35Pharma

Best-In-Class Ligand Traps for Diseases of High Unmet Medical Need

Press Release

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  • Financing led by Frazier Life Sciences with participation from new investors including Vivo Capital, Janus Henderson Investors, Deep Track Capital, Paradigm BioCapital Advisors and Columbia Threadneedle

Montreal, QC, Canada (Nov 26, 2024)  – 35Pharma, a clinical-stage biopharmaceutical company developing TGF-beta superfamily therapeutics, today announced the closing of an oversubscribed $53 million Series C financing. The company plans to use the proceeds to advance its pipeline of Activin and GDF inhibitors, HS135 for pulmonary hypertension and HS235 for cardiometabolic disease and obesity.

The Series C financing was led by Frazier Life Sciences with participation from additional new investors that included Vivo Capital, Janus Henderson Investors, Deep Track Capital, Paradigm BioCapital Advisors, Columbia Threadneedle, as well as from existing investors VenBio, Surveyor Capital, Logos Capital and Marshall Wace.

“We are delighted to close this Series C financing, which brings multiple new marquee healthcare investors into our cap table,” said Ilia A. Tikhomirov, CEO of 35Pharma. “This financing is intended to support initial clinical proof-of-concept studies for HS135 in pulmonary hypertension, as well as advance HS235 – our candidate for the treatment of HFpEF and obesity – through a Phase 1 proof-of-biology trial in obese and overweight healthy volunteers.”

“Targeting Activin- and GDF-mediated signaling has emerged as an important therapeutic approach across cardiometabolic and pulmonary disease,” said Kevin Li, M.D., Principal at Frazier Life Sciences. “Drawing from its deep expertise in TGF-beta biology and protein engineering, 35Pharma has developed two clinical-stage assets with the potential for best-in-class efficacy and safety. Frazier Life Sciences is pleased to support the team in advancing their pipeline through the clinic, and toward the goal of transforming the standard of care in pulmonary hypertension, obesity, and heart failure.”


About 35Pharma
35Pharma is a clinical-stage biopharmaceutical company focused on developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology, combined with superior protein engineering, to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands, while sparing beneficial homeostatic ligands. For more information, please visit www.35pharma.com

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

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  • Oral presentation will feature HS235, the Company’s Phase 1 Activin and GDF inhibitor for cardiometabolic disease and obesity
  • HS235 improved body composition, and rescued left ventricular function and exercise capacity in a murine obese HFpEF model

Montreal, QC, Canada (Nov 03, 2024)  – 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced that it has been selected for an oral presentation at ObesityWeek® 2024 in San Antonio, TX, USA (Nov 3-6, 2024).

HS235 is an Fc-fused ligand trap that selectively and potently neutralizes pathological Activins and growth differentiation factors (GDFs). The Company has recently been cleared to commence Phase 1 clinical testing of HS235 in overweight and obese healthy subjects, and anticipates sharing initial data from this trial during the second half of 2025. 

During an oral presentation at Obesity Week 2024, 35Pharma Chief Scientific Officer Maureen O’Connor will share pre-clinical data with HS235 demonstrating its dual metabolic and cardiac activity in a murine model of obese Heart Failure with preserved Ejection Fraction (HFpEF). 

In this heart failure model, HS235 treatment positively impacted both cardiac function and metabolic health. Specifically, HS235 administration resulted in: 

  • decrease in fat mass, including pericardial fat
  • increase in muscle mass
  • rescue of left ventricular function
  • reduction of circulating NT-proBNP, a biomarker of heart failure
  • return of exercise capacity to the levels of lean control

Details of the upcoming presentation at ObesityWeek® are as follows:

Title: HS235, a Novel Activin and GDF Ligand Trap, Is Efficacious in a Model of Obesity-Related HFpEF (Oral-030)

Session: Corporate Orals Session 1

Date & Time: November 4th, 2024, 8:30 AM – 8:45 AM

Location: Henry B. González Convention Center, San Antonio, TX, Room 207


About 35Pharma
35Pharma is a clinical-stage biopharmaceutical company focused on the design and development of best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for Pulmonary Hypertension, obesity and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands while sparing beneficial homeostatic ligands.

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

For more information, please visit www.35pharma.com

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  • Phase 1 clinical trial with HS235 in overweight and obese subjects cleared by Health Canada; dosing is expected to begin in 4Q24
  • HS235 is a novel ligand trap that potently and selectively neutralizes pathological Activins and GDFs, validated drivers of cardiometabolic disease
  • Phase 1 study will evaluate HS235 safety, PK and pharmacodynamic responses

Montreal, QC, Canada (Oct 18, 2024)  – 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced it received a No Objection Letter from Health Canada for its Clinical Trial Application to initiate HS235-001, a Phase 1 study of HS235 in overweight and obese healthy subjects.

“HS235 selectively and potently neutralizes pathological Activins and GDFs and demonstrated profound activity in preclinical models of heart failure and obesity.” said Ilia Tikhomirov, 35Pharma’s CEO. “HS235 effects include restoration of heart function and exercise tolerance, accompanied by fat-selective weight loss and increased skeletal muscle mass. We anticipate sharing initial data from the Phase 1 trial in overweight and obese healthy subjects during the second half of 2025.”

HS235-001 is a Phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate single and multiple ascending sub-cutaneous doses of HS235 in overweight and obese healthy subjects. Key readouts of the study include safety, pharmacokinetics and pharmacodynamic effects. Dosing is expected to begin in late 2024.

Pre-clinically, HS235 demonstrated the potential to treat a broad spectrum of cardiometabolic diseases, both as a monotherapy and in combination with glucagon-like peptide-1 receptor agonists (GLP-1 RAs):

  • In an obesity Heart Failure with Preserved Ejection Fraction (HFpEF) model, HS235 demonstrated both improved body composition and rescued left ventricular function. Specifically, HS235 monotherapy led to:
    • Increased skeletal muscle mass
    • Reduced fat mass
    • Rescue of left ventricular pressure
    • Restoration of exercise tolerance
  • In diet induced obesity (DiO) models, the addition of HS235 to GLP-1 RAs led to quantitatively and qualitatively superior responses. Specifically, the HS235 and GLP-1 RA combination demonstrated:
    • Up to 50% more fat loss than GLP-1 RA alone
    • Entirely preserved or increased skeletal muscle mass
    • All of the weight loss in the study occurred as a result of fat mass loss

Taken together, these pre-clinical results support the potential of HS235 both as a monotherapy in obese HF, and in combination with a GLP-1 RA as a fat-selective treatment of obesity, a disease of excess adipose tissue.


About 35Pharma
35Pharma is a clinical-stage biopharmaceutical company focused on the design and development of best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for Pulmonary Hypertension, obesity and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands while sparing beneficial homeostatic ligands.

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

For more information, please visit www.35pharma.com

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Montreal, QC, Canada (June 19, 2024) – 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced it will be participating at the following investor conferences: 

Leerink Partners Private Company Connect

  • Date: June 25 – 26th, 2024
  • Location: Virtual

Piper Sandler 2nd Annual Virtual Obesity Day Fireside Chat 

  • Date: June 26th, 2024
  • Time: 1:30 – 1:55PM EST
  • Location: Virtual

About 35Pharma 
35Pharma is a clinical-stage biopharmaceutical company specializing in TGF-beta superfamily therapeutics for the treatment of Cardiometabolic Disease and Obesity. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta ligands while sparing beneficial homeostatic ligands.

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

For more information, please visit www.35pharma.com

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  • Oral presentation will feature HS135, the Company’s Phase 1 novel Activin and GDF inhibitor 

Montreal, QC, Canada (Mar 25, 2024) – 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced that it has been selected for an oral presentation at the American College of Cardiology 73rd Annual Scientific Session (ACC.24) in Atlanta, GA, USA (April 6 – 8, 2024).

The presentation will feature pre-clinical data on HS135, the Company’s Phase 1 novel Activin and GDF inhibitor, in models of Pulmonary Hypertension and Heart Failure as part of Session 904, “Highlighted Original Research: Pulmonary Vascular Disease and the Year in Review”.

Details of the presentation are as follows:

  • Date: April 7th, 2024
  • Time of presentation: 9:02 AM – 9:12 AM
  • Location: Georgia World Congress Center, Atlanta, GA, Room B314

Abstract: 904-12 – HS135, A Novel Activin and GDF Trap, Is Highly Efficacious in Preclinical Models of Pulmonary Hypertension and Obesity-Associated Heart Failure with Preserved Ejection Fraction

About 35Pharma 
35Pharma is a clinical-stage biopharmaceutical company specializing in TGF-beta superfamily therapeutics for the treatment of Pulmonary Hypertension, Heart Failure and obesity. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta ligands while sparing beneficial homeostatic ligands.

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

For more information, please visit www.35pharma.com

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  • Oral presentation will feature HS135, the Company’s Phase 1 novel Activin and GDF inhibitor 
  • Selected to present during PAH focussed ATS Mini Symposium 

35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced that it has been selected for an oral presentation at the 2024 American Thoracic Society (ATS) International Conference in San Diego, CA, USA (May 17 – 22, 2024).

The presentation will feature data on HS135, the Company’s Phase 1 novel Activin and GDF inhibitor, in models of Pulmonary Hypertension and will form part of the thematic Mini Symposium: Lessons learned from large scale clinical trials in PAH.

Details of the presentation are as follows:

  • Date: May 19th, 2024
  • Time of presentation: 9:39 AM – 9:51 AM
  • Location: San Diego Convention Center

Abstract: 6036 – HS135, A Novel Activin and GDF Trap, Is Highly Efficacious in Models of Group 1 and Group 2 Pulmonary Hypertension (PH)


About 35Pharma 
35Pharma is a clinical-stage biopharmaceutical company specializing in TGF-beta superfamily therapeutics for the treatment of Pulmonary Hypertension, Heart Failure and obesity. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta ligands while sparing beneficial homeostatic ligands.

Contact
Julia Schoelermann, VP Corporate Development, 35Pharma
info@35pharma.com

For more information, please visit www.35pharma.com