Krystal Biotech Announces Launch of Jeune, a Gene-Based Aesthetics Company, and Initial Phase 1 Safety Data for KB301 in Aesthetic Indications -…
Posted: March 24, 2021 at 12:46 pm
- Initial data from Cohort 1 of the PEARL-1 study shows safety and tolerability of repeat KB301 injections
- Dr. Bhushan Hardas M.D., MBA appointed President, Jeune, Inc.
PITTSBURGH, March 24, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (Krystal) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced the launch of Jeune, Inc., a wholly owned subsidiary of Krystal Biotech, and initial safety data from the ongoing Phase 1 trial of Jeunes lead product candidate, KB301 for treatment of aesthetic skin conditions.
Jeune was formed to advance innovative aesthetic medicines and has an exclusive license to a portfolio of candidates derived from Krystals proprietary technology platform. Jeunes products are designed to directly address biological changes in the skin associated with intrinsic and extrinsic aging. The lead product candidate, KB301, delivers the human COL3A1 gene to increase production of normal type III collagen at the site of administration.
My initial clinical experience with KB301 injections has been highly encouraging, said Dr. Mark Nestor, director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement. Not only were the injections well-tolerated, but we see clear signs of new collagen generation which underscores the potential of this treatment to directly address the declining levels of collagen that lead to wrinkles and other skin changes.
Initial data from Cohort 1 in the PEARL-1 studyThe Phase 1, open-label, dose-ranging study is being conducted in adult subjects aged 18-75 (NCT04540900). The primary outcome measure in this first-in-human study was to assess the safety profile of KB301. Secondary outcome measures include COL3A1 transgene expression. In Cohort 1, three different dose levels of KB301 were evaluated in seven (7) healthy subjects who received two intradermal injections into healthy buttock tissue spaced 30 days apart (day 0, day 30). KB301 injected areas were compared to uninjected or saline injected control tissue within the same subject. Treatment and control sites were biopsied at day 2 or day 32. Initial results are as follows:
More detailed data from Cohort 1 will be presented as an e-Poster talk at the Society for Investigative Dermatology (SID) Annual Meeting, held virtually May 3-8.
The presentation will be available on-demand for those registered for the SID conference from May 3, 2021 May 31, 2021. The poster will also be available on the companys website at http://www.jeuneinc.com
The company plans to begin enrollment in the efficacy cohorts of the Phase 1 study in the second half of 2021.
Jeune, Inc. LeadershipJeune has assembled a veteran team of leaders and advisors, comprised of pharmaceutical and biotechnology executives who together have decades of experience developing products in the aesthetic medicine space. Dr. Bhushan Hardas M.D., MBA will join the company on March 29th, 2021 as President of Jeune. Before joining Jeune, Dr. Hardas served as Chief Scientific Officer, Executive Vice President, Global Head of Licensing at Almirall and previously served as Chief Medical Officer of Allergan's Dermatology and Medical Aesthetics business.
I am thrilled to be joining Jeune at such an exciting time. With the ability to deliver genes directly to skin cells, this platform has tremendous potential to address underlying biological changes in aging or photo-damaged skin, noted Dr. Hardas. We are starting with KB301 and type III collagen which I look forward to advancing through the clinic, and the team is already working on pipeline programs that will address additional proteins of interest.
Prior to joining Allergan, Dr. Hardas served as Senior Vice President, Global Head of Dermatology and Aesthetics R&D and Chief Scientific Officer of the North American Business at Merz Pharmaceuticals. Dr. Hardas received advanced training in clinical immunology and molecular biology at King's College at the University of London, in London, England. He also completed a research fellowship in the Department of Dermatology at the University of Michigan, and received his Master of Business Administration degree in healthcare management from the University of California - Irvine.
We are thrilled to welcome Bhushan to Jeune, said Krish S. Krishnan, chairman and chief executive officer of Krystal Biotech. His expertise and development experience in aesthetics is an important asset presently and will help guide next steps for both the pipeline and Jeune overall.
Jeune, Inc. Board Krish Krishnan, Chairman and CEO at Krystal Biotech will serve as the Chairman of the Jeune Board. Joining Mr. Krishnan on the Board are Marc Forth, President and CEO of Aeon BioPharma and Suma Krishnan, Founder and COO of Krystal Biotech.
AboutJeune Inc. Jeune Inc., a subsidiary of Krystal Biotech, is a biotechnology company leveraging a clinically validated gene-delivery platform to fundamentally address and reverse the biology of aging and/or damaged skin. For more information, please visithttp://www.jeuneinc.com
AboutKrystal BiotechKrystal Biotech, Inc.(NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging its novel, redosable gene therapy platform and in-house manufacturing capabilities to develop therapies to treat serious rare diseases. For more information, please visit http://www.krystalbio.com.
Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., or its subsidiary Jeune, Inc., including but not limited to statements about the development of Krystals and Jeunes product candidates, such as plans for the design, conduct and timelines of ongoing clinical trials of KB301 the clinical utility of KB301, the ability of these candidates to fundamentally address and potentially reverse the biology of aging or damaged skin, plans to pursue research and development of other product candidates; and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including KB301 and such other important factors as are set forth under the caption Risk Factors in Krystals annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystals views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystals views as of any date subsequent to the date of this release.
CONTACTS:
Investors:Whitney Ijemwijem@krystalbio.com
Media:Mary CoyleTellMed Strategiesmary.coyle@tmstrat.com
Source: Krystal Biotech, Inc.; Jeune, Inc.
- This Pitt program is leveling up the gene therapy workforce in Pittsburgh - University of Pittsburgh - March 12th, 2024
- Opinion | Banning Gain-of-Function Research Would Do Far More Harm Than Good - Medpage Today - March 12th, 2024
- The Biggest Challenges Facing Broader Adoption of Novel Cell and Gene Therapies - Pharmaceutical Executive - March 12th, 2024
- Research and development areas of focus - Bristol Myers Squibb - March 4th, 2024
- Overcoming the challenges of gene therapy - Drug Discovery News - March 4th, 2024
- Breakthrough Gene Therapy for LHON: Vision Restoration in Focus at Medical Conference - BNN Breaking - March 4th, 2024
- Revolutionizing Healthcare: Global Gene Therapy Market Surges to US$ 3.44 Billion by 2022 As Revealed In Ne... - WhaTech - March 4th, 2024
- Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions - pharmaphorum - March 4th, 2024
- Complement system response to AAV vector gene therapy - EurekAlert - February 23rd, 2024
- 10 gene therapy companies you should know about - Labiotech.eu - February 23rd, 2024
- Fetal surgery expert Tippi MacKenzie shifts to in-utero gene therapy - STAT - February 23rd, 2024
- Rejuvenate Bio Announces Gene Therapy-Mediated Partial Reprogramming Extends Lifespan and Reverses Age ... - Business Wire - February 23rd, 2024
- Combatting HIV using gene therapy - Drug Target Review - February 23rd, 2024
- Expanding the Horizons of Cell and Gene Therapy - RegMedNet - February 23rd, 2024
- Global Advanced Therapy Medicinal Products CDMO Market Analysis Report 2024-2030: : Increasing Investment and ... - Yahoo Finance UK - February 23rd, 2024
- 2023 gene therapy research STAR Grant winners announced - Pacific Biosciences - February 13th, 2024
- Lifetime Cost of DEB Gene Therapy Could Be $15-$22 Million - Medscape - February 13th, 2024
- 5 Things Youll Learn in Frederick Community Colleges New Cell and Gene Therapy Essentials Certificate ... - BioBuzz - February 13th, 2024
- Regenxbios investigational gene therapy shows promise in Hunter syndrome - PMLiVE - February 13th, 2024
- Topical Gene Therapy Effective in Treating Debilitating Eye Condition - InventUM - University of Miami - February 13th, 2024
- Bayer Says First Patient Randomized In Askbio Phase II Gene Therapy Trial - XM - February 13th, 2024
- Top 3 grants in regenerative medicine: January 2024 - RegMedNet - February 13th, 2024
- Realistic Expectations, Limitations With Gene Therapy for Parkinson Disease: Ignacio Mata, PhD - Neurology Live - February 5th, 2024
- Gene-Based Therapy May Slow Development of Life-Threatening Heart Condition - NYU Langone Health - February 5th, 2024
- After Promising Early Efficacy, Eli Lilly Eager to Study Hearing Loss Gene Therapy in More Children - precisionmedicineonline.com - February 5th, 2024
- Gene therapy hailed as medical magic wand for hereditary swelling disorder - The Guardian - February 5th, 2024
- France Approves Gene Therapy Clinical Trial to Treat Hearing Loss in Children - The Hearing Review - February 5th, 2024
- Early Trial Success for Inherited Deafness Gene-Therapy - RegMedNet - February 5th, 2024
- Can gene therapy be the key to restoring hearing loss? - Labiotech.eu - February 5th, 2024
- Jaguar Gene Therapy Announces FDA Clearance of IND to Study JAG201 in a Genetic Form of Autism Spectrum ... - Business Wire - February 5th, 2024
- FDA inspection clears Abeona's gene therapy BLA By Investing.com - Investing.com - February 5th, 2024
- Hearing Restored in Deaf Children in Gene Therapy Clinical Trial - Securities.io - February 5th, 2024
- Experimental gene therapy allows kids with inherited deafness to hear - The Associated Press - January 28th, 2024
- Children with genetic deafness have hearing restored with gene therapy: Study - ABC News - January 28th, 2024
- Positive Phase 1/2 Clinical Trial Data for an Investigational Gene Therapy for Genetic Hearing Loss to be Presented at ... - Investors | Eli Lilly and... - January 28th, 2024
- UChicago Medicine among the first in the country to offer newly approved sickle cell gene therapies - UChicago Medicine - January 28th, 2024
- Gene Therapy Allows an 11-Year-Old Boy to Hear for the First Time - The New York Times - January 28th, 2024
- Gene therapy restores hearing in children with hereditary deafness - EurekAlert - January 28th, 2024
- Experimental gene therapy helps treat kids with inherited hearing loss - CBS News - January 28th, 2024
- Children's Hospital of Philadelphia Performs First in U.S. Gene Therapy Procedure to Treat Genetic Hearing Loss - PR Newswire - January 28th, 2024
- Gene Therapy Brings Hearing to Kids With Congenital Deafness - U.S. News & World Report - January 28th, 2024
- Gene Therapy Restores Hearing in Small Trial for Kids With Hereditary Deafness - Technology Networks - January 28th, 2024
- Cell Therapies on Ice: Seven Trends in Cryopreservation To Enable Cell and Gene Therapy Research - Technology Networks - January 28th, 2024
- Gene Therapy Brings Hearing to Kids With Congenital Deafness - HealthDay - January 28th, 2024
- Gene therapies restore hearing in several kids with inherited deafness - Livescience.com - January 28th, 2024
- 11-Year-Old Boy Hears For First Time Ever Thanks To Gene Therapy Breakthrough - IFLScience - January 28th, 2024
- Innovative Gene Therapy Restores Hearing In Deaf Child, Offering Potential Cure - Study Finds - January 28th, 2024
- Sound of Success, Gene Therapy Breakthrough Grants Hearing to Deaf Children in China-Harvard Study - Hoodline - January 28th, 2024
- Perspectives in FTD Research Webinar: Gene Therapy for FTD -- What Do I Need to Know? | AFTD - AFTD - January 20th, 2024
- UK leads the way in cell and gene therapy - Research Professional News - January 20th, 2024
- Charles River's (CRL) New Launch to Boost Gene Therapy Programs - Yahoo Finance - January 20th, 2024
- UK maintains status as an attractive destination for advanced therapy clinical trials - BioPharma-Reporter.com - January 20th, 2024
- Understanding the impact of AI on the advancement of gene therapy development - pharmaphorum - January 20th, 2024
- Gene therapy TSHA-102 delivered to 1st child in REVEAL trial - Rett Syndrome News - January 20th, 2024
- AAV Vectors in Gene Therapy Market is Predicted to Observe Skyrocketed Growth During the Study Period (2019-2032 ... - PR Newswire - January 20th, 2024
- Family pins hopes on gene therapy - The Recorder and Times - January 20th, 2024
- Arbor, 4DMT partner on new gene therapies in ALS, other diseases - ALS News Today - January 11th, 2024
- The year of gene therapy? FDA's Marks calls for solutions to regulatory, manufacturing challenges - BioWorld Online - January 11th, 2024
- Gene Therapy Approvals Expected to Ramp Up in 2024 Amid Manufacturing, Cost Challenges - BioSpace - January 11th, 2024
- Turning On Gene Therapy with the pA Regulator - RegMedNet - January 11th, 2024
- Revolutionizing Healthcare: Gene Therapy Market Projected to Reach USD 46.5 billion by 2030 at a 22. - PharmiWeb.com - January 11th, 2024
- Regeneron CEO Reveals the Game-Changing Potential of Gene Therapy in Biotech! - BioTecNika - January 11th, 2024
- Bayer's AskBio checks off another early win for gene therapy platform with Parkinson's safety data - FierceBiotech - January 11th, 2024
- Are Rare Brain Diseases the Next Commercial Frontier for Gene Therapy? - MedCity News - January 3rd, 2024
- Novartis, Voyager Ink Up-to-$1.3B Expansion of Neuro Gene Therapy Collaboration - Genetic Engineering & Biotechnology News - January 3rd, 2024
- Novel switch turns genes on/off on cue, a promising step toward safer gene therapy - Phys.org - January 3rd, 2024
- Which Therapeutic Areas Experts Think Will Gain Traction In 2024 - Clinical Leader - January 3rd, 2024
- Voyager Therapeutics and Novartis Announce Major Licensing Deal in Gene Therapy Field - Medriva - January 3rd, 2024
- We Are About to Enter the Golden Age of Gene Therapy - Inverse - January 3rd, 2024
- Revolutionizing Gene Therapy: Baylor Researchers Develop RNA-Based Switch for Therapeutic Protein Control - BNN Breaking - January 3rd, 2024
- Casgevy and Lyfgenia: Two Gene Therapies Approved for Sickle Cell Disease - Yale Medicine - December 25th, 2023
- Top story: Family connects with researchers behind Canavan gene therapy - UMass Medical School - December 25th, 2023
- Excision Bio Seeks to Suppress HIV Replication With CRISPR Gene Therapy - AJMC.com Managed Markets Network - December 25th, 2023
- Hemgenix Gene Therapy Shows Long-Term Efficacy, Safety in Hemophilia B Patients - Managed Healthcare Executive - December 25th, 2023
- The missing piece of the puzzle - EUobserver - December 25th, 2023
- Brace yourselves for these trends in clinical research in 2024 - Labiotech.eu - December 25th, 2023
- RegMedNet's 2023 remix: top content of the year - RegMedNet - December 25th, 2023
- BU Researchers Helped Develop the First FDA-Approved Gene Therapies to Treat Sickle Cell Disease - Boston University - December 16th, 2023
- Research discovers that mice possess a natural gene therapy system - Phys.org - December 16th, 2023
- Cell- and gene-therapy hub bound for Lake Success; New York to invest up to $150 million - Newsday - December 16th, 2023