Kolon TissueGene Implements Layoffs Following Phase 3 Osteoarthritis Trial Failure

In an age that looks ahead toward AI-driven drug development, we should also look back at the scientific frameworks set decades ago regarding preclinical research. In every major drug programme, between the first idea and the first human dose, there lies an uncomfortable reality: animals are still used, sometimes usefully, sometimes imperfectly, and increasingly alongside better, human-relevant alternatives.

The John Hopkins Center for Alternatives to Animal Testing¹, established in 1981, shows that this controversial topic has been recognised for decades, with serious efforts made to replace and reduce animal use rather than justify its use indefinitely.

However, for complete, whole-organism questions, nothing yet fully substitutes a living system with circulating blood, an immune response, and multi-organ interactions. That is why regulators still expect animal data before first-in-human studies, and why millions of animals continue to be used each year. Ignoring this fact does not make progress towards animal-free research any closer.

At the same time, clinging to animals as the “gold standard” is scientifically and ethically questionable. New methodologies, such as organ-on-a-chip, advanced 3D cultures, and computational or AI models, can sometimes predict human responses better than the traditional preclinical models. A human Liver-Chip correctly identified 87% of drugs known to cause drug-induced liver injury, whereas all 27 drugs had previously passed preclinical animal testing².

Published in 1959, the 3Rs framework (replacement, reduction, refinement) is not just an ethical slogan, it is a scientific strategy for more precise, human-relevant data³. Now, with the rise of non‑animal preclinical models, we can propose the 3Is for embedding human‑centred methodologies directly into the core of preclinical science: invest, improve, and integrate.

References

1. Goldberg AM. A History of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT): The First 28 Years (1981–2009). Appl Vitro Toxicol. 2015 Jun 1;1(2):99–108. doi:10.1089/aivt.2015.0015

2. Ewart L, Apostolou A, Briggs SA, Carman CV, Chaff JT, Heng AR, et al. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Commun Med. 2022 Dec 6;2(1):154. doi:10.1038/s43856-022-00209-1

3.Hubrecht RC, Carter E. The 3Rs and Humane Experimental Technique: Implementing Change. Anim Open Access J MDPI. 2019 Sep 30;9(10):754. doi:10.3390/ani9100754 PubMed PMID: 31575048; PubMed Central PMCID: PMC6826930.

October 29, 2026 — New York City 🗽🇺🇸

We’re giving away 5 passes to the Galien Forum, and if you have ever wanted to be in a room with the people leading some of the most influential companies in pharma, this is your opportunity.

Taking place on October 29, 2026, in New York City, the Galien Forum brings together global chairs, senior executives, scientists, innovators and decision-makers for meaningful conversations about the ideas shaping the future of medicine and healthcare.Attendees will have the opportunity to hear from and connect with leaders from Johnson & Johnson, Pfizer, Roche, Regeneron, Merck and other globally recognized organizations.

These are the people operating at the cutting edge of the industry developing new treatments, advancing scientific research, building breakthrough technologies and making the decisions that influence the direction of the pharmaceutical industry at large.

For more than 20 years, Prix Galien USA has recognized the innovations transforming patient care. The Galien Forum creates an opportunity to go beyond the awards and hear directly from the leaders, researchers and organizations behind that progress.

You can see the post HERE!

Follow The Galien Foundation on LinkedIn to stay updated on announcements, speakers, and innovations and upcoming event.

The Advanced Research Projects Agency for Health (ARPA-H) has awarded Siemens Healthineers up to $31.1 million over five years to accelerate the development of autonomous, remote endovascular robotics. The project focuses on automated long-distance mechanical thrombectomy for acute ischemic stroke, enabling robotic interventions without direct human input at the bedside.

Siemens Healthineers is contributing $5.4 million as a cost share, raising total program investment to $36.5 million. Stryker is participating as a key sub-awardee, expanding on a strategic partnership established in 2025 to advance robotic neurovascular interventions.

The technology addresses severe geographical disparities in acute stroke treatment across the United States. Over 50% of the US population lives more than an hour away from a thrombectomy-capable center. Only ~12% of the 335,000 eligible stroke patients in the US currently receive mechanical thrombectomy annually. The award operates under ARPA-H's Autonomous Interventions and Robotics (AIR) program, managed by Dr. Ileana Hancu.

The European Commission has officially granted regulatory authorization for Johnson & Johnson's combination of Tecvayli (teclistamab) and Darzalex (daratumumab) to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

The decision allows the off-the-shelf, bispecific antibody doublet to be utilized as early as second-line treatment across European Union member states. European approval follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) in June 2026. The decision arrives five months after the USFDA cleared the combination under its Commissioner’s National Priority Voucher (CNPV) pilot program.

Regulatory filings were supported by Phase 3 MajesTEC-3 study data, where the regimen demonstrated an 83% reduction in the risk of disease progression or death and a greater than 50% reduction in overall risk of death compared to standard-of-care control arms.

Werewolf Therapeutics has concluded its strategic alternatives process by entering into a definitive all-stock reverse merger agreement with Ambros Therapeutics. Concurrent with the transaction, the combined entity secured commitments for a $150 million private placement co-led by RA Capital Management and Janus Henderson Investors. Upon closing, pre-merger Werewolf shareholders will own approximately 6.8% to 7% of the combined company, which will operate under the Ambros Therapeutics branding, trade on Nasdaq under the ticker symbol "AMBX," and focus entirely on advancing Ambros' late-stage rare disease pipeline.

The merger significantly strengthens Ambros’ balance sheet, projecting a cash runway into the first half of 2029. This capital cushion fully funds the clinical completion and regulatory submission of lead drug candidate neridronate. Neridronate, an aminobisphosphonate with FDA Breakthrough Therapy and Fast Track designations, is undergoing Phase 3 evaluation for complex regional pain syndrome type 1 (CRPS-1).

The Phase 3 CRPS-RISE trial is enrolling approximately 270 adult patients with the warm subtype of CRPS-1 and a positive triple-phase bone scan, measuring changes in pain intensity over 12 weeks against placebo following four 100 mg intravenous infusions over 10 days. With enrollment completion targeted around late 2027 to early 2028, neridronate could become the first FDA-approved therapeutic for CRPS-1.

Kolon TissueGene is eliminating 37 positions at its Rockville, Maryland facility, effective August 31, according to a Worker Adjustment and Retraining Notification (WARN) Act filing. The strategic workforce reduction follows the failure of ACTiVION-II, the first of two pivotal US Phase 3 trials evaluating its cell and gene therapy, TG-C, for knee osteoarthritis.

In the 531-patient ACTiVION-II study, TG-C failed to demonstrate statistically significant improvements over placebo in pain and functional mobility at Month 12, missing its co-primary endpoints (VAS pain score and WOMAC total score) as well as all key secondary endpoints. Despite the efficacy miss, TG-C demonstrated a clean safety profile with no new safety signals.

Addressing shareholders in a video statement, CEO Seng Ho Jeon expressed deep regret over the trial outcome and committed to conducting a comprehensive, data-driven review of the program. Company leadership indicated that the operational downsizing reflects a broader realignment of priorities while awaiting topline results from the second US Phase 3 study, ACTiVION-I, which are anticipated in October.