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HiFiBiO Therapeutics
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237 Putnam Ave, Cambridge, MA, 02139 USA
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HFB200301, a first-in-class agonistic anti-TNFR2 monoclonal antibody, in combination with tislelizumab, an investigational anti-PD-1 immune checkpoint inhibitor, for the treatment of advanced solid tumor.


Lead Product(s): HFB200301,Tislelizumab

Therapeutic Area: Oncology Product Name: HFB200301

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 23, 2023

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HFB200603 is a single-digit nanomolar binder to human and cynomolgus BTLA, capable of blocking BTLA interaction with its ligand HVEM, inducing the production of inflammatory cytokines in the tumor microenvironment of different human tumor types.


Lead Product(s): HFB200603,Tislelizumab

Therapeutic Area: Oncology Product Name: HFB200603

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2023

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Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200603 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200603.


Lead Product(s): HFB200603,Tislelizumab

Therapeutic Area: Oncology Product Name: HFB200603

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement November 18, 2022

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Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.


Lead Product(s): HFB200301,Tislelizumab

Therapeutic Area: Oncology Product Name: HFB200301

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 15, 2022

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HiFiBiO Therapeutics will use the proceeds from the financing to advance two lead antibody oncology assets into Phase I clinical trials - HFB200301, a novel anti-TNFR2 antibody and HFB301001, a differentiated second generation anti-OX-40 antibody.


Lead Product(s): HFB200301

Therapeutic Area: Oncology Product Name: HFB200301

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Mirae Asset Financial Group

Deal Size: $75.0 million Upfront Cash: Undisclosed

Deal Type: Series D Financing June 14, 2021

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The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from the Ministry of Health of the Russian Federation.


Lead Product(s): HFB30132A

Therapeutic Area: Infections and Infectious Diseases Product Name: HFB30132A

Highest Development Status: Phase IProduct Type: Large molecule

Recipient: Pharmsynthez

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership November 23, 2020

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Partnership with ABL Bio supports HiFiBiO Therapeutics' rapid clinical advancement of its SARS-CoV-2 neutralizing antibody, HFB30132A, for the treatment of COVID-19 patients.


Lead Product(s): HFB30132A

Therapeutic Area: Infections and Infectious Diseases Product Name: HFB30132A

Highest Development Status: IND EnablingProduct Type: Large molecule

Recipient: ABL Bio

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 14, 2020

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Through this collaboration, HiFiBiO will use its proprietary technology platforms to identify novel AML targets and anti-AML specific antibodies for Kite’s use in cell therapies.


Lead Product(s): Anti-AML specific antibodies

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: DiscoveryProduct Type: Large molecule

Partner/Sponsor/Collaborator: Kite Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration September 03, 2020

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The highly differentiated antibody, HFB30132A, has been rapidly identified, engineered, and evaluated in multiple preclinical studies. A Phase I single-IV administration ascending dose study will assess the safety, tolerability, and pharmacokinetics of HFB30132A.


Lead Product(s): HFB30132A

Therapeutic Area: Infections and Infectious Diseases Product Name: HFB30132A

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

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Company leverages its unprecedented antibody drug discovery and development engine empowered by proprietary single-cell profiling technology to identify, engineer, and evaluate multiple neutralizing antibodies against SARS-CoV-2.


Lead Product(s): Mono & Bi-specific antibodies

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Coronavirus Immunotherapy Consortium

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 17, 2020

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