RareCyte Raises $22M Financing Round

RareCyte, Inc., a Seattle, WA-based life sciences company, completed a $22M financing round.

The round was led by HealthQuest Capital, with participation from 5AM Ventures and company founder, Ron Seubert. In conjunction with the funding, David Kabakoff, PhD, Partner at HealthQuest Capital, joined the RareCyte Board of Directors. Andy Schwab, Managing Partner at 5AM Ventures also joined the RareCyte Board.

The company intends to use the funds to globally expand the sales of its instrument and consumables platform used in research and clinical markets, develop applications for its new tissue multiplexing platform, and release new liquid biopsy assays.

Led by Joe Victor, President and CEO, RareCyte offers fully integrated solutions for high resolution multiplex rare cell analysis of blood and tissue samples from preclinical through clinical and translational research enabling development of next generation precision medicines for numerous therapeutic areas including immuno-oncology.

The company’s platform which includes AccuCyte® Sample Preparation, RarePlex® Staining Kits, CyteFinder® Instruments, and the CytePicker® Retrieval Module, has been adopted by academic medical institutions and biopharma companies to gain a richer understanding of complex diseases, such as cancer.

Leveraging microscope slides as the substrate, the platform fits into clinical laboratory workflows and enables high-throughput processing of blood and tissue samples from clinical studies of all sizes. CyteFinder can analyze up to seven biomarker channels using immunofluorescent staining to facilitate deeper analysis of rare cell phenotypes.

The integrated CytePicker retrieves single cells of interest, allowing customers to build unique phenotype and genotype datasets at the single cell level to advance their research and clinical programs.

Source. FinSMEs. December 23, /2019

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Achilles Therapeutics raises $120M in Series B round for cancer cell therapy

Stevenage, U.K.-based Achilles Therapeutics said Tuesday that it had raised 100 million pounds – equal to about $120 million – in a Series B round, led by RA Capital Management. Founding investor Syncona participated, along with Forbion, Perceptive Advisors and Redmile Group.

The company said proceeds for the round will be used to launch two clinical trials of its product candidates in non-small cell lung cancer and melanoma. Its pipeline page lists multicenter Phase I/IIa studies for both indications. Both trials are listed also on ClinicalTrials.gov, with the page for the NSCLC study stating it is currently open for recruitment.

Achilles’ approach involves personalized T-cell therapies that target clonal neoantigens, which are protein markers unique to each patient that are present on the surface of cancer cells. The starting material for the products, known as clonal neoantigen T cells – or cNeT – consists of T cells isolated from a tumor sample known as tumor-infiltrating lymphocytes, or TILs.

“The Achilles approach integrates years of multi-disciplinary scientific and clinical knowledge from immuno-oncology, cell therapy and genomics with the goal of creating a TIL-based therapeutic enriched with T cells reacting against clonal neoantigens,” RA Capital Management Derek DiRocco said in a statement. “We believe this approach may represent the optimal way to expand the utility of polyclonal TIL therapy to multiple solid tumor types and has the potential to provide profound clinical benefit for patients living with cancer.”

TILs represent one of multiple kinds of cell therapies currently in development for cancers. Another company developing them is Iovance, which said in July that, per discussions with the Food and Drug Administration, it could use data from its Phase II study of a TIL in cervical cancer to seek the agency’s approval.

Other types of cell therapies include T-cell receptors, or TCRs, and chimeric antigen receptor T-cells, or CAR-T. Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel) are CAR-Ts with FDA approval for blood cells, both targeting the CD19 antigen.

Source. Medcity News, Alaric Dearment, September 4, 2019

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VeriSIM Life Raises $5.2M in Funding

VeriSIM Life, a San Francisco, CA-based company that is building digital animal and human simulations to avoid unnecessary drug testing in animals, raised $5.2M in funding.

The round was co-led by OCA Ventures and Serra Ventures with participation from Susa Ventures, Intel Capital, Stage Venture Partners, Village Global, Twin, and Loup Ventures.

The company intends to use the funds to optimize its models through expanded academic partnerships, grow a team to include talent in the engineering and operations space, and engage larger pharma institutions.

Led by Dr. Jo Varshney, DVM/PhD, Founder and CEO, a multi-disciplinary veterinary, along with a team of scientists and engineers in machine learning and in silico simulation, VeriSIM Life uses expertise in machine learning and engineering to produce models that serve as “digital” animals and humans.

The company is now looking to source additional opportunities with more partnering companies in the biotech and pharma space, inclusive of medical development impacting both humans and animals. With prior launches into partnerships and co-development with big companies, academia and CROs, VeriSIM

Life is now positioned to continue their proof of concept and fully implement solutions for companies looking to move from bench to bedside.

Source. FinSMEs, Staff, August 14, 2019

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AI drug discovery company Recursion Pharmaceuticals raises $121M Series C

Salt Lake City-based biotech Recursion Pharmaceuticals, which is part of the group of companies looking to use AI technology to accelerate drug development, has raised a $121 million Series C financing round led by Scottish Mortgage Investment Trust.

New participants in the round include institutional investors like Intermountain Health, the University of Minnesota and the Texas Tech University System.

Recursion’s technology works by generating millions of cellular images and using AI-based software as a way to analyze the data set and screen potential therapeutic compounds against a variety of diseased cells.

The new capital will go towards building out the company’s machine learning-based drug development system to add new features to predict pharmacology safety and the discovery of new chemical entities.

Resources will also be directed at helping to build out the company’s clinical pipeline, which includes clinical-stage programs for neurological diseases cerebral cavernous malformation and neurofibromatosis type 2. The company also has pre-clinical programs for conditions like Batten disease, Tay-sachs disease and hereditary hemorrhagic telangiectasia.

“With these new resources, we will continue to drive toward a future in which drugs are developed—by people—with a new level of understanding about human biology that was simply not possible before machines,” Recursion CEO Chris Gibson said in a statement.

While Recursion is prioritizing its own drug development programs. the company also plans to continue to explore partnerships with big pharma companies in areas including immuno-oncology, oncology, aging and inflammation.

Earlier this year, Takeda Pharmaceutical exercised an option for drug candidates in two rare diseases based on the Recursion’s efforts and extended their drug discovery collaboration. Recursion also launched a research partnership with Sanofi to help the company identify new uses for its clinical stage small molecules.

Investors put more than $1 billion last year into companies exploring applications meant to use AI to accelerate drug discovery drawn in by the ability to apply technology to the expensive and laborious process of developing new therapies.

New York AI biotech company Schrödinger closed a $110 million earlier this year and Daphne Koller’s Insitro raised a $100 million Series A and announced a $250 million machine learning partnership with Gilead to develop NASH drugs.

Source. MedCity News, Kevin Truong, July 16, 2019 

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Houston-based AlloVir Raises $120 Million Series B For Virus-Targeting Immunotherapies

By James Rowley 

Houston-based biopharmaceutical company AlloVir (formerly known as ViraCyte) recently announced $120 million in Series B funding. Fidelity Management and Research Company led the deal. Participating investors include Gilead Sciences, F2 Ventures, Invus, Leerink Partners, Redmile Group, EcoR1 Capital, and Samsara BioCapital.

AlloVir is also the first venture to publicly join the portfolio of ElevateBio, a recently-launched Cambridge, MA-based company which aims to advise and assist cell and gene therapy upstarts throughout the discovery, development, and commercialization lifecycle. Earlier this month, ElevateBio announced it raised $150 million in venture funding led by UBS Oncology Impact Fund. AlloVir financiers Samsara BioCapital, Redmile Group, and EcoR1 Capital also back ElevateBio.

According to a press release published by ElevateBio on Wednesday, AlloVir “is a leading innovator in allogenic, off-the-shelf, multi-virus specific T-cell immunotherapies.” What does that mean?

Let’s break it down:

“Allogenic,” meaning, basically, that biological material used to create the company’s treatments are sourced from (compatible) donors, rather than from the patient themselves.

 

“Off-the-shelf,” in this specific case, means that AlloVir’s products could be integrated into a treatment regime immediately, sitting in storage in the meantime. In the context of T-cell therapeutics (which we’ll get to in a moment), a treatment wouldn’t be “off the shelf” if it required sampling, modifying, and culturing cells from the patient.

 

Jumping out of order a bit: T cells are a foundational part of the human immune system. There are many types of T cells, all of which play specific roles in responding to infection. Cancer patients, HIV positive people, transplant recipients, people with chronic infections, people with autoimmune diseases, or other immuno-suppressed populations have lower counts of these key cells. This makes them more susceptible to infection and illness.

 

According to AlloVir, its primary T cell therapy offering, Viralym-M (ALVR105), can target six different viral pathogens, including: BK virus (which can affect kidney transplant patients), cytomegalovirus, adenovirus, Epstein-Barr virus (which causes mononucleosis, aka “mono”), JC virus, and human herpesvirus 6.

Preliminary research findings on the company’s next therapy, ALVR106, which “targets four common and devastating community-acquired respiratory viruses” were published in the journal Haematologica last month.

So, basically, AlloVir is in the business of sourcing and training immune cells from healthy donors to fight viral infections in folks with compromised immune systems.

AlloVir’s therapies are still in clinical trials. The company published results from its Phase 2 study in the Journal of Clinical Oncology, finding that 93 percent of treated patience "demonstrated a clinical response (or met clinical response criteria) following treatment with Viralym-M.” ElevateBio CEO David Hallal told Xconomy that AlloVir will start Phase 3 trials of Viralym-M in 2020.

AlloVir’s as-yet-unnamed ALVR106—targeting respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus—is expected to enter the first phase of clinical trials within the next 12 months, according to coverage in Biospace.

This latest funding round brings AlloVir’s total backing to at least $159 million. The company (which at the time was still called ViraCyte) filed a Form D with the SEC in September 2018. The regulatory filing disclosed the company closed at least $30 million out of a targeted $50 million funding round. It’s unclear whether ViraCyte has closed the remaining $20 million from that round.

Prior to that deal, the company raised $8.99 million in grant funding from the Cancer Prevention and Research Institute of Texas.

Note. The Crunnchbase News team are not doctors or medical researchers, and we don’t play them on the internet. If we got any part of this wrong, please email the author: jason@crunchbase.com

Source. Crunchbase, James Rowley, May 23, 2019

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ElevateBio Gets $150M to Grow a Crop of Gene & Cell Therapy Startups

By Frank Vinulan

When a biotech startup is ready to test an experimental therapy it faces a pricey choice: Should it make its drug in-house, or hire a contract manufacturer? The decision is particularly expensive for companies developing complex gene and cell therapies, which need to make large batches of engineered viruses to test their work.

A new Cambridge, MA, company called ElevateBio aims to offer an alternative path.

ElevateBio is building a facility that is intended to manufacture experimental gene and cell therapies for multiple startups, and aims to invest in those companies and help them grow. The company has raised $150 million led by UBS Oncology Impact Fund and F2 Ventures to execute its plan. Co-founder and CEO David Hallal says that the ElevateBio site will be more efficient as a shared resource than it would be if it were owned by a single company.

“We get to build it once and then run multiple companies through it,” he says.

Startups developing chemical drugs often lean on contract manufacturers to make their products. But ElevateBio chief scientific officer Mitch Finer says contractors are too expensive for most cell and gene therapy startups. Gene and cell therapy products involve engineering viruses and filling them with genetic instructions. And for some gene and cell therapies, companies have to extract cells from a patient, modify them in a lab, and infuse them back into the body—a complex and costly process that can take weeks. Finer saw this firsthand as the chief scientific officer of cell and gene therapy developer Bluebird Bio (NASDAQ: BLUE), which built its own manufacturing capabilities. Last year, it reported $448 million in research and development expenses alone.

The need for gene and cell therapy manufacturing expertise has grown considerably as these cutting edge treatments have progressed forward. Multiple gene and cell therapies are now approved in the US and Europe, and many more are in development. The FDA, for instance, could approve the spinal muscular atrophy gene therapy Zolgensma, from Novartis (NYSE: NVS), this month. Others for hemophilia, beta-thalassemia, Duchenne muscular dystrophy, and more could follow.

Biopharma is investing heavily in gene therapy’s future: Roche, Biogen (NASDAQ: BIIB), Johnson & Johnson (NYSE: JNJ), and Pfizer (NYSE: PFE) have all bought gene therapy assets this year. What’s more, two contract manufacturers who specialize in gene and cell therapy work, Paragon Bioservices and Brammer Bio, have both been acquired since March. Upon buying Paragon for $1.2 billion, Catalent (NYSE: CTLT) estimated that the addressable market for gene therapy tools is worth $40 billion, and “is expected to have sustained growth of 25 percent in the medium term.”

ElevateBio is trying to capitalize on this momentum by meeting the manufacturing needs of startups. It is currently building a 100,000 square-foot complex in Waltham, MA, that it calls BaseCamp (pictured above). The site, which is still under construction, will be capable of manufacturing both gene and cell therapies, Finer says. BaseCamp will be able to support several companies, though Hallal wouldn’t say how many it can house at one time. Finer adds that the facilities will meet quality control standards and the requirements of US and European regulations.

But ElevateBio isn’t doing this just to be a contract manufacturer. It will operate as a holding company that invests in nascent cell and gene therapy startups spun out of academia. Hallal says his team is already talking with scientists at universities in the US and abroad about bringing their early gene and cell therapy work into ElevateBio.

ElevateBio’s plan is to nurture these startups until they progress, get more private financing, or go public, Hallal says. Each startup that leaves the nest will clear the way for a new company. The goal is to spark a cycle of gene and cell therapy companies being created, grown, and spun out of the Waltham space, Hallal says.

ElevateBio’s Waltham facility is expected to become fully operational in the second half of next year. But Hallal says startups can start working with the company sooner. Right now, it has lab space in Cambridge.

EcoR1 Capital, Redmile Group, and Samsara BioCapital invested in ElevateBio along with UBS Oncology and F2. Before emerging from stealth, ElevateBio was incubated within MPM Capital, where both Hallal and Finer are executive partners.

Source. Xeconony, Frank Vinulan, May 13, 2019

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Backed by OrbiMed, Lilly and now Advantech, China’s InventisBio loads up $70M to propel cancer, metabolic pipeline

By Amber Tong

Almost two years after bagging a $19 million round for its early-stage R&D amid some sweeping reforms in China’s regulatory world, Shanghai-based InventisBio is back on stage with $70 million in Series C cash and a global Phase II game plan.

Advantech Capital and CMBI — both recognizable names in China — co-led the round, followed by Pudong Innotek. They join existing investors Lilly Asia Venture and OrbiMed Asia in backing a startup bootstrapped by Merck vet and company founder Yaolin Wang, who left the pharma giant in 2015 to start InventisBio.

Now, InventisBio spreads its clinical development team between the US and China with help from a crew of CRO support, plowing away at small molecule drugs for cancer and metabolic diseases. Its most advanced assets, D-0316 and D-0120, target non-small cell lung cancer and gout respectively.

D-0316 was the subject of a recent licensing deal with Betta Pharma, in which the seasoned partner would help accelerate development and claim rights to commercialization in China while InventisBio keeps its options on other regions of the globe.

Benjamin Qiu, co-head of Healthcare Investment at Advantech, took the chance to highlight D-0502, an estrogen receptor degrader (SERD) for ER-positive breast cancer that’s brewing in Phase I as a “front-runner of similar products being developed globally.”


Wang previously told Endpoints News that he will be fielding InventisBio’s first approval in the next year or so, by moving directly from Phase I into pivotal trials. That ambitious timeline seems less likely now, though with strong financial backing and a helpful NMPA — which encouraged domestic innovation by greenlighting the first homegrown checkpoints just weeks ago — the company will still be looking to move as fast as it can.


Source. End Point News, Amber Tong, March 12, 2019

Maze Therapeutics launches with nearly $200M to explore genetic modifiers’ role in disease

By Alaric Dearment

Several venture capital firms have teamed up to launch a new company that aims to create drugs based on the differences in DNA that often protect people from diseases to which they are genetically predisposed.

Third Rock Ventures and ARCH Venture Partners said Thursday that they would lead the launch of Maze Therapeutics. The new company has obtained $191 million from the two venture capital firms and participating firms including Google’s GV, Foresite Capital, Casdin Capital, Alexandria Venture Investments and additional undisclosed investors. The company currently has a temporary address in Redwood City, California, according to its website.

The company’s scientific approach focuses on genetic modifiers, which are genes that affect the severity of diseases. According to the company, the amount of genetic data collected from people has led to a better understanding of how genetic mutations cause disease. But what remains unclear is why some people who are carriers of genes for diseases and would be expected to have them instead show mild symptoms or are not affected. Genetic modifiers often cause those differences, and Maze’s aim is to create medicines based on them.

Research in this area goes back more than a decade. Scientists at the Massachusetts Institute of Technology and Harvard University’s Broad Institute published research on the benefits of genetic modifiers in sickle cell disease as early as 2008. Two of the company’s founders, Mark Daly and Sekar Kathiresan, came from the Broad Institute, according to Maze’s website. However, they are not named in the 2008 paper. Maze’s website does not specify which disease areas the company is pursuing.

“At Maze, we are focused on expanding our understanding of the natural disease protection provided by genetic modifiers through an integrated approach that combines studying natural human genetic variation across the globe and conducting large-scale experiments of gene perturbations,” said Charles Homcy, the company’s interim CEO and also a partner at Third Rock, in a statement.

According to the company’s website, it is combining large-scale human genetics with functional genomics, which are integrated with known biology using data science technology to understand how modifier genes confer protection and can be targeted with drug therapies. Upon finding a protective genetic modifier, the company intends to modulate it using drug discovery approaches, including the devleopment of small-molecule pharmaceuticals, biologics or gene therapies.

Source. MedCity News, Alaric Dearment, March 1, 2019

MPM Capital raises $400M in seventh venture fund

By Alaric Dearmen

Cambridge, Massachusetts-based MPM Capital said Thursday that it had raised $400 million for its seventh venture fund, BioVentures 2018, or BV2018. The amount raised is consistent with what the company set out to raise in its Form D filed in February 2018 with the Securities and Exchange Commission.

“Over two decades of investing, MPM has developed long-standing and strategic partners with academia, biotech and large pharma,” MPM co-founder Luke Evnin said in a statement. “Vital to our objective of delivering new treatments to improve the lives of patients, these relationships support our ongoing discovery of next-generation translational science and provide financing and acquisition opportunities across our portfolio.”

The firm said it is currently investing the money from BV2018 and its two oncology-focused funds, which together have more than $1 billion in capital. BV2018 in particular will be invested across multiple therapeutic areas, including oncology, immunology and neuroscience, along with cell, gene and nucleic acid therapies. 

In November,MPM participated as an existing investor in a $70 million Series C funding round for South San Francisco, California-based Harpoon Therapeutics, which had been led by New York-based OrbiMed. The company is developing T-cell engager therapies, and its lead product candidate, HPN424, is in a Phase I study for prostate cancer. Last month, the company filed with the SEC for an $86.25 million initial public offering. And earlier this month, it announced that it expected to raise $75.6 million.

Another MPM portfolio company, TCR2 Therapeutics, also made its IPO earlier this month, announcing on Feb. 13 that it had been priced at $75 million. TCR2 made news last month when, along with Gossamer Bio, it reportedly sought to use a legal maneuver permitted by the SEC to go public automatically during the government shutdown, when the agency was unable to sign off on IPOs.

Source. Med City News, Alaric Dearmen, February 22, 2019

Healthcare Analytics firm Aetion gets 27M from biopharma, healthcare companies

By Alaric DeArment

A healthcare analytics company that provides data for life sciences companies, payers, providers and regulatory agencies has attracted an infusion of investment from several healthcare companies.

New York-based Aetion said Tuesday that it received a $27 million investment from drugmakers Sanofi and UCB, as well as McKesson Ventures and Horizon Health Services. Amgen Ventures had invested money earlier, while existing investors participating included NEA, Flare Capital and Lakestar. The investment caps a $63 million Series B funding round and brings the total amount of funding the company has received to $77 million since it was launched in 2015.

Aetion plans to use the funding to build up its product, the Aetion Evidence Platform, and move into therapeutic area-related intelligence, outcomes-based contracting for payers and promote RWE globally. It noted that RWE is particularly important for value-based care.

The company’s focus is on real-world evidence, delivered through the platform, which analyzes data to produce what it calls transparent, rapid and scientifically validated answers on treatments, costs and outcomes. “We’re entering a new era in which nearly the entire healthcare ecosystem – from biopharma and regulators to payers and technology companies – recognizes the importance of using real-world evidence to reduce the time and cost to bring new therapies to market,” CEO Carolyn Magill said in a statement. “This funding demonstrates that the industry’s leaders, who are using our technology to drive healthcare’s most critical decisions, view Aetion as a trusted partner vital to their long-term success.”

The company said its product is used by eight of the 15 largest biopharma companies, payers, academic institutions and international regulatory bodies, including the Food and Drug Administration. The company started its partnership with the FDA in 2018 to recreate 30 randomized clinical trials through real-world evidence in order to demonstrate RWE’s value as an “accelerant” to drug approval and access decisions, in a study titled DUPLICATE. The study is referenced in the FDA’s RWE program framework.

The FDA announced the framework in December, with the goal of using RWE to support drug development. The idea is to use information gathered from patients and healthcare professionals in order to inform and shape the agency’s decisions across its development efforts around pharmaceuticals and biologics. It’s part of the 21st Century Cures Act, which requires the FDA to release a plan for how it will continue to advance those efforts.

Source. MedCity News, Alaric DeArment, February 6, 2019