Micreos Pharmaceuticals Partners With Biologics CDMO Northway Biotech for Its Engineered Endolysin Therapeutic Manufacturing Program
Micreos is focused on developing best-in-class targeted therapeutics to precisely target harmful pathogens that cause disease flares to help address significant unmet medical needs in dermatology and oncology.
As part of the partnership, Northway Biotech will apply its significant expertise in biologics manufacturing to develop a scalable GMP production process for Micreos' engineered endolysin technology. The collaboration will also include developing and validating robust analytical methods, cell bank manufacturing, technology scale-up for cGMP Drug Substance generation, and IND/IMPD supporting documentation preparation, to ensure that the production of Micreos' engineered endolysins complies with stringent regulatory standards for clinical trials.
Matt Regan, CEO of Micreos, stated: "This partnership with Northway Biotech marks a significant milestone for Micreos as we advance our engineered endolysins into scalable therapeutics for clinical trials. By developing targeted medicines that address the underlying pathophysiology associated with disease aggravation in conditions such as atopic dermatitis and cutaneous T-Cell lymphoma, and by leveraging Northway's significant manufacturing expertise, we are poised to make a meaningful impact on patient care in areas of great unmet medical need."
Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, highlighted the mutual commitment to high-quality manufacturing: "We are honored to contribute to Micreos' innovative engineered endolysin therapies. With a dedicated and highly experienced team in recombinant protein process development and scale-up, we aim to accelerate Micreos' development by providing cGMP drug substance material available by the end of summer 2024."
André Markmann, PhD, VP of Business Development at Northway Biotech, added: "Micreos' engineered endolysins address critical healthcare challenges. We are excited to support Micreos in advancing their breakthrough therapy into clinical trials at a rapid pace while ensuring the highest standards."
About MEndoB
Micreos' MEndoB is the first-in-class and potentially best-in-class dual-active domain, targeted medicine designed for optimum activity on human skin. It works through targeted enzymatic degradation of the targets cell wall, rapidly killing the harmful pathogen, but without triggering drug resistance or having any off target affects. Micreos' engineering expertise has enhanced drug stability and activity but has also been validated to effectively penetrate biofilms, eliminate dormant & hard to kill pathogenic cells, and potentially deliver synergies with other medications. With demonstrated preclinical efficacy, MEndoB holds significant promise for treating chronic and difficult-to-treat conditions in dermatology and oncology.
About Micreos
Micreos is a preclinical-stage biopharmaceutical company developing highly innovative, targeted therapies as a new way to treat chronic conditions in dermatology and oncology where there is a high unmet medical need. With its advanced engineering platform, Micreos is developing targeted medicines that selectively eliminate harmful pathogens while preserving the beneficial microbiome, paving the way for future indications in dermatology, oncology, and beyond.
For more information, visit www.micreos.com.
About Northway Biotech
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA.
For more information, please visit www.northwaybiotech.com.
Micreos Contact:
Matt ReganCEO and Board member, Micreos Pharmaceutical AGm.regan@micreos.com
Northway Biotech Contact:
Vladas Algirdas BumelisCEO and Chairman of the Boardvladas.bumelis@northwaybiotech.com
Contact Information
Vladas Bumelis CEO and Chairman of the Boardvladas.bumelis@northwaybiotech.com
SOURCE: Northway Biotech
View the original press release on ACCESS Newswire
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
3 hours ago
- Business Wire
FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of PepGen
NEW YORK--(BUSINESS WIRE)--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against PepGen Inc. ('PepGen' or the 'Company') (NASDAQ: PEPG) and reminds investors of the August 11, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (i) PGN-EDO51 was less effective and safe than Defendants had led investors to believe; (ii) the CONNECT2 study was dangerous or otherwise deficient for purposes of U.S. Food and Drug Administration ('FDA') approval; (iii) as a result of all the foregoing, PepGen was likely to halt the CONNECT2 study, and PGN-EDO51's clinical, regulatory, and commercial prospects were overstated; and (iv) as a result, Defendants' public statements were materially false and misleading at all relevant times. On July 30, 2024, PepGen issued a press release announcing purported 'positive clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51' in its ongoing CONNECT1 study. Among other results, the Company reported that 'PGN-EDO51 achieved a mean absolute dystrophin level of 0.61% of normal and a 0.26% change from baseline after 4 doses, measured at week 13 by Western blot analysis.' However, as subsequently noted by a Stifel analyst, 'the magnitude of dystrophin increase was below what [PepGen] anticipated, which is disappointing[.]' Likewise, a Leerink Partners analyst noted that the low dose missed PepGen's expectations of 1% or greater dystrophin expression. On this news, PepGen's stock price fell $5.55 per share, or 32.69%, to close at $11.43 per share on July 31, 2024. On December 16, 2024, PepGen issued a press release announcing that it had received a clinical hold notice from the FDA regarding an Investigational New Drug ('IND') application 'to initiate the [CONNECT2] clinical trial in patients with [DMD]' in the U.S. Notably, the FDA's issuance of a clinical hold notice for the IND application indicated that the FDA had concerns regarding risks posed to patients in the CONNECT2 study and/or there were other deficiencies associated with the study. On this news, PepGen's stock price fell $0.17 per share, or 3.63%, to close at $4.51 per share on December 16, 2024. On January 29, 2025, PepGen issued a press release providing updates regarding safety concerns observed in the CONNECT1 study and the FDA's concerns regarding the CONNECT2 study. With respect to the CONNECT1 study, the press release stated, inter alia, that '[d]osing of one of the[] . . . participants [in the 10 mg/kg cohort] was paused due to a reduction of his estimated glomerular filtration rate[.]' In addition, PepGen 'ha[d] received communication from Health Canada . . . request[ing] additional information from the Company to address Health Canada's safety concerns before any further dose escalation or enrollment of any additional participants at the current dose levels.' With respect to the CONNECT2 study, the same press release stated, in relevant part, that '[t]he Company is working with the FDA to address its questions regarding supportive data for the dosing levels planned for the patient population.' Following these disclosures, PepGen's stock price fell $0.40 per share, or 21.74%, to close at $1.44 per share on January 30, 2025. On March 4, 2025, PepGen issued a press release 'announc[ing] its voluntary decision to temporarily pause the [CONNECT2] study . . . until the Company can review results from the 10 mg/kg cohort in the ongoing [CONNECT1] study.' On this news, PepGen's stock price fell $0.53 per share, or 18.86%, to close at $2.28 per share on March 4, 2025. Then, on May 28, 2025, PepGen issued a press release announcing that 'PGN-EDO51 did not achieve target dystrophin levels' in the CONNECT1 study and had chosen to discontinue development of its DMD programs. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding PepGen's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the PepGen class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.
Business Wire
5 days ago
- Business Wire
Lantern Pharma's Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial
DALLAS--(BUSINESS WIRE)-- Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression. "GBM remains one of the most difficult cancers to treat, with virtually no meaningful therapeutic advances in nearly 17 years. We believe our unique combination approach has the potential to offer new hope for patients and their families." Dr. Chamberlain Share The planned Phase Ib/2a clinical trial (IND 178511) is designed to investigate the safety, tolerability, and preliminary efficacy of STAR-001 in combination with spironolactone in patients with recurrent GBM, one of the deadliest and most aggressive forms of brain cancer. GBM represents approximately 15% of all brain tumors and has a median survival of approximately 12 months from initial diagnosis, with fewer than 5% of patients surviving beyond five years. "This FDA clearance represents a significant milestone for Starlight Therapeutics and our mission to bring innovative treatment options to patients facing the most challenging forms of brain and CNS cancers," said Dr. Marc Chamberlain, Chief Medical Officer of Starlight Therapeutics. "GBM remains one of the most difficult cancers to treat, with virtually no meaningful therapeutic advances in nearly 17 years. We believe our unique combination approach has the potential to offer new hope for patients and their families while advancing a novel mechanism to challenge these recurrent brain cancers." Targeting GBM Through Innovative Synthetic Lethality STAR-001 (also referred to as LP-184 when focused on other solid tumor indications) is a synthetically lethal, brain-penetrant, novel DNA-damaging agent that has demonstrated promising preclinical activity against various solid tumors, including pediatric and adult brain cancers. Lantern Pharma has previously been awarded both FDA Orphan Drug Designation and FDA Fast Track Designation for STAR-001 in GBM, underscoring the significant unmet medical need and the drug's potential to address it. An existing Phase 1a trial to determine safety, dosing, the maximum tolerated dose (MTD) and tolerability across a range of solid tumors, including GBM, is currently underway and expected to complete enrollment in the current quarter. This trial is expected to help establish a baseline dosing level and expectations of drug-concentration in tumor and plasma for future clinical trials, including those being planned by Starlight Therapeutics. The combination of STAR-001 with spironolactone, an existing FDA approved drug, represents a scientifically rational approach to treating GBM. STAR-001 is a blood-brain barrier permeable small molecule that leverages synthetic lethality to exploit DNA damage repair (DDR) deficiencies, particularly those overexpressing PTGR1. Approximately 60% of GBM cells overexpress PTGR1 levels sufficient to activate STAR-001. Spironolactone significantly enhances this therapeutic effect by inducing degradation of ERCC3, a critical protein involved in nucleotide excision repair (NER). This mechanism leads to NER deficiency (NERD), making GBM cells significantly more sensitive to STAR-001 and less capable of repairing the DNA damage caused by the administration of STAR-001. This synergistic approach is particularly promising in GBM which has often become resistant to therapies in the recurrent setting. AI-Driven Drug Development Platform Starlight Therapeutics was formed to pursue the focused clinical development of central nervous system (CNS) oncology indications developed and advanced through Lantern Pharma's proprietary artificial intelligence drug development platform, RADR®. This AI-driven approach enables the identification of optimal drug-cancer combinations and patient populations most likely to benefit from treatment, significantly reducing the time and cost typically associated with traditional drug development. "The clearance of this IND demonstrates the power of our efficient, data-driven drug development model in identifying promising therapeutic opportunities in areas of high unmet medical need," said Panna Sharma, President and CEO of Lantern Pharma. "Through Starlight Therapeutics, we are positioned to dedicate focused resources and expertise to advancing treatments for some of the most challenging cancers affecting the brain and central nervous system in both adults and children, while developing meaningful therapies that can reach patients in an accelerated timeline compared to traditional drug development processes." Market Opportunity and Next Steps With GBM representing an annual market opportunity of $3 to $5 billion globally and case numbers accelerating worldwide, there is an urgent need for innovative treatment approaches. The current standard of care has remained largely unchanged for over 15 years, highlighting the critical importance of novel therapeutic strategies like the STAR-001 combination. Starlight is targeting commencement of the Phase Ib/2a trial in late 2025 or early 2026, subject to additional funding, and plans to provide regular updates on trial preparation, patient enrollment progress, and preliminary data as they become available. About Glioblastoma Multiforme (GBM) Glioblastoma multiforme is the most common and aggressive form of primary brain tumor in adults, accounting for approximately 15% of all brain tumors. Despite aggressive multimodal treatment including surgery, radiation, and chemotherapy, the prognosis remains extremely poor, with a median survival of only 12 months and a five-year survival rate of less than 5%. The blood-brain barrier presents a significant challenge in treating GBM, as most therapeutic agents cannot effectively penetrate brain tissue. About Starlight Therapeutics Starlight Therapeutics is a wholly owned subsidiary of Lantern Pharma Corp., specifically focused on the clinical development of innovative treatments for central nervous system oncology indications. The company leverages Lantern Pharma's proprietary AI drug development platform to identify and advance promising therapeutic combinations for adult and pediatric patients with brain and CNS cancers. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, time, and failure rate of oncology drug discovery and development. Lantern's proprietary AI platform RADR® uses machine learning and multiomic data to solve complex, billion-dollar drug development challenges. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, Lantern has built a pipeline of promising, clinical stage drug candidates, including molecules that target novel cancer mechanisms and targets. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; estimates and plans regarding our subsidiary Starlight Therapeutics Inc. and the product candidate STAR-001; our strategic plans to advance the development of our drug candidates, including STAR-001, and our antibody drug conjugate (ADC) development program; estimates regarding the development timing for STAR-001; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
Business Upturn
6 days ago
- Business Upturn
Purespring Therapeutics receives UK CTA approval for Phase I/II clinical trial of PS-002 in patients with primary IgA nephropathy (IgAN)
First patient in Phase I/II clinical trial expected to be enrolled in Q4 2025 UK Clinical Trial Application (CTA) approval shortly follows U.S. IND clearance and granting of European Medicine Agency (EMA) orphan drug designation, enabling readiness for initiation across sites in both the U.S. and Europe PS-002, Purespring's lead precision nephrology programme, targets the complement pathway known to be a driver of IgA nephropathy and is supported by a wealth of preclinical data London – 5 August 2025 – Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today announces that its UK Clinical Trial Application (CTA) for a planned Phase I/II study of PS-002, Purespring's lead programme, in patients with IgA nephropathy (IgAN) has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the NHS Health Research Authority (HRA) and Research Ethics Committee (REC). Advertisement 'The CTA approval for our Phase I/II clinical trial of PS-002 represents another key milestone as we complete our transition to a clinical-stage precision nephrology company,' said Haseeb Ahmad, Purespring's Chief Executive Officer. 'Building on the recent FDA IND clearance and EMA orphan drug designation, this further validates the potential of our podocyte-targeting approach to go beyond symptom management and directly target kidney disease at its source. Looking ahead, we are committed to working closely with regulators and sites across the U.S. and Europe with the view to expand the therapeutic options available for people living with IgAN.' PS-002 was developed to target the underlying cause of many kidney diseases by modulating complement activation in the kidney via precision targeting of podocytes. The programme is initially focused on the treatment of IgA nephropathy (IgAN), a rare and chronic autoimmune kidney disease that primarily affects young adults. In IgAN, aberrant immunoglobin A (IgA) protein becomes trapped in the kidney's filters, known as the glomeruli, causing complement activation, inflammation, damage and scarring. A significant proportion of affected patients will go on to develop kidney failure despite currently available therapies. The Phase I/II clinical trial, which is expected to enroll its first patient in Q4 2025, will evaluate local administration of PS-002 to treat IgAN. In the Phase 1 part of the Phase I/II study, the main read-outs will be safety parameters, which, together with efficacy biomarkers, will be leveraged to select a dose for the Phase 2 part of the study. This second phase will be used to further define the safety profile and provide early markers of efficacy. Enabled by this latest regulatory approval and the recent U.S. IND clearance, as announced in July 2025, the Phase I/II study will recruit patients across the U.S. and Europe. For further information, contact: Purespring: Peter Mulcahy [email protected] +44 (0)20 3855 6324 LinkedIn ICR Healthcare Amber Fennell, Sarah Elton-Farr [email protected] Notes to Editors About Purespring Purespring is developing therapies to halt or prevent kidney disease, one of humankind's most poorly treated disease areas. Founded on the work of Professor Moin Saleem, Professor of Paediatric Renal Medicine at the University of Bristol, Purespring is the first company to successfully treat kidney disease by targeting the podocyte, a specialised cell that is implicated in the majority of renal disease. Purespring's platform approach enables streamlined gene therapy development for both acquired and genetic renal diseases, offering the potential to halt, reverse and even cure both rare and common kidney diseases. The Company currently has a pipeline of programmes in development including the lead asset for treatment of IgA Nephropathy (IgAN) and other complement mediated kidney disease. The Company also has programmes for disease caused by mutations in the gene NPHS2, as well as other monogenic glomerular kidney diseases. Based in London, the Purespring team combines world-leading expertise in podocyte biology and kidney disease with a wealth of experience in gene therapies, anchored in a culture of diversity, creativity and delivery. Purespring is backed by leading biotech investors, including Syncona Limited, Sofinnova Partners, Gilde Healthcare, Forbion, and the British Business Bank and has raised £115m ($149m) to date. For more information please visit: and follow us on LinkedIn. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
