MedinCell | December 01, 2022
MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation
This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023
It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion
The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide
MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
BUSINESS INSIGHTS, PHARMA TECH
Koneksa | January 18, 2023
On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment.
The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period.
In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology.
Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”
(Source – Business Wire)
Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.
Citius Pharmaceuticals, Inc. | November 22, 2022
Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023.
"This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK,"
Jaime Bartushak, Chief Financial Officer of Citius
About the Technology Business Tax Certificate Transfer Program
The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s.
About the New Jersey Economic Development Authority
The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.