Prolific Machines Selected to Join FDA's Emerging Technology Program, Advancing the Company's Novel Biomanufacturing Platform
EMERYVILLE, Calif.--(BUSINESS WIRE)--Prolific Machines, a biotechnology company revolutionizing biologics manufacturing, announced today that it has been accepted into the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Emerging Technology Program. This highly competitive program supports the development of innovative technologies that have the potential to transform therapeutics manufacturing.
"This is a testament to the potential of our technology to unlock cheaper, faster, and higher quality protein production, particularly for difficult-to-produce therapeutics."
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Prolific Machines' selection by the FDA recognizes the novelty and promise of its Photomolecular Platform as a way to enhance biopharmaceutical manufacturing for many new and existing types of biologics. Prolific believes that 10-30% of promising novel, often more complex, targets are abandoned in early discovery due to their complexity. Complex therapeutics are expected to make up a significant share of the drug development pipeline in the near-future — up to 40% by 2030. Prolific believes its technology offers a potent solution for these types of manufacturing challenges.
"We are honored to be accepted into the FDA's Emerging Technology Program," said Deniz Kent, PhD, CEO & Co-Founder, Prolific Machines. "This is a testament to the potential of our technology to unlock cheaper, faster, and higher quality protein production, particularly for difficult-to-produce therapeutics. We look forward to working closely with the FDA to advance our platform and make more therapies accessible to patients sooner and cheaper."
The company's platform offers a novel approach to cellular control, utilizing light-control to revolutionize protein production. Its technology offers precise, efficient, and scalable solutions for biopharmaceutical manufacturing to solve biopharma's most complex protein manufacturing challenges, maximize titer and protein consistency and quality. Prolific recently completed the world's largest demonstration of optogenetics at 200L-scale in a stainless steel bioreactor.
About Prolific Machines
Prolific Machines is redefining biologics manufacturing, offering solutions from benchtop to pre-clinical scale. Founded in 2020, the Bay Area company's pioneering Photomolecular platform brings together advanced optogenetic tools and proprietary closed-loop control capabilities to solve major protein production challenges for early-stage biotechnology and leading pharmaceutical partners. The company is on a mission to create a healthier, more sustainable tomorrow and is supported by leading investors, including Ki Tua Fund, the corporate venture arm of the Fonterra Co-operative Group; Breakthrough Energy Ventures; Mayfield; SOSV; In-Q-Tel; and others. To learn more, visit prolific-machines.com.
And to qualify for a risk-free manufacturability assessment, or to become a research partner, contact partners@prolific-machines.com.
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Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Citius Oncology, Inc. 1-844-459-6744. Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns 92% of Citius Oncology. For more information, please visit Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma or Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our ability to use the latest technology to support our commercialization efforts; our need for substantial additional funds; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully implement and maintain distribution agreements with current or other future distribution partners; potential disruptions or performance issues involving third-party logistics providers; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at including in Citius Oncology's and Citius Pharma's Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allenir@ 908-967-6677 x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ View original content to download multimedia: SOURCE Citius Oncology, Inc. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
