Participated · Series C · Aug 2022

Senda Biosciences is a Cambridge, MA-based company that leverages nature to program targeted, potent, and tunable medicines. Its proprietary programmable medicines platform includes an mRNA engine and an atlas of nature-derived programmable systems at the molecular level across all kingdoms of life. Using that platform, Senda is developing a new class of SendRNA™ medicines intended for infectious, genetic, metabolic, and autoimmune diseases, as well as oncology, and to advance mRNA therapeutics, vaccines, gene-editing, and protein-based therapies. The company says it programs human cells both from within and from outside to create targeted and tunable therapeutic effects. Led by CEO Guillaume Pfefer, Senda plans to use recent funding to drive further development of its platform and advance its first programs into clinical testing. The company positions its technology as accessing the full code provided by nature required to program cells. Senda Biosciences, based in Cambridge, Mass., develops medicines by harnessing molecular interactions that have evolved between humans, plants, and bacteria. Its platform enables deployment of proteins or genetic material throughout the body, tunable modulation of the immune system, and precise intervention at the point of interaction between human and non-human species. The company is led by CEO Guillaume Pfefer, Ph.D., and CSO Scott Plevy, M.D. Proceeds from the financing will be used to advance the development of the company’s platform and its therapeutic programs into clinical trials. Senda raised a $55M Series B extension, bringing total Series B funding to $98M and total funding raised to date to $143M. Flagship Pioneering, Senda’s founder, participated in the round alongside new and existing investors. Senda Biosciences combines microbiome science, computational biology, environmental genomics and AI to develop new therapeutics that act in the gastrointestinal tract with minimal systemic exposure. The company launched with $88 million in funding from Flagship Pioneering and is a 50‑person startup. Senda is the product of a merger that includes Kintai Therapeutics and three other Flagship ventures; Kintai had launched with about 60 employees and was working on ulcerative colitis and metabolic syndrome programs. Leadership includes CEO Guillaume Pfefer, a former GlaxoSmithKline executive, and CSO Scott Plevy, formerly of Synlogic and Janssen. Senda expects to ask the FDA to begin six clinical trials by the end of 2022 targeting multiple sclerosis, Parkinson’s disease, chronic kidney disease, obesity and cancer. Company executives say their medicines are designed not to be uptaken, enabling disease modification or prevention with zero systemic exposure, and they aim for greater precision than many current microbiome approaches.

Participated · Series C · Apr 2022

Tessera Therapeutics has built a GENE WRITING platform that programs Mobile Genetic Elements to write and rewrite DNA in human cells. The platform can change any base pair to any other, make small insertions or deletions, and write entire genes into the genome using delivery of only RNA. Tessera has evaluated and engineered tens of thousands of natural and synthetic MGEs and further optimizes candidates for efficiency, specificity, and fidelity. The company positions GENE WRITING as a distinct approach from nuclease-based editing (e.g., CRISPR) with potential applications across genetic diseases, cancer, and preventive medicines. Tessera says the technology could enable curative, scalable, and easily administered genetic medicines both in vivo and ex vivo. Financially, the company announced it raised over $300 million in a Series C to advance the platform and its mission of curing disease by writing in the code of life. Tessera Therapeutics, founded by Flagship Pioneering and unveiled in July 2020, is developing a platform called Gene Writing that can change base pairs, make small insertions or deletions, and write entire genes into the genome. The company says its platform can engineer somatic genomes without double-stranded breaks and with minimal reliance on host DNA repair, permanently add new DNA to dividing cells, and deliver new sequences using only RNA. Tessera positions Gene Writing as a distinct approach that overcomes limits of nuclease-based gene editing and AAV-based gene therapy. The technology is intended to expand the range of diseases tractable by genetic approaches, including cardiovascular, oncological, neurodegenerative, and infectious diseases. Tessera plans to use new capital to accelerate research and development, expand its team, and build manufacturing and automation capabilities to advance multiple therapeutic programs toward clinical development.

Participated · Series B · Nov 2021

Biolinq is a healthcare technology company developing precision intradermal biosensors to improve metabolic health. Its initial product is a wearable biosensor patch with an array of tiny electrochemical microsensors that measure glucose continuously just beneath the skin’s surface, providing real-time feedback via a color-changing indicator light on the upper forearm. The device is designed to combine glucose monitoring with activity and sleep information to support people with Type 2 diabetes not on insulin. Biolinq’s platform is positioned for future multi-analyte sensing capabilities and the company says it has spent the last decade developing the underlying technology. The company recently completed a US pivotal trial and submitted for regulatory review; its intradermal glucose sensor remains investigational and is not yet FDA cleared. A $100 million Series C will finance the company’s push from development toward commercial readiness as it pursues US regulatory approval; Biolinq is headquartered in San Diego. Biolinq develops a wearable patch that uses an array of tiny electrochemical microsensors placed in the intradermal space to measure glucose and relative activity from just beneath the skin surface. The device is designed for simplicity and user feedback, with an intuitive on-device display that notifies users when glucose is within or outside target ranges. Its sensor array is engineered for redundancy, reliability and multi-analyte capabilities without the use of introducer needles or bleeding. Biolinq describes the intradermal glucose sensor as investigational and not yet cleared or approved by the FDA. The company is headquartered in San Diego, CA. Proceeds from the completed financing will fund completion of a U.S. pivotal clinical trial this year and support a subsequent FDA submission. Biolinq is developing a wearable biosensor platform whose first product is a needle-free, intelligent continuous glucose sensor with a novel integrated display on the device. The device leverages semiconductor-industry innovation to miniaturize electrochemical sensors into a micro-array of miniature biosensors roughly 25 times smaller than conventional glucose sensors, enabling redundant measurements for reliability. Early feasibility studies demonstrated the microarray patch can track glucose continuously for up to seven days in people with diabetes. Biolinq’s approach includes multiplexed sensing capabilities and immediate biosensor feedback designed to simplify diabetes management and support future consumer health and wellness applications. The company is advancing clinical, regulatory, manufacturing and commercialization milestones to expand the sensing category. Financially, Biolinq completed a $100 million Series B financing, described as a record private capital raise in the continuous glucose monitoring space, with a broad syndicate of strategic and financial investors. Biolinq is developing a skin-applied, minimally-invasive electrochemical biosensor platform that analyzes interstitial fluid to provide actionable health information. Its first commercial product aims to let people with diabetes continuously monitor blood glucose without the pain and hassle of traditional continuous glucose monitoring systems. The platform is wirelessly enabled and designed to simultaneously measure multiple biomarkers, enabling a pipeline of biomonitoring products. Biolinq plans to use new financing to support growth of its technology platform and to fund additional clinical studies. The company completed its first clinical study in 2018 and reports promising initial clinical results. Biolinq was founded in 2012 and is located in San Diego. Biolinq develops a skin-applied, minimally-invasive electrochemical biosensor platform that analyzes biomarkers in interstitial fluid. Its wirelessly-enabled, nickel-sized biosensor patch is designed to continuously monitor multiple biomarkers and its first commercial product targets blood glucose monitoring without the pain and hassle of traditional CGM systems. The company emphasizes factory calibration (no finger sticks), low cost-of-goods, high manufacturing uniformity, and ease of use. Biolinq intends to leverage its novel manufacturing approach to increase access to CGM and simplify diabetes management. The platform’s ability to simultaneously measure multiple biomarkers supports plans to build a pipeline of additional biomonitoring products. Biolinq was founded in 2012 (as Electrozyme, LLC) and is located in San Diego.

Participated · Series B · Aug 2020

Exo develops a handheld ultrasound device together with Exo Works, a point-of-care workflow platform that streamlines exam review, documentation and billing in under one minute. The device combines artificial intelligence, medical imaging and silicon technology to enable use in settings from cardiology to lung scans and at-home monitoring. Exo says the device will cost around the price of a laptop, aiming to make ultrasound more widely accessible. The company is focused immediately on commercializing the device, building out its informatics platform (currently being piloted across the U.S.), and ramping production and its sales force. Exo has raised over $320 million in total funding since its 2015 founding, including a $40 million raise in 2020. The company plans to bring the handheld device to market after securing U.S. FDA approval and is based in Redwood City, California. Exo is developing a handheld ultrasound device built on patented Piezoelectric Micromachined Ultrasound Transducer (pMUT) technology intended to deliver industry-leading image quality, affordability and portability. The device is paired with cloud-based workflow software and data apps designed to improve interoperability, documentation and clinician workflow in emergency and critical care settings. Exo will use its Series B+ funding to finish product development and bring its data and workflow apps to market. The company says its technology is intended to image denser body compositions and provide powerful diagnostic capabilities for frontline physicians. Exo highlights a team with experience from Apple, GE, Google, Johnson & Johnson, Maxim, Medtronic and Siemens and envisions a multi-functional platform that could converge diagnostics and therapeutics. Financially, the Series B+ follows an August 2019 Series B that raised $35 million and brings Exo’s total funding to nearly $100 million.

Participated · Series C · Jun 2020

4D Molecular Therapeutics is a clinical-stage precision gene medicines company that harnesses directed evolution to develop precision-guided AAV gene therapies. Its proprietary Therapeutic Vector Evolution platform enables a disease-first approach to customize AAV vectors to target specific tissues, aiming for targeted delivery, efficient transduction, reduced immunogenicity, and resistance to pre-existing antibodies. The company focuses on lysosomal storage diseases, ophthalmology, neuromuscular diseases, and cystic fibrosis and pursues both rare and large-market indications. Proceeds from the recently closed financing will be used to advance multiple product candidates through initial clinical proof-of-concept, expand internal GMP manufacturing capabilities, and progress the pipeline and next-generation platform. 4DMT expects to initiate clinical trials in 2020 for 4D-310 (Fabry disease), 4D-125 (X-linked retinitis pigmentosa, subject to an exclusive option for Roche), and 4D-110 (choroideremia, licensed to Roche), and is supporting IND-enabling studies for 4D-710 (aerosol treatment for cystic fibrosis). The company designs vectors to enable routine clinical routes and improved therapeutic profiles to address previously untreatable patient populations. 4D Molecular Therapeutics develops targeted, customized next-generation adeno-associated virus (AAV) gene therapy products using its Therapeutic Vector Evolution discovery platform. The platform applies principles of evolution and natural selection across over 100 million unique AAV variants from more than 35 proprietary libraries to identify vectors that target specific tissues via clinically optimal routes at lower doses. 4DMT engineers vectors with resistance to pre-existing antibodies to improve delivery and efficacy across organs and disease indications. The company intends to treat both rare genetic diseases and larger-market conditions through internal programs and partnered programs. Its lead intravitreally delivered AAV gene therapy candidate for choroideremia is expected to enter clinical trials in 2019. Proceeds from the recent financing will be used to advance the Therapeutic Vector Evolution platform and the company’s pipeline. 4DMT uses a Therapeutic Vector Evolution discovery platform to create proprietary AAV vectors optimized for specific target cells, organs, routes of administration, and antibody evasion. Its lead pulmonary program, 4D-710, employs an AAV vector designed to deliver CFTR to lung airway cells via aerosolized delivery. The company is advancing multiple internal products toward clinical trials while also partnering with biopharma companies including Pfizer, Roche, uniQure, AGTC and Benitec. 4DMT says its platform deploys roughly 100 million unique AAV variants and applies selection methods to identify highly optimized vectors. Management includes co-founders David Kirn (CEO) and David Schaffer (acting CSO), who emphasize collaboration with clinicians and patient advocates. The article reports targeted IND-enabling work for 4D-710 supported by non-dilutive funding from the Cystic Fibrosis Foundation Therapeutics.