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Ambros launches with $125M for non-opioid drugs & the EU proposes Biotech Act I

 

👉 Unlock capital and business building support for your cancer start-up.

Good morning! While two U.S. biotechs elsewhere in this newsletter are launching with $100M+ war chests, Germany’s T-CURX just closed a €17.7M Series A, which is considered a meaningful early round in Europe. The Würzburg-based company is advancing non-viral CAR-T therapies for AML and solid tumors, built on virus-free gene transfer and lipid nanoparticle technologies designed to make CAR-T manufacturing cheaper, faster, and more scalable. Different continents, same ambition… but very different number of zeros.

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—Joachim E.

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SNAPSHOT

Ambros launches with $125M to target chronic pain without opioids

Addicted to Love. Valentines Candy Hearts. Photo by Portland Photographer Lance Reis / KickassDesigns on Insta.

 

Ambros Therapeutics, co-founded by Vivek Ramaswamy and Keith Katkin, has launched with $125M in Series A funding to develop neridronate, a non-opioid treatment for Complex Regional Pain Syndrome type 1 (CRPS-1). The round was co-led by RA Capital and Enavate Sciences, with contributions from Abiogen and other investors.

Why it matters: There are currently no FDA-approved treatments for CRPS-1 outside of Italy. Ambros’ effort offers hope to patients suffering from this rare, debilitating pain condition and supports a broader shift away from opioids in chronic pain management.

Backstory: Neridronate has been used in Italy since 2014 to treat CRPS, but previous global development attempts failed due to early trial results. Recent open-label data, however, suggest long-term potential. Ambros has secured North American rights from Italy’s Abiogen Pharma to pursue new trials.

Big picture: The FDA is actively encouraging non-opioid pain treatments. Ambros' initiative aligns with growing regulatory support and public demand for safer alternatives in pain care.

Zoom in: CRPS-1 affects ~65,000 Americans annually, causing severe limb pain post-injury. Ambros’ Phase 3 trial (CRPS-RISE) will enroll 270 patients with this specific condition.

Yes, but: Ramaswamy, best known for founding Roivant Sciences and co-leading the short-lived Department of Government Efficiency (DOGE) alongside Elon Musk, is taking time out of running for Ohio governor to launch this venture. The company also boasts a leadership team with deep biotech experience to support the endeavour.

What's next: Ambros will begin its pivotal U.S. trial, with expected completion by December 2027, and regulatory work to bring neridronate to North American markets, potentially expanding beyond CRPS-1.

Early-stage funding for your oncology start-up

 

There are many routes to patient impact, but there’s no doubt that start-ups are the lifeblood of cancer innovation.

However, far too many breakthroughs stall in their early stages due to a funding gap between cutting-edge research and a start-up becoming ready for scale-up investment. That’s where Cancer Research Horizons’ Ventures team comes in.

We’re here to enable entrepreneurial researchers and founding teams by providing investment from our £30m Seed Fund, business building support, and access to our unparalleled network of experts, mentors, and investors.

SNIPPETS

What’s happening in biotech today?

✉️ RNA delivery: Addition Therapeutics has emerged from stealth with $100 M in funding to develop a novel form of gene therapy aimed at treating both rare and chronic diseases. Spun out of UC Berkeley research, the company uses lipid nanoparticles to deliver RNA and a specialized enzyme into cells, where the RNA is copied into DNA and integrated into the genome. This approach aims to avoid limitations of traditional gene therapies, such as high cost, short durability, and safety risks from viral delivery. Addition is collaborating with the Gates Foundation on an HIV therapy and developing additional programs with unnamed pharmaceutical partners.

 🧫 Bispecific deal: Bristol Myers Squibb (BMS) has entered a multiyear antibody discovery and development agreement with Harbour BioMed, potentially worth up to $1.1 B. The collaboration focuses on advancing multi-specific antibody programs using Harbour’s fully human antibody platform, Harbour Mice, which enhances biologic drug discovery. Harbour will receive $90 M upfront, with the remainder tied to development and commercial milestones. The deal also allows BMS to utilize Harbour’s clinical trial capabilities in China. This partnership follows other significant deals by both companies, including Harbour’s $4.4 B agreement with AstraZeneca and BMS’s recent acquisitions and collaborations in the bispecific and cell therapy space.

☣️ Toxin tacklers: MBX Capital has raised over $100 M to invest in early-stage biotech and health tech startups focused on “deep health”, an approach targeting the root environmental causes of chronic diseases, such as exposure to industrial toxins and synthetic chemicals. MBX will deploy $1–$4 M per company across therapeutics, platform technologies, and preventive solutions. Central to its strategy is the Atom Network, a community of industry experts from major pharmaceutical companies who support startup evaluation and growth. Initial investments already include Vivodyne, Arine, and Freedom Biosciences, all aligned with MBX’s focus.

🔬 KRAS crackdown: Oncolytics Biotech has reported promising results for its oncolytic virus therapy, pelareorep, in treating second-line metastatic colorectal cancer patients with KRAS mutations and microsatellite-stable disease, a particularly difficult subgroup to treat. In a completed study combining pelareorep with Avastin and FOLFIRI chemotherapy, 33% of patients achieved an objective response, significantly outperforming the historical 6–11% response rates for standard therapy alone. Additionally, progression-free and overall survival more than doubled compared to conventional treatments. Translational data also showed increased KRAS-mutant–specific T-cell activity, providing biological support for the observed clinical benefits and reinforcing plans for a controlled study.

 💵 Series B: Aeovian Pharmaceuticals has raised $55 M in an oversubscribed Series B financing to advance its lead candidate, AV078, into a Phase II proof-of-concept study for tuberous sclerosis complex (TSC)-related refractory epilepsy. TSC is a rare genetic disorder affecting about one million people globally, often leading to hard-to-treat epilepsy. AV078 targets mTORC1-driven mechanisms underlying these seizures, aiming to address a key unmet need in this patient population.

SNAP AGAIN

EU proposes Biotech Act I to fast-track health innovation and biotech scale-ups

 

Why it matters: Europe risks losing biotech leadership to other regions without faster innovation, clearer regulation, and better access to capital. The Biotech Act I addresses these issues head-on, aiming to keep R&D and commercialization in the EU.

Backstory: Despite world-class science, Europe has lagged in translating discoveries into patient-ready therapies, largely due to slow, fragmented clinical trial processes and limited funding for late-stage biotech firms.

Zoom in: The Act proposes faster EU trial approvals via binding review timelines, simplified and harmonised clinical trials process, and a new “FAST EU” initiative for emergency responses. To support all of this, a new €1B European Investment Bank-backed venture debt instrument will support biotech firms ready to scale but not yet publicly listed. Launch is expected by 2026–2027.

Big picture: The Act complements the EU’s broader updated Bioeconomy Strategy, released in response to China’s aggressive biotech plans.

What's next: Biotech Act II will address food and industrial biotech in 2026. While this proposal sounds thrilling, legislation must now be approved and implemented across all EU states.

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