PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)




PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)

Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment

LYT-200 is currently being evaluated in two Phase 1/2 trials for the potential treatment of AML/MDS and head and neck cancers

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (“AML”). Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need.

“Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients,” said Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology work. “This milestone builds on the FDA’s recognition of LYT-200’s promise, including Orphan Drug designation for AML and a second Fast Track designation for head and neck cancers, both of which were granted last year. By targeting galectin-9, a key driver of cancer proliferation and immune suppression, LYT-200 represents a novel and promising approach for patients in need, and we look forward to the continued development of this program.”

LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly via apoptosis and DNA damage as well as reactivating central anti-cancer effectors of the immune system. LYT-200 is the most advanced clinical program against galectin-9 and is being evaluated in two ongoing clinical trials, including:

1. Phase 1/2 clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). In this trial, LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of clinical activity as single agent and in combination.
2. Phase 1/2 trial in advanced/metastatic solid tumors, including head and neck cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. To date, LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene’s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.

The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”), in combination with anti-PD1 therapy. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational oncogenic and immunosuppressive protein, galectin-9, for the potential treatment of hematological malignancies and locally advanced metastatic solid tumors, including head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data support the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggest a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that, in several cancers, galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in solid tumor models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in in vivo cancer models. LYT-200 is currently being evaluated in two ongoing Phase 1/2 adaptive design trials for the potential treatment of AML/MDS and head and neck cancers.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to development plans for LYT-200, potential benefits to patients, and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com

US Media

Justin Chen

jchen@tenbridgecommunications.com

Nimble Science Launches Groundbreaking GI Health Data Platform, Welcomes Prof. Eran Segal to Scientific Advisory Board




Nimble Science Launches Groundbreaking GI Health Data Platform, Welcomes Prof. Eran Segal to Scientific Advisory Board

CALGARY, Alberta–(BUSINESS WIRE)–#GIhealth–Nimble Science, a precision medicine company empowering biopharma and digestive health companies with access to novel GI health data, announces the launch of its revolutionary data platform. This cutting-edge platform is designed to transform therapeutic and diagnostic development across various healthcare fields, including gastrointestinal, neurological, metabolic, consumer, and animal health.

In tandem with the launch, Nimble Science proudly welcomes Prof. Eran Segal, a globally recognized computational biologist from the Weizmann Institute of Science with deep expertise in personalized medicine, nutrition, and the complex interplay between genetics, the microbiome, and health, to its Scientific Advisory Board (SAB). Prof. Segal will provide strategic guidance as the company pioneers innovative solutions leveraging its growing database of precision intestinal data.

The new SIMBA GI Health Data Platform is powered by Nimble Science’s proprietary SIMBA^TM Capsule, a first-in-class ingestible device that collects and preserves precise, high-quality samples directly from the small intestine. The SIMBA Capsule has been integrated into over 19 global clinical studies, delivering solutions to customers evaluating disease conditions and therapeutic product interaction. The data platform now empowers users with data quality indexing and access to valuable insights derived from a growing repository of matched metagenomic data sets from healthy and disordered small intestinal samples.

“The ability to provide high quality, scalable data insights is a turning point in healthcare innovation for Nimble and our partners, and opens the door to discoveries previously out of reach,” said Sabina Bruehlmann, Co-Founder and CEO of Nimble Science. “The addition of Professor Eran Segal to the SAB, speaks to the quality of the SIMBA Capsule data and its massive potential for health innovation.“

Prof. Eran Segal, who leads a multidisciplinary team at the Weizmann Institute of Science, shared his enthusiasm for joining Nimble’s SAB: “The small intestinal microbiome is a critical frontier in understanding and improving human health. Nimble’s innovative platform offers an unprecedented opportunity to map microorganisms in this vital region at scale, shedding light on disease mechanisms and enabling the development of transformative diagnostics and therapeutics and targeted interventions for a vast range of health conditions.”

Building upon the successful launch, Nimble Science is actively expanding partnerships across the healthcare, life sciences, and consumer product sectors to unlock the full potential of this groundbreaking multi-omic data.

About Nimble Science

Nimble Science is a precision medicine company providing a multi-omic data platform to advance healthcare innovation. Its SIMBA^TM Capsule enables unparalleled access to the microenvironment of the small intestine. Nimble’s mission is to revolutionize health innovation by empowering researchers and clinicians with transformative tools to unlock new possibilities in diagnostics, therapeutics, and beyond.

The company is supported by leading life science investors, including Fusion Fund, Seventure Partners, Joyance Partners and Ki Tua Fund, who recognize the transformative potential of Nimble’s groundbreaking approach to health product innovation and precision medicine.

Contacts

For further information please contact:
Nimble Science
Sabina Bruehlmann, CEO

1.866.493.4633

sabina@nimblesci.com

Cyrus Biotechnology Announces Selection of CYR212 as Clinical Candidate for Chronic IgG-driven Autoimmune Disease Including Myasthenia Gravis and Immune Thrombocytopenia




Cyrus Biotechnology Announces Selection of CYR212 as Clinical Candidate for Chronic IgG-driven Autoimmune Disease Including Myasthenia Gravis and Immune Thrombocytopenia

Therapeutic can address $20 Billion autoimmune market

SEATTLE–(BUSINESS WIRE)–Cyrus Biotechnology, an AI-driven therapeutics company, announced today that its CYR212, an engineered next-generation reduced-immunogenicity and half-life extended Immunoglobulin-G (IgG) protease, has been selected as its clinical development candidate for chronic IgG-driven autoimmune disease. CYR212 was selected based on promising recent preclinical data from evaluations of pharmacokinetics, pharmacodynamics and immunogenicity in animal models. Preclinical studies in rabbits confirmed a significant extension of half-life and pharmacodynamic IgG-reducing activity compared to the wild type (WT) Streptococcus pyogenes IdeS protease, from which CYR212 has been developed.

Studies during the development of CYR212 have shown rapid, titratable, dose-dependent and sustained depletion of IgG, and no immunogenicity response upon either a first or second dose in rabbits. This is in contrast with WT IdeS, which shows a high anti-drug antibody (ADA) response similar to what is observed in patients.

CYR212, engineered for extended half life and reduced T- and B-cell mediated immunogenicity using Cyrus’s AI platform, maintains the favorable properties of the WT enzyme, including high stability, manufacturability, and in vitro and in vivo enzymatic activity. This profile is consistent with a superior therapeutic candidate for the treatment of a broad range of IgG-mediated diseases.

“CYR212 addresses over $20B of potential clinical market opportunities in IgG-driven autoimmune disease, including rheumatological, neurological, dermatological, and hematological immune pathologies,” said Cyrus CEO Lucas Nivon, PhD. “IgG is the principal antibody type responsible for blocking infections, but in IgG-mediated autoimmune disease it attacks host tissues, causing a broad range of often severe disease,” Nivon added. An example is generalized Myasthenia Gravis (gMG) where IgG targets neuromuscular receptor proteins leading to degenerative neurological disease. In Immune Thrombocytopenia (ITP), IgG targets glycoproteins on the surface of platelets leading to platelet depletion, disruption of the clotting cascade and dangerous internal bleeding.

A clinically approved version of WT IdeS is marketed for narrow indications and is being evaluated in several acute IgG-mediated indications, but short half-life and high immunogenicity – both of which CYR212 directly addresses – limit its much broader utility.

The very low anticipated doses required for CYR212 efficacy will likely make administration of the drug far more convenient than it is for anti-FcRn biologics – the current best in class therapeutics for multiple chronic IgG-mediated autoimmune diseases. Anti-FcRn antibody therapeutics reduce IgG levels via binding of the neonatal Fc receptor (FcRn), inhibiting IgG recycling and lowering circulating IgG levels. The ability of CYR212 to deplete circulating IgG in a matter of hours and the potential for prefilled-syringe sub-1ml subcutaneous administration would greatly benefit patients. The FcRn drugs show peak IgG depletion only after several weeks of administration using lengthy (up to 60 minutes) infusions of large volumes – typically over 10mL.

“We have now demonstrated that CYR212 shows no ADAs up to 30 days at a clinically relevant dose in rabbits and confirmed the subcutaneous bioavailability of CYR212 in preclinical PK studies,” said Cyrus CSO Erik Procko, PhD. “Based on modeling of these preclinical PK data and PK of approved related biologics, we anticipate at least a 4 week dosing interval for clinical use of CYR212.”

Cyrus plans to take CYR212 into clinical studies in indications where the anti-FcRn class have so far not proven sufficiently potent for clinical approval (ITP), or where lower IgG levels achievable by CYR212 are likely to lead to better efficacy (gMG).

In gMG, CYR212 is likely to achieve improved dosing convenience and faster speed of action. Clinical data in gMG shows that the anti-FcRn’s such as Efgartigimod and Nipocalimab are potent in symptom reduction, but lower IgG levels correlate with better clinical outcomes and IgG levels <15% of normal have never been tested because these therapeutics have limited potency.

In ITP, no anti-FcRn therapeutic has yet been approved, and hematologists are looking for lower IgG levels to be achieved over longer periods of time than the anti-FcRn class can deliver. Therefore, CYR212 has the potential to be the first approved IgG-lowering agent in ITP.

About Cyrus Biotechnology

Cyrus Biotechnology is a Seattle-based pre-clinical-stage AI-driven therapeutics company with an internal pipeline of novel biologics primarily in autoimmune indications. In addition to IdeS, Cyrus is also advancing multiple discovery stage cytokine programs based on years of experience with partners in cytokine optimization. The company was co-founded with Prof. David Baker, 2024 Nobel Prize winner and inventor of Rosetta and numerous protein design AI tools. Cyrus has worked with dozens of Pharma firms on protein redesign for novel therapeutics, including Genentech and Janssen. In 2021 Cyrus started an internal therapeutics pipeline. The company is funded by lead investor Orbimed, with Agent Capital, Hillhouse, Alexandria, and others.

For more information about Cyrus please visit https://cyrusbio.com/

NOTICE: The information contained in this document is dated as of January 9, 2025. Cyrus Biotechnology, Inc. (the Company) disclaims any obligation to update such information after such date. This document contains forward–looking statements reflecting the Company’s current expectations that necessarily involve risks and uncertainties. Actual results and the timing of events may differ materially from those contained in such forward-looking statements due to a number of factors and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contacts

Lucas Nivon

lucas@cyrusbio.com
206-258-6561

European Commission Approves the Extension of the Indication of Palforzia® to the Treatment of Toddlers With Confirmed Peanut Allergy




European Commission Approves the Extension of the Indication of Palforzia® to the Treatment of Toddlers With Confirmed Peanut Allergy

BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), announces that the European Commission (EC) has approved the extension of indication of Palforzia® (defatted powder of Arachis hypogaea L., semen (peanut)) for the treatment of toddlers (ages 1 through 3) with a confirmed diagnosis of peanut allergy. The marketing authorisation covers all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein and Norway).

This approval of the extension of indication of Palforzia® to toddlers, follows the July 2024 approval by the U.S. Food and Drug Administration (FDA). Palforzia® is the first and only EMA and FDA approved oral immunotherapy for toddlers with a confirmed diagnosis of peanut allergy.

“Peanut allergy is one of the most frequent food allergies. Early intervention is crucial to reduce the risks of accidental exposure and may be very important in improving long-term outcomes. The approval of Palforzia for toddlers represents for the medical community a meaningful advancement in managing allergy at a pivotal stage in a child’s development,” stated Dr Katharina Blümchen, Professor at the University of Medicine of Frankfurt, Clinic for Pediatric and Adolescent Medicine, Department of Pneumology, Allergology, Infectiology, and Gastroenterology.

“The approval of Palforzia® by the European Commission highlights the need for a treatment to help alleviate the burden of peanut allergy for young patients and their family,” said Michele Antonelli, CEO of Stallergenes Greer. “In addition to the risk of severe reactions from accidental exposure, peanut allergy can have significant psychological consequences on disease sufferers and their families while negatively impacting quality of life. We are proud of this milestone which highlights Stallergenes Greer’s commitment to the patients and healthcare professionals we serve.”

Palforzia® is designed to gradually increase the body’s ability to tolerate small amounts of peanut (desensitisation) through carefully controlled and supervised initial dose escalation, up-dosing and maintenance. The extension of the indication enables treatment to be initiated at an earlier age, thus offering young children and their families the opportunity to reduce the risk of severe allergic reactions from accidental exposure to peanut allergens, with adjustment of contraindications.¹

The approval is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.²

Palforzia®’s broader accessibility highlights Stallergenes Greer’s mission to bring innovative therapies to patients across all stages of life. Beyond food allergy treatments, the company offers a diverse portfolio, including sublingual and subcutaneous immunotherapies for respiratory and insect venom allergies.

ABOUT PALFORZIA®

Palforzia® is indicated by the European Medicine Agency (EMA) in all 27 European member states, Iceland, Liechtenstein and Norway, for the treatment of patients aged 1 to 17 years with a confirmed diagnosis of peanut allergy. It is indicated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia® may be continued in patients 18 years of age and older. Palforzia® should be used in conjunction with a peanut-avoidant diet.

Palforzia® is also approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy; Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older. Palforzia® is to be used in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

ABOUT POSEIDON PHASE 3 STUDY

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years of age in North America and Europe.

The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia® to Stallergenes Greer in September 2023.

Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.

In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).

ABOUT STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com.

________________________

¹ Summary of Product Characteristics. Rev 19 dec 2024

² https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

Palforzia®: © 2025, Société des Produits Nestlé S.A. or its affiliates

Contacts

Communications
Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

Azafaros to Present at J.P. Morgan’s 43rd Annual Healthcare Conference




Azafaros to Present at J.P. Morgan’s 43rd Annual Healthcare Conference

LEIDEN, Netherlands–(BUSINESS WIRE)–#Adults–Azafaros, a company focused on developing treatments for the unmet needs of patients with rare lysosomal storage disorders, today announced that it will present at J.P. Morgan’s 43^rd Annual Healthcare Conference on Thursday, January 16, 2025.

The company’s presentation will begin at 8:30 a.m. PT/11:30 am (Eastern Time).

The presentation will focus on the company’s lead product, nizubaglustat, a potential treatment for rare lysosomal storage disorders with neurological involvement including GM1/GM2 gangliosidoses and Niemann Pick type C (NPC).

Positive topline data reported earlier this year from the company’s successful Phase 2 study investigating nizubaglustat in GM2 and NPC patients demonstrated that the compound had a positive safety profile. Preliminary improvements or stabilization of clinical endpoints were observed in the majority of patients, highlighting encouraging early efficacy trends for the compound.

Azafaros is preparing to initiate Phase 3 studies with nizubaglustat in GM1/GM2 gangliosidoses and NPC in Q2, 2025.

About nizubaglustat

Nizubaglustat is a small molecule, orally available and brain penetrant azasugar with a unique dual mode of action, developed as a potential treatment for rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick disease type C (NPC).

Nizubaglustat has received the following designations and support:

United States Food and Drug Administration (FDA)

Rare Pediatric Disease Designations (RPDD) for the treatment of GM1 and GM2 gangliosidoses and NPC.

Orphan Drug Designations (ODD) for GM1 and GM2 gangliosidosis (Sandhoff and Tay-Sachs Diseases) and NPC.

Fast Track Designation and IND clearance for GM1/GM2 gangliosidoses and NPC

European Medicines Agency (EMA)

Orphan Medicinal Product Designation (OMPD) for the treatment of for GM1 and GM2 gangliosidosis GM2 Gangliosidosis.

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Innovation Passport for the treatment of GM1 and GM2 gangliosidoses.

About GM1 and GM2 gangliosidoses

GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) are lysosomal storage disorders caused by the accumulation of GM1 or GM2 gangliosides respectively, in the central nervous system (CNS), resulting in progressive and severe neurological impairment and premature death. These diseases mostly affect infants and children, and no disease-modifying treatments are currently available.

About Niemann-Pick disease type C (NPC)

Niemann-Pick disease type C is a progressive, life-limiting neurological lysosomal storage disorder caused by mutations in the NPC1 or NPC2 gene and aberrant endosomal-lysosomal trafficking, leading to the accumulation of various lipids, including gangliosides in the CNS. The onset of disease can happen throughout the lifespan of an affected individual, from prenatal life through adulthood.

About Azafaros

Azafaros is a clinical-stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms using compound discoveries made by scientists at Leiden University and Amsterdam UMC and is led by a team of highly experienced industry experts. Azafaros aims to build a pipeline of disease-modifying therapeutics to offer new treatment options to patients and their families. By applying its knowledge, network and courage, the Azafaros team challenges traditional development pathways to rapidly bring new drugs to the rare disease patients who need them. Azafaros is supported by a syndicate of leading Dutch and Swiss investors including Forbion, BioGeneration Ventures (BGV), BioMedPartners, Asahi Kasei Pharma Ventures, and Schroders Capital.

Contacts

For further information:

Azafaros B.V.

Email: info@azafaros.com
www.azafaros.com

Bonerge Announces the New 108 Person Clinical Trial: Exploring Skin and Organ Anti-Aging Innovations




Bonerge Announces the New 108 Person Clinical Trial: Exploring Skin and Organ Anti-Aging Innovations

NEW YORK–(BUSINESS WIRE)–Bonerge announced the initiation of its clinical trial, focusing on Fisetin, Urolithin A, and Ergothioneine. Involving 108 participants, this trial aims to evaluate their combined effects on skin health and organ rejuvenation when taking orally, providing more reliable options for the market.

Senolytics Research: Advancing the Science of Anti-Aging

In recent years, Senolytics research has advanced rapidly, with institutions like the Mayo Clinic and Wake Forest University at the forefront. Despite fruitful research, identifying optimal applications to translate Senolytics into market solutions remains crucial.

In October 2024, the Mayo Clinic published groundbreaking findings in Nature Aging, identifying 67 plasma proteins, with IL-23R emerging as a promising anti-aging biomarker¹.

The study explored various promising Senolytics, including Fisetin, demonstrating a positive response in reducing senescence-related proteins and indicating potential for organ rejuvenation via senescent cell clearance².

The concept of organ rejuvenation offering deeper insights into its systemic effects and guiding anti-aging strategies. Senolytics show strong potential for organ rejuvenation applications and promise broader future prospects.

Bonerge’s Clinical Trial: Exploring Skin as the Key to Rejuvenation

The skin, the largest organ of the human body, is the most visible indicator of aging and a key target for anti-aging. Bonerge has launched a clinical trial focused on skin anti-aging, involving 108 participants.

The trial evaluates skin anti-aging effects by assessing factors like skin heme, skin inflammation, transepidermal water loss, wrinkles, skin elasticity, skin firmness, melanin levels, and skin tone. Spanning 56 days, it aligns with two skin regeneration cycles, providing a detailed analysis of these key skin health indicators.

Three ingredients tested in the trail:

• Fisetin: Among natural ingredients, fisetin has the strongest activity in clearing senescent cells. Its core mechanism promotes apoptosis of senescent cells and reduces SASP (Senescence-Associated Secretory Phenotype) secretion, alleviating chronic inflammation and combating inflammaging³, contributing to organ rejuvenation.
• Urolithin A: A rising star in nutritional supplements, Urolithin A has shown significant anti-photoaging effects. Photoaging, primarily caused by UVA (ultraviolet A) radiation, accelerates skin aging. Urolithin A helps protect skin by reducing the senescent phenotype of skin fibroblasts triggered by UVA, lowering intracellular ROS (reactive oxygen species), and activating antioxidant enzymes. These actions collectively support skin health and combat the harmful effects of photoaging⁴.
• Ergothioneine: Currently recognized as the only antioxidant that targets mitochondria, it reduces oxidative damage within mitochondria, supporting energy production and potentially preventing cellular aging⁵.

Key Focus: Exploring Individual Ingredients and Combined Synergies

In this clinical trial, while examining the skin anti-aging effects of individual ingredients, the combination of the three ingredients have also been tested to explore the synergistic effects on skin health and anti-aging.

Path Ahead: Trial Progress and Future Expectations

The clinical trial is progressing as planned and is expected to conclude in March 2025. Bonerge is hopeful that this study will provide valuable evidence for the anti-aging market, paving the way for the application of Senolytics in skin health and broader anti-aging treatments.

References

[1] Chase M. Carver, et al. IL-23R is a senescence-linked circulating and tissue biomarker of aging. Nature Aging, Dec 2024.

[2] Researchers discover an aging and inflammation biomarker – Mayo Clinic News Network
[3] Matthew J. et al. Fisetin is a senotherapeutic that extends health and lifespan. EBioMedicine 36 (2018).

[4] Wenjie Liu, et al. Urolithin A protects human dermal fibroblasts from UVA-induced photoaging through NRF2 activation and mitophagy. J Photochem Photobiol B. 2022 Jul.

[5] Brown, Lisa, et al. L-Ergothioneine and Its Protective Role in Cellular Health. Journal of Clinical Nutrition, vol 56.

Contacts

Cecilia Yang

+1 (949) 712-7328

sales@bonerge.com

KitoTech Medical Introduces PainPause, a Consumer Product That Provides A Safe and Effective New Approach to Treating Pain




KitoTech Medical Introduces PainPause, a Consumer Product That Provides A Safe and Effective New Approach to Treating Pain

SEATTLE–(BUSINESS WIRE)–KitoTech Medical announces the launch of its revolutionary new treatment for pain – PainPause. Designed like a patch making it easy to use yet with the strength to treat serious pain, PainPause contains patented tiny Micro-Points that are able to shut down pain without drugs. PainPause remains in place on the skin for a week providing long-lasting pain relief with a single treatment.

PainPause effectively treats a wide range of painful musculoskeletal conditions including back pain, sciatica, neck pain, knee pain, hip pain, plantar fasciitis, carpal tunnel syndrome, and tennis elbow. Its remarkable treatment effects have been shown in two clinical studies where ~90% of patients achieved clinically significant pain relief that lasted for a week with a single treatment. This compares favorably to other pain relief products that are only effective in a small subset of people and able to relieve pain for a few hours. PainPause works by a unique mechanism of action to treat pain. When the patch is applied, the product’s Micro-Points target and activate receptors right underneath the skin surface. These activated receptors provide powerful signals to nerves that shut down pain.

Ron Berenson, MD, President and CEO of KitoTech, stated: “We are excited to introduce PainPause onto the consumer market which represents a major advance in treating pain. It stands out from other products in its ability to treat the most challenging types of pain including severe and chronic pain. Tens of millions of Americans suffer from painful musculoskeletal conditions and most fail to achieve pain relief with currently available over the counter (OTC) products. PainPause provides them with a convenient, safe and long-term solution to treat their pain without the expense and inconvenience of having to use healthcare practitioners.”

PainPause is available on Amazon and at www.painpause.com.

About KitoTech Medical

KitoTech is a Seattle-based consumer products company dedicated to addressing unmet needs for common healthcare problems. Based on its patented Micro-Point technology, KitoTech has developed and is marketing two OTC products – microMend to close wounds and now PainPause to treat pain. Both are patented products backed by clinical data demonstrating their effectiveness. PainPause is an exciting new addition to the company’s product line. It has the potential to make a major impact on healthcare given that pain is the most common medical condition in the US. More detailed information about the products can be found at painpause.com and micromendskinclosure.com.

Contacts

Customer Contact:
Ronald Berenson, MD

KitoTech Medical, Inc.

Phone (206) 395-8920

info@kitotechmedical.com

Aptar Announces 2025 Quarterly Conference Call Dates




Aptar Announces 2025 Quarterly Conference Call Dates

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced the dates and times of quarterly conference calls for the year. Any updates to these dates or times will be communicated in subsequent press releases.

Quarterly Conference Calls

About Aptar

Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

This press release contains forward-looking statements. Expressions or future or conditional verbs such as “will” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Ks and Form 10-Qs. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investor Relations Contact:
Mary Skafidas

Mary.skafidas@aptar.com
+1 347-351-6407

Media Contact:
Katie Reardon

katie.reardon@aptar.com
+1 815-479-5671

Nasdaq Grants Revelation Biosciences Inc. Continued Listing




Nasdaq Grants Revelation Biosciences Inc. Continued Listing

SAN DIEGO–(BUSINESS WIRE)–$REVB #GEMINI–Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the treatment of disease, announced today that the Nasdaq Hearings Panel issued a decision letter granting Revelation’s request to continue its listing on The Nasdaq Stock Market, subject to its stock trading at or above $1.00 for at least ten consecutive trading days by February 14, 2025.

Additionally, the Nasdaq Hearings Panel confirmed that the Company has regained compliance with the Equity Requirement of Listing Rule 5550(b)(1) for which the Company was issued a notice of delisting for failure to comply with Equity Requirement of Listing Rule 5550(b)(1) on August 14, 2024.

“We are very thankful to the Nasdaq Hearings Panel for recognizing the significant progress made following the tumultuous time for the Company post SPAC merger,” said James Rolke, Chief Executive Officer of Revelation. “Now that our obligations from the SPAC merger have settled, we can focus on the development of Gemini and we look forward to the initiation of our Phase 1b clinical study in chronic kidney patients shortly.”

On December 3, 2024, the Company announced the successful exercise of warrants for $4 million. On December 2, 2024, Revelation announced FDA acceptance of the Gemini IND. The Company expects to initiate its Phase 1b clinical study in the first half of 2025. Previously the Company reached a milestone with successfully completing the GMP manufacture of the Gemini drug product to support clinical trials.

For more information on Revelation, please visit www.RevBiosciences.com.

About Gemini

Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD^®) that reduces the damage associated with inflammation by reprograming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner. Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. Earlier this year Revelation announced positive Phase 1 clinical data for intravenous treatment with Gemini. The primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity as observed through expected changes in multiple biomarkers including upregulation of IL-10.

Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Contacts

Company Contacts

Mike Porter

Investor Relations

Porter LeVay & Rose Inc.

Email: mike@plrinvest.com

Chester Zygmont, III

Chief Financial Officer
Revelation Biosciences Inc.

Email: czygmont@revbiosciences.com

Amgen’s IMDYLLTRA®▼ (tarlatamab) Granted a Conditional Marketing Authorisation for Third-Line Treatment of Extensive-Stage Small Cell Lung Cancer in the United Kingdom




Amgen’s IMDYLLTRA®▼ (tarlatamab) Granted a Conditional Marketing Authorisation for Third-Line Treatment of Extensive-Stage Small Cell Lung Cancer in the United Kingdom

• IMDYLLTRA® is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy¹
• Lung cancer is the third most common cancer in the UK, with more than 49,000 cases diagnosed in the UK between 2017 and 2019²
• Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers³
• In the Phase 2 DeLLphi-301 study, involving 99 patients with ES-SCLC, tarlatamab demonstrated a 41% objective response rate (95% Confidence Interval [CI]: 32 to 52) for the primary end point and 9.7-month median duration of response (range: 5.9, not estimable [NE])^1,4

CAMBRIDGE, England–(BUSINESS WIRE)–Today, Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to IMDYLLTRA^® for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy.¹

Small cell lung cancer (SCLC) is an aggressive lung cancer subtype that accounts for approximately 15% of lung cancers.³ ES-SCLC is characterised by rapid tumour growth and metastatic spread.⁵ Patients with SCLC are often diagnosed after the cancer has reached an advanced stage because symptoms do not typically appear early in the disease.⁶

“The MHRA’s granting of a conditional marketing authorisation for tarlatamab is a significant step forward for people living with small cell lung cancer. More than 34,000 people die from lung cancer in the UK each year.² There is a vital need for novel treatments, particularly for the extensive stage of small cell lung cancer, where outcomes are especially poor,” said Tony Patrikios, Executive Medical Director, Amgen UK & Ireland. “This licence brings us one step closer to offering a new treatment option to eligible patients.”

The conditional marketing authorisation is based on results from the Phase 2 open label, multicentre study DeLLphi-301, which evaluated tarlatamab in patients with ES-SCLC who had failed two or more prior lines of treatment.⁴ Results from the study found that tarlatamab at the 10 mg every two weeks (Q2W) dose (N=99) demonstrated an objective response rate (ORR) of 41% (95% Confidence Interval [CI]: 32 to 52) and a median duration of response (DoR) of 9.7 months (range: 5.9, not estimable [NE]).¹

“Extensive-stage small cell lung cancer is an extremely difficult cancer to treat. While initial response rates to current treatment of chemotherapy, with the addition of radio- and immunotherapy, are high, duration of response is often short. Subsequent current treatments have had low success rates,” said Alastair Greystoke, MBChB, MSc, PhD, FRCP, Professor of Precision Oncology and Honorary Consultant Medical Oncologist, Newcastle University & Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.

IMDYLLTRA (tarlatamab) is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumour cells and CD3 expressed on the surface of T cells. The bispecific binding of tarlatamab to T cells and DLL3-positive tumour cells triggers T-cell activation, production of inflammatory cytokines, release of cytotoxic proteins, which results in redirected lysis of tumour cells.¹

The most common side effects reported with tarlatamab were cytokine release syndrome (53.8%), pyrexia (36.9%), dysgeusia (30.0%), decreased appetite (29.4%), constipation (27.5%), fatigue (26.9%), anaemia (25.0%) and asthenia (21.9%). Other very common side effects include nausea, hyponatraemia and dyspnoea.¹

IMDYLLTRA^® has been granted a conditional marketing authorisation by the MHRA. This means that further evidence on this medicinal product is awaited.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

NOTES TO EDITORS

About Small Cell Lung Cancer

SCLC is one of the most aggressive and devastating solid tumour malignancies, accounting for ~15% of the 49,000 patients diagnosed with lung cancer in the UK each year.^2,3,10 ES-SCLC has a median survival of approximately 9–12 months and less than a 2% 5-year relative survival rate.¹¹ Despite patients being initially sensitive to first-line platinum-based chemotherapy, most patients relapse within months and require subsequent treatment options.¹² Current second-line treatments have shown limited survival (median overall survival: 25.9 weeks),¹¹ while there are very limited options available for third-line treatment.⁷

About IMDYLLTRA^®

IMDYLLTRA (tarlatamab) is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumour cells and CD3 expressed on the surface of T cells. The bispecific binding of tarlatamab to T cells and DLL3-positive tumour cells triggers T-cell activation, production of inflammatory cytokines, release of cytotoxic proteins, which results in redirected lysis of tumour cells.¹

For further product information, please see the Summary of Product Characteristics, which will be available at: https://www.medicines.org.uk/emc/product/15878

Indications

In the UK, IMDYLLTRA^® is indicated for the treatment of adult patients with ES- SCLC with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy.¹

About Amgen UK

Amgen’s mission is to serve patients. A biotechnology innovator since 1980, our science- based heritage is at the heart of everything we do. We remain on the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. In the UK, Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. As a regional hub, we employ around 650 people in the UK and Ireland across our commercial, R&D and corporate functions. Committed to driving sustainable solutions that can adapt to an ever-evolving health system, we are proud to serve patients every day.

For more information visit https://www.amgen.co.uk/

References

1. IMDYLLTRA^® (tarlatamab) Summary of Product Characteristics. Will be available at: https://www.medicines.org.uk/emc/product/15878.
2. Cancer Research UK. Lung cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer. Last accessed: January 2025.
3. Macmillan Cancer Support. Small cell lung cancer (SCLC). Available at: https://www.macmillan.org.uk/cancer-information-and-support/lung-cancer/small-cell-lung-cancer. Last accessed: January 2025.
4. Ahn MJ, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J. 2023;389(22):2063–2075.
5. Cancer Research UK. Limited and extensive stage (small cell lung cancer). Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/limited-extensive. Last accessed: January 2025.
6. National Health Service. Lung Cancer Overview. Available at: https://www.nhs.uk/conditions/lung-cancer/. Last accessed: January 2025.
7. Paz-Ares L, et al. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023;41(16):2893–2903.
8. Ramalingam SS, et al. Poster TPS8603. J Clin Oncol. 2022;40(16).
9. Amgen. FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER. Available at: https://www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer. Last accessed: January 2025.
10. Zhang X, et al. CAR-T Cell Therapy in Hematological Malignancies: Current Opportunities and Challenges. Front Immunol. 2022;13:927153.
11. National Institute for Health and Care Excellence. Topotecan for the treatment of relapsed small-cell lung cancer TA184. Available at: https://www.nice.org.uk/guidance/ta184/. Last accessed: January 2025.
12. Dingemans AMC, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(7):839–853.
13. Rojo F, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237–243.

Contacts

Sejal Sachdev, Amgen UK Corporate Affairs

ssachd01@amgen.com