Luigi Manenti, MD joins HiFiBiO Therapeutics as SVP, Global Head of Clinical Development

Dr. Manenti’s LinkedIn

Luigi Manenti, MD will join the company as Senior Vice President, Global Head of Clinical Development, and become a member of the company’s senior leadership team.

CAMBRIDGE, Mass. – April 7th, 2021 – HiFiBiO Therapeutics has brought on Luigi Manenti, MD, to oversee its clinical organization.

Dr. Manenti joins as Senior Vice President, Global Head of Clinical Development and will report directly to HiFiBiO’s President and CEO, Liang Schweizer. He will grow the clinical team in preparation for two oncology Phase I clinical trials: HFB301001, a differentiated OX-40 agonist, and HFB200301, a novel anti-TNFR-2 agonist, both slated to begin later this year. Additionally, he will work with the leadership team to strengthen company internal pipeline and external partnership and drive clinical strategy.

Dr. Manenti comes on board after serving at Novartis Oncology, where he was the Team Leader for Solid Tumors in Global Pipeline Strategy. He and his team oversaw the early commercial / pipeline strategy for internal and external assets in solid tumors. He also held the role of Global Clinical Program Leader at the Novartis Institutes for BioMedical Research for numerous assets including capmatinib (Tabrecta) and MBG453 (sabatolimab). His earlier roles include multiple positions at Roche in Switzerland and China including Translational Medicine Site head.

Luigi holds an MD from the University of Pavia. He conducted preclinical and clinical research in ovarian cancer at the Mario Negri Institute for Pharmacological Research in Italy.

“Luigi brings decades of experience in early-stage oncology clinical development, identification of innovative therapeutic candidates, and pipeline strategy,” said Schweizer. “He has deep expertise in translational clinical oncology with an extensive track record of designing and leading innovative clinical trials. I am delighted to welcome him to HiFiBiO as we continue to advance our single-cell DIS® platform and pipeline of innovative therapeutics.”

“I was impressed with HiFiBiO’s industry leading single-cell technology and application in clinical development such as indication selection to potentially maximize patients benefit. I am so excited to be joining an organization with such an impressive pipeline, talented team, and dedicated mission to develop therapies to treat cancer patients,” said Luigi.

HFB3010 (OX40)

HFB301001 is a second-generation novel, fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to previous anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L, does not result in reduced levels of OX-40 on T-cells, and leads to superior anti-tumor activity in a human OX-40 knock-in mouse model compared to a benchmark antibody. HiFiBiO is also applying a biomarker strategy by leveraging its DIS® platform to select patients who may benefit the most from treatment.

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 candidate antibody that binds potently and selectively to TNFR2, recognizes cyno TNFR2, and induces CD4 and CD8 T-cell activation and proliferation cooperatively with TNFα without requiring crosslinking. In vivo, HFB200301 demonstrates potent antitumor activity alone and combined with anti-PD-1. It is also well tolerated in mice and NHPs. HiFiBiO is also utilizing its DIS® platform to implement a biomarker strategy for HFB2003.


About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The company’s strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit

HiFiBiO Therapeutics and the HiFiBiO Therapeutics logo, and DIS® are trademarks of HiFiBiO and its affiliates.