Selective TGF-β Superfamily Therapeutics

About BYOMass

BYOMass is a preclinical pharmaceutical company developing novel biologic and small molecule drugs to modulate specific members of the TGF-β superfamily, for the treatment of orphan and common diseases of high unmet medical need. Our mission is to:

  • Harness human biology
  • Target causative mechanisms
  • Deliver novel therapeutics
  • Transform patient lives

TGF-β Superfamily in Disease

The TGF-β superfamily of secreted factors includes more than 30 members, including transforming growth factors (TGFs), growth differentiation factors (GDFs), activins, inhibins, nodal, lefty, and bone morphogenetic proteins (BMPs). These proteins are master regulators of a wide range of physiological processes including tissue morphogenesis, tissue repair, hematopoiesis, immunoregulation and reproductive function. Dysregulation of individual proteins cause multiple diseases and disorders, including inflammation, catabolism, fibrosis, appetite loss, and carcinogenesis.

Inhibiting TGF-β directly or blocking receptors with multiple signaling ligands is not an attractive therapeutic approach due to safety concerns. Selectively targeting specific members and pathways within the superfamily has the potential to be a meaningful class of therapeutics within oncology, inflammatory/immune, fibrotic, and metabolic diseases.

At BYOMass, we are delivering a new era of selective TGF-β superfamily therapeutics. We have a home-grown, pathway-driven pipeline of novel biologics and first-in-class small molecules that offer safe and transformative efficacy for orphan and common diseases of high unmet medical need.

Building a TGF-β Superfamily Pathway Pipeline on
Precision Medicine Principles

BYOMass is pioneering a precision medicine approach to treat patients with high unmet medical need where specific TGF-β superfamily members play a major role in their disease. Our approach to building a therapeutic pipeline follows these principles:

Efficacy

Harnessing human biology and causal mechanisms of disease for transformative efficacy

Safety

Avoiding known toxicities associated with directly blocking TGF-β or subfamily receptors

Preclinical to Clinical Translation

Utilizing plasma biomarkers to stratify patients and build confidence in human dose (PK/PD)

Modality

Developing novel biologics and small molecules

Clinical Candidates Built to Survive

Establishing conservative human dose predictions with high confidence in PK/PD and optimal therapeutic index to ensure ability to fully test a first-in-class mechanism in patients

Clinical Development Flexibility & Path

Building innovative clinical development plans to deliver an early sign of efficacy in Phase 1 in an accelerated timeframe and capital-efficient manner. Designing programs for rapid ‘orphan drug’, specialty-focused, and general medicine indications of high unmet medical need to improve patient lives

BYOMass Leadership

We are a highly experienced drug discovery and development team from large pharma with the cost efficiency of an agile start-up. Our leadership team has a successful track record of delivering novel therapeutics across multiple indications.

  • Management
    V. Margaret Jackson, D.Phil. (Oxon) Founder and Chief Executive Officer

    Dr. Jackson has worked in pharmaceutical and biotech R&D for more than 20 years, holding executive leadership roles at Pfizer, Napa Therapeutics, and Juvenescence. She specializes in identifying transformative drug discovery projects and translating them into high value clinical drug development programs with an emphasis on translational efficacy, early safety derisking, mechanistic biomarkers, target engagement biomarkers, and PK/PD modelling. She has built and led multiple matrix preclinical and clinical development teams from hit identification to Phase 1/2 clinical studies. She has consistently delivered first-in-class and best-in-class programs, spanning small molecules and biologics for women’s health, diabetes, obesity, anorexia-cachexia and fibrotic diseases. Dr. Jackson obtained a First Class Honors Degree in biomedical sciences from the University of Ulster, awarded a D.Phil. in neuropharmacology from the University of Oxford and received a Royal Society University Research Fellowship for gastrointestinal research at the University of Melbourne. Dr. Jackson is an alumni member of Springboard Enterprises for Women Entrepreneurs. 

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    Pete Leone, MBA CBO/BD

    Dr. Leone is a life sciences entrepreneur with more than 30 years of experience at public and private biopharmaceutical and medical device companies. In addition to BYOMass, Dr. Leone consults with various public and private biotechs, including F-Star/Spring Bank Pharmaceuticals, Selva Therapeutics, and Innate Biotherapeutics in business development and general management. He also serves on corporate and not-for-profit boards, including SeromYx Systems, Third Monday Foundation, and Nuestros Pequeños Hermanos – NPH USA Northeast region. Prior to this, Dr. Leone led business development efforts for Bicycle Therapeutics (Nasdaq: BCYC). Previously, he worked in various management roles at Arrowhead Pharmaceuticals (Nasdaq: ARWR). Before Arrowhead Pharmaceuticals, Dr. Leone was a cofounder of three venture-backed companies, including Mersana Therapeutics (Nasdaq: MRSN). Early in his career, he worked in systems engineering at General Electric, in marketing at Procter & Gamble, and was a partner at Corporate Decisions, now part of Mercer. Dr. Leone holds an A.B. in engineering science with pre-med studies from Dartmouth College and an MBA from the Stanford University Graduate School of Business.

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    Daniel Geffken, MBA Senior Financial Advisor

    Since 2011, Mr. Geffken has been serving as the Founding Managing Partner of Danforth Advisors, a leading financial and strategy consulting firm to the life sciences industry, leading a team of more than 130 consultants in strategic CFO advisory, accounting, and operational support for over 225 active clients. He has more than 30 years of experience as CFO or executive level advisor for companies ranging from start-ups to publicly traded companies with $1 billion+ market capitalizations. Mr. Geffken has served as CFO and strategic consultant to numerous companies, including Apellis Pharmaceuticals, Cidara Therapeutics, GenePeeks, Homology Medicines, Stealth BioTherapeutics, and Transkaryotic Therapies. As CFO of Transkaryotic Therapies, he negotiated and closed five equity transactions totaling $600 million – including the largest private placement in biotechnology history at the time. Since 2013, he has participated in seven initial public offerings and raised more than $2 billion in equity and debt securities for life science companies over the course of his career. Mr. Geffken has served as board member and chairman of audit and compensation committees of both public and private life science companies, including Windtree Therapeutics.

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  • R&D Team
    Alan Brown, Ph.D. Medicinal Chemist

    Dr. Brown has more than 30 years of industry experience and has worked across all areas of drug discovery, from hit generation to development candidate identification in seven different therapeutic areas. Dr. Brown has personally been involved in 20 projects which have resulted in new medicines being tested in humans. Prior to BYOMass, Dr. Brown served as Head of Chemistry at Benevolent AI. Before that, he was Head of Chemistry for the Pain and Sexual Health Therapeutic Areas at Pfizer. He is a member of the Alzheimer’s Research UK (UCL) Scientific Advisory Board and has served as a member of the UK Government’s Strategic Advisory Team for the Physical Sciences. Dr. Brown is author/named inventor on more than 80 peer-reviewed scientific papers and patents. He received his Ph.D. and B.S. from the University of Glasgow.

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    Mark Gardner, Ph.D. Computational Chemist

    Dr. Gardner has worked with major organizations in global health drug discovery on a range of drug discovery projects tackling global health diseases, including malaria, TB, schistosomiasis, leishmaniasis, human African trypanosomiasis, and Chagas disease. Most recently, Dr. Gardner led the medicinal chemistry and project management for a successful drug discovery project in schistosomiasis under a collaboration with Professor Quentin Bickle at the London School of Tropical Medicine. Previously, he was a medicinal and computational chemist for 19 years at Pfizer, where he set up and managed the Lead Discovery Group, led outsourcing for the chemistry department, chaired a $90 million file enrichment collaboration, and developed a number of chemoinformatic design tools. Prior to that, Dr. Gardner spent a year in business and IT consultancy at Accenture. Dr. Gardner obtained a B.Sc. in chemistry from Imperial College and a Ph.D. in natural product synthesis from the University of Cambridge, where he then did postdoctoral research in computational chemistry.

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    Theresa O’Keefe, Ph.D. Biologics

    Dr. O’Keefe is a scientific consultant supporting the development of biotherapeutic drugs, cell therapies, medical devices, and diagnostics from late research through development and into the clinic. In addition, she is an adjunct professor at UMASS Chan Medical School, teaching biotherapeutic drug development. Dr. O’Keefe has more than 20 years industry experience in positions from director to CSO working in start-ups through large pharma, including LeukoSite, Millennium Pharmaceuticals, Takeda, Critical Therapeutics, Pfizer, Mend Therapeutics, and ONEighty C Technologies. At Pfizer, she developed their virtual Gene-to-Biotherapeutic programs. She is an inventor on more than 30 published patents and many patent applications, including ENTYVIO® (vedolizumab), Takeda’s antibody for the treatment of Crohn’s disease. Following the award of her Ph.D. in molecular immunology from Tufts University, Dr. O’Keefe spent more than six years in the U.K. at the MRC Laboratory of Molecular Biology in Cambridge, working with Drs. Michael Neuberger and César Milstein. Dr. Milstein is a Nobel laureate for his work on monoclonal antibodies. She has several papers in top-tier research journals, including first author articles in Science, Journal of Experimental Medicine, and PNAS.

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    Kelly A. Byrnes-Blake, Ph.D. PDM

     

    Dr. Byrnes-Blake has been a pharmacokineticist supporting drug research and development for more than 19 years. Her previous industry experience includes large pharma, as well as a mid-sized biotech company, with the primary focus of her work being the development of protein therapeutics. She supported several protein-based therapeutic projects from early research through IND-enabling studies and into Phase 1 and 2 clinical trials. Dr. Byrnes-Blake has supported the development of growth factors, cytokines, as well as monoclonal antibodies and Fc-fusion proteins. Dr. Byrnes-Blake works as a PK consultant in the pharmaceutical and biotech industry, providing scientific expertise and support for nonclinical PK and TK analysis, interspecies scaling and dose/regimen selection for preclinical toxicology and first-in-human studies, and clinical PK. Dr. Byrnes-Blake is a co-author on several peer-reviewed scientific publications and abstracts. She earned a Ph.D. in pharmacology from the University of Arkansas for Medical Sciences. During her Ph.D., she received specific training in pharmacokinetics and studied antibody-based therapies for drugs of abuse. Dr. Byrnes-Blake also holds a dual bachelor’s degree in biology and mathematics from Western Washington University.

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    Frank Spriggs Bioanalytical

    Mr. Spriggs is a bioanalytical consultant with more than 15 years in the field. He started his career at CuraGen corporation reviewing SAGE analysis data, annotating gene dictionaries, and conducting biomarker discovery work. He joined the PKDM Protein Labs at Amgen, where he learned the science of regulated large molecule bioanalysis. After that Mr. Spriggs worked at Pfizer, where he started his involvement in the American Association of Pharmaceutical Sciences (AAPS). At AAPS, he held positions in both the BIOTEC and Regulatory Sciences sections. He then transitioned to the CRO space and worked at AIT Bioscience and KCAS Bioanalytical and Biomarker Services. Mr. Spriggs received a B.S. in microbiology from Ohio University and an M.S. in Regulatory Affairs and Quality Assurance from Temple University.

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    Diana Marcantonio, Ph.D. PK/PD

    Dr. Marcantonio is a biologist with more than 10 years of experience in the pharmaceutical and biotech industries. In addition to BYOMass, Dr. Marcantonio is currently the Director of Biology at Applied BioMath, where she guides strategy and provides biological and disease area expertise on projects to help clients make informed decisions during drug R&D. Prior to joining Applied BioMath, Dr. Marcantonio served as Associate Director, Biology at FogPharma. Before that, she was Project Lead and Lead Scientist at Merrimack Pharmaceuticals. Dr. Marcantonio earned her Ph.D. in biological engineering from MIT and a B.S. in bioengineering from the University of California, Berkeley.

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    Marque Todd, DVM, MS, DABT Regulatory Toxicology

    Dr. Todd is a board-certified regulatory toxicology expert. She trained as a veterinarian and completed postdoctoral work in molecular immunology and cancer biology. She has more than 20 years of experience working in the biopharmaceutical industry. Dr. Todd has extensive experience with a variety of biologic modalities including monoclonal antibodies, bi-specific antibodies, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, cell therapies, and therapeutic vaccines. She also has extensive experience in developing diverse biotherapeutic modalities and small molecules for oncology. Dr. Todd has been involved in the preparation and submission of nonclinical sections of early and late-stage regulatory documents including INDs and BLAs/NDAs and has participated in numerous successful health authority meetings. Prior to becoming an independent consultant, Dr. Todd was a Research Fellow at Pfizer and served as a Principal Scientist at Amgen and Chiron. In addition to her industry roles, Dr. Todd served as an Adjunct Professor at UC San Diego Extension, where she co-taught a course on nonclinical toxicology and drug development with sessions focused on the nonclinical development of biotherapeutics and oncology products.

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  • Scientific Advisors
    Tao He, Ph.D.

    Dr. He works on protein manufacturing for BYOMass. He has over 20 years of experience in pharma and biotech and is an expert in protein-based drug discovery and development. Dr. He has co-authored more than 25 peer-reviewed publications and nine granted patents. In addition to his work at BYOMass, he is the co-founder of JOINN Biologics, a CDMO dedicated to biologics development and manufacturing. Prior to JOINN Biologics, Dr. He served as a Research Fellow at Pfizer. Before Pfizer, he was director of proteomics at Wyeth. Prior to that, he was a Director at Celera Corporation as well as Senior Scientist III at Novartis. For being a pioneer in establishing developability assessment for biologics development, Dr. He was a keynote speaker at Bioprocessing Summit. He received his Ph.D. from University of Maryland and a B.S. in biochemistry from Nanjing University.

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    Howard Levine, Ph.D.

    Dr. Levine has more than 40 years of experience in the biopharmaceutical industry, where he has assisted numerous companies in developing biological products, provided strategic input in the development of new manufacturing technologies, and participated in the successful commercialization of several of these products. Dr. Levine is also the national leader of the BioProcess Technology Group, a part of the life sciences practice of BDO USA, LLP, a professional services company. Previously, he founded and was President and CEO at BioProcess Technology Consultants (BPTC), Inc., a leading consulting company that provides integrated strategic, technical, and regulatory advice on biopharmaceutical product development to a broad range of companies. Before founding BPTC, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation. Prior to that, he held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma Corporation. Dr. Levine is a frequently invited lecturer on manufacturing strategy, downstream processing, and commercialization of biotechnology products and an author of numerous peer-reviewed publications. He holds a Ph.D. in chemistry from the University of Chicago, and he completed a postdoctoral fellowship at Harvard University.

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    George Dranitsaris, Ph.D.

    Dr. Dranitsaris is a clinical drug development consultant with expertise in oncology/hematology, immunology, rare diseases, diabetes, and blood products and biologicals. His areas of interest include clinical trials of drug products or medical devices, real world data analysis, and patient reported outcomes research. He has more than 150 publications in the national and international literature, is past president of the Canadian Association of Pharmacy in Oncology, a statistical reviewer for the Journal of Clinical Oncology, and a member of the editorial board of Oncogene, Pharmacoeconomics – Open, and Current Oncology. His graduate training at the University of Toronto included biostatistics, econometrics, decision analysis, and clinical epidemiology.

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  • Board of Directors
    Greg Bailey, M.D.

    Dr. Bailey, the cofounder and CEO of Juvenescence, is a physician, financier, and biotech entrepreneur with extensive experience founding and financing healthcare companies. Dr. Bailey is also the chairman of Portage Biotech, Inc. (OTCBB: PTGEF), a publicly traded oncology drug development company. He was a former managing partner of Palantir Group, Inc., a merchant bank specializing in biotech and intellectual property, and he was the initial financier and an independent director of Medivation, Inc. (Nasdaq: MDVN), acquired by Pfizer in 2016. He also led the seed financing of Biohaven Pharmaceuticals Holding Company Ltd. and joined the board in 2014. Previously, he founded or financed Ascent Healthcare Solutions, VirnetX Inc. (VHC:AMEX), and SalvaRx Group PLC. Dr. Bailey has an M.D. from the University of Western Ontario and practiced emergency medicine for 10 years prior to becoming a serial entrepreneur.

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    Declan Doogan, M.D.

    Dr. Doogan has more than 30 years of experience in the global pharmaceutical industry and is the Chief Medical Officer and Cofounder of Juvenescence. In addition to his role at Juvenescence, Dr. Doogan is the Chairman and Cofounder of Biohaven Pharmaceuticals, Portage Biotech, and PH Precision Med and a visiting professor at Glasgow University. Previously, Dr. Doogan was Head of Worldwide Drug Development at Pfizer, where he worked in the US, UK, and Japan. Previously, he was also Head of R&D at Amarin Corporation. Dr. Doogan earned his M.D. from Glasgow University, and he is a Fellow of the Royal College of Physicians and Surgeons of Glasgow. He also holds an honorary degree of D.Sc. from the University of Kent in the U.K. 

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    Stephen Hoffman, M.D., Ph.D.

    Dr. Hoffman has more than 30 years of experience in founding, leading, and advising biotech companies advancing innovative therapeutic pipelines. He most recently served as CEO of Aerpio Pharmaceuticals and prior to that was a senior advisor to PDL BioPharma, a General Partner at TVM Capital and a Managing Director at Skyline Ventures. Before his positions in venture capital, Dr. Hoffman served as President, CEO, and a member of the board of directors of Allos Therapeutics, where he remained as Chairman of the Board until it was acquired by Spectrum Pharmaceuticals. He currently serves on the Boards of Directors of AcelRx Pharmaceuticals, Dicerna Pharmaceuticals, Danforth Advisors, and Apic Bio. Dr. Hoffman holds a Ph.D. in bio-organic chemistry from Northwestern University and an M.D. from the University of Colorado School of Medicine.

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    V. Margaret Jackson, D.Phil. (Oxon)

    Dr. Jackson is the Founder and Chief Executive Officer of BYOMass Inc. She has worked in pharmaceutical and biotech R&D for more than 20 years, holding executive leadership roles at Pfizer, Napa Therapeutics, and Juvenescence. She specializes in identifying transformative drug discovery projects and translating them into high value clinical drug development programs with an emphasis on translational efficacy, early safety derisking, mechanistic biomarkers, target engagement biomarkers, and PK/PD modelling. She has built and led multiple matrix preclinical and clinical development teams from hit identification to Phase 1/2 clinical studies. She has consistently delivered first-in-class and best-in-class programs, spanning small molecules and biologics for women’s health, diabetes, obesity, anorexia-cachexia and fibrotic diseases. Dr. Jackson obtained a First Class Honors Degree in biomedical sciences from the University of Ulster, awarded a D.Phil. in neuropharmacology from the University of Oxford and received a Royal Society University Research Fellowship for gastrointestinal research at the University of Melbourne. Dr. Jackson is an alumni member of Springboard Enterprises for Women Entrepreneurs. 

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