Weekly roundup: Breakthrough trials, strategic partnerships, and investor insights
This week’s roundup captures the accelerating pace of innovation across the global biotech and pharmaceutical landscape. From Hansa Biopharma’s landmark Phase 3 trial success in kidney transplantation to DaltonTx’s £4 million seed raise for AI-driven drug discovery, the sector is brimming with breakthroughs. Xeltis, Poolbeg Pharma, and Heidelberg Pharma are all advancing important trials, while Synaffix signed an interesting dual-payload ADC deal with Qurient and AMSilk expanded its partnership with Evonik – highlighting the growing synergy between science and sustainability.
As anticipation builds for Optimum’s 17th Annual Healthcare Investor Conference, industry leaders share candid insights on venture capital, market resilience, and the evolving metrics of value in biotech investing in Optimum TV’s mini-series ‘Countdown to Conference’.
Hansa’s imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
Hansa Biopharma announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm.
The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean estimated Glomerular Filtration Rate (eGFR) with a p-value of <0.0001. The Company plans to submit a BLA under the accelerated approval pathway to the US Food and Drug Administration (FDA) by the end of 2025.
Access the presentation linked here.
DaltonTx raises £4 million seed financing to build the AI backbone of drug discovery
DaltonTx, a UK-based technology company, exited from stealth and completed a £4 million seed financing round to build adaptive, AI-enabled discovery platforms that will reshape the economics, timelines, and outcomes of R&D, helping breakthrough medicines reach patients faster.
Xeltis poised for commercialisation following excellent clinical data from aXess EU pivotal multicentre trial
Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced successful clinical data from the aXess EU pivotal trial, demonstrating the transformative potential of aXess in hemodialysis treatment.
ACT appointed for Poolbeg Pharma’s POLB 001 Phase 2a trial and supply of approved bispecific antibody drug secured at no cost
Poolbeg Pharma, a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announced that it had appointed Accelerating Clinical Trials Limited to conduct the upcoming POLB 001 Phase 2a trial. It has also secured the supply of an approved bispecific antibody drug for the trial at no cost.
Lonza’s Synaffix collaborates with Qurient Therapeutics to enable development of dual-payload ADC
Synaffix, a Lonza company focused on commercialising its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with potential best-in-class therapeutic index, jointly announced that it has entered into a licensing agreement with Qurient Co. Ltd., a clinical-stage biopharmaceutical company based in South Korea, for the development of a dual-payload ADC.
Evonik and AMSilk extend partnership for sustainable biotech silk materials
Evonik and AMSilk, a global leader in advanced biomaterials based on silk proteins, have deepened their collaboration with a long-term agreement to produce sustainable silk proteins at industrial scale. Building on their initial manufacturing agreement from 2023, the companies have commissioned a manufacturing line at Evonik’s Slovakian site for AMSilk’s high-performance silk.
Heidelberg Pharma advances to Cohort 9 in Phase I/IIa trial of lead ATAC candidate HDP-101 in multiple myeloma
Heidelberg Pharma, a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), announced the initiation of Cohort 9 in its ongoing Phase I/IIa dose escalation trial of lead program, HDP-101, the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma.
Neuraxpharm presented new ublituximab data in multiple sclerosis at ECTRIMS Congress 2025 alongside partner TG Therapeutics
Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announced its participation at the 41st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Congress, taking place in Barcelona from 24–26 September.
📺Optimum TV
Have you been watching Optimum TV’s mini-series Countdown to Conference? Ahead of Optimum’s 17th Annual Healthcare Investor Conference being held on Thursday October 9th at The King’s Fund in London – we talked to upcoming illustrious speakers on the agenda.
Episode 3: This week, we sat down with Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners and a seasoned life science investor. Antoine shares his insights into today’s investment landscape — speaking with optimism about the future of healthcare and the critical importance of “picking winners” and backing them with conviction.
Episode 2: Seasoned life science investor Søren Møller, Managing Partner of Novo Holdings Seed Investments, talks about the up-and-down year 2025 is proving to be for the life science market, how this has impacted investment decisions, and the importance of “ploughing on”. Watch the episode here
Episode 1: Guest Philip Brainin, Associate at Sound Bioventures, discusses why junior VCs are vital to the industry, why he picked venture capital over being a doctor or pursuing academic research, and how we can better measure the true value of innovative medicines. Watch the episode here ⬇️
🔥Hot topic
Biotech investors are typically measured – and rewarded – for their financial performance alone. But this can lead to a mismatch between an investment’s financial and social return. In plain speak, a new drug can do fantastically well financially, while being of limited value in terms of its public health impact. The reverse can also be true.
Can a new framework drawn up by Philip Brainin and Bibhash Mukhopadhyay of Sound Bioventures help? And would investors pay it any heed?
Find out in this week’s hot topic below ⬇️
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