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Krystal Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the Lung

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月曜日, 4月 22, 2024

FDA, Cancer, Inhalation, Interleukin, Suma, Food, Cystic fibrosis, Drug, KRYS, NCT, Senior, Research and development, Patient, Lung, Clinical trial, Krystal, Gene, Pharmaceutical industry

PITTSBURGH, April 22, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung, for the treatment of patients with locally advanced or metastatic solid tumors of the lung.

Key Points:

“Cytokine delivery via inhalation is a first-of-its-kind therapeutic approach made possible by the unique attributes of Krystal’s HSV-1-based vector platform.
Together with intratumoral KB707, inhaled KB707 has the potential to significantly expand the clinical utility of cytokine therapy to treat a wide range of otherwise difficult-to-treat and standard of care refractory solid tumors.
“Dosing the first patient in our inhaled KB707 trial is another important milestone for our oncology program and for Krystal,” said Suma Krishnan, President, Research & Development, Krystal Biotech.
In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-PD-1 relapsed/refractory locally advanced or metastatic melanoma.

Jersey Telecom (JT Group) Expands into North America with Advanced Fraud Prevention Platform and Solutions

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月曜日, 4月 29, 2024

As real-time payments redefine the global financial landscape Jersey Telecom (JT Group) is intensifying its American operations to respond to the growing market.

Key Points:

As real-time payments redefine the global financial landscape Jersey Telecom (JT Group) is intensifying its American operations to respond to the growing market.
As an advanced mobile alert system, MoneyGuard is designed to help financial institutions fight fraud through real-time omni-channel communications including SMS, WhatsApp, push alerts, email and voice.
This trend is forecasted to continue, driven by evolving fraud threats and the increasing adoption of real time payments.
MoneyGuard tackles this challenge head-on by integrating sophisticated mobile intelligence and customer engagement capabilities into everyday financial transactions, enhancing fraud detection and prevention in real-time.

Kodiak Establishes Industry Advisory Council, Taps Leaders from Walmart, UPS, and Beyond to Help Guide Development and Deployment of Autonomous Trucks

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水曜日, 3月 27, 2024

Kodiak's Industry Advisory Council brings together a diverse array of forward-thinking industry leaders to help shape the company's product development, deployment, and public engagement as it focuses on the commercialization of autonomous trucks.

Key Points:

Kodiak's Industry Advisory Council brings together a diverse array of forward-thinking industry leaders to help shape the company's product development, deployment, and public engagement as it focuses on the commercialization of autonomous trucks.
Inaugural members of the Kodiak Industry Advisory Council represent prestigious brands and organizations including the Arkansas Trucking Association , Loadsmith , Walmart , Werner Enterprises , and UPS .
Their unique perspectives will help to lead and shape the ways we approach industry and driver engagement, industry transformation, and driving public acceptance of autonomous trucks."
The Kodiak Industry Advisory Council will help to guide and influence Kodiak's product and strategic roadmap, and will help to shape how autonomous trucks will benefit and impact the trucking industry, society, and the world.

Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung

Retrieved on:

火曜日, 2月 13, 2024

NCT, Lung, MD, Research and development, FDA, Food, Cancer, Ochsner, Metastasis, KRYS, Interleukin, Tumor microenvironment, Patient, Gene, Clinical trial, Disease, Suma, Pharmaceutical industry

PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy.

Key Points:

“The therapeutic benefits of cytokine therapy for the treatment of solid tumors have long been recognized, but difficult to harness due to toxicities when given systemically.
In January 2024, the FDA cleared an amendment to the Company’s Investigational New Drug application to evaluate inhaled KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors of the lung.
In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-programmed cell death protein-1 relapsed/refractory locally advanced or metastatic melanoma.
“We look forward to the first patient being dosed with inhaled KB707 later this year.”

Krystal Biotech Announces Publication in the New England Journal of Medicine on the Application of B-VEC to Treat Ocular Complications in Patient with Dystrophic Epidermolysis Bullosa

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木曜日, 2月 8, 2024

PITTSBURGH, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced data on the compassionate use of beremagene geperpavec (B-VEC), administered as an eyedrop to treat a patient with dystrophic epidermolysis bullosa (DEB) with cicatrizing conjunctivitis has been published in the New England Journal of Medicine (NEJM). The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.

Key Points:

The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.
Over 25% of patients with DEB develop ocular complications such as corneal erosions, abrasions, blistering and scarring that can lead to impaired vision.
The NEJM publication describes the first application of B-VEC to treat ocular complications in a patient with DEB under a compassionate use program.
If approved, this approach could drastically benefit these patients.”
A patient presented with severe cicatrizing conjunctivitis secondary to DEB.

Krystal Biotech Receives Orphan Drug Designation from the Japanese MHLW for Beremagene Geperpavec-svdt (B-VEC)

Retrieved on:

火曜日, 12月 19, 2023

Research and development, Suma, Concha bullosa, Research, MHLW, ODD, DEB, KRYS, Patient, Safety, Pharmaceutical industry

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).

Key Points:

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).
“Receiving ODD is an important step in expediting the development of B-VEC in Japan and underscores the unmet needs of patients with DEB,” said Suma Krishnan, President, Research & Development, Krystal Biotech, Inc. “We look forward to working closely with MHLW to bring this important treatment to patients in Japan as soon as possible.”
The orphan drug designation system in Japan aims to support the development of drugs for diseases that affect fewer than 50,000 patients in Japan, for which significant unmet medical need exists.
An investigational therapy is eligible to qualify for ODD if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected.
Specific measures to support the development of orphan drugs include subsidies for research and development expenditures, prioritized consultation regarding clinical development, reduced consultation fees, tax incentives, priority review of applications, reduced application fees, and extended registration validity period.

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Retrieved on:

月曜日, 11月 27, 2023

Research and development, Marketing, Suma, Concha bullosa, EMA, MAA, Orphan, DEB, KRYS, Committee, Patient, CHMP

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.

Key Points:

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.
A CHMP opinion is anticipated in the second half of 2024.
Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.
Previously, VYJUVEK received Orphan Drug Designation and PRIority Medicines (PRIME) eligibility from the EMA.

Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Retrieved on:

火曜日, 9月 5, 2023

KRYS, Research and development, Failure mode and effects analysis, Suma, SERPINA1, AATD, Patient, Liver, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry

KB408 IND filed on August 15, 2023

Key Points:

KB408 IND filed on August 15, 2023
PITTSBURGH, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).
AATD is caused by mutations in the SERPINA1 gene that lead to decreased levels and/or decreased functionality of alpha-1 antitrypsin protein.
Over time, the deficiency can lead to progressive enzymatic destruction of the lung tissue, ultimately causing life-threatening pulmonary impairment and severe respiratory insufficiency.
KB408 is an inhaled (nebulized) formulation of the Company’s novel replication-defective, non-integrating HSV-1-based vector designed to deliver two copies of the SERPINA1 transgene, that encodes for human alpha-1 antitrypsin protein, for the treatment of AATD.

Krystal Biotech Announces Pipeline Expansion into Oncology and FDA Acceptance of IND Application for Lead Oncology Candidate KB707

Retrieved on:

水曜日, 7月 26, 2023

The Company will host an investor conference call and webcast, Thursday, July 27, 2023, at 8:00 am ET, to discuss the KB707 program.

Key Points:

The Company will host an investor conference call and webcast, Thursday, July 27, 2023, at 8:00 am ET, to discuss the KB707 program.
The presentation for the investor conference call is attached to the Company’s Form 8-K .
Two formulations of KB707 are in development, a solution formulation for transcutaneous injection and an inhaled (nebulized) formulation for lung delivery.
“We believe KB707 is a unique and highly differentiated drug candidate with the potential to unlock the capabilities of cytokine-based immunotherapy,” said Suma Krishnan, President of Research & Development at Krystal Biotech.

Technical Support Outsourcing Market to Grow at a CAGR of 7.47% from 2021 to 2026| CSS Corp., Essentiel Outsourcing S.L., Flatworld Solutions Pvt. Ltd., and more to emerge as key players- Technavio

Retrieved on:

金曜日, 7月 21, 2023

Technavio report analyzes the market's competitive landscape and offers information on several market vendors including - Aress Software and Education Technologies P Ltd., Computer Generated Solutions Inc., CSS Corp., Essentiel Outsourcing S.L., Flatworld Solutions Pvt.

Key Points:

Technavio report analyzes the market's competitive landscape and offers information on several market vendors including - Aress Software and Education Technologies P Ltd., Computer Generated Solutions Inc., CSS Corp., Essentiel Outsourcing S.L., Flatworld Solutions Pvt.
Major Trends- The emergence of chatbots is one of the key technical support outsourcing market trends.
Significant Challenges- Outsourcing leading to compromise on the quality of technical support is one of the significant challenges restricting the technical support outsourcing market growth.
The shift from CAPEX to OPEX is a key factor driving market growth during the forecast period.