Oxford, UK – 16th April 2026 – Alethio Therapeutics, a biopharmaceutical company developing novel treatments for myeloproliferative neoplasms (MPN), today announced the unveiling of ATX‑011, a first‑in‑class, mutation‑agnostic antibody with potential to disrupt the $2B Essential Thrombocythemia (ET) market. Alongside this, the Company announces the appointment of Steve R. Coats, PhD, a veteran biologics leader, as Chief Development Officer, to advance the ATX-011 programme towards IND submission, targeted for Q1 2027.
- ATX-011 offers a potent, fast acting, durable solution for ET, a disease that is riddled with risk of serious complications, morbidity and mortality.
- ATX-011 is designed to replace Hydroxyurea’s (HU) 50-year reign as standard of care, overcoming its critical limitations: slow, months-long achievement of platelet control and significant toxicities – including a 13% skin‑cancer risk – while most patients on HU still fail to reach target platelet counts, creating a clear need for safer, faster therapies.
- Significant commercial opportunity: 40–50% of HU patients suffer resistance, intolerance, or chronic toxicity, with no reduction in the risk of transformation to more aggressive disease forms – underscoring the substantial unmet need.
- ATX-011 is mutation-agnostic and engineered for the entire ET population – delivering platelet normalisation – within days – in non-human primate models.
- Best‑in‑class safety emerging: non-human primate data show zero myelosuppression, and no safety signals – a clean profile that HU cannot match.
- Rapid path to PoC: targeting H1 2028 for clinical proof‑of‑concept data, following a Q1 2027 IND.
- Leadership strengthened: Steve R. Coats, PhD, appointed as Chief Development Officer, brings world-class biologics development experience across IND submissions, translational planning, and regulatory engagement.
Essential Thrombocythemia, a chronic blood disorder characterised by high platelet counts, remains a large, underserved market of >140,000 patients in the US, with thrombosis risk, disease progression, and treatment‑related toxicities driving significant morbidity.
Hydroxyurea – a 50-year-old chemotherapeutic – remains the most widely used treatment even though platelet control typically takes months and is not achieved by most patients, while broad myelosuppression, frequent resistance or intolerance, and DNA‑damage concerns persist, with no reduction in the risk of progression to more aggressive disease. Emerging precision approaches targeting mutant CALR address only a narrow subset of patients.
Through Alethio’s ARTEMIS target‑discovery and development engine, the Company identified a surface target that enables selective removal of platelets and the mutant stem/progenitor cells that drive excess platelet production – independent of the patient’s driver mutation – and orthogonally validated this target using samples from more than 80 MPN patients. Combined with ATX‑011’s mutation‑agnostic, rapid‑acting antibody mechanism, this approach positions the candidate to serve the majority of the ET population and deliver a step‑change in clinical outcomes.
Rohit Batta, Chief Executive Officer of Alethio Therapeutics, said:
“Essential Thrombocythemia has been inadequately treated for half a century by a toxic and outdated standard of care. ATX‑011 was engineered to change that trajectory. Our mutation‑agnostic approach means no patient is left behind, and our pre‑clinical non-human primate data showing rapid platelet‑lowering and an exceptional safety profile give us confidence that we can redefine what is possible in MPN care. Our expanding MPN pipeline positions us to address the majority of MPN biology with multiple differentiated programmes. With our Series A fundraising progressing and Steve joining the leadership team, we are positioned to accelerate decisively towards our 2027 IND and 2028 clinical proof‑of‑concept data for ATX-011.”
Steve R. Coats, PhD, Chief Development Officer, commented:
“I joined Alethio because ATX‑011 stands out as one of the most compelling pre‑clinical programmes in the ET field. Its ability to act rapidly, across all mutational backgrounds, with a clean safety profile is highly differentiated in a space dominated by an aging chemotherapeutic and narrow genetic sub‑segment approaches. I look forward to driving ATX‑011 through IND‑enabling development and into first‑in‑human studies.”
In his role at Alethio Tx, Steve will lead the development strategy for ATX-011, which has demonstrated an ability to profoundly reduce systemic platelet levels in non-human primates. Steve brings more than 30 years of biopharmaceutical R&D leadership experience and deep expertise in advancing monoclonal antibody and antibody–drug conjugate (ADC) therapies from discovery through clinical development. Most recently, Steve served as CDO at ImmunOs Therapeutics where he led R&D, CMC and translational teams, expanded the company’s pipeline, and played a key role in securing financing and strategic partnerships.
Prior to that, during a 15-year tenure at AstraZeneca/MedImmune, he led global cross-functional teams delivering multiple novel antibodies and ADCs through IND/CTA submissions and into Phase 2 clinical trials. At AstraZeneca, Steve advanced five ADC programmes into clinical development and played a key role in the landmark ADC licensing transaction with Daiichi Sankyo, which included a $1.3 billion upfront payment and up to $7 billion in total potential value.
“Steve is a highly accomplished development leader with exceptional experience in biologics development strategy, translational science and global regulatory execution,” said Rohit Batta. “His track record of advancing complex tumour-targeting biologics into clinical development and securing high-value strategic partnerships makes him ideally positioned to lead ATX-011 into the clinic and advance our portfolio of potentially disease-modifying therapies.”
ATX‑011 is one of several medicines in Alethio’s growing pipeline – including next‑generation ADCs – purpose‑built to address the unmet need across the full disease spectrum of MPN.
ENDS
Contacts
Rohit Batta, CEO Alethio Therapeutics
[email protected]
Mark Swallow, Sandi Greenwood, MEDiSTRAVA
[email protected]
Notes to Editors
About Alethio Therapeutics
Alethio Therapeutics is pioneering the development of disease-modifying therapies for patients with chronic blood cancers, with the aim of helping them live fully, freely and well. The Company is focused on myeloproliferative neoplasms (MPNs), a group of chronic, incurable, and ultimately fatal blood cancers, where currently approved treatments are not selectively targeting disease-driving cells. The Company’s lead programme, ATX-011, is a first-in-class monoclonal antibody (mAb) based on a novel target identified on mutant stem cells that drive MPN disease progression. Alethio Therapeutics has generated compelling pre-clinical data for ATX-011, paving the way for IND-enabling studies in 1H 2027. The Company is also advancing a programme targeting mutant CALR – a key driver mutation in MPNs. Alethio Therapeutics’ pipeline is powered by its proprietary ARTEMIS discovery and development engine, which integrates access to leading MPN biobanks, single-cell sequencing, organoids, and bioinformatics to de-risk first-in-human trials and identify new mutant drivers, expanding therapeutic reach and market potential. Alethio Therapeutics is led by a highly experienced team and board, with Oxford Science Enterprises as its anchor investor.
www.alethiotherapeutics.com