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Technical.ly
4 days ago
- Business
- Technical.ly
This startup's mission to extend human life sounds like sci-fi, and investors are betting $20M on it
Startup profile: Tolerance Bio Founded by: Francisco Leon Year founded: 2023 Headquarters: Philadelphia, PA Sector: Life sciences Funding and valuation: $20.2 million raised at an undisclosed valuation, according to the company Key ecosystem partners: Columbus Venture Partners, Ben Franklin Technology Partners When Francisco Leon talks about the medical science behind the biotech company he founded in 2023, it sounds like something out of a movie. The company, Tolerance Bio, focuses on preserving the body's immune system by restoring the function of an organ called the thymus. The organ, long believed to be as useful in adults as the appendix (that is, not at all), may actually be the key to slower aging and prolonged life spans. 'Immune tolerance is at the core of almost all medical needs,' Leon told Now, Tolerance Bio is moving toward the first trials of its proprietary stem cell therapy, focusing first on children born without a thymus. The thymus, a small gland located behind the breastbone in the upper chest, controls immune tolerance by creating T-cells, white blood cells that fight infections and cancerous cells, and can also prevent the body from attacking healthy cells. It's a vital organ, but even in a perfectly healthy person, it only functions at 100% for the first two years of life, and then, Leon said, it starts to shrink. By adulthood, the thymus functions at just 10%, which is why the medical community didn't think it was needed in adults. That changed in 2023, when an article published in the New England Journal of Medicine concluded that the surgical removal of the residue of the thymus in adults led to an increase in the five-year mortality rates due to cancer and autoimmunity. Subsequent research in nursing homes, Leon said, found that the better the thymic function, the lower the incidence of cancer, autoimmunity and infection. 'That's why we started the company,' Leon said, 'we are trying to restore thymic function.' From genetic diseases to anti-aging One of the main focuses of Tolerance Bio's research and development is using its cell implantation therapy to cure DiGeorge syndrome, also known as 22q11.2 deletion syndrome, a genetic condition where a baby is born without a thymus, or with one that is underdeveloped. Children with this condition struggle to fight infections and often have heart problems or other serious medical issues. Restoring the thymus has the potential to save babies who, with cases of complete DiGeorge syndrome, have a life expectancy of two to three years without medical intervention. Since the thymus naturally loses functionality as a person ages, Leon and his team also aim to develop treatments for adults, including a drug for healthy people that could potentially delay aging and increase longevity. 'We can regenerate the thymus by implanting cells intramuscularly; it's a new science,' Leon said. It's yet to be proven in humans, but if they can show the principle in human patients, he said, they can potentially apply it to other conditions, including Type 1 diabetes, cancer, organ diseases, other immune deficiencies, and, potentially, Alzheimer's disease. A $20 million seed round Leon, who leads a hybrid team of 10 from Tolerance Bio headquarters at the B+labs incubator at the Cira Centre in Philadelphia, is an immunologist who came to the US from Spain 25 years ago. After starting out working for pharmaceutical companies, including helping to develop drugs in immunology and oncology, he became an entrepreneur, cofounding the drug development companies Celimmune (acquired by Amgen in 2017) and Provention (acquired by Sanofi in 2023). Provention developed the drug Tzield, which can delay the onset of Type 1 diabetes in at-risk patients. 'It was the first drug ever to delay the onset of an autoimmune disease,' Leon said. 'You give it to children that show signs of being about to become diabetic, but still don't need insulin.' By the time Sanofi acquired Provention, Leon was ready to turn his focus to preventing and regenerating the thymus. He started Tolerance Bio, initially as a concept, bringing two members of the Provention team with him and partnering with University of Florida academic Holger Russ as Tolerance Bio's scientific cofounder. Tolerance Bio closed a $20.2 million seed round in December 2024. Led by Columbus Venture Partners, it included Ben Franklin Technology Partners, Criteria Bio Ventures, Sessa Capital, BioAdvance, Pacific 8 Ventures and individual biotechnology investors with an interest in thymus regeneration. 'We now know that thymic evolution is the main limiter of human life — it is the beginning of aging,' Leon said. 'There is a strong correlation between thymic function and longevity in humans and animals.' 'This almost sounds like science fiction' Even the Tolerance Bio team is amazed at the potential. 'This almost sounds like science fiction, in some respects,' said Phil Ball, Tolerance Bio's SVP and head of business development and operations, who previously worked with Leon at Provention. 'The technology that science needed to get to this point is, even for me, who's worked in the industry for so long, is absolutely amazing.' Translating that technology into actual products that reach as many patients as possible is a priority for the team. 'Ultimately, if we don't have approved products, it's been wasted time,' said Ball, who has spent 25 years in the industry, starting in the UK, where he worked for small biotech companies before moving to the US and eventually settling in Chapel Hill, North Carolina. The team's expert on scaling up clinical manufacturing, Poh Yeh-Chuin, is based in Cambridge, Massachusetts. He previously worked for Beam Therapeutics, where he led a cell process development group that developed products currently being manufactured — one, a stem cell program for sickle cell disease, the other a CAR-T therapy program for cancer treatment. Prior to that, he was part of the startup Semma Therapeutics (since acquired by Vertex), helping to develop a Type 1 diabetes treatment using pancreatic stem cells. 'It's very related to the work that we're doing here at Tolerance,' Poh said. 'Especially the cell therapy part, because both the pancreas as well as the thymus are derived from what we call the endoderm lineage.' Simply put, the endocrine system — including the pancreas, the thymus and the thyroid — comes from the same type of embryonic cells, which can be used in the treatment of endocrine disorders. Justin Vogel, Tolerance's chief financial officer and the other former Provention team member, grew up at the Jersey Shore and still lives in New Jersey. While the team is spread out, Vogel frequently comes to work at the Philadelphia office. While much of what they do at Tolerance Bio is focused on complex biotechnology, Vogel also stressed the importance of getting involved with the people and organizations they are trying to help. Members of the team attended the recent 22q at The Zoo event in Philadelphia, part of a global awareness event held at zoos around the world led by the International 22q11.2 Foundation. 'We're a very patient-focused organization,' Vogel said. 'It's so important to hear all the stories and meet the families, and it really resonates with us and gives meaning to what we try to do for these kids.'
Yahoo
28-01-2025
- Business
- Yahoo
Lutris Pharma Secures $30 Million Financing to Advance the Development of Biopharmaceutical to Improve Anti-Cancer Drug Effectiveness
Topical LUT014 Treats EGFRi (Epidermal Growth Factor Receptor Inhibitor) Induced Acneiform Rash, Potentially Improving The Treatment's Efficacy And Patients' Quality of Life TEL AVIV, Israel, Jan. 28, 2025 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose-limiting toxicity, today announced that it has secured a $30 million financing to advance the development of LUT014, an innovative topically applied gel aimed at reducing EGFRi-induced rashes, a common adverse side effect of these cancer-fighting therapies. The round was led by Columbus Venture Partners and Pontifax Venture Capital, an existing investor, with Peregrine Ventures and aMoon Fund also participating. While EGFRi therapies are highly effective for the treatment of cancer, they have dose-limiting skin toxicities, leading to substantial discontinuation of patients' treatment in less than three months due to intolerable acneiform rashes. LUT014, a novel B-Raf inhibitor, is used for patients who develop dose-limiting rashes, potentially allowing them to continue EGFRi treatment with an improved quality of life. "We are grateful to these investors who recognize the potential of LUT014 to address the significant unmet need caused by the toxicity of EGFRi therapies, which are otherwise effective therapeutic regimens. This financing will enable us to continue the clinical development of LUT014 with the goal of treating the acneiform rash to improve life quality and enabling adherence to EGFRi therapies," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "The development and ultimate commercialization of LUT014 aligns with our mission to improve anti-cancer therapy effectiveness and to meaningfully impact the quality of life for patients." In October 2024, Lutris successfully completed enrollment in the international phase 2 trial of LUT014 in patients with metastatic colorectal cancer (mCRC) treated with EGFRi therapy who develop dose-limiting acneiform rash. The company expects to report top-line results from this trial during the first half of 2025 at a major medical meeting. "Based on the broad use of EGFRi's to treat cancer and the dermal toxicity that often emerges, many of these patients do not receive the optimal treatment against their cancer, either due to dose reduction or outright discontinuation in response to the intolerable dermal toxicity," stated Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma. "Despite extensive research efforts in the past, no standard of care has emerged to deal with this prevalent issue, leading to a significant unmet medical need. By reversing the inhibitory effect of EGFRi therapy on downstream signaling in the skin cells, we believe that LUT014 has the potential to become an important therapeutic for EGFR inhibitor induced skin toxicity and can have a tremendous impact for patients who currently have no other effective treatment options." "Acneiform rash is the most common side effect of EGFRi therapies, with up to 90% of patients experiencing an adverse dermatologic event, taking a toll which can be detrimental to their therapy. It is all too common that patients terminate treatment due to these effects, leading to continued disease progression and prolonged treatment. The need to manage this condition is crucial and Lutris is doing just that with the advent of LUT014," said Dr. Yael Gruenbaum-Cohen, DMD, PhD, Partner at aMoon Fund. "As development of LUT014 proceeds, we can foresee a paradigm shift wherein EGFRi treatment will be regularly coupled with LUT014 as a valuable adjunct. This aligns with aMoon's mission of helping people live longer, healthier lives, and we are proud to support Lutris on their journey towards success." About EGFR Inhibitor-Induced RashEGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway. Drugs called EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have failed prior chemotherapy. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy. Accordingly, LUT014 has the potential to impact not only on quality of life but also on oncologic outcome. About LUT014LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to reactivate the MAPK pathway and reverse the rash induced by the inhibition of this signaling pathway. About Lutris PharmaLutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma's lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently completed a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and has successfully completed a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients. For more information, please visit Contacts: Lutris PharmaNoa Shelach, Ph.D. Chief Executive Officer ir@ Rx Communications GroupMichael Miller+1-917-633-6086mmiller@ View original content to download multimedia: SOURCE Lutris Pharma
