Weekly roundup: Designations, data and a dealmaker
Kaerus Bioscience’s lead candidate KER-0193 granted Orphan Drug Designation and Rare Pediatric Drug Designation by U.S. FDA for treatment of Fragile X syndrome (FXS)
Kaerus Bioscience announces that its lead candidate KER-0193 has been granted both Orphan Drug and Rare Pediatric Drug Designations for the treatment of Fragile X syndrome (FXS) by the U.S. Food and Drug Administration (FDA). This news follows the successful completion of a Phase 1 clinical trial.
Leucid Bio announces treatment of first patient in AERIAL trial of NKG2D CAR-T therapy LEU011 for solid tumours
Leucid Bio announces that the first patient has been dosed in the Phase 1 AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with refractory solid tumours. LEU011 is the first CAR-T candidate for the treatment of solid tumours to be manufactured at Great Ormond Street Hospital (GOSH), and its development has been accelerated by the successful first close of a Series A1 financing.
Resolution Therapeutics announces regenerative macrophage therapy (RMT) manufacturing process & candidate testing suite at ASGCT 2025
Resolution Therapeutics shares key data from two presentations at the American Society of Gene & Cell Therapy’s (ASGCT) 28th Annual Meeting in New Orleans, US, May 13-17, 2025. The data included updates on Resolution’s proprietary manufacturing process, which enables the robust and scalable GMP-compliant manufacture of autologous engineered RMT products, including lead asset RTX001.
Heidelberg Pharma to present promising new clinical data on its lead ATAC candidate HDP-101 at EHA 2025
Heidelberg Pharma announces that it will be presenting new clinical data on its lead Amanitin-based ADC candidate, HDP-101 at the 30th European Hematology Association (EHA) Congress, taking place in Milan, Italy, from 12 – 15 June 2025. An R&D Webinar will follow on 17 June 2025.
In addition, Heidelberg Pharma announced the election of Dr. Karl Benedikt Biesinger as the new Chairman of the Supervisory Board, with Dr. Klaus Schollmeier also joining as a new board member.
📺Optimum TV
As a biotech CEO, how do you raise funds when the market doesn’t seem interested? How do you strike a deal when the phones go silent?
Watch former Ablynx CEO Edwin Moses talk to Optimum TV about the attributes needed to succeed – and why he’s still actively involved in the industry as a non-executive chair of several life science companies.
Industry events
📍Bio€quity Europe 2025
The Optimum team travelled to Bruges this week for the 25th anniversary edition of Bio€quity and what a celebratory event it was! The conference aimed to answer the question ‘what’s next for biotech?’, with themes of globalisation, data sharing and cross-border challenges dominating this year’s panels.
Fantastic to see our clients Novo Holdings, Ariceum, Curve Therapeutics, Vesper Bio, Outrun Therapeutics, Heidelberg Pharma, Nucleome Therapeutics, Resolution Therapeutics, Sofinnova Partners, Leucid Bio, DISCO Pharmaceuticals, Infinitopes, Ona Therapeutics, Oxolife, Tanai Therapeutics, Crimson Gateway and iOnctura participating in the conference, as well as connecting with new and existing industry peers.
Thank you to BioCentury and EBD for organising yet another wonderful event.
👥 Optimum’s 17th Annual Healthcare Investor Conference
Summer is fast approaching and it is now less than five months until Optimum’s 17th Annual Healthcare Conference 2025! Returning to the King’s Fund this autumn, this prestigious invitation only event brings together investors and executives from across the life sciences sector, register your interest today.
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