted in Q2 2027; Taiwan-first TFDA IND in 2028, with first-in-human in Taiwan in 2029 and the US filing to follow.
Pancreatic cancer treatment $2.9B (2024) → $5.8B (2030). Cancer pain therapeutics ~$1.8B (2025) → $2.6B (2035). Reference markets, not revenue forecasts.
Four further pathways on the same drug substance
Each expansion pathway would reuse the lead indication's drug substance, manufacturing process, and analytical release assays. They are sequenced after first-in-human data and are not part of the current development plan.
The immediate extension of the lead indication — converting unresectable tumors toward resectable. Same delivery route, same investigators. $2.9B → $5.8B.
Prostate, melanoma and others: local injection instead of radical surgery and its morbidity. Screening continues in bladder, thyroid and breast. $17.0B → $32.0B.
TME normalization is the direct rationale for cold-to-hot conversion; ~70–80% of patients do not respond durably to ICIs. $46–59B → $182–252B.
Fibrosarcoma and leiomyosarcoma cells were killed in vitro at IC50 values comparable to carcinoma lines; superficial lesions offer simpler access than the pancreas. $1.5B → $3.1B.
Founders with a track record of building and exiting biotech companies
Co-founder of BioTissue Holdings, grown from start-up to 340+ employees and $100M+ annual revenue. Author of 50+ patents; recipient of the SBA Tibbetts Award.
Co-founder of BioTissue Holdings; financial and operational leadership through $100M+ in private equity fundraising.
Vice Superintendent, E-Da Hospital; Professor Emeritus, National Taiwan University. Leads medical affairs, KOL engagement, and clinical protocol design.
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Amy Tseng, CPA, MBA — Corporate Treasurer. Investor inquiries, partnership discussions and general questions are received at this address and answered directly.