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Showing posts with label Biotech. Show all posts
Showing posts with label Biotech. Show all posts

Monday, May 11, 2020

Dyno Therapeutics Raises $9M in Seed Financing


Dyno Therapeutics, Inc., a Cambridge, Mass.-based biotechnology company applying artificial intelligence (AI) to gene therapy, raised $9m in not previously announced seed financing round.

The round – secured when Dyno spun out of the lab of Prof. George Church of Harvard – was co-led by Polaris Partners and CRV. 

Led by Eric Kelsic, Ph.D., CEO and Co-founder, the company has also launched from stealth mode with its proprietary platform, CapsidMap™. The platform applies proprietary artificial intelligence technology to discover and design novel AAV capsids, the cell-targeting protein shell of viral vectors. CapsidMap systematically generates and then evaluates millions of new AAV variants at scale, accelerating the identification of improved AAV vectors. It uses advanced machine learning search algorithms, combined with high-throughput experiments generating massive quantities of in vivo data, to accelerate the creation of superior synthetic AAV capsids. Through its R&D and collaborations with biopharmaceutical companies, Dyno has active programs focused on novel gene therapy vectors for ophthalmic, muscle, central nervous system (CNS), and liver diseases. The platform builds on certain intellectual property developed in the lab of George Church, Ph.D., who is Robert Winthrop Professor of Genetics at Harvard Medical School (HMS) and a Core Faculty member at Harvard’s Wyss Institute for Biologically Inspired Engineering. Dyno has an exclusive option to enter into a license agreement with Harvard University for this technology. Church is a co-founder of Dyno and Chairman of the company’s Scientific Advisory Board.

Alan Crane, a co-founder of Dyno and Entrepreneur Partner at Polaris Partners, and Dylan Morris, General Partner at CRV, have joined Dyno’s board of directors, with Alan Crane serving as Dyno’s Executive Chairman.

In addition, founders include Sam Sinai, Ph.D., Lead Machine Learning Scientist, Adrian Veres, Ph.D., Scientific Advisor, and Tomas Bjorklund, Ph.D., a scientific advisor of Dyno who is Associate Professor at Lund University and a leader in AAV capsid engineering.

Source. FinSMEs, May 11, 2020

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Monday, May 4, 2020

MEDcraze Raises $3M in Seed Financing

MEDcraze LLC, an Atlanta, GA-based online platform startup that provides patient information and access to new medical technologies, completed a £3m seed funding round.
This financing has been made exclusively by JG Griffeth Investments LLC.

The company will use the proceeds to make key hires and continue to build out additional platform features, expand advertising efforts and opportunities for medical device, biotech and pharmaceutical companies that have recently launched new products.

Led by Carey Markey, Founder and CEO, and Manny Trujillo MD, Plastic Surgeon and Co-Founder, MEDcraze is an online community which allows recently diagnosed patients with an upcoming surgical procedure to obtain access to applicable advancements in medical technology. They can then take this information and have an elevated discussion, based on technology, with their healthcare provider.

Source. FinSMEs, May 4, 2020

This post was brought to you by Woewoda Communications, your partner in the Canadian startup market; offering strategic communications & public relations services to Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

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Friday, May 1, 2020

Alume Biosciences Closes $5.5M Series A Financing Round

Alume Biosciences, Inc., a La Jolla, Calif.-based biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, completed a Series A funding in the amount of $5.5m

Backers included co-founder Chrysa Mineo (formerly of Receptos and Neurocrine Biosciences) and Dan Bradbury (co-founder and Executive Chairman of Equillium, Inc. and former CEO of Amylin).

Founded by Quyen Nguyen, MD, PhD, with co-founders Brett Berman, MD, FACC, Chrysa Mineo and scientific co-founder Mike Whitney, PhD, Alume is a biotechnology company that is developing nerve-targeted pharmaceutical agents for surgical and therapeutic use. The company’s first product, ALM-488, is a fluorescently labeled peptide-dye conjugate that makes human nerves “glow,” helping surgeons reduce injury to critical nerves during surgery.

Alume intends to develop agents including ALM-488 to be used as an adjunct during surgery to help surgeons see nerves better compared to current visualization with white light alone.

The company’s technology has the potential to improve the accuracy of nerve identification, decrease operative time, and lead to better outcomes for patients.

Intellectual property underpinning Alume was licensed from the University of California, San Diego (UCSD), where Dr. Nguyen is a Professor in the Department of Surgery and Director of the Facial Nerve Clinic.

Source. FinSMEs, May 1, 2020

This post was brought to you by Woewoda Communications, your partner in the Canadian startup market; offering strategic communications & public relations services to Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

Are you a pre-seed to late stage funded Canadian startup that needs to grow or scale? Give us a call! One of our representatives would love to explain how we vertically design, and then systematically layer each of our communication platforms to effectively reach niche target audiences for our clients. WC offers a unique synergistic approach to effectively communicate our client's message to their target audience. 

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Thursday, April 2, 2020

Aspen Neuroscience Raises $70M in Series A Financing

Aspen Neuroscience, a San Diego, CA-based biotechnology company developing the first autologous neuron replacement therapy to treat Parkinson disease, closed a $70m Series A funding round.

The round was led by OrbiMed with participation from ARCH Venture Partners, Frazier Healthcare Partners, Domain Associates, Section 32, and Sam Altman.

Led by Dr. Howard Federoff, Chief Executive Officer, Aspen Neuroscience is a development stage, private biotechnology company that uses innovative genomic approaches combined with stem cell biology to deliver patient-specific, restorative cell therapies that modify the course of Parkinson disease. Aspen’s therapies are based upon the scientific work of stem cell scientist, Dr. Jeanne Loring, who has developed a novel method for autologous neuron replacement.

The company’s lead product, ANPD001, is currently undergoing investigational new drug (IND)-enabling studies for the treatment of sporadic forms of Parkinson disease.

The second product, ANPD002, combines gene correction and autologous neuron therapy for the treatment of genetic forms of Parkinson disease.

The funding will support the completion of all remaining IND-enabling studies and FDA submission of the IND relating to Aspen’s lead product (ANPD001), as well as the recruitment and screening of a trial-ready cohort of persons with Parkinson disease and the manufacture of their cells for the lead product. Additionally, the capital will allow the company to obtain meaningful data from the Phase 1 clinical study to show evidence of biological effect of the therapy and lay the foundation for the Phase 2 multi-center randomized controlled study.

The financing will also support the continued R&D pipeline which includes autologous gene-corrected dopamine neurons for heritable forms of Parkinson disease risk (ANPD002) and programs that extend beyond dopamine neurons and explore the treatment of diseases marked by neuroinflammation.

In addition to the funding, Aspen added several executives to the Board of Directors including the new Chairman, Faheem Hasnain, who is Founder and Chairman of Gossamer Bio.

Other additions include: 

Tom Daniel, Chairman of Locana and Venture Partner at ARCH Ventures, and Peter Thompson, Co-founder and Chairman of Silverback Therapeutics and Partner at OrbiMed. 

These members join existing Directors which include Federoff, David Barker, former CSO of Illumina, and Stephen Squinto, Co-founder of Alexion Pharmaceuticals, Co-founder and former CEO of Passage Bio and Executive Partner at OrbiMed.

Source, FinSMEs, April 1, 2020

This post was brought to you by Woewoda Communications, your partner in the venture capital, private equity and startup markets; offering strategic communications, public relations & investor relation services to Canadian VCs, PEs, Angels, Endowments/Trusts, Family Offices, and Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

Are you a Canadian GP/LP/CI or a Canadian startup that needs to grow or scale? Give us a call! One of our representatives would love to explain how we vertically design, and then systematically layer each of our communication platforms to effectively reach niche target audiences for our clients. WC offers a unique synergistic approach to effectively communicate our client's message to their target audience.

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Friday, December 27, 2019

Nagi Bioscience Raises CHF 1.8M in Seed Funding

Nagi Bioscience SA, a Lausanne, Switzerland–based life-science-tech company developing technology for the in vitro testing of drugs and chemicals, closed a CHF1.8m seed financing round.
Backers included investiere, Zürcher Kantonalbank, NEST pension fund and private investors from Switzerland and United States.
The company intends to use the funds to complete the development of its first product and prepare its market access.
Founded in January 2019 by Dr. Matteo Cornaglia, CEO, and and Dr. Laurent Mouchiroud, CSO, as a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL), Nagi Bioscience has developed “Organism-on-Chip” technology, which leverages the combined use of microfluidics and microscopic worms (the validated biological model C. elegans) to provide a new sustainable alternative to traditional animal testing to pharma, chemical, cosmetic industries and biomedical research. This solution complies with the emerging directives for the replacement, reduction and refinement of animal testing, i.e. the so-called “3Rs” principles, and allows reducing costs and delays of pharmaceutical and chemical research.
Nagi Bioscience has already prototypes under validation in collaboration with key industrial players in the chemical and biotech fields.
Furthermore, the company announced the assignment of Dr. Chris Radloff to the Board of Directors. He is a board director and angel investor in several startups and brings to the company 20+ years of expertise in the life-science-tech field.
Source. FinSMEs, December 23, 2019

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Friday, September 20, 2019

Versantis Closes CHF16M Series B Financing Round

Versantis, a Zurich, Switzerland-based clinical-stage biotech company developing therapies for rare liver and pediatric diseases, closed a CHF16m Series B financing.

The round was led by Swisscanto Invest by Zürcher Kantonalbank with participation from Esperante Ventures, investiere, existing investors Redalpine HealthEquity, and Zürcher Kantonalbank Start-up Finance.

With the closing of this financing round, Dr. Robert Schier, Investment Director PE/VC Health-Tech at Swisscanto Invest, will join Versantis’ Board of Directors.

The company intends to use the funds to advance clinical development of novel therapeutics for liver diseases. In particular, the funds will accelerate the completion of ongoing Phase 1b studies with VS-01 and advance its clinical development up to clinical proof-of-efficacy (phase 2a) in 2 indications.

Led by Dr. Vincent Forster, CEO and co-founder, and Dr. Meriam Kabbaj, COO and co-founder, Versantis is a clinical-stage biotech company focused on the development of orphan drugs in liver diseases and pediatric inborn errors of metabolism. The company is pursuing innovative therapies for the acute care of serious liver conditions based on its proprietary liposomes-based detoxification platform technology.

Its lead candidate, VS-01, is currently being evaluated in first-in-human clinical trials, with outcomes expected mid-2020.

Source. FinSMEs, September 19, 2019

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Sunday, August 18, 2019

Motif Ingredients Raises $27.5 Million, Rebrands as Motif FoodWorks

The company formerly known as Motif Ingredients today announced that it has raised $27.5 million in new funding and rebranded itself as Motif FoodWorks. The new funding was led by General Atlantic with participation from CPT Capital, and follows a $90 million Series A that Motif raised when it launched in February of this year.

Motif is carving out an interesting space for itself in the food tech world as they are in the business of helping other companies develop new alternative meat, dairy and egg products. Smaller startups that don’t have an R&D budget as big as Beyond Meat or Impossible Foods can enlist Motif as a more affordable alternative for creating alternative foods. As my colleague Catherine Lamb wrote about Motif earlier this year:

Motif will use engineered microbes (like yeast) to “brew” food proteins that can mimic the same ones that give animal products their unique taste and texture. The resulting ingredients can be used to make everything from regular ol’ cow milk and chicken meat to more unique offerings, like sturgeon eggs and camel milk.

Because of its approach and its unique business model, we named Motif to our Food Tech 25: Twenty Five Companies Creating the Future of Food in 2019 earlier this summer.

We spoke with Jon McIntyre, CEO of Motif, a few months ago, who said that they’re in conversations to develop new ingredients with over twenty companies of various sizes.

Motif is certainly striking while the iron is hot. Demand for alternative proteins like plant-based burgers is growing, as the success of Beyond Meat’s going public and the nationwide rollout of the Impossible Whopper have illustrated. In its press announcement, Motif said it will use the new money to “add to and accelerate its product pipeline; expand academic collaborations across a broad set of molecular food science disciplines; scale its science and regulatory staff; and deepen its research and development efforts.”

As for the name change, Motif said the re-branding better recognizes its technology partnership with Ginkgo Bioworks, the Boston-based biotech company from which it spun out.

Michele Fite, Chief Commercial Officer of Motif Ingredients will be speaking at our Smart Kitchen Summit this October. Get your ticket now to see her and a ton of other great speakers.

Source. The Spoon, Chris Albrecht, August 15, 2019

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This post was brought to you by Woewoda Communications, your partner in the venture capital, private equity and startup markets; offering strategic communications, public relations & investor relation services to Canadian VCs, PEs, Angels, Endowments/Trusts, Family Offices, and Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

Are you a Canadian GP/LP/CI or a Canadian startup that needs to grow or scale? Give us a call! One of our representatives would love to explain how we vertically design, and then systematically layer each of our communication platforms to effectively reach niche target audiences for our clients. WC offers a unique synergistic approach to effectively communicate our client's message to their target audience.

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Thursday, August 15, 2019

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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This post was brought to you by Woewoda Communications, your partner in the venture capital, private equity and startup markets; offering strategic communications, public relations & investor relation services to Canadian VCs, PEs, Angels, Endowments/Trusts, Family Offices, and Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

Are you a Canadian GP/LP/CI or a Canadian startup that needs to grow or scale? Give us a call! One of our representatives would love to explain how we vertically design, and then systematically layer each of our communication platforms to effectively reach niche target audiences for our clients. WC offers a unique synergistic approach to effectively communicate our client's message to their target audience.

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Wednesday, July 17, 2019

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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Wednesday, July 10, 2019

BioNTech raises $325M series B round to advance cancer pipeline

BioNTech has raised $325 million (€289 million) in a private fundraising round. The series B positions the immuno-oncology player to advance its multidrug clinical pipeline and grow its manufacturing footprint.

Mainz, Germany-based BioNTech operated for a decade without raising a headline-grabbing round, opting instead to run on money from its billionaire majority owners and partnership fees, such as the $310 million in upfront and near-term milestones put up by Genentech. That changed early in 2018 when BioNTech raised $270 million in a Redmile Group-led series A round.

Now, BioNTech has raised $325 million in a round led by Fidelity Management & Research Company. Other existing investors including Redmile and the Struengmann Family Office contributed to the series B round, but two-thirds of the cash came from new investors.

BioNTech will use the cash to build on the work facilitated by its series A round. The company now has seven candidates in eight clinical trials. BioNTech’s most advanced assets are derived from its mRNA platform, which established it as a rival to CureVac and Moderna. But the pipeline now also features cell therapies, small molecules and immune checkpoint modulators.

The expansion and advancement of the pipeline has dialed up BioNTech’s fundraising needs. Some of the additional cash will fund studies of the candidates. Another slice will enable the expansion of BioNTech’s manufacturing capacity to support drug development and potentially commercialization.

Talking to Reuters at the time of the series A round, BioNTech identified the need to “invest enormously in manufacturing” as a key driver of its ongoing hunger for large sums of money. Reports earlier in the year suggested that BioNTech would sate that hunger with an $800 million IPO around the end of 2019. Crossover investors are among the organizations to contribute to the series B round.

In returning to private investors, BioNTech has raised one of the largest ever private biotech rounds in Europe. Immunocore raised a $320 million series A round in 2015, but few other European biotechs have raised triple-digit private rounds, let alone secured hauls of more than $300 million.

Source. FierceBioTech, Nick Paul Taylor, July 9, 2019

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This post was brought to you by Woewoda Communications, your partner in the venture capital, private equity and startup markets; offering strategic communications, public relations & investor relation services to Canadian VCs, PEs, Angels, Endowments/Trusts, Family Offices, and Canadian startups involved in ICT, IoT, blockchain, life sciences, healthcare, agribusiness, clean energy, fintech, AI and robotics.

Are you a Canadian GP/LP/CI or a Canadian startup that needs to grow or scale? Give us a call! One of our representatives would love to explain how we vertically design, and then systematically layer each of our communication platforms to effectively reach niche target audiences for our clients. WC offers a unique synergistic approach to effectively communicate our client's message to their target audience.

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Wednesday, July 3, 2019

Bayer powers Versant cell therapy startup to $250M round

Versant Ventures’ Century Therapeutics has exited stealth with $250 million to take allogeneic cell therapies into the clinic. Bayer’s VC wing led the investment with the support of Versant and Fujifilm Cellular Dynamics (FCDI).

Century, like other allogeneic cell therapy players, is trying to improve on autologous products that require the administration of a patient’s own cells back to them by creating off-the-shelf alternatives. The potential of allogeneic therapies has attracted a lot of attention—Allogene Therapeutics alone has raised more than $500 million—but Century thinks it can improve on existing approaches.

That belief rests on Century’s use of self-renewing induced pluripotent stem cells (iPSC). Century puts these cells through multiple rounds of cellular engineering to create master cell banks. By expanding and differentiating the cells in these banks into immune effector cells, Century thinks it can supply “vast amounts” of homogeneous off-the-shelf products. Other developers of allogeneic cell therapies work with nonrenewable donor-derived cells.

Versant set Century up last year to build on the research of the biotech’s scientific cofounders, Marcela Maus, M.D., Ph.D., of Harvard Medical School and Hiro Nakauchi, M.D., Ph.D., of Stanford University School of Medicine.
A partnership with Fujifilm subsidiary FCDI followed later in 2018, providing Century with access to an iPSC platform, immune effector cell differentiation protocols and a manufacturing service provider.  

Leaps by Bayer, the VC wing of the German life science company, has committed $215 million to enable Century to build on this platform. With the involvement of Versant and FCDI bringing the size of the round up to $250 million, Century is positioned to move multiple iPSC-derived treatments for blood cancers and solid tumors into human testing.

The pursuit of iPSC-derived cell therapies may take Century into uncharted waters. Maus is among the researchers to previously note the challenges this will entail, telling Cancer Discovery last year that “we don’t have a long safety track record of using pluripotent stem cells clinically, much less genetically manipulated ones.” Other researchers have questioned how companies will convince the FDA that their products are completely free from undifferentiated stem cells. 

Century is well equipped to try to overcome these hurdles. As well as raising $250 million, Century has put together a leadership team with deep experience in immuno-oncology and cell therapies.

Ex-Juno Therapeutics CSO Hyam Levitsky, M.D., has taken up the post of president of R&D at Century. Luis Borges, Ph.D., an ex-Amgen scientist who spent the past two years at Cell Medica, has come on board as CSO. And longtime Celgene and Roche employee Adrienne Farid, Ph.D., has arrived as chief development officer. This team will be led by Lalo Flores, Ph.D., who helped to guide Versant’s Novira Therapeutics to a takeover by Johnson & Johnson in 2015.


Source. FierceBiotech, Nick Paul Taylor, July 1, 2019

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Sunday, June 30, 2019

PanTheryx Lands $50M to Use “First Milk” to Target Gut Microbiome

There’s a reason why mothers are instructed to breastfeed their babies soon after they’re born. The milk they produce in the days after giving birth is rich in nutrients, immune cells, and antibodies. While this “first milk,” also known as colostrum, is crucial in getting newborns off to a healthy start, PanTheryx CEO Mark Braman says the fluid’s components can also help resolve gastrointestinal disorders rooted in the gut microbiome. Now, the company has $50 million in new capital to ramp up its research.
The fresh cash comes from Perceptive Advisors, a firm that invests in life science companies. Boulder, CO-based PanTheryx has already commercialized a product developed to relieve diarrhea in children and adults. Braman says his company’s approach can also apply to clostridium difficile infection, a type of gut infection. Other GI diseases that the company is researching include two types of inflammatory bowel disease: Crohn’s disease and ulcerative colitis.
The PanTheryx expansion plans come as a growing number of biotech startups take aim at the gut microbiome, with some of them encountering setbacks. Much about the microbiome and its role in disease remains a mystery, but Braman, a former Pfizer (NYSE: PFE) executive, contends that nourishing gut bacteria is an untapped solution.
“The gut influences so many different diseases,” Braman says. “It only stands to reason that nutrition will play an important role in that.”
Founded in 2007, Braman says PanTheryx’s initial focus was acute infectious diarrhea, a type of diarrhea typically caused by viruses. The disease is common, and it kills an estimated 1.5 million to 2.5 million children worldwide each year. Studying the data, PanTheryx found that incidence of diarrhea was quite low in babies, particularly in the first six months of life. That research led the company’s scientists to colostrum. Obtaining colostrum from new mothers isn’t practical, so PanTheryx turned to bovine colostrum, the first milk produced by dairy cows.
PanTheryx’s anti-diarrhea product, called DiaResQ, is a powder meant to be mixed with water and then swallowed. In addition to colostrum, the product contain antibodies from chicken eggs. Braman says this combination addresses viral, bacterial, and parasitic causes of infectious diarrhea. The product was developed to pass through the stomach and into the small intestine where it binds to pathogens and flushes them out, Braman says. The components of the product also reduces inflammation and promotes repair of tissue in the gut.
Data from a clinical trial enrolling 325 children were mixed, however. According to results published last year in BMJ Global Health, the PanTheryx product was no better than a placebo at reducing the duration of diarrhea, the main goal of the study. But the stool of children who were given the PanTheryx product showed a “significant reduction” in pathogens that cause diarrhea. PanTheryx went ahead and launched DiaResQ last year, and the product is now available over-the-counter online and through retailers such as Walmart (NYSE: WMT), CVS Health (NYSE: CVS), and Walgreens.
Beating a placebo in a clinical trial is essential to support FDA approval of a drug. But the PanTheryx diarrhea product isn’t a drug. It’s a “food for special dietary use.” Products in this category address a particular dietary need and don’t require a prescription or a physician’s supervision. The slightly narrower “medical foods” category encompasses products intended for dietary management of a specific disease. Medical foods are intended to be taken under medical supervision.
Foods for special dietary use and medical foods face limitations on the claims that they can make, and those restrictions have gotten PanTheryx into hot water. In 2017, the FDA sent a warning letter to PanTheryx subsidiary APS Biogroup saying that therapeutic claims on labels characterized the products as drugs, which they were not. Braman says the products belonged to a PanTheryx customer. In addition to its own colostrum production, PanTheryx is also a contract manufacturer for companies that incorporate the fluid in products such as baby formula. He says the labeling language was changed to address FDA concerns. [Paragraph corrected to state that APS received one, not two, warning letters.]
Bovine colostrum is the backbone of PanTheryx’s product pipeline. The colostrum comes from 1.4 million cows at 1,000 US dairy farms, which freeze the first milk on site, Braman says. PanTheryx picks up the colostrum and trucks it to facilities in Phoenix and Ripon, CA, that PanTheryx acquired in 2017 to bolster its production capabilities. In addition to securing colostrum supply, Braman says his company also has patents on its production process, which involves pasteurizing the colostrum and drying it. But PanTheryx does not bioengineer the antibodies or proteins in the colostrum. Braman says the antibodies that end up in the product depend on the vaccines given to the animals.
“The cow and hen are the bioprocessor,” Braman says. “They’re very efficient at delivering antibodies and growth factors into the final product.”
As PanTheryx expands its research to specific GI disorders, it will need to produce more robust data that stands up to greater scrutiny. To date, PanTheryx’s research in c. diff infection and inflammatory bowel disease is preclinical. The company is also studying applications of its technology in addressing drug induced injuries, such as the gut damage caused by chemotherapy. Braman says clinical trials testing PanTheryx candidates in these applications could start by the end of this year.
Not all of the PanTheryx product candidates will be biologic drugs. Some might be medical foods, which offer a faster path to market because the FDA does not require them to go through the three phases of clinical trials required of drugs. That’s the pathway chosen by Whole Biome, a San Francisco company that plans to launch a type 2 diabetes medical food next year. Braman says that if all goes well, PanTheryx’s medical foods could reach the market in two years. The company’s biologic drugs could follow two to three years after that.
Earlier investors in PanTheryx include private equity firm Pegasus Capital Advisors. PanTheryx says it has raised $170 million total. The new $50 million in capital will be split between commercialization of DiaResQ and research and development of new product candidates. Depending on the progress of the research, Braman says those candidates could be developed in partnership with pharmaceutical companies or with large food or nutrition companies.
“We know the kinds of resources they can [bring to] bear, we don’t have to develop this all ourselves,” says Braman, a former vice president in Pfizer’s nutrition group. “We do believe it’s important to at least get the preclinical and Phase 1 work so you have sufficient data that would interest big players.”
Source. Xeconomy, Frank Vinluan, June 26, 2019

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Thursday, June 20, 2019

Cybrexa Therapeutics Completes $13.4M in Series B1 Funding

Cybrexa Therapeutics, a New Haven, CT-based biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor targeting platform, completed a $13.4m Series B1 financing.

Backers in the round, which brings total capital raised to date to $21.1m, included CT Innovations, HighCape Capital Special Opportunities Fund, and Cycle Venture Partners.

The company intends to use the funds to advance its first clinical candidate CBX-11 (alphalexTM-rucaparib) into clinical development and to progress additional programs in its preclinical pipeline.

Led by Per Hellsund, President & CEO, Cybrexa is a biotechnology company dedicated to developing an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells.

The company’s lead candidate, CBX-11 (alphalex™-rucaparib), is in preclinical development with advancing plans to initiate clinical development by 1Q 2020.

Source. FinSMEs, Staff, June 20, 2019

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Thursday, May 23, 2019

Wild Earth Closes Series A with $11 Million from VegInvest, Bits x Bites, VECTR, P.O.V., and M Ventures

Wild Earth, Inc., a startup reinventing pet food with biotech, today announced it has closed its Series A with an investment of $11 million led by VegInvest, a venture capital firm supporting early-stage companies striving to replace the use of animals in the food system and other industries. This is VegInvest's second investment in Wild Earth; other current investors include Mark Cuban's Radical Investments, Felicis Ventures, Peter Thiel's Founders Fund, and Mars Petcare, bringing total funding to $16 million.

The investment is being used to accelerate Wild Earth's development of its no-meat food for dogs made from an eco-friendly and renewably sourced fungi, a complete protein containing all ten essential amino acids. The company expects the dry kibble formula to be available in the second half of 2019.

Wild Earth also announced it has moved into its new headquarters in Southwest Berkeley at Outermost House, significantly expanding its R&D and business facilities. Outermost House, located in a historic space of a former chocolate factory, was envisioned by VegInvest in 2017 as a global innovation hub for vegan food tech companies.

"Wild Earth and VegInvest share a foundation of values and innovation in this effort to achieve a food system that works better for people, the planet, and animals," said Wild Earth CEO Ryan Bethencourt. "Their experience helping future-of-food companies reach the market will absolutely increase our timeline for commercial availability of our dog food with fungi protein."

"Given the shocking amount of animal farming required for pet food, and the environmental strain caused by feeding companion animals, Wild Earth represents an important component of a more sustainable and humane food system," said Amy Trakinski, managing director of VegInvest, who joins Wild Earth's board of directors. "We're investing in Wild Earth not only to impact this market but because Ryan and his team can provide valuable leadership to other companies in the plant-based innovation space."

New York-based VegInvest provides early-stage capital and guidance to companies in industries like vegan food products and food technology, alternatives to animal testing, and restaurant chains. By replacing the use of animals, VegInvest sees financial opportunities as well as more sustainable and scalable solutions. Current investments include JUST and Veggie Grill.

Wild Earth also welcomed global investors in its funding round. Shanghai-based Bits x Bites is China's first future-of-food fund. VECTR is a leading private equity group based in Hong Kong. Berlin-based P.O.V. is one of Germany's leading food funds.

Wild Earth's fungi-based products require dramatically fewer resources than farming animals to produce the same nutritional value. In addition to a complete protein without animal ingredients, the veterinarian-developed formula offers omega fatty acids, digestion-boosting enzymes, and prebiotics to support gastrointestinal microbiomes. Since 25-30 percent of meat's environmental impact in the U.S. is attributed to pet food, Wild Earth believes its Koji protein is necessary if we hope to sustainably feed more than a billion pets expected by 2050. According to a recent study, 35 percent of pet parents would be willing to feed a vegan diet that meets their animal's nutritional needs.

Wild Earth treats are currently available online at WildEarth.com, Amazon.com, PupJoy.com, select brick-and-mortar retail stores, and wholesale to pet food retailers.

Source. PR Newswire, May 22, 2019

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Tuesday, May 14, 2019

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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