The Alliance for Regenerative Medicine Announces Record Sector Financing in 2020

The regenerative medicine sector attracted $15.9 billion in financing through just the first three quarters of the year, shattering the previous record of $13.5 billion

Washington, DC – ( NewMediaWire ) – November 19, 2020 – Global financing for the regenerative medicine and advanced therapy sector set an annual record of $15.9 billion through just the first three quarters of 2020, according to  data  released today by the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines.

Despite the COVID-19 pandemic, financing for the cell, gene, and tissue-based therapies sector surpassed the previous record of $13.5 billion set during full-year 2018.

“There is strength across all types of investment and stages of the pipeline, from early-stage cell-based immuno-oncology to late-stage gene therapies,” said Janet Lambert, CEO of ARM. “The outlook for patients has never been brighter.”

Investors remain bullish about the promise of profound, durable, and possibly curative regenerative medicines to treat a range of diseases and disorders.

Public financing continues to drive the sector, through both IPOs ($2.8 billion YTD) and follow-on financings ($5.7 billion YTD). At $4.1 billion year-to-date, venture capital financing is also on track to surpass the previous record of $4.3 billion set in 2019.

“The rapid advancement of the science behind regenerative medicine makes this a very dynamic time for investors and a hopeful time for patients,” said Jason Rhodes, a partner at Atlas Venture. “The breadth of approaches now available — from CRISPR to CAR-Ts to lentiviruses and non-viral gene therapies — enables us to pick the right tool for the specific biology that we’re addressing.”

Highlights from ARM’s third-quarter 2020 data include:

Gene therapy financing was $3.5B in Q3 2020 and $12 billion YTD, up 178% and 114% from 2019 levels respectively; cell therapy financing reached $3 billion in Q3 2020 and $11 billion YTD, up 97% and 242%, respectively; tissue-based therapy financing was $226 million in Q3 2020 and $311 million YTD, up 11% and 311% respectively.*

At the end of Q3 2020, there were 1,109 regenerative medicine clinical trials ongoing worldwide – 373 in gene therapy, 492 in cell-based immuno-oncology, 202 in cell therapy, and 42 in tissue-based therapies.

Of the 1,109 clinical trials, 388 target more prevalent diseases, including prevalent cancers (159), cardiovascular disease (35), diseases of the central nervous system (33), infectious diseases including COVID-19 (38), and diabetes (17).

There are 97 ongoing Phase 3 clinical trials, with regulatory decisions expected in the coming months in the US and Europe for several product candidates across cell, gene, and tissue-based therapies; cell-based immuno-oncology now comprises more than half of the 418 Phase 1 trials.

There are 1,026 regenerative medicine and advanced therapy developers active globally, up from 1,001 in our previous report covering the first half of 2020. Of the current total, 536 are active in gene therapy, 641 are active in cell therapy, and 135 are active in tissue-based therapies.

* Some companies utilize multiple technology types, and financings for

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Sanofi, GSK to supply vaccine doses to WHO-backed alliance

PARIS (Reuters) – French drugmaker Sanofi and Britain’s GlaxoSmithKline will supply 200 million doses of their COVID-19 candidate vaccine to a global inoculation scheme backed by the World Health Organization.

There is no internationally-approved treatment against COVID-19, which has killed more than 1.16 million people, and the two companies’ vaccine is still undergoing phase 1 and 2 trials, from which first results are expected by late November or early December.

They said on Wednesday they had signed a statement of intent with vaccine alliance GAVI, which is coordinating the global scheme, known as COVAX.

COVAX, which aims to deliver 2 billion vaccine doses around the world by the end of 2021, has already sealed agreements this year with AstraZeneca and Novavax.

It aims to discourage national governments from hoarding COVID-19 vaccines and to focus vaccinating the most high-risk people first in every country.

More than 180 nations including China have joined the plan but some, including the United States, have opted to stick with their own supply deals.

Sanofi and GSK signed a $2.1 billion deal with Washington during the summer to supply it with more than 100 million doses of the same vaccine, which they hope to present for regulatory approval next year.

The companies also have similar agreements with the European Union, Britain and Canada.

Their candidate vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.

Sanofi is also working on another vaccine project with U.S. company Translate Bio that will use a technology known as messenger RNA (mRNA) which instructs cells in the body to make coronavirus proteins that then produce an immune response.

Clinical trials for this project are expected to start in the fourth quarter.

COVAX is co-led by GAVI, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI).

(Reporting by Vishwadha Chander in Bengaluru, Matthias Blamont in Paris; Editing by Shounak Dasgupta and John Stonestreet)

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Quidel Corporation Joins Global Lyme Alliance as Sponsor for the GLA ‘Fight Lyme With Avril Lavigne and Friends’ Virtual Concert Oct. 24

As part of its commitment to help educate Americans on the perils of Lyme disease, Quidel Corporation announced today that it will be one of the sponsors of the inaugural Global Lyme Alliance (GLA) “#FightLyme With Avril Lavigne & Friends” concert being held on Oct. 24. Quidel is the diagnostic health care manufacturer behind the industry’s most rapid and reliable in-office test for Lyme disease, the Sofia 2 Lyme FIA test.

“The Global Lyme Alliance has been a passionate and important partner for Quidel in our fight against Lyme disease,” said Judi Tilghman, Ph.D., vice president of technology assessment at Quidel. “Over the years they have helped fund the most urgent and promising research in the field, while expanding education and awareness programs for the general public and physicians. We’re honored to be their partner for this wonderful upcoming event.”

Being held in lieu of its annual gala, GLA will be presenting the inaugural #FightLyme With Avril & Friends virtual concert featuring Avril Lavigne, Rob Thomas, OneRepublic, Alessia Cara and host Wilmer Valderrama. The concert is designed to raise awareness and funds for GLA and The Avril Lavigne Foundation in support of their fight to conquer Lyme disease and other tick-borne diseases through research, education, awareness and patient services. Both Lavigne and Thomas have experienced Lyme disease on a personal level, and Lavigne is also a GLA board member who has been extremely vocal about the fight against Lyme disease.

The Oct. 24 concert will begin at 8 p.m. Eastern Time. Tickets can be purchased and more information is available at https://tinyurl.com/y54dn89a. More information on the Global Lyme Alliance can be found at GLA.org.

Lyme disease afflicts as many as 400,000 Americans every year and can lead to a number of serious, life-threatening problems if not caught early. Leading the way in Lyme disease testing is Quidel’s innovative Sofia® 2 Lyme FIA test. This test provides a patient as well as his or her physician with indicative results within minutes as opposed to days, which has historically been the norm. Performed in the privacy of a doctor’s office or local clinic, it is also the only test that can get results from a simple finger prick of blood. Given that the vast majority of patients tested are negative, not having to wait days for test results allows physicians and nurse practitioners to more rapidly treat those patients with positive results while more quickly pursuing other diagnosis and treatment for those who test negative.

About Quidel Corporation

Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive

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The Alliance for Regenerative Medicine Announces Election of 2021 Officers, Executive Committee, and Board of Directors

Washington, DC, Oct. 21, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, announced today the election of its 2021 Officers, Executive Committee, and Board of Directors.

The Executive Committee and Board of Directors oversee the formation and execution of ARM’s strategic priorities and focus areas over the coming year. The committee and board are subject to an annual re-election or rotation process, with nominations and approval by the ARM membership and current Board.

“We are pleased to welcome such an accomplished group of executives to the 2021 ARM board of directors,” said Janet Lambert, CEO of ARM. “As scientists, commercial leaders, and regulatory experts, the new members of the board will be instrumental in helping ARM and its members deliver transformative and potentially curative regenerative medicines to patients around the world.” 

ARM 2021 Officers:

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics (Chairman)

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics (Vice Chairman)

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific (Secretary)

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics (Treasurer)

ARM 2021 Executive Committee:
*new to the Executive Committee for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific 

* Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics 

Bob Smith, MBA – SVP, Global Gene Therapy Business, Pfizer Inc.

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics

* Arthur Tzianabos, Ph.D. – President and CEO, Homology Medicines

* Christopher Vann – COO, Autolus Therapeutics 

ARM 2021 Board of Directors:
*new to the Board for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Ronald Bartek – Co-Founder and President, Friedreich’s Ataxia Research Alliance

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific

Bradley Campbell, MBA – President and COO, Amicus Therapeutics

Cindy Collins, MBA – President and CEO, Editas Medicine

* Maria Fardis, Ph.D., MBA – President and CEO, Iovance Biotherapeutics

Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Jonathan Garen, M.S. – CBO, uniQure

* Bobby Gaspar, M.D., Ph.D. – CEO, Orchard Therapeutics

Michael Hunt, ACA – CFO, ReNeuron

Jerry Keybl, Ph.D. – Senior Director, Cell & Gene Therapy, MilliporeSigma

* Louise Rodino-Klapac, Ph.D. – SVP, Gene Therapy, Sarepta Therapeutics

Ann Lee, Ph.D. – SVP and Head of Cell Therapy Development & Operations, Bristol Myers Squibb

* Dave Lennon, Ph.D. – President, Novartis Gene Therapies

Bruce Levine, Ph.D. – Barbara and Edward Netter Professor in Cancer Gene Therapy, and Founding Director, Clinical Cell and Vaccine Production Facility, Department of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

John Maslowski, M.S. – President and CEO, Castle Creek Pharmaceuticals

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

* Adora Ndu, PharmD,

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