CELL AND GENE THERAPY

Exact Sciences Acquires PreventionGenetics to Accelerate Availability of Hereditary Cancer Testing for More Patients

Exact Sciences Corporation | January 10, 2022

Exact Sciences Corp. announced it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases.

"PreventionGenetics is a natural fit with Exact Sciences, and we're thrilled to have their talented team join in our mission to make earlier cancer detection a routine part of medical care. We share in PreventionGenetics' belief that genetics can transform medicine, improve lives, and help eradicate cancer. With our deep relationships in primary care and PreventionGenetics' strong reputation among genetics specialists, Exact Sciences can help more people understand their inherited risk of cancer to catch it earlier and treat it more effectively."

Kevin Conroy, Exact Sciences chairman and CEO

Nearly 300,000 health care providers and more than 200 large U.S. health systems rely on Exact Sciences' Cologuard® and Oncotype DX® tests in primary care, women's health, oncology, and other specialties. In partnership with the PreventionGenetics team, Exact Sciences plans to leverage its unmatched commercial reach in diagnostics to expand hereditary cancer and genetic testing throughout the U.S. and globally.

PreventionGenetics is a CLIA-certified and CAP-accredited clinical DNA testing laboratory, providing more than 5,000 predefined genetic tests for nearly all clinically relevant genes, additional custom panels, and comprehensive germline whole exome and whole genome sequencing tests. With a goal to improve lives through genetic testing, PreventionGenetics offers tests spanning decades of life including proactive health and wellness, cancer risk and screening, pediatric and adult-onset rare diseases, and others. These high-quality genetic tests are supported by deep sequencing capabilities and more than 100 peer-reviewed publications.

Like Exact Sciences, the PreventionGenetics team is relentless in their pursuit of quality. This focus, combined with a best-in-class customer experience and turnaround times, has earned PreventionGenetics a strong reputation and brand recognition among genetics specialists and counselors.

Transaction Terms
Under the terms of the agreement, PreventionGenetics received total consideration of $190 million, comprised of 50% in Exact Sciences common stock and 50% in cash. PreventionGenetics expects preliminary, unaudited 2021 revenue of approximately $36 million and $3 million in adjusted EBITDA. XMS Capital served as financial advisor to Exact Sciences and K&L Gates served as its legal advisor. CrossTree Capital served as financial advisor to PreventionGenetics, and Winston & Strawn served as legal advisor.

About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome® and whole exome sequencing test, PGxome®.

About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer.

Spotlight

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

Spotlight

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

Related News

CELL AND GENE THERAPY

Casma Therapeutics Raises $46.0 M in Series C Funding

Casma Therapeutics, Inc. | November 21, 2022

Casma Therapeutics, Inc., a biotechnology company engaging the autophagy system to provide innovative new medicines, announced the closing of a Series C financing round of $46.0 million. New investors participating in the round include Amgen Ventures, LLC, Astellas Venture Management, Eisai Co., Ltd., Euclidean Capital, Mirae Asset, and Ono Venture Investment. Current investors Eventide Asset Management, LLC, Schroders Capital, The Column Group, Third Rock Ventures, and other funds also participated in the financing. Dr. Hiromichi Kimura, Investment Director of Astellas Ventures, has joined the board of directors. Dr. Tomotaka Okino of Ono Venture Investment and Amgen Ventures have joined as board observers. Casma will use proceeds to advance its lead program for MYD88 mutant lymphoma through preclinical and into IND enabling studies. “The closing of this financing has strengthened our resources to continue advancing our drug pipeline focused on autophagy-based degradation. We are thrilled to welcome several top-tier investors who recognize the potential of our biological platforms and therapeutic assets targeting well-known high-value and traditionally undruggable targets.” Keith Dionne, Ph.D., Chief Executive Officer of Casma Therapeutics, Inc "Casma’s autophagy-based degradation platform, PHLYT™, is unique and impressive,” commented Dr. Kimura. “Along with a rich pipeline of autophagy degraders, the company has also established a highly qualified team with extensive scientific experience in drug development. We expect that this round of funding will accelerate development of Casma’s pipeline assets, especially its degrader for MYD88 mutant tumors.” About Casma Therapeutics, Inc. Casma Therapeutics, Inc. is developing novel cellular degradation approaches based on the autophagy pathway to open new target areas for drug discovery and development that will profoundly impact the lives of patients. Autophagy is a conserved cellular process that contributes to overall cellular homeostasis. The autophagy machinery targets large and complex disease targets such as organelles, protein aggregates and large signaling complexes and before directing them to the lysosome for elimination. By selectively degrading disease targets by autophagy, Casma expects to arrest or reverse the progression of disease in multiple oncology, inflammation, neurodegeneration, and metabolic disorders.

Read More

CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Enlaza Therapeutics Launches with $61 Million Financing to Advance the First Covalent Biologic Therapeutic Platform

Enlaza Therapeutics | December 19, 2022

Enlaza Therapeutics, the first covalent biologic platform company, announced its official launch with the closing of $61 million in seed financing. The financing was led by Avalon Ventures and joined by Lightspeed Venture Partners, Frazier Life Sciences, and Samsara BioCapital. The financing will be used to further advance Enlaza’s proprietary War-LockTM platform and build a pipeline of covalent biologics with an initial focus on developing novel, differentiated cancer therapeutics with targeted efficacy and low toxicity. “We’ve combined recent breakthroughs that allow introduction of proprietary unnatural amino acids to protein drugs, which enables specific covalent binding to their target proteins. Our covalent biologic platform is white-space technology, and we are pioneering an entirely new class of biologic therapeutics with the potential for significantly improved efficacy and safety to address numerous indications and disease areas.” Sergio Duron, Ph.D., CEO of Enlaza Therapeutics “Enlaza has built a highly differentiated therapeutic platform which, for the first time, will enable covalent biologics,” said Jay Lichter, Ph.D., Managing Partner of Avalon Ventures. “The platform provides the opportunity to develop drugs against multiple target classes, offering opportunities across all therapeutic areas.” The War-Lock platform creates highly specific therapeutic warheads that lock onto targets of interest, producing broadly applicable therapeutic candidates with excellent drug-like properties. For example, protein drugs derived from the platform can be modified to incorporate various payloads, creating antibody-drug conjugates (ADCs) or radioligand therapies (RLTs) with specific target tissue delivery, without the need for half-life extension engineering. Enlaza has generated preclinical data for its oncology drug candidates showing fast tumor penetration coupled with high systemic clearance, high tumor retention, and low off-target toxicity. “The breadth of Enlaza’s platform will be transformative across multiple modalities,” said Shelley Chu, M.D., Ph.D., Partner at Lightspeed Venture Partners. Marcos Milla, Ph.D., Venture Partner at Samsara BioCapital said, “The Enlaza platform opens the possibility to enhance the therapeutic index of biologic drugs in a way that is not accessible with platforms relying on conventional recombinant technologies. It also offers an opportunity to address hard to target cell surface molecules in a highly specific fashion.” “We are impressed with the in vitro and in vivo data the team has generated and believe that Enlaza can build an industry leading pipeline of important new protein drugs employing its incomparable technological advantage,” said Jamie Topper, M.D., Ph.D., Managing Partner of Frazier Life Sciences. Enlaza’s War-Lock platform is based on technologies exclusively licensed from UCSF, negotiated through UCSF’s Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the University, and The Scripps Research Institute. About Enlaza Therapeutics Enlaza Therapeutics is pioneering the field of covalent biologics. These novel classes of protein therapeutics deliver more efficacious and safer treatments for patients. The company's proprietary War-LockTM platform leverages leading synthetic biology technology for site-specific covalent coupling driven by drug binding. Enlaza is building a pipeline of first-in-class covalent biologics.

Read More

INDUSTRIAL IMPACT

FogPharma Announces $178 Million Series D Financing to Advance Pipeline of First-in-Class Helicon Polypeptide Therapeutics Targeting

FogPharma | November 22, 2022

FogPharma®, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to the vast majority of therapeutic targets, including those previously considered “undruggable,” today announced a $178 Million Series D financing. The financing round includes new investors ARCH Venture Partners, Milky Way Investments and Fidelity Management & Research Company and existing investors VenBio Partners, Deerfield Management, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Farallon Capital Management, HBM Healthcare Investments, Casdin Capital, and PagsGroup, also participated. Proceeds from the Series D financing will be used to advance and accelerate FogPharma’s growing pipeline of hyperstabilized α-helical polypeptide therapeutics, a proprietary new class of drugs designed to overcome the limitations of today’s precision medicines with broad applicability to the vast majority of disease targets and therapeutic areas. FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor with potential applicability to significant cancer patient populations, is expected to enter clinical development in mid-2023. In addition, FogPharma is advancing other first-in-class programs against important, biologically validated cancer targets that have remained elusive to other approaches including TEAD, NRAS, Pan-KRAS, ERG and Cyclin E1. “FogPharma continues to make rapid progress on our moonshot mission to achieve universal druggability – a world where no targets are off-limits to medicine. We believe that Helicon polypeptides, a compelling new therapeutic modality, represent the future of precision medicine. We are thrilled by the support of our investors and will continue to build our platform capabilities, product pipeline which aims to address a significant percentage of cancer patient populations, and our phenomenal team across all levels as we aim to create one of the most impactful new classes of drugs in history.” Gregory Verdine, Ph.D., founder, chairman and chief executive officer of FogPharma In connection with the Series D Financing, Rick Klausner, M.D., has been appointed to FogPharma’s board of directors. In addition, Dr. Verdine has been appointed as chairman of the board. “The team at FogPharma is building an unprecedented new therapeutic modality and robust pipeline with the potential to make a meaningful difference in the lives of cancer patients,” said Dr. Klausner. “I am excited to join the board of directors and be part of something special – particularly at this important time as FogPharma continues to impressively scale its science, team, operations and infrastructure, with the goal of advancing its first Helicon polypeptide therapeutic into the clinic.” Dr. Klausner is currently the founder and chief scientist of Altos Labs and founder and chairman of Lyell Immunopharma. Dr. Klausner was founder and director of Juno Therapeutics and founder and director of GRAIL. He is also the chairman of Sonoma Biotherapeutics and co-founder and chairman of Lifemine Therapeutics. Previously, Dr. Klausner served as senior vice president, chief medical officer and chief opportunity officer of Illumina Corporation and as executive director for global health for the Bill and Melinda Gates Foundation. Dr. Klausner was appointed by Presidents Clinton and Bush as the eleventh director of the U.S. National Cancer Institute (NCI) between 1995 and 2001. Dr. Klausner served as chief of the Cell Biology and Metabolism Branch of the National Institute of Child Health and Human Development as well as a past president of the American Society of Clinical Investigation. He has served in senior advisory roles to the U.S., Norwegian, Qatari and Indian governments. About FogPharma’s Universal Druggability Platform and Helicon™ Polypeptide Therapeutics Existing drug classes are limited in both reach and applicability, with more than 80% of known human protein disease targets considered “undruggable” because they are beyond the reach of both antibodies and small molecules. FogPharma’s Helicon peptide drug discovery engine integrates directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, artificial intelligence including deep learning and machine learning, structure-based drug discovery, cancer genomics and biology, and multiscale manufacturing to rapidly discover Helicon polypeptide therapeutics. This novel therapeutic modality combines the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules to address the limitations of today’s precision medicines and reach the most difficult targets – achieving universal druggability. About FOG-001 FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor. Dysregulation of the Wnt/β-catenin signaling pathway has been shown to occur in at least 20% of all human cancers. In the U.S. alone, FOG-001 has the potential to become a new treatment option for >1 million patients suffering from a broad range of intractable cancers. In biochemical and cellular studies, FOG-001 has been shown to potently, precisely and selectively disrupt the interaction of β-catenin with its obligate downstream transcription factor, TCF. Preclinical studies have demonstrated the ability of FOG-001 to cause tumor growth inhibition and regression by disrupting β-catenin-dependent signaling. FOG-001 is the inaugural member of FogPharma’s TCF-Catenix family of direct-acting β-catenin antagonists and combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell, where it directly binds the key oncogenic driver β-catenin; and FOG-001 blocks TCF-β-catenin engagement at the most downstream node in the canonical Wnt pathway, thus abrogating the signal transmission mechanism by which most, if not all, known Wnt pathway mutations are believed to drive oncogenesis. About FogPharma FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ polypeptides. Through this novel therapeutic modality, FogPharma aims to address the limitations of existing drug classes and achieve universal druggability – a world where no targets are off-limits to new medicines. Spun out of Harvard University by pioneering academic scientist and successful biotech company builder Dr. Gregory Verdine, FogPharma is advancing a broad pipeline of Helicon polypeptide therapeutics against important and biologically validated cancer targets that have remained elusive to other approaches, with the goal of providing new targeted treatment options for significant cancer patient populations. FogPharma is headquartered in Cambridge, Mass., and has raised more than $360 million to date from leading life sciences investors.

Read More