singular focus on life sciences and healthcare

We support innovative early-stage companies with a mission to translate groundbreaking science into transformative therapies

investment
criteria

Therapeutics

We are agnostic about diseases and modalities, but prioritise companies developing novel platform-based therapeutic approaches with good IP protection or hard-to-replicate know-how addressing unmet clinical needs by generating proprietary assets

Bio-IT

We focus on medical software solutions for clinical use, as well as computational solutions for drug discovery and development

Geography

We focus on private companies in the US and Europe as key innovation hubs, with the goal to identify global technological leaders regardless of their location

Stage

We prefer to invest from Series Seed to Series B, where our team’s expertise is employed the most efficiently and helps to achieve early value inflection points. We like to lead / co-lead as part of a strong syndicate and are an active investor normally having board presence.

People

We prefer to support strong teams combining scientific, medical, and business expertise with a clear vision relevant for the next stage of company development

Added value

We speak the same language as scientific founders and seek to support our portfolio companies by developing a deep understanding of the technology and making available our experience, expertise, as well as networks in academia and investor community

team

Located on both sides of the Atlantic, our team combines deep expertise in science, technology, healthcare, venture investment, and market access. The team is complemented by KOLs at the top of their fields

Alexey Konov, PhD

Managing Partner

Alexey is a Managing Partner at Biovision Ventures and is based in Netanya, Israel. He has over 15 years of experience in senior roles in biotech VC and 20+ years in pharma and science, including work in France, Finland, Germany, and the USA.

Alexey graduated from MSU and received a PhD degree in molecular biology from Louis Pasteur University (France) in 1998, followed by a post-doctoral tenure in Finland.

In 1998-2004, Alexey worked at Monsanto Europe, a branch of Monsanto, where he supported a number of key company products’ regulatory filings in the CIS as Scientific Outreach Lead for the CIS region.

Dr. Konov then joined Bioprocess Holding, where he was responsible for the formation of its early-stage biotech portfolio and the USD 100M captive venture fund, where he served as an investment director and board member of the fund’s portfolio companies across the globe.

In 2014, Alexey started his first venture fund, currently fully invested with a few successful exits.

Alexey is responsible for business development, deal origination, and investor relations, while remaining deeply involved in the evaluation of investment opportunities and serving on the boards of portfolio companies, including past board positions in Retrosense Therapeutics (acquired by Allergan for $555M in 2016) and Bonti (acquired by Allergan for $285M in 2018).

Alexey Konov, PhD

Managing Partner

Alexey is a Managing Partner at Biovision Ventures and is based in Netanya, Israel. He has over 15 years of experience in senior roles in biotech VC and 20+ years in pharma and science, including work in France, Finland, Germany, and the USA.

Alexey graduated from MSU and received a PhD degree in molecular biology from Louis Pasteur University (France) in 1998, followed by a post-doctoral tenure in Finland.

In 1998-2004, Alexey worked at Monsanto Europe, a branch of Monsanto, where he supported a number of key company products’ regulatory filings in the CIS as Scientific Outreach Lead for the CIS region.

Dr. Konov then joined Bioprocess Holding, where he was responsible for the formation of its early-stage biotech portfolio and the USD 100M captive venture fund, where he served as an investment director and board member of the fund’s portfolio companies across the globe.

In 2014, Alexey started his first venture fund, currently fully invested with a few successful exits.

Alexey is responsible for business development, deal origination, and investor relations, while remaining deeply involved in the evaluation of investment opportunities and serving on the boards of portfolio companies, including past board positions in Retrosense Therapeutics (acquired by Allergan for $555M in 2016) and Bonti (acquired by Allergan for $285M in 2018).

Igor Gonikhin, CFA

Partner

Igor is a Partner at Biovision Ventures and is based in Berlin, Germany. He joined our team in 2017 as an Investment Director. He employs his investment experience and passion for natural sciences to lead the firm’s deal-making activities, focusing on financial and legal aspects. Igor is also active in investor relations and network-building for Biovision Ventures.

He has over 10 years of experience in investment and finance across a wide range of industries. Igor started his career in Deloitte&Touche Corporate Finance, where he spent five years advising companies and managing fundraising transactions and valuations in a variety of industries. He then worked for three years at Da Vinci Capital, a private equity firm managing the assets of global institutional investors, where he was responsible for investment process management and deal structuring and execution, and supervised portfolio companies in financial services, IT, and consumer sectors.

Igor graduated with an honours degree from the International College of Economics and Finance, a joint educational project of the London School of Economics and Higher School of Economics. He holds a double diploma in Banking and Finance, as well as a CFA designation.

Igor Gonikhin, CFA

Partner

Igor is a Partner at Biovision Ventures and is based in Berlin, Germany. He joined our team in 2017 as an Investment Director. He employs his investment experience and passion for natural sciences to lead the firm’s deal-making activities, focusing on financial and legal aspects. Igor is also active in investor relations and network-building for Biovision Ventures.

He has over 10 years of experience in investment and finance across a wide range of industries. Igor started his career in Deloitte&Touche Corporate Finance, where he spent five years advising companies and managing fundraising transactions and valuations in a variety of industries. He then worked for three years at Da Vinci Capital, a private equity firm managing the assets of global institutional investors, where he was responsible for investment process management and deal structuring and execution, and supervised portfolio companies in financial services, IT, and consumer sectors.

Igor graduated with an honours degree from the International College of Economics and Finance, a joint educational project of the London School of Economics and Higher School of Economics. He holds a double diploma in Banking and Finance, as well as a CFA designation.

Darkhan Itemgenov

Partner, Finance

Darkhan is a Partner at Biovision Ventures and is based in London. He is responsible for the firm's finance function and actively involved in investor relations.

Darkhan has a background as an entrepreneur across fintech, HoReCa, and other industries, and is a healthcare enthusiast and investor.

He received his business degree at the Coventry University in London.

Darkhan Itemgenov

Partner, Finance

Darkhan is a Partner at Biovision Ventures and is based in London. He is responsible for the firm's finance function and actively involved in investor relations.

Darkhan has a background as an entrepreneur across fintech, HoReCa, and other industries, and is a healthcare enthusiast and investor.

He received his business degree at the Coventry University in London.

Ivan Olovnikov, PhD

Head of Scientific Analysis

Ivan is the Head of Scientific Analysis at Biovision Ventures and joined our team in 2017. He is responsible for analyzing innovations behind target companies` technologies and helping build the fund`s pipeline. He is also active in expanding the KOL network and tracking trends in biosciences and pharmacology.

Prior to Biovision Ventures, Ivan worked as a postdoc on telomere biology at the Institute of Molecular Genetics and on artificial signalling pathways at the University of Queensland. Before that, he worked as a visiting graduate student at California Institute of Technology, where he performed breakthrough research on small RNA pathways in eukaryotes and bacteria. He also has experience as a biotech startup founder.

Ivan graduated from MSU with a degree in Bioengineering and Bioinformatics, and earned a PhD in Molecular Biology there.

Ivan Olovnikov, PhD

Head of Scientific Analysis

Ivan is the Head of Scientific Analysis at Biovision Ventures and joined our team in 2017. He is responsible for analyzing innovations behind target companies` technologies and helping build the fund`s pipeline. He is also active in expanding the KOL network and tracking trends in biosciences and pharmacology.

Prior to Biovision Ventures, Ivan worked as a postdoc on telomere biology at the Institute of Molecular Genetics and on artificial signalling pathways at the University of Queensland. Before that, he worked as a visiting graduate student at California Institute of Technology, where he performed breakthrough research on small RNA pathways in eukaryotes and bacteria. He also has experience as a biotech startup founder.

Ivan graduated from MSU with a degree in Bioengineering and Bioinformatics, and earned a PhD in Molecular Biology there.

Sophia Zubanova, PhD

Associate

Sophia is an Associate at Biovision Ventures and joined our team in 2018. She is responsible for therapeutics investments, including scouting for new opportunities, conducting market and scientific research, deal flow management, and performing detailed due diligence. She is also involved in the supervision of selected portfolio companies.

Prior to Biovision Ventures, she dedicated seven years to research in biochemistry and molecular biology as a Research Fellow, and conducted scientific and market research in the oncogenetic field at a human genome research company as an analyst.

Sophia graduated from MSU with a degree in Chemistry, and earned her PhD in Biochemistry and Biotechnology with a specialization in genetic engineering and bioinformatics.

Sophia Zubanova, PhD

Associate

Sophia is an Associate at Biovision Ventures and joined our team in 2018. She is responsible for therapeutics investments, including scouting for new opportunities, conducting market and scientific research, deal flow management, and performing detailed due diligence. She is also involved in the supervision of selected portfolio companies.

Prior to Biovision Ventures, she dedicated seven years to research in biochemistry and molecular biology as a Research Fellow, and conducted scientific and market research in the oncogenetic field at a human genome research company as an analyst.

Sophia graduated from MSU with a degree in Chemistry, and earned her PhD in Biochemistry and Biotechnology with a specialization in genetic engineering and bioinformatics.

Alexander Martynov, PhD

Associate

Alexander is an Associate at Biovision Ventures and joined our team in 2018. He is responsible for projects at the intersection of biology and IT, including identifying new investment opportunities, conducting scientific and market research, and performing detailed due diligence.

Prior to Biovision Ventures, he studied entrepreneurial economics at Massachusetts Institute of Technology (USA). Before that, he spent a year as a visiting PhD student at Harvard Medical School (USA), where he computationally studied cellular homeostasis. He also has experience as a founder of startups engaged in computational drug development and emotion recognition based on physiological signals.

Alexander graduated from MSU with a degree in Bioengineering and Bioinformatics, and earned his PhD at the Skolkovo Institute of Science andTechnology, where he performed computational assessment of the CRISPR-Cas mechanism of action.

Alexander Martynov, PhD

Associate

Alexander is an Associate at Biovision Ventures and joined our team in 2018. He is responsible for projects at the intersection of biology and IT, including identifying new investment opportunities, conducting scientific and market research, and performing detailed due diligence.

Prior to Biovision Ventures, he studied entrepreneurial economics at Massachusetts Institute of Technology (USA). Before that, he spent a year as a visiting PhD student at Harvard Medical School (USA), where he computationally studied cellular homeostasis. He also has experience as a founder of startups engaged in computational drug development and emotion recognition based on physiological signals.

Alexander graduated from MSU with a degree in Bioengineering and Bioinformatics, and earned his PhD at the Skolkovo Institute of Science andTechnology, where he performed computational assessment of the CRISPR-Cas mechanism of action.

Philipp Pletnev, PhD

Senior Analyst

Philipp is a Senior Analyst at Biovision Ventures and joined our team in 2022. His responsibilities include the scientific and technological analysis of investment opportunities within his areas of expertise, as well as supervision of selected portfolio companies.

Philipp has 9 years of experience in molecular biology with a specialization in RNA biology and functional genomics. Prior to Biovision Ventures, he spent 4 years in university-industry R&D collaborations in the fields of diagnostic systems and cell-based HTS platforms.

Philipp graduated from MSU with a degree in Chemistry and earned his PhD in Bioorganic Chemistry there.

Philipp Pletnev, PhD

Senior Analyst

Philipp is a Senior Analyst at Biovision Ventures and joined our team in 2022. His responsibilities include the scientific and technological analysis of investment opportunities within his areas of expertise, as well as supervision of selected portfolio companies.

Philipp has 9 years of experience in molecular biology with a specialization in RNA biology and functional genomics. Prior to Biovision Ventures, he spent 4 years in university-industry R&D collaborations in the fields of diagnostic systems and cell-based HTS platforms.

Philipp graduated from MSU with a degree in Chemistry and earned his PhD in Bioorganic Chemistry there.

Robert Karl

Venture Partner

Robert is a Venture Partner at Biovision Ventures and is based in Switzerland. He uses his vast commercial and operational expertise in accessing potential investment opportunities, and helps portfolio companies with business development and change management, including through roles on boards of directors.

Robert has more than 20 years of experience in global pharmaceutical companies, including in senior roles in Schering Plough, Merck Sharp and Dohme, and Mallinckrodt. He has a long track record in international business development and worked in most of the major markets globally.

In 2016 Robert started his own pharmaceutical distribution business, ADEXILIS. The company has since successfully grown its business in Europe, Turkey, and the Middle East, and is expanding rapidly to new markets.

Robert Karl

Venture Partner

Robert is a Venture Partner at Biovision Ventures and is based in Switzerland. He uses his vast commercial and operational expertise in accessing potential investment opportunities, and helps portfolio companies with business development and change management, including through roles on boards of directors.

Robert has more than 20 years of experience in global pharmaceutical companies, including in senior roles in Schering Plough, Merck Sharp and Dohme, and Mallinckrodt. He has a long track record in international business development and worked in most of the major markets globally.

In 2016 Robert started his own pharmaceutical distribution business, ADEXILIS. The company has since successfully grown its business in Europe, Turkey, and the Middle East, and is expanding rapidly to new markets.

Olga Krylova, PhD

Senior Advisor

Olga is the Director for Business Development at Otsuka Europe based and a Senior Advisor to Biovision Ventures. She has over 20 years of business, industry, and academic experience in life sciences and biotechnology.

Before Otsuka, Olga spent seven years with Pfizer as Senior Director in External R&D Innovations (UK) and Senior Director in Strategic Research and Partnerships (Eastern Europe, Israel and Russia). Prior to Pfizer, Olga held scientific and business development positions at Mitsui and GSK.

She graduated from MSU with a degree in Biology and received a PhD from the Russian Academy of Sciences in Neuroscience. She then did her post-doctoral research at Imperial College, London.

Olga Krylova, PhD

Senior Advisor

Olga is the Director for Business Development at Otsuka Europe based and a Senior Advisor to Biovision Ventures. She has over 20 years of business, industry, and academic experience in life sciences and biotechnology.

Before Otsuka, Olga spent seven years with Pfizer as Senior Director in External R&D Innovations (UK) and Senior Director in Strategic Research and Partnerships (Eastern Europe, Israel and Russia). Prior to Pfizer, Olga held scientific and business development positions at Mitsui and GSK.

She graduated from MSU with a degree in Biology and received a PhD from the Russian Academy of Sciences in Neuroscience. She then did her post-doctoral research at Imperial College, London.

Fyodor Urnov, PhD

Senior Advisor-at-large

Dr. Urnov is a Professor at the University of California Berkeley Dept of Molecular & Cell Biology, a Scientific Director at the Innovative Genomics Institute, and a Senior Advisor-at-large to Biovision Ventures.

His core research expertise is in CRISPR-based genome and epigenome editing, where he is widely regarded as one of the pioneers. Dr. Urnov is an author of 180+ scientific articles and publications. In addition to his academic career, Dr. Urnov served as the Chief Scientific Officer at Sangamo Therapeutics, where he demonstrated the first use of zinc fingers to edit DNA in human cells. He is also a co-founder of several high-profile life sciences startups in the US.

Dr. Urnov graduated from MSU with a degree in Virology, and received his PhD in Biology at Brown University.

Fyodor Urnov, PhD

Senior Advisor-at-large

Dr. Urnov is a Professor at the University of California Berkeley Dept of Molecular & Cell Biology, a Scientific Director at the Innovative Genomics Institute, and a Senior Advisor-at-large to Biovision Ventures.

His core research expertise is in CRISPR-based genome and epigenome editing, where he is widely regarded as one of the pioneers. Dr. Urnov is an author of 180+ scientific articles and publications. In addition to his academic career, Dr. Urnov served as the Chief Scientific Officer at Sangamo Therapeutics, where he demonstrated the first use of zinc fingers to edit DNA in human cells. He is also a co-founder of several high-profile life sciences startups in the US.

Dr. Urnov graduated from MSU with a degree in Virology, and received his PhD in Biology at Brown University.

Alex Lugovskoy, PhD

Senior Advisor

Dr. Lugovskoy is an Entrepreneur in Residence at Atlas Venture, CEO and founder of Diagonal Therapeutics, and a Senior Advisor to Biovision Ventures.

Alex has over 20 years of experience in senior roles and a strong track record of building value in biopharmaceutical companies in the US, including COO at Dragonfly Therapeutics, CDO at Morphic Therapeutic, Associate Director of Drug Discovery at Biogen, and others. He is an Associate Editor of mAbs, a multidisciplinary journal dedicated to antibody research and development, and an author of 100+ patents and manuscripts.

Dr. Lugovskoy received an MSc degree in Chemistry at MIT and a PhD degree in Biophysics at Harvard University. He also holds an Advanced Certificate for Executives in Management, Innovation and Technology from MIT Sloan School of Management.

Alex Lugovskoy, PhD

Senior Advisor

Dr. Lugovskoy is an Entrepreneur in Residence at Atlas Venture, CEO and founder of Diagonal Therapeutics, and a Senior Advisor to Biovision Ventures.

Alex has over 20 years of experience in senior roles and a strong track record of building value in biopharmaceutical companies in the US, including COO at Dragonfly Therapeutics, CDO at Morphic Therapeutic, Associate Director of Drug Discovery at Biogen, and others. He is an Associate Editor of mAbs, a multidisciplinary journal dedicated to antibody research and development, and an author of 100+ patents and manuscripts.

Dr. Lugovskoy received an MSc degree in Chemistry at MIT and a PhD degree in Biophysics at Harvard University. He also holds an Advanced Certificate for Executives in Management, Innovation and Technology from MIT Sloan School of Management.

Dmitry Samarsky, PhD

Senior Advisor

Dr. Samarsky is the Chief Technology Officer at Sirnaomics and a Senior Advisor to Biovision Ventures.

He is one of the leading authorities in the RNA field and has been at the inception of RNAi technology. Dr. Samarsky's experience includes senior roles in R&D in a number of companies, including Silence Therapeutics, RiboBio, and others. He has authored more than 40 scientific papers, articles, book chapters, patents and patent applications, and is a Distinguished Editorial Board Member of the Journal of RNA & Genomics.

Dr. Samarsky graduated from Ivan Franko National University of Lviv, Ukraine with a degree in Biochemistry, and received his PhD in Biochemistry and Molecular Biology at the University of Massachusetts, Amherst.

Dmitry Samarsky, PhD

Senior Advisor

Dr. Samarsky is the Chief Technology Officer at Sirnaomics and a Senior Advisor to Biovision Ventures.

He is one of the leading authorities in the RNA field and has been at the inception of RNAi technology. Dr. Samarsky's experience includes senior roles in R&D in a number of companies, including Silence Therapeutics, RiboBio, and others. He has authored more than 40 scientific papers, articles, book chapters, patents and patent applications, and is a Distinguished Editorial Board Member of the Journal of RNA & Genomics.

Dr. Samarsky graduated from Ivan Franko National University of Lviv, Ukraine with a degree in Biochemistry, and received his PhD in Biochemistry and Molecular Biology at the University of Massachusetts, Amherst.

Ron Newbold, PhD

Advisor

Dr. Ronald Newbold is the CEO of the Empire Discovery Institute in New York, Vice Chairman of the Board of the Licensing and Ventures Group at the University of Virginia, and an Advisor to Biovision Ventures.

Ronald is a scientist with a strong academic background and a business development executive for large and small biopharmaceutical companies, with over 27 years of experience including VP External R&D Innovation at Pfizer and SVP, Head of US Business Development & Alliance Management at Otsuka. He brings research and business experience with two Nobel laureates and collaboration with numerous world-class scientists and venture capital investors.

Ronald received his Ph.D. in Synthetic Organic Chemistry at the University of Rochester and a did postdoctoral fellowship at Harvard University. He also received an MBA at the Columbia University.

Ron Newbold, PhD

Advisor

Dr. Ronald Newbold is the CEO of the Empire Discovery Institute in New York, Vice Chairman of the Board of the Licensing and Ventures Group at the University of Virginia, and an Advisor to Biovision Ventures.

Ronald is a scientist with a strong academic background and a business development executive for large and small biopharmaceutical companies, with over 27 years of experience including VP External R&D Innovation at Pfizer and SVP, Head of US Business Development & Alliance Management at Otsuka. He brings research and business experience with two Nobel laureates and collaboration with numerous world-class scientists and venture capital investors.

Ronald received his Ph.D. in Synthetic Organic Chemistry at the University of Rochester and a did postdoctoral fellowship at Harvard University. He also received an MBA at the Columbia University.

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news

Immusoft Reports Promising Early Data for Lead Candidate in MPS I

October 17, 2024

Immusoft Reports Promising Early Data for Lead Candidate in MPS I

18.10.2024

Arda Therapeutics Secures $43M Series A Financing to Advance Targeted Cell Depletion Therapies

October 9, 2024

Arda Therapeutics Secures $43M Series A Financing to Advance Targeted Cell Depletion Therapies

9.10.2024

Elucid Receives U.S. 510(k) Clearance of PlaqueIQ™ Image Analysis Software to Aid Cardiovascular Disease Assessment

October 1, 2024

Elucid Receives U.S. 510(k) Clearance of PlaqueIQ™ Image Analysis Software to Aid Cardiovascular Disease Assessment

8.10.2024

Immusoft to Announce Positive Phase 1 Data for First Engineered B Cell Therapy in a Clinical Trial

September 23, 2024

Immusoft to Announce Positive Phase 1 Data for First Engineered B Cell Therapy in a Clinical Trial

24.9.2024

Pandica POC clinical trial results published in Pancreatology

September 14, 2024

Pandica POC clinical trial results published in Pancreatology

1.10.2024

Sorriso Pharmaceuticals Completes Enrollment in Phase 1b Clinical Trial of Patients with UC

September 3, 2024

Sorriso Pharmaceuticals Completes Enrollment in Phase 1b Clinical Trial of Patients with UC

10.9.2024

Contineum Therapeutics Announces Publication of Encouraging Data in PNAS on PIPE-307, Its M1 Receptor Selective Inhibitor, in Clinical Development for Relapse-Remitting Multiple Sclerosis

July 31, 2024

Contineum Therapeutics Announces Publication of Encouraging Data in PNAS on PIPE-307, Its M1 Receptor Selective Inhibitor, in Clinical Development for Relapse-Remitting Multiple Sclerosis

8.8.2024

Elucid Commences International PRE-VUE CCT Registry Study

July 18, 2024

Elucid Commences International PRE-VUE CCT Registry Study

10.9.2024

The DNA/RNA Revolution is Underway. Solving Specific Targeting is Next

July 15, 2024

The DNA/RNA Revolution is Underway. Solving Specific Targeting is Next

8.8.2024

Radar Therapeutics Raises $13.4M in Seed Funding to Develop Smart Programmable Medicines Using Molecular RNA Sensors

May 23, 2024

Radar Therapeutics Raises $13.4M in Seed Funding to Develop Smart Programmable Medicines Using Molecular RNA Sensors

23.5.2024

Sorriso Pharmaceuticals Announces First Patients Dosed in Phase 1b Clinical Trial for Patients with Ulcerative Colitis

May 17, 2024

Sorriso Pharmaceuticals Announces First Patients Dosed in Phase 1b Clinical Trial for Patients with Ulcerative Colitis

22.5.2024

Contineum Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

May 16, 2024

Contineum Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

14.6.2024

Contineum prices biotech’s latest IPO, raising $110M for neuroinflammatory drugs

April 5, 2024

Contineum prices biotech’s latest IPO, raising $110M for neuroinflammatory drugs

5.4.2024

A case report published on the application of PandiCath® technology to treat severe case of acute pancreatitis

January 27, 2024

A case report published on the application of PandiCath® technology to treat severe case of acute pancreatitis

4.3.2024

Immusoft: In a World First, a Patient’s Antibody Cells Were Just Genetically Engineered

December 15, 2023

Immusoft: In a World First, a Patient’s Antibody Cells Were Just Genetically Engineered

15.12.2023

Fierce Biotech: new Tune preclinical data suggests HBV therapy is hitting the right notes

December 7, 2023

Fierce Biotech: new Tune preclinical data suggests HBV therapy is hitting the right notes

12.12.2023

Tune Therapeutics Reveals Epigenetic Editing Program Targeting Hepatitis B Virus

November 13, 2023

Tune Therapeutics Reveals Epigenetic Editing Program Targeting Hepatitis B Virus

23.11.2023

Elucid closes $80m Series C for AI cardiovascular risk diagnostic tool

November 9, 2023

Elucid closes $80m Series C for AI cardiovascular risk diagnostic tool

13.11.2023

Tune Therapeutics Co-founder, Genome Editing Pioneer Fyodor Urnov on Commercializing CRISPR Therapies and Epigenomic Tuning

August 30, 2023

Tune Therapeutics Co-founder, Genome Editing Pioneer Fyodor Urnov on Commercializing CRISPR Therapies and Epigenomic Tuning

31.8.2023

Pipeline Therapeutics Announces First Subject Dosed with PIPE-791 in Phase 1 Study

August 1, 2023

Pipeline Therapeutics Announces First Subject Dosed with PIPE-791 in Phase 1 Study

15.8.2023

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791

June 8, 2023

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791

28.6.2023

Tune Therapeutics Unveils Breakthrough Data Showing Stable and Durable Epigenetic Regulation in Non-Human Primates

May 22, 2023

Tune Therapeutics Unveils Breakthrough Data Showing Stable and Durable Epigenetic Regulation in Non-Human Primates

15.8.2023

J&J opens the valve on $50M MS partnership with Pipeline

April 17, 2023

J&J opens the valve on $50M MS partnership with Pipeline

17.4.2023

Immusoft Acquires Exclusive, Worldwide Rights To Intellectual Property For Genome Edited Primary B Cells From The University Of Minnesota

March 27, 2023

Immusoft Acquires Exclusive, Worldwide Rights To Intellectual Property For Genome Edited Primary B Cells From The University Of Minnesota

28.6.2023

Immusoft Awarded $8M in Funding from CIRM for MPS I Clinical Program

January 27, 2023

Immusoft Awarded $8M in Funding from CIRM for MPS I Clinical Program

28.2.2023

Pipeline Therapeutics to Present Multiple Posters at SFN 2022 Neuroscience Annual Meeting

November 8, 2022

Pipeline Therapeutics to Present Multiple Posters at SFN 2022 Neuroscience Annual Meeting

8.1.2023

PanDх Ltd has attended the American Pancreatic Association 2022 Annual Meeting

November 6, 2022

PanDх Ltd has attended the American Pancreatic Association 2022 Annual Meeting

19.2.2023

Immusoft Announces FDA Clearance of IND Application for ISP-001 for MPS I, the First Engineered B Cell Therapy to Enter into Clinical Trials

September 2, 2022

Immusoft Announces FDA Clearance of IND Application for ISP-001 for MPS I, the First Engineered B Cell Therapy to Enter into Clinical Trials

8.1.2023

A new gene therapy based on antibody cells is about to be tested in humans

September 1, 2022

A new gene therapy based on antibody cells is about to be tested in humans

8.1.2023

Genetically-engineered B cells, the cells that make our bodies' antibodies, will be harnessed to treat a rare disease.

By Antonio Regalado

September 1, 2022

Computer illustration of plasma cells (B-cells, orange) secreting antibodies (white) against viruses (blue).

JUAN GAERTNER/SCIENCE PHOTO LIBRARY VIA GETTY

During the covid-19 pandemic, antibodies played a front-and-center role. We took vaccines in the hope our bodies would make more. In home test kits, antibodies stuck to paper strips helped spot the virus and tell us if we were infected.

Less attention was paid to B cells, the immune-system cells that actually make antibodies, churning out as many as 10,000 a second—and which, after an infection, can persist for years inside your bone marrow.

Now a biotechnology company based in Seattle says the US Food and Drug Administration has agreed to let it move forward with the first study in humans of a new type of gene therapy, using genetically engineered B cells. The company, Immusoft, plans to harness B cells to treat a rare inherited disease called MPS-1.

“I feel 100% confident in stating we are the first to get the green light to enter clinical trials,” says Sean Ainsworth, the CEO of Immusoft.

The concept is to engineer B cells so that they manufacture other proteins instead of antibodies. For MPS, what’s needed is an enzyme whose absence causes diverse and devastating symptoms.

Patients with the illness are currently treated with weekly infusions of the missing enzyme, but it’s not enough to cure the disease outright. Immusoft says it can engineer B cells to produce the enzyme instead.

Blood cures

The proposed MPS treatment, which is set to be tested sometime in the next six months at the University of Minnesota Medical School, is the latest example of an approach in which researchers carry out gene therapy on cells in the blood, genetically programming them to give them entirely novel functions.

The advantage of using blood-system cells to add new genes to a person’s body is that they can be removed from a patient, engineered in the lab, and then returned to the same person through an IV drip.

Of the approximately 15 gene therapies approved by regulators in the US or Europe, more than half involve adding gene cargo either to bone marrow stem cells (which make all red blood and immune cells) or to white blood cells called T lymphocytes.

According to the National Cancer Institute, six approved gene-therapy treatments for blood cancers in the US involve engineering T cells. Other gene therapies, like one for sickle-cell disease, involve completely replacing a person’s bone marrow with genetically corrected blood stem cells.

So far, B cells haven’t gotten the same attention—indeed, genetically engineered versions have never been tested in a human. That’s partly because “engineering B cells is not that easy,” says Xin Luo, a professor at Virginia Tech who in 2009 demonstrated how to generate B cells that have an added gene.

That early work, carried out at Caltech, explored whether the cells could be directed to make antibodies against HIV, perhaps becoming a new form of vaccination.

While that idea didn’t pan out, now biotech companies like Immusoft, Be Biopharma, and Walking Fish Therapeutics want to harness the cells as molecular factories to treat serious rare diseases. “These cells are powerhouses for secreting protein, so that’s something they want to take advantage of,” says Luo.

Immusoft licensed the Caltech technology and got an early investment from Peter Thiel’s biotech fund, Breakout Labs. Company founder Matthew Scholz, a software developer, boldly predicted in 2015 that a trial could start immediately. However, the technology the company terms  “immune-system programming” didn’t turn out to be as straightforward as coding a computer.

Ainsworth says Immusoft had to first spend several years working out reliable ways to add genes to B cells. Instead of using viruses or gene editing to make genetic changes, the company now employs a transposon—a molecule that likes to cut and paste DNA segments.

It also took time to convince the FDA to allow the trial. That’s because it’s known that if added DNA ends up near cancer-promoting genes, it can sometimes turn them on.

“The FDA is concerned if you are doing this in a B cell, could you develop a leukemia situation? That is something that they are going to watch pretty closely,” says Paul Orchard, the doctor at the University of Minnesota who will be recruiting patients and carrying out the study.

B-cell factories

The first human test could resolve some open questions about the technology. One is whether the enhanced cells will take up long-term residence inside people’s bone marrow, where B cells typically live. In theory, the cells could survive decades—even the entire life of the patient. Another question is whether they’ll make enough of the missing enzyme to help stall MPS, which is a progressive disease.  

“I don’t know if they are going to be successful, but it’s exciting for all of us that they have gotten permission to start a trial,” says Richard James, whose lab at the University of Washington is also developing approaches to engineering B cells.

James says a key advantage of the technology is that engineered cells won’t cause an immune reaction. By contrast, it’s believed that when gene therapies use viruses to get new DNA into the body, the patient will develop immunity to the treatment. That means if such therapies wear off—and there are mounting signs from medical studies that they do—poeple can’t get a second dose.  

“With cells, you can re-dose ad nauseam, because they aren’t immunogenic. You can give the patient a certain amount, add more, or don’t add more,” says James. The treatment also isn’t as grueling and intensive as replacing a person’s bone marrow.

If the treatment works for MPS, researchers have ideas for what diseases could be next. It has to be a condition where free-floating proteins in the blood, the kind pushed out by B cells, make a difference. Ainsworth says Immusoft is interested in using the cells to deliver follistatin, a gene that causes muscle growth, as a potential treatment for sarcopenia, or body wasting. Producing the clotting factors missing in hemophilia patients is another possible application.  

“The home run is to have a delivery system that is as safe as possible,” says Orchard. “We’ll have to wait and see.”

Correction: The original version of this article misstated the role of antibodies in Covid-19 test kits used at home. The tests do not detect antibodies. Instead, the tests use antibodies to detect the SARS-CoV-2 virus.

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Immusoft, a cell therapy company dedicated to improving the lives of patients with rare diseases, announced today that it has signed a research collaboration and license option agreement with Takeda Pharmaceutical Company Limited ("Takeda") to discover, develop and commercialize transformative cell therapies in rare inherited metabolic disorders with central nervous system (CNS) manifestations and complications using Immusoft’s Immune System Programming (ISP™) technology platform, which modifies a patient’s B cells and instructs the cells to deliver gene-encoded therapies. The collaboration will focus on delivering protein therapeutics across the blood-brain barrier, a promising area of Immusoft’s research, which has the potential to enable the treatment of diseases with high unmet need.

We continue to build our internal capabilities as well as partner with innovative companies early on in the discovery process to advance our next-generation gene and cell therapy ambitions for rare genetic and hematologic diseases
Vitali Proutski — CEO and co-founder of PanDx

Under the terms of the agreement, Immusoft will receive an undisclosed upfront payment and research funding support. The company is also eligible to receive future option fees and milestone payments with a total potential value of more than $900 million if all options are exercised and all milestones are achieved over the course of the partnership. Takeda has options to exclusively license the programs at the preclinical stage and Immusoft is eligible for tiered royalties on future products resulting from the partnership. Takeda would be responsible for further preclinical and clinical development, and commercialization.

Immusoft and Takeda partner to discover and develop cell therapies for rare inherited metabolic disorders. Credit: Belova59 / Pixabay.

About Immusoft

Immusoft is a cell therapy company focused on developing novel therapies for rare diseases using a sustained delivery of protein therapeutics from a patient’s own cells. The company is developing a technology platform called Immune System Programming (ISP™), which modifies a patient’s B cells and instructs the cells to produce gene-encoded medicines. The B cells that are reprogrammed using ISP become miniature drug factories that are expected to persist for many years. The company is based in Seattle, WA. For more information, visit www.immusoft.com.

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