GEN: NIH Invests $248.7 Million to Ramp up COVID-19 Testing

By | Uncategorized | No Comments

Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.

The initiative is called NIH’s Rapid Acceleration of Diagnostics (RADx). “The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH director Francis S. Collins, MD, PhD. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”

The seven companies range in scope from small start-ups to large publicly-held organizations and their corresponding technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs.

Click here to read the entire article from GEN

Adaptive Phage Therapeutics Announces Mayo Clinic as Lead Investor in Convertible Note Financing

By | News | No Comments

GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.

Mayo Clinic is collaborating with APT to conduct a clinical trial using PhageBankTM investigational therapy to address the significant unmet need for alternative treatments for chronic infections following joint replacement (referred to as “periprosthetic joint infections,” or “PJIs”). Proceeds from the convertible note are designated to initiate the trial.

“Prosthetic joint infection is a potential complication of joint replacement implantation that can be very serious and lead to loss of life or limb. As we face a growing public health threat from drug-resistant bacterial infections, we need more research to assess phage therapy’s potential to help people with these infections and save lives,” said Gina Suh, M.D., infectious diseases specialist and one of the experts at Mayo Clinic leading the research collaboration with APT.

APT has supported Mayo Clinic physicians in the treatment of multiple patients with end-stage chronic PJIs under emergency use approvals by the US Food and Drug Administration (FDA). In each case, the patient faced serious challenges due to chronic and refractory infections unresponsive to commercially approved therapies following knee replacement implantations. Use of APT’s PhageBank in lieu of surgery is often referred to as the “Haverty Protocol,” in recognition of John Haverty, the first PJI patient treated with investigational PhageBank therapy at Mayo Clinic. The research is published in the July issue of Clinical Infectious Diseases (CID).

APT anticipates initiating the PJI trial at Mayo Clinic in the fall of 2020. If successful, the company anticipates potential commercial availability in 2023. Based on an international survey of hospital payers and doctors, conducted by Triangle Insights Group, it is estimated that APT’s PhageBank treatment of PJI represents a commercial market of more than $900 million per year.

“APT is pleased that Mayo Clinic recognizes the value of phage therapy and its role in treating chronic PJI infection. Current standard of care can cost up to $400k per patient and often results in five-year mortality rates comparable to those of colon cancer,” said Greg Merril, co-founder and chief executive officer, Adaptive Phage Therapeutics.

Last month, APT announced a collaboration with Mayo Clinic to advance and commercialize a phage susceptibility test (PST) to be offered as a laboratory developed test for worldwide commercial availability by Mayo Clinic Laboratories. PST will enable rapid identification of patient-specific precision therapy for challenging bacterial infections.

Mayo Clinic and Dr. Suh have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

About Antimicrobial Resistance (AMR)

According to the Centers for Disease Control, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result.1 The World Health Organization estimates that superbugs will kill up to 10 million people globally each year by 2050.2 Thirty-five percent of common human bacterial infections are already resistant to currently available medicines in some high-income countries.3

According to the World Health Organization, there is a US $100 trillion potential cost in terms of lost global production between now and 2050.4 The indirect costs of drug-resistant infections to the individual and society from morbidity, disability, premature deaths and reduced effective labor supply are estimated to cause a decrease in the global economic output of 1–3% by 2030, with estimated losses ranging from US $1 trillion to US $3.4 trillion annually if no action is taken.5

About Periprosthetic Joint Infections (PJI)

Periprosthetic joint infections (PJIs), are infections involving a joint prosthesis and adjacent tissue, which develop following a joint replacement implantation. PJIs have been projected to occur in approximately two percent of joint replacement surgeries performed. Risk factors for PJI include co-morbidities of obesity, diabetes or rheumatoid arthritis, among others. PJI is known to occur more frequently in revision surgeries, and the majority of PJIs occur within one year of surgery. The economic impact to the healthcare industry is projected to reach more than $1.62 billion in 2020. PJIs are painful and create a tremendous burden for individual patients.9

About Phage

Bacteriophage (“phage”) are viruses that host on bacteria. Phage have evolved to become the most prolific killers of bacteria on earth. Phage have been used for clinical applications since their initial discovery at the beginning of the twentieth century. The ability of phage to replicate exponentially and kill bacteria suggests that they could play a vital role in our armamentarium for the treatment of infectious diseases.8 There are an estimated 10 phage for each bacteria on earth, and each phage strain has evolved to eradicate a narrow range of bacteria. The introduction of penicillin in the 1940s displaced interest in commercial development of phage. With the growing crisis of bacterial resistance to antibiotics, there has been renewed interest in phage therapy.

About PhageBank

PhageBank is an ever-expanding collection of genetically diverse, carefully screened, and purified phage that are collectively broad spectrum, negating the effects of bacterial resistance that increasingly diminish the effectiveness of antibiotics. In 2017, APT acquired world-wide exclusive commercial rights to PhageBank from the biodefense program of the U.S. Department of Defense. APT is advancing the technology through innovation in bioinformatics, rapid phage-bacteria matching and phage purification methods in an approach capable of providing a precision-matched therapy based upon the diagnosis of a specific bacterial pathogen.

About Adaptive Phage Therapeutics (APT)

APT is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 23 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.

REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update and Program Updates for RGX-314 for the Treatment of Wet AMD

By | News | No Comments

ROCKVILLE, Md., Aug. 4, 2020 /PRNewswire/ —

  • Company on track to initiate RGX-314 subretinal delivery pivotal program by the end of 2020
  • RGX-314 was generally well-tolerated in 42 patients at all dose levels in Phase I/IIa trial
  • Positive interim update from Cohorts 4 and 5 at one year informs pivotal program
    • Durable treatment effect observed with stable to improved visual acuity and retinal thickness
    • Demonstrated meaningful reductions in anti-VEGF treatment burden over one year
      • 61% and 85% reduction of anti-VEGF injections in Cohorts 4 and 5, respectively
      • 73% of patients (8/11) in Cohort 5 remain anti-VEGF injection-free
    • Intraocular RGX-314 protein expression levels are dose-dependent at one year
  • Phase II trial for RGX-314 for the treatment of wet AMD using suprachoroidal delivery (AAVIATE) is active
    • Enrollment expected to begin in Q3 2020; interim data update from first cohort expected by end of 2020
  • Company to host conference call and webcast on Tuesday, August 4 at 8:30a.m. ET, featuring wet AMD Key Opinion Leaders, Robert Avery, M.D., Dante Pieramici, M.D., and Peter Kaiser, M.D.

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today reported positive one year data from patients in Cohorts 4 and 5 of the Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). The Company plans to initiate a pivotal program for subretinal delivery of RGX-314 in patients with wet AMD by the end of 2020. In addition, REGENXBIO today announced that a Phase II trial of RGX-314 for the treatment of wet AMD delivered to the suprachoroidal space (AAVIATE) is active and expected to enroll patients in the third quarter of 2020.

“Today’s results provide further evidence of the clinical profile of RGX-314 as a promising one-time gene therapy treatment paradigm for patients with wet AMD,” said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. “The data demonstrated stable to improved visual acuity and retinal thickness, as well as a meaningful reduction in anti-VEGF injection burden, in these higher dose levels at one year. Results from the Phase I/IIa trial will inform the design of the pivotal program of RGX-314 in patients with wet AMD, which we look forward to initiating by the end of this year.”

Dr. Pakola continued: “I am also pleased to announce that our AAVIATE trial, a Phase II trial of RGX-314 for the treatment of wet AMD utilizing the SCS Microinjector, is active and we expect to dose the first patient this quarter. The targeted, in-office suprachoroidal delivery approach may provide additional options for patients in all settings of patient care. We anticipate providing an interim data update from the first cohort in late 2020.”

“Based on the overall results to date from the Phase I/IIa trial, I believe that RGX-314 has the potential to profoundly impact all aspects of clinical management for patients with wet AMD,” said Robert Avery, M.D., Founder of California Retina Consultants and Research Foundation and investigator surgeon in the Phase I/IIa RGX-314 trial. “Wet AMD affects a large number of adults, and often results in loss of vision over time due to non-compliance with the current standard of care of frequent anti-VEGF injections. I am encouraged that RGX-314 has the potential to become a one-time gene therapy treatment option for a broad range of patients.”

Study Design and Safety Update from Phase I/IIa Trial of RGX-314 for the Treatment of Wet AMD using Subretinal Delivery

In the Phase I/IIa trial of RGX-314, 42 patients with long-standing severe wet AMD requiring frequent anti-vascular endothelial growth factor (anti-VEGF) injections were treated across five dose cohorts, with doses ranging from 3×109 GC/eye to 2.5×1011 GC/eye. Patients were enrolled into all dose cohorts independent of their neutralizing antibody titers to AAV and did not receive prophylactic or supplemental immune suppressive corticosteroid therapy for RGX-314.

Patients in the study are being assessed each month for two years and will receive safety follow-up for five years after RGX-314 administration. Efficacy assessments for the study include number of anti-VEGF intravitreal injections, change in vision as measured by Best Corrected Visual Acuity (BCVA), change in central retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT), and RGX-314 protein expression levels as measured from aqueous samples by electrochemiluminescence immunoassay (ECL).

As of July 13, 2020, RGX-314 was generally well-tolerated across all cohorts. Eighteen serious adverse events (SAEs) were reported in 11 patients, including 17 that were not related to RGX-314. One possibly drug-related SAE of significant decrease in vision was reported in Cohort 5 at Month 11 in a patient who had retinal pigmentary changes that involved the macula. The most common nonserious adverse events in the eye were generally assessed as mild (77%). These included post-operative conjunctival hemorrhage (69% of patients), post-operative inflammation (36% of patients), eye irritation (17% of patients), eye pain (17% of patients), and post-operative visual acuity reduction (17% of patients). In 67% of patients across all cohorts, and in 83% of patients in Cohorts 3 through 5, retinal pigmentary changes were observed on imaging, the majority of which were in the peripheral inferior retina. Retinal hemorrhage was observed in 24% of patients and is an anticipated event in patients with severe wet AMD. There have been no reports of clinically determined immune responses, drug-related ocular inflammation, or post-surgical inflammation beyond what is expected following routine vitrectomy.

Summary of Data from Cohorts 4 and 5 of Phase I/IIa Trial of RGX-314 for the Treatment of Wet AMD using Subretinal Delivery

Today’s update includes data from Cohorts 4 and 5 as of July 13, 2020. Each cohort enrolled 12 patients each at doses of 1.6×1011 GC/eye and 2.5×1011 GC/eye, respectively.

Patients in Cohort 4 and Cohort 5 at one year after administration of RGX-314 demonstrated stable visual acuity with a mean BCVA change of +4 letters and -2 letters from baseline, respectively, as well as decreased retinal thickness, with a mean change in CRT of -61 µm and -79 µm, respectively.

There was a clinically significant and meaningful reduction in anti-VEGF treatment burden in both Cohorts 4 and 5 compared to the 12 months prior to RGX-314 administration. Patients in Cohort 4 received a mean of 4.1 injections over one year following administration of RGX-314, a 61% reduction in treatment burden. Patients in Cohort 5 received a mean of 1.4 injections over one year following administration of RGX-314, a reduction in treatment burden of 85%.

In Cohort 4, three out of twelve (25%) patients received no anti-VEGF injections over one year, and these patients demonstrated a mean BCVA improvement of +6 letters and a mean reduction in CRT of -62 µm at one year. In Cohort 5, eight out of the eleven (73%) patients observed through one year have received no anti-VEGF injections after administration of RGX-314 and these patients demonstrated a stable mean BCVA change of 0 letters and a mean reduction in CRT of -95 µm at one year.

Consistent with previous results, intraocular RGX-314 protein expression levels were observed in a dose-dependent manner across each cohort at one year after administration of RGX-314. The mean protein expression levels in Cohort 4 and Cohort 5 were 420.9 ng/ml and 457.5 ng/ml, respectively.

Study Design for Phase II Trial for RGX-314 for Treatment of Wet AMD using Suprachoroidal Delivery (AAVIATE)

REGENXBIO also announced that a Phase II trial, AAVIATE, to evaluate the suprachoroidal delivery of RGX-314 in patients with wet AMD, will begin dosing patients in the third quarter of 2020. AAVIATE is a multi-center, open-label, randomized, active-controlled, dose-escalation study that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector, a targeted, in-office route of administration.

AAVIATE will enroll 40 patients with severe wet AMD who are responsive to anti-VEGF treatment. Patients will be randomized to one-time RGX-314 SCS delivery versus monthly 0.5 mg ranibizumab intraocular injection at a 3:1 ratio and two dose levels of RGX-314 will be evaluated: 2.5×1011 GC/eye and 5×1011 GC/eye. Patients will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RGX-314.

The primary endpoint of the study is mean change in vision, as measured by BCVA, at 40 weeks from baseline compared to monthly ranibizumab. Other endpoints include mean change in CRT and number of anti-VEGF intravitreal injections.

The Company expects to report interim data from the first cohort of this trial by the end of 2020.

Conference Call

In connection with this announcement, REGENXBIO will host a webcast and conference call with accompanying slides today at 8:30 a.m. ET. This event will feature Robert Avery, M.D., Founder of California Retina Consultants and Research Foundation, Dante Pieramici, M.D., Director, California Retina Research Foundation and Partner, California Retina Consultants, and Peter Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine and Cole Eye Institute.

To access a live or recorded webcast of the call and accompanying slides, please visit the “Investors” section of the REGENXBIO website at www.regenxbio.com. To access the live call by phone, dial (888) 317-6003 (domestic) or (412) 317-6061 (international) and enter the passcode 6960652. The recorded webcast will be available for approximately 30 days following the call.

About RGX-314

RGX-314 is being developed as a potential one-time treatment for wet AMD, diabetic retinopathy, and other additional chronic retinal conditions treated with anti-VEGF. RGX-314 consists of the NAV AAV8 vector encoding an antibody fragment which is designed to inhibit VEGF, modifying the pathway for formation of new leaky blood vessels which lead to retinal fluid accumulation and vision loss.

About the Phase I/IIa Clinical Trial of RGX-314

RGX–314 is being evaluated in a Phase I/IIa, multi-center, open-label, multiple-cohort, dose–escalation study in adult patients with wet AMD in the United States. The study includes patients previously treated for wet AMD who are responsive to anti-VEGF therapy. The study is designed to evaluate five escalating doses of RGX-314, with six patients in the first three dose cohorts and 12 patients in the fourth and fifth dose cohorts. Patients were enrolled into all dose cohorts independent of their neutralizing antibody titers to AAV and did not receive prophylactic immune suppressive oral corticosteroid therapy before or after administration of RGX-314. The primary endpoint of the study is safety at 6 months following administration of RGX-314. Secondary endpoints include visual acuity, retinal thickness on SD–OCT, ocular RGX-314 protein expression, and the need for additional anti-VEGF therapy. Following completion of the primary study period, patients enter a follow-up period and will continue to be assessed until week 106 for long-term safety and durability of effect.

About Wet AMD

Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time.

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Forward-Looking Statements

This press release includes “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO’s business, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2019, and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Tricia Truehart
Investor Relations and Corporate Communications
347-926-7709

Investors:
Eleanor Barisser, 212-600-1902
eleanor@argotpartners.com

Media:
David Rosen, 212-600-1902
david.rosen@argotpartners.com

(PRNewsfoto/REGENXBIO Inc.)

Jennifer Butler, Executive Vice President and General Manager, Innate Pharma US Inc. sits down with Rich Bendis for BioTalk

By | BioTalk, News | No Comments

Jennifer Butler, Executive Vice President and General Manager, Innate Pharma US Inc. joins Rich Bendis on BioTalk to discuss her career, bringing Innate from France to the US, and goals.

Listen now on Apple https://apple.co/3i30Bxs, Google https://bit.ly/2PkUw2U, Spotify https://spoti.fi/31gDh8n, TuneIn https://bit.ly/3fqn7i3, and YouTube Audio https://bit.ly/3kgU9ou.

Jennifer Butler was appointed Executive Vice President and General Manager of Innate Pharma US Inc. in March 2019.

Prior to her appointment, Ms. Butler served as Chief Business Officer, Chief Commercial Officer and Head of US operations, responsible for global business development and commercial strategy at Tessa Therapeutics, a clinical-stage oncology company. She previously served for more than 10 years in various commercial and strategy roles with increasing responsibility at AstraZeneca/MedImmune across several therapeutic areas. Ms. Butler also previously worked in strategic healthcare consulting and as an analyst in Equity Capital Markets at Merrill Lynch.

Ms. Butler has more than 20 years of strategic marketing and commercial leadership expertise along with general management experience.

Click Here to Read the Transcript.

The Washington Post Names RoosterBio a 2020 Top Washington-area Workplace

By | News | No Comments

FREDERICK, MD. (PRWEB) JULY 30, 2020

RoosterBio has been named one of The Washington Post’s 2020 Top Workplaces in the Washington, D.C. area. Winners were selected based solely on employee feedback gathered through an anonymous third-party survey administered by Energage, LLC, which measured several aspects of workplace culture, including alignment, execution, and connection. This award is the third award received by the RoosterBio for its outstanding workplace culture since 2019.

“As our leadership team was transforming RoosterBio from an incubator startup company into a worldwide regenerative medicine products leader, we wanted to build the kind of company we all wanted to work for,” said RoosterBio CEO Margot Connor. “It is gratifying to realize that this effort is paying off. As we navigate the new challenges that COVID-19 has presented this year, we remain nimble and adaptable, but focused on retaining the high-quality workforce that we have.”

The full list of winners along with additional content will run in print in a special Top Workplaces magazine on October 14, 2020 and will be available on The Post’s site. The Washington Post will also host an awards ceremony in October to recognize the 200 top-ranked companies.

“Now in its seventh year, The Post’s Top Workplaces list continues to highlight the companies that are leaders in the Washington-area in terms of employee engagement and satisfaction,” said Washington Post Top Workplaces editor Dion Haynes. “We had a record number of employees participate in the survey this year, making it clear that these organizations have made cultivating an atmosphere of support and respect a priority.”

In 2019, RoosterBio won the Frederick County Best Places to Work award in the medium-sized employer category by Frederick County and City Governments, and the Frederick County Chamber of Commerce. Most recently, Rooster Bio was named a 2020 Top 50 Workplace in Frederick Magazine.

About RoosterBio
RoosterBio, Inc. is a privately held cell manufacturing platform technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio’s products are high-volume, cost-effective, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded, and used in development, leading to marked time and cost savings for customers. RoosterBio’s innovative products and collaborative relationships are ushering in a new era of productivity and standardization into the field. Visit http://www.roosterbio.com.

About The Washington Post
The Washington Post is an award-winning news leader whose mission is to connect, inform, and enlighten local, national and global readers with trustworthy reporting, in-depth analysis and engaging opinions. It combines world-class journalism with the latest technology and tools so readers can interact with The Post anytime, anywhere.

About Energage, LLC
Headquartered in Exton, PA., Energage (formerly known as WorkplaceDynamics) is a leading provider of technology-based employee engagement tools that help leaders to unlock potential, inspire performance, and achieve amazing results within their organizations. As the research partner behind the Top Workplaces program, Energage has surveyed more than 47,000 organizations representing well over 16 million employees in the United States.

Johns Hopkins Receives $35M in Federal Funding for COVID-19 Blood Plasma Trials

By | News | No Comments

Researchers will test convalescent blood plasma therapy in two nationwide trials to determine its effectiveness in treating COVID-19 patients

Johns Hopkins researchers have received $35 million in funding from the U.S. Department of Defense for two nationwide clinical trials to test the effectiveness of a convalescent blood plasma outpatient treatment that may help COVID-19 patients’ immune systems fight the virus.

The randomized double blind trials totaling 1,100 people will be conducted at over 20 ambulatory clinics in medical centers across the U.S., including the Navajo Nation, and will help researchers determine whether convalescent blood plasma therapy—a transfusion of a blood product from COVID-19 survivors that contains antibodies—can effectively be used to treat people in the early stage of COVID-19 illness or prevent the infection in those at high risk of exposure to the virus at their home or jobs.

Currently, there are no FDA-approved vaccines to prevent infection with the SARS-CoV-2 virus, which causes COVID-19, nor approved treatments for the illness in its earliest stage. There are also no outpatient therapies to prevent hospitalization or death.

“This is a story of great synergy between researchers and institutions to carry out important studies that will inform our nation and the world on how effective plasma can be to prevent COVID-19 and to treat early disease,” says Arturo Casadevall, a Bloomberg Distinguished Professor who holds joint appointments in Bloomberg School of Public Health and School of Medicine. To initiate the clinical trial, Casadevall and his colleagues assembled a broad collaboration of investigators at Johns Hopkins and at participating medical centers across the U.S.

Image caption:Shmuel Shoham from Johns Hopkins Medicine and David Sullivan from the Bloomberg School of Public Health discuss the blood plasma clinical trials and their potential applications.

Leaders of the trials include Casadevall and his colleagues Shmuel Shoham, associate professor of medicine at School of Medicine, David Sullivan, professor of molecular microbiology and immunology at the Bloomberg School of Public Health, and Daniel Hanley, director for multisite clinical trials in the Institute for Clinical and Translational Research at the School of Medicine.

“Blood plasma therapy may have the most potential in providing immediate immunity to people at high risk of COVID-19 exposure and treating COVID-19 early to prevent hospitalization or death,” says Sullivan. “For definitive proof of this, we need a rigorous randomized clinical study to evaluate it.”

The prevention trial will include 500 people who have been exposed to COVID-19 in their home or at work as health care providers. The companion trial will have another 600 participants who have early COVID-19 disease, meaning they are within eight days of their first symptoms but are not sick enough to be in a hospital. All participants will be over age 18. The researchers aim to complete recruitment of participants to the trial in early fall 2020.

Convalescent blood plasma therapy involves transfusing a portion of blood called plasma from people who have recovered from the virus. When separated from red and white blood cells and platelets in the blood, plasma is the yellow-tinged liquid that includes proteins called antibodies, which glom on to foreign substances such as viruses and either mark them for destruction by the immune system or disrupt a virus’ ability to multiply and grow.

Physicians have used the treatment for severe diseases in hospitals for more than a century, often during epidemics such as the influenza pandemic of 1918 and the more recent outbreak of severe acute respiratory syndrome in 2003. Laboratory experiments in the past have shown that the therapy neutralizes many viruses. However, the treatment is often used in the chaotic phases of a crisis without the rigors of a large clinical trial.

There is very little clinical data proving the effectiveness of using the therapy in outpatient clinics, according to the researchers. Currently, only hospitalized patients have access to any type of therapy for COVID-19.

“Because plasma from recovering patients is widely available, it may be a rapid low-cost treatment of major value in early stages of epidemics. A randomized trial is needed to clearly demonstrate these historical and laboratory proven benefits,” says Hanley.

The blood plasma used in these trials is being collected from many organizations, including the New York Blood Center and the American Red Cross. One donor can provide plasma for up to three people. Trial participants will receive one IV infusion of the plasma at an outpatient facility, which usually takes about an hour.

As part of the trials, participants with COVID-19 will be monitored over four weeks to determine the course of the disease and its severity. Participants who have been exposed to the virus will be evaluated over four weeks for development of COVID-19 infection, including symptom checks and laboratory testing for the virus and antibodies. The researchers will examine the long-term immunity of both groups at three months after infusion with convalescent plasma.

From the trials, Shoham says, the researchers hope to learn if blood plasma can prevent infection or squash it where it begins. “There are also biological implications,” he says, adding that blood plasma therapy could expand treatment options for viral diseases. “We’re reviving an old approach to fight pathogens, and it may be useful for other viruses or parasites such as malaria.”

Image of virus and cells
Johns Hopkins responds to COVID-19

Coverage of how the COVID-19 pandemic is affecting operations at JHU and how Hopkins experts and scientists are responding to the outbreak

Johns Hopkins research into convalescent blood plasma therapy was previously funded by $3 million from a Bloomberg Philanthropies gift and $1 million from the state of Maryland. Johns Hopkins also received a $1 million award supplement from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. Additionally, the researchers used the National Center for Advancing Translational Sciences Trial Innovation Network and the National COVID-19 Convalescent Plasma Project at Michigan State University to develop interest in the trial among participating centers.

Jason Roos, deputy joint program executive officer for chemical, biological, radiological and nuclear defense, says, “We’ve seen that convalescent plasma can benefit patients suffering from some of the worst effects of COVID-19. The JPEO-CBRND is excited to be working with Johns Hopkins University to determine whether that same plasma could help protect our Joint Forces from COVID-19, either by preventing infection altogether or drastically reducing their symptoms. Those types of beneficial outcomes would help us make sure our servicemen and women stay healthy so they can complete their mission.”

Other key faculty supporting this project include virologists Andy Pekosz and Sabra Klein of the Johns Hopkins Bloomberg School of Public Health and transfusion medicine experts Evan Bloch and Aaron Tobian of the School of Medicine.

BioFactura Awarded $1 Million SBIR Contract for Development of a Marburg Virus Therapeutic

By | News | No Comments

Contract awarded by the Joint Science & Technology Office–Chemical and Biological Defense of the Department of Defense

FREDERICK, Md.July 29, 2020 /PRNewswire-PRWeb/ — BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based bioprocess suitable to meet surge requirement needs for rapid manufacture of a monoclonal antibody (mAb) therapeutic against the Marburg virus (MARV) biothreat.

MARV is a member of the same family as Ebola virus, causes lethal viral hemorrhagic fever, and is classified as a Category A priority pathogen by the NIH, due to high case fatality rates and suspected weaponization. There are currently no MARV vaccines or therapeutics approved for human use. With so much focus on Ebolavirus over the last few years, MARV antibody development efforts have lagged considerably and few MARV-specific mAbs have been described. This problem leaves the U.S. in a vulnerable situation to treat and manage a MARV outbreak. Under the contract, BioFactura will use its proprietary StableFastTM Biomanufacturing Platform to develop a process for this crucial therapy against MARV that is easily scalable for production at large manufacturing cGMP (current Good Manufacturing Practices) facilities.

Dr. Darryl Sampey, President and CEO of BioFactura, stated, “This Chem-Bio Defense Phase II award builds upon our successful early development of a highly productive StableFast cell line during the SBIR Phase I contract. We look forward to working with our partners at the DoD to develop the drug manufacturing process for advanced testing and clinical readiness to meet threats to the warfighter.”

“This government contract for the development of a novel Marburg virus therapeutic countermeasure is the
result of continued efforts to create highly effective therapeutics that can be deployed in the event of a biological threat. The current COVID pandemic has taught us a valuable lesson: Strategic preparedness in conjunction with an organized effort at containment and treatment, can mitigate the effects of these deadly pathogens. We applaud the JSTO-CBD and DoD for their foresight,” said Jeffrey Hausfeld MD. MBA., Chairman and Chief Medical Officer of BioFactura, Inc.

This project is supported by the Defense Threat Reduction Agency under Contract No. HDTRA1-20-C-0033. Any opinions, findings and conclusions or recommendations expressed in this press release are those of the
authors and do not necessarily reflect the views of Defense Threat Reduction Agency.

About BioFactura, Inc.

BioFactura, Inc. (Frederick MD) develops and commercializes high-value biodefense medical countermeasures and biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases. http://www.biofactura.com

Thrive Earlier Detection Closes $257 Million Series B Financing

By | News | No Comments

Proceeds to Advance CancerSEEK, a Liquid Biopsy Test Designed to Detect Multiple Cancers at Earlier Stages of Disease, into Registrational Trial

Financing Co-Led by Casdin Capital and Section 32 and Includes Multiple New Top-Tier Investors

Cambridge, MASS., July 29, 2020 – Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, today announced that it has raised $257 million in a Series B financing. The round was led by Casdin Capital and Section 32, with participation from new investors Bain Capital Life Sciences, Brown Advisory, Driehaus Capital Management, Intermountain Ventures, Janus Henderson Investors, Lux Capital, Moore Strategic Ventures, Perceptive Advisors, Rock Springs Capital, Sands Capital, funds and accounts advised by T. Rowe Price Associates, Inc., and other undisclosed investors. All of Thrive’s Series A investors returned to participate in the Series B financing. Thrive also announced that Eli Casdin has been appointed to the board of directors.

“Since our founding in 2019, Thrive has continued to make tremendous progress in our pursuit towards changing the face of cancer,” said David J. Daly, chief executive officer of Thrive. “In April, we published data from the first ever prospective and interventional study of a multi-cancer screening test in an asymptomatic population. Our blood test more than doubled the number of cancers first detected by screening, enabling better outcomes and, in some cases, potential cure for these patients. With this financing, we are well-positioned to advance our test into a robust registrational trial and continue to work closely with key stakeholders to remove barriers to ensure timely access, including future reimbursement for CancerSEEK.”

Thrive’s vision is to incorporate its blood test, CancerSEEK, into routine medical care and detect more cancers at earlier stages when they can be more effectively treated and, in many cases, cured. Today, the vast majority of people are diagnosed only after symptoms appear, often coinciding with late stage, metastatic disease, and poor outcomes. CancerSEEK, used in combination with standard-of-care screening tests has the potential to shift this paradigm to a new reality where the majority of cancers, including many with no screening options today, are diagnosed through screening and at earlier stages.

“We are proud to partner with a diverse group of world class investors who share in our vision to make earlier detection of cancer an accessible and affordable part of our healthcare system,” said Steven J. Kafka, Ph.D., chairman of Thrive and managing partner at Section 32. “We are also thrilled to welcome Eli Casdin to our board of directors. Eli has deep and broad expertise in diagnostics and biotech, and he will provide tremendous value to Thrive.”

Mr. Casdin has spent the last 17 years focused on and investing in disruptive technologies and business models across life sciences and healthcare. In 2011, he founded Casdin Capital, a life science technology investment firm to provide growth equity to private and public companies throughout the industry continuum.

“In the collective search to bend the mortality curve on cancer, the disruptive potential of earlier detection has long been a promise. But now, in a real-world study of 10,000 individuals, Thrive’s blood test integrated with standard-of-care, has delivered on this potential and shows the power of detecting cancers before they spread. While there is more work ahead, it is clear that the future has now arrived. I’m excited to join the board and help in my small way to usher in this new era,” said Eli Casdin, chief investment officer of Casdin Capital.

About Casdin Capital

Casdin Capital, LLC was founded in 2011 and brings a deep understanding, expertise and long-term perspective to financing the next generation of life science innovation. Specific only to the firm’s diagnostics and molecular information portfolio, Casdin Capital has invested in many of the leading pioneers, including but not limited to Foundation Medicine, Invitae, Adaptive Biotechnologies, Flatiron Health and 23andMe. In addition, Eli Casdin currently serves on the board of directors of Exact Sciences, a leader in the field of molecular screening for cancer. For more information, please visit www.casdincapital.com.

About Section 32

Section 32 is a venture capital fund investing at the frontiers of technology, healthcare and the life sciences with the goal to improve the human condition by accelerating the discovery, development, adoption and distribution of important technologies and lifesaving medicines. Founded by Bill Maris, the firm’s focus areas include biotechnology, therapeutics, advanced diagnostics, precision medicine, software, cybersecurity, machine learning and artificial intelligence. For more information, please visit www.section32.com.

Thrive Earlier Detection Corp. is a healthcare company focused on incorporating earlier cancer detection into routine medical care to extend and save lives. Thrive is developing CancerSEEK, a liquid biopsy test that is designed to detect many cancers at earlier stages of disease. CancerSEEK will serve as the core of Thrive’s integrated cancer information offering. For more information, please visit www.thrivedetect.com.

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., Virtually Sits Down with Rich Bendis for BioTalk

By | BioTalk, News | No Comments

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google https://bit.ly/3hz2jpU, Apple https://apple.co/3eYLiUs, Spotify https://spoti.fi/3f3cqBU, TuneIn https://bit.ly/302voUG, and YouTube (Audio Only) https://bit.ly/3f3cQZ0

Darryl Sampey co-founded BioFactura in 2004 and has guided the venture over the past 15 years from start-up through incubator stages to become a significant biopharmaceutical product development and clinical manufacturing company. As President and CEO, Dr. Sampey manages all strategic and scientific endeavors of the Company. Before BioFactura, he led both process development and manufacturing teams at Human Genome Sciences, Inc. (HGS) honing his skills developing and scaling up new biologics processes and control strategies. During his tenure with HGS, Dr. Sampey played key roles in the start-up, commissioning, and validation of the company’s first cGMP manufacturing facility and associated development laboratories. Prior to his work at HGS, Dr. Sampey gained industrial experience in the commercial research laboratory designing and optimizing fermentation and product recovery processes for novel vaccines at North American Vaccine, Inc. His work in vaccine research has since progressed to internationally-approved vaccines for whooping cough in infants and meningitis in adults. Darryl Sampey began his career in biotechnology at the University of Maryland graduating first in his class with a Bachelor of Science in Chemical Engineering, Magna Cum Laude, and, subsequently earned a Ph.D. in Bioengineering.

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate

By | News | No Comments
  • Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
  • Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
  • Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”

The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is currently in clinical trials. It is one of the candidates funded and supported by Operation Warp Speed (OWS), the U.S. government’s program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available.

Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, “As COVID-19 vaccine candidates progress through the pipeline, Emergent stands ready alongside leading innovators to rapidly deploy our CDMO services to help meet the substantial demand for a vaccine – anchored on our foundational expertise in development and manufacturing and propelled by our commitment to our mission – to protect and enhance life.”

This agreement follows and is in addition to the landmark public-private CDMO partnership between Emergent and the Biomedical Advanced Research and Development Authority (BARDA) announced in June to pave the way for OWS high-priority innovators.

Activities under this agreement will be performed at Emergent’s Baltimore Bayview facility, where certain manufacturing capacity reserved by BARDA through the CDMO task order issued to Emergent under OWS will be used. Emergent’s Baltimore Bayview facility is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

The CIADM has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

Financial Considerations
The company will provide an update to its 2020 financial outlook incorporating expectations related to this agreement and any other relevant information when it reports its second quarter financial results on July 30, 2020.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Emergent’s Response to COVID-19
Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.

Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments – COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding and will be evaluated in two studies of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. With $34.6 million in funding from the Department of Defense and in collaboration with the Mount Sinai Health System and ImmunoTek Bio Centers, COVID-HIG will also be evaluated for post-exposure prophylaxis in populations at high risk of COVID-19, such as front-line health care workers and the military. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in Phase 2 clinical studies in 2020. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.

Emergent is deploying its CDMO capabilities, capacities, and expertise to support the U.S. government’s Operation Warp Speed to pave the way for innovators to advance COVID-19 programs. The company is working with four innovators to develop and manufacture COVID-19 vaccine candidates. For the COVID-19 vaccine response, Emergent’s integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at its Baltimore Bayview facility, and drug product manufacturing at its Baltimore Camden and Rockville facilities, all in Maryland.

For 22 years Emergent has focused on advancing public health, and its multi-pronged approach to tackling COVID-19 demonstrates its commitment to its mission – to protect and enhance life.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to produce viable COVID-19 vaccine candidates at the prescribed scale and on the anticipated timeline and pave their potential pathway to licensure, the total value and anticipated duration of activities under the announced AstraZeneca contract as well as the negotiation of any further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Media Contact:
Miko B. Neri
Senior Director, Global Communications & Public Affairs
240-631-3392
NeriM@ebsi.com

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

 

emergent logo.jpg

Source: Emergent BioSolutions

Join our Mailing List