Protocols

Celgene partners on Phase 0 cancer drug studies; FDA lifts clinical hold on Xencor’s bispecific

→  Celgene is tying up with Seattle-based Presage Biosciences to test its early-stage cancer drugs on patients in Phase 0 studies. In Phase 0, patients are given microdoses of a drug to test patient responses. It’s one way to help increase the odds of success, and help overcome the inherent limitations of animal studies.

Hideho Okada

Tmunity and the University of California San Francisco will enter a licensing and research collaboration to advance TCR therapies for currently incurable pediatric cancers with high mortality rates. The company says that initial research will focus on diffuse intrinsic pontine glioma (DIPG), a rare and highly aggressive brain stem tumor, which affects around 300 children in the US each year. Hideho Okada, a professor of neurological surgery at UCSF who devised the TCR at the center of the pact, will work with Tmunity through IND-enabling studies.

“This collaboration with UCSF embodies our commitment to advance novel T cell therapies into the clinic faster. Sadly, children who are diagnosed with DIPG currently have very few therapeutic options and there has been little progress in improving treatments and overall survival rates for DIPG over the last few decades,” said CEO Usman “Oz” Azam, adding that their new therapy is also a potential breakthrough for other gliomas.

→ More than two months after the FDA ordered a partial hold on a Phase I study of Xencor’s CD123 x CD3 bispecific, XmAb14045, the biotech says it can now resume recruitment of patients. Regulators lifted the hold, apparently satisfied with an amended protocol that now features guidance on the monitoring and clinical management of cytokine release syndrome — which caused one of the two deaths that investigators tracked in the study. The other patient died from acute pulmonary edema.

→ Swiss biotech AMAL Therapeutics is testing its cancer vaccine with Boehringer Ingelheim’s PD-1, BI754091, in a Phase Ib trial that will recruit Microsatellite Stable (MSS) patients with stage IV colorectal cancer. The idea is to see how ATP128 — which comprises a cell penetrating peptide for antigen delivery, a TLR peptide agonist and a multiple antigenic domain — performs both as a single agent and in combo. Boehringer is providing its drug for joint ownership of the results.

→ Singapore’s technology agency has enticed a Hong Kong-based pharmaceutical group called Aptorum to establish a venture fund catered to health care startups in Singapore. Together, they will raise $90 million to fund up to 20 startups, some of which have already been identified as companies working on 2D and 3D magnetic resonance imaging and surgical robotics. Aeneas Capital, which is also controlled by Aptorum co-founder Ian Huen, will also chip in. 


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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