Gaithersburg: Salubris Biotherapeutics Announces $32 Million Financing to Advance Novel Complex Biologics for Cardiovascular, Oncology, and Neurodegenerative Diseases

Reports Promising Early Data from Lead Clinical Program, JK07, for the Treatment of Heart Failure with Reduced Ejection Fraction 

Initiates Enrollment in Second Cohort of JK07 Phase 1 Dose Escalation Study

SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases. SalubrisBio was founded in August 2016 as a wholly-owned subsidiary of the China-based pharmaceutical company Shenzhen Salubris Pharmaceuticals Co. Ltd. Headquartered in Gaithersburg, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment to innovation and expansion into the global market and retains the core philosophy of developing therapeutics for large patient populations with significant unmet needs.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment, which was completed in the fourth quarter of 2021, will be used to advance the current pipeline, including continuation of an ongoing Phase 1b clinical trial and initiation of two additional Phase 1b clinical trials in 2022, and to further expand the pipeline through R&D.

“SalubrisBio is poised for a transformational year and I’m excited about the remarkable opportunities that lie ahead for us,” said Sam Murphy, Chief Executive Officer of SalubrisBio. “We are focused on advancing our programs and securing additional funding to progress the development of our portfolio of antibody fusion proteins and other complex biologics.”

Since its inception, SalubrisBio has built a drug discovery and development platform to address significant unmet medical needs in cardiovascular diseases, cancer and neurodegenerative diseases. The company has multiple assets in clinical/preclinical development and additional programs at the discovery stage. SalubrisBio’s lead asset, JK07, is an antibody-based NRG-1 fusion protein currently in Phase 1 trials to assess safety and tolerability and to explore activity in subjects with heart failure with reduced ejection fraction [HFrEF]. JK07 is the first bi-specific antibody globally to enter a clinical trial in a cardiovascular indication.

Results from Cohort 1 (n=5) of the ongoing randomized, double-blind, placebo-controlled, dose-escalation study demonstrate a favorable safety profile and promising signals of clinical benefit with JK07 over placebo, with observed maximum improvement in ejection fraction of up to 18% absolute over baseline (>50% relative improvement). Enrollment of Cohort 2 is ongoing and SalubrisBio plans to report additional data from this HFrEF trial at future medical meetings. In addition, the FDA has agreed on the initiation of a Phase 1 study of JK07 in heart failure with preserved ejection fraction [HFpEF], preparations for which are now underway.

“Heart failure patients experience a high burden of symptoms, and mortality remains high despite approved therapies,” said Dr. Wilson Tang, lead investigator and Research Director for the Section of Heart Failure and Cardiac Transplant Medicine at Cleveland Clinic. “The Cohort 1 data are positive and support the biological rationale for JK07. We are ​encouraged by JK07’s potential to address unmet needs in heart failure with reduced ejection fraction and look forward to better understanding its full potential in heart failure with preserved ejection fraction as well.”

JK07 HFrEF Phase 1 Study Design

The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study with five dose levels planned to assess the safety, tolerability, immunogenicity, pharmacokinetics, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. The size of the cohorts will range from five to nine subjects. Each cohort includes a single active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized single-dose administration of JK07 or placebo [3:1] in the remainder of the cohort.

For more information on the JK07 clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT04210375.

About Heart Failure

Heart failure affects an estimated 6.2 million Americans1 and more than 64 million people worldwide2. HFrEF and HFpEF each affect over 3 million patients in the US alone. Heart failure is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death. In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly. JK07 is in development for the treatment of both HFrEF and HFpEF.

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor which has shown promising activity in HFrEF but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

 

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Now in its 17th year, the Kensington Day of the Book Festival is a family-friendly street festival featuring 150+ renowned authors, poets, and literary organizations. Enjoy live music on five stages, special guest speakers, military veteran writers and comedians, poetry readings, cookbook demos, children's program, and much more.

Admission is free, and attendees will also be able to explore a marketplace of books and food offerings from local vendors.

Not your average book festival! This festival offers something for everyone!

17th Annual Kensington Day of the Book Festival

Sunday, April 21, 2024, 11am-4pm (held rain or shine!)

Howard Avenue, Kensington, MD 20895

www.dayofthebook.com

Instagram: @kensingtonbookfestival

Contact: Elisenda Sola-Sole, Festival Director

[email protected]

301-949-9416 (text preferred)

FEST OF SPRING Caribbean Wine Food & Music Festival

Get ready to experience the vibrant colors, tantalizing flavors, and infectious rhythms of the Caribbean at the FEST OF SPRING Caribbean Wine Food & Music Festival! Hosted by RHU LLC, this exciting festival is set to take place on May 18, 2024, at the picturesque 16700 Barnesville Rd in Boyds, MD.

Step into a world where the Caribbean spirit comes alive! From 12:00 PM onwards, immerse yourself in a sensory journey that celebrates the unique culture, cuisine, and music of the Caribbean. Whether you're an African American, a Reggae or Soca music enthusiast, a wine lover, or part of the vibrant Caribbean diaspora, this festival promises to delight and captivate you in every way.

Let the enticing aromas of mouthwatering Caribbean dishes tantalize your taste buds. Feast on traditional delicacies prepared by expert chefs, showcasing the rich and diverse culinary heritage of the Caribbean. Indulge in flavorful jerk chicken, succulent seafood, and delectable plantain dishes that will transport you straight to the islands.

Accompanying the culinary extravaganza is a carefully curated selection of premium wines, ensuring the perfect pairing for your palate. Sip on fine wines from renowned vineyards, each sip a reflection of the Caribbean's vibrant spirit. Discover new flavors, expand your wine knowledge, and savor unforgettable moments with every glass.

As the sun sets, get ready to groove to the infectious rhythms of Caribbean music. Feel the pulsating beats of reggae, soca, dancehall, and calypso, moving your body to the lively melodies. Live performances by talented musicians and performers will keep the energy high, ensuring a night of unforgettable entertainment.

Don't miss this opportunity to embrace the Caribbean spirit and celebrate the arrival of spring in style! Tickets are available on AllEvents, so secure your spot today. Join us at the FEST OF SPRING Caribbean Wine Food & Music Festival, where cultures collide and unforgettable memories are made.

LIVE PERFORMANCES By: CULTURE Feat. Kenyatta Hill, EXCO LEVI, IMAGE BAND, RAS LIDJ REGG'GO with Special Guest SUGAR BEAR FROM E.U. & MORE! & MORE!

MUSIC By: DJ ABLAZE, DJ SMALLY & NAJ SUPREME

2 NIGHT Camping packages available: RV/CAMPER $200 | TENTS $150 Starting on Friday May 17 @ 5pm | 30 RV SPACES | 30+ TENT SPACES

KIDS 12 & UNDER FREE!!!

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