Monthly Archives

October 2019

MockV Solutions Announces Collaboration Focused on Predicting Viral Clearance During AAV Bioprocess Development

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Rockville, MD – October 16, 2019 – MockV Solutions, Inc. (MockV or the Company), a company developing innovative products to analyze viral clearance during process development, announced today that it has signed a test and study agreement with REGENXBIO Inc. (REGENXBIO), Thermo Fisher Scientific Inc. (Thermo Fisher) and Texcell-North America, Inc. (Texcell NA) to evaluate MockV’s MVM-MVP Kit for predicting Minute Virus of Mice (MVM) clearance during adeno-associated virus (AAV) bioprocessing.

The intention of this test and study agreement is to determine if the non-infectious Mock Virus Particles (MVP) could be used as an accurate and economic indicator of MVM clearance during AAV purification process development studies, and to determine if MVM and Xenotropic Murine Leukemia Virus (XMuLV) clearance can be achieved through Thermo Fisher’s POROS® CaptureSelect™ AAVX affinity resin. Implementing affinity chromatography resins like POROS CaptureSelect AAVX enables a scalable platform approach to AAV downstream processing. However, it is unknown if model viruses such as MVM and XMuLV would separate from AAV during processing and enable viral clearance reduction claims. This collaboration will address this question through live viral clearance spiking studies (performed at Texcell NA).

The MVM-MVP Kit contains a non-infectious MVP spiking surrogate that mimics the physicochemical characteristics of MVM, a small and physiochemically resistant parvovirus used as a universal standard for assessing viral clearance during process validation studies.

“Affinity chromatography can contribute to viral reduction in the downstream processing of mAb therapeutics,” said Brandon Pence, Vice President and General Manager, Purification and Pharma Analytics at Thermo Fisher. “However, viral clearance is not well characterized in emerging therapeutic modalities like gene therapy. These studies have the potential to provide critical data and process parameter insights on the effect of affinity chromatography on viral clearance in AAV processes, as well as additional classes of viral vectors.”

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Cerecor To Sell Pediatric Portfolio to AYTU BioScience

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ROCKVILLE, Md., Oct. 14, 2019 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for pediatric rare diseases and neurology, announced today that it has entered into an asset purchase agreement with AYTU BioScience, Inc. (“AYTU”) to sell Cerecor’s Pediatric Portfolio in a deal valued in excess of $32 million.   The consideration includes a combination of cash and Aytu preferred stock totaling $17 million and the assumption of Cerecor’s outstanding payment obligations payable to Deerfield CSF, LLC (“Deerfield Note”) and certain other liabilities in excess of $15 million, providing non-dilutive cash generation for the Cerecor.  The funds from the transaction extend the runway towards NDA submission of CERC-801 and its associated Priority Review Voucher (PRV).

Dr. Simon Pedder,  Executive Chairman of the Board,  commented, “We believe this a positive deal for both the business and our shareholders.  In totality, it improves our cash position, and removes our debt obligations.  It allows the organization to focus on, and invest in, our fast-to-market pipeline in rare orphan diseases with the CERC-800s series.   It also accelerates our build toward the launch of CERC-801 which will deliver the first approved product for Congenital Disorders of Glycosylation.  Currently there are no FDA approved treatments  for this underserved patient population. Lastly,  it  enables us to further CERC-301 into the clinic in both Diabetic Orthostatic Hypotension and Intradialytic Hypotension, two therapeutic areas with significant market size and unmet medical need.”

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Emmes Awarded New NIH Contracts that Address the Nation’s Opioid Addiction Crisis

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The Company is Hiring Additional Staff to Support its Awards Totaling Over $9 Million

ROCKVILLE, Md.Oct. 10, 2019 /PRNewswire/ — Emmes today announced the award of eight new task order contract awards associated with the Helping to End Addiction Long-termSM Initiative, known as the NIH HEAL InitiativeSM. The total value for the eight contracts is more than $9 million. The contract awards’ duration ranges from one to five years.

The National Institutes of Health launched the HEAL Initiative in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The eight Emmes contract awards are among 375 grants, contracts, and cooperative agreements across 41 states made by the National Institutes of Health in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis.

“The new contracts recognize our 10-year track record for providing data and statistics support to the research sponsored by NIH’s National Institute for Drug Abuse (NIDA),” said Dr. Paul Van Veldhuisen, Emmes’ chief operating officer. “It’s extremely satisfying for our company and our staff to join with leading researchers across the country in combatting the opioid epidemic.”

As the data and statistical center for the NIDA-sponsored National Drug Abuse Treatment Clinical Trials Network, or CTN, Emmes will play a critical role supporting the enhancement of the CTN to address opioid research. This enhancement will include activities to improve access to high-quality addiction treatment, including studies of the delivery of Opioid Use Disorder (ODU) in general medical settings, as well as ways to prevent the progression of moderate to severe ODU.

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Viela Bio Enters Strategic Collaboration with Mitsubishi Tanabe Pharma to Develop and Commercialize Inebilizumab for Autoimmune Diseases in Japan and Other Asia Regions

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Viela Bio is eligible to receive an upfront licensing fee of $30 million as well as development and commercialization milestones and payments based, in part, on sales revenue

GAITHERSBURG, M.D., Oct. 09, 2019 (GLOBE NEWSWIRE) — Viela Bio, Inc. (“Viela”) and Mitsubishi Tanabe Pharma Corporation (“MTPC”) today announced a collaboration focused on the development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in nine Asia regions for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.

“This partnership adds to our ability to commercialize inebilizumab globally, subject to regulatory approval,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “As a well-established pharmaceutical company in Japan, Mitsubishi Tanabe has strong product development and commercialization capabilities in Asia, and we believe, is an ideal partner for expanding inebilizumab’s potential reach to thousands of additional patients in need of viable treatments, with NMOSD as an initial indication.”

Under terms of the collaboration, Viela will receive an up-front licensing fee of $30 million as well as additional payments contingent on certain development and commercial milestones, plus payments based, in part, on sales revenue. MTPC will be responsible for leading development and commercialization of inebilizumab in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore, and Taiwan.

“Our organization is delighted to partner with Viela to develop and commercialize their promising product candidate inebilizumab for autoimmune and inflammatory diseases,” said Masayuki Mitsuka, MTPC President & Representative Director. “Inebilizumab is an exciting product candidate that, based on the results from the N-MOmentum pivotal study, is well-positioned to provide meaningful benefit for patients with NMOSD, and potentially additional diseases, subject to regulatory approval. We are excited to work with Viela to advance inebilizumab in Japan and other Asia regions, and look forward to a productive partnership between our companies.”

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Intralytix Opens New HQ in Columbia, Maryland for Phage Research and Manufacturing Facility

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October 7, 2019

On October 4th, 2019, Intralytix officially opened its brand new 33,000 sq. ft. facility in Columbia, Maryland. The new facility is located in the Columbia Gateway Community and will serve as the Company’s new headquarters, including; research and laboratory space, executive offices, and a substantially increased manufacturing facility.

In a previous statement Dr. Alexander Sulakvelidze, the Company’s Executive Vice President and Chief Scientific Officer remarked, “This expansion further solidifies Intralytix’s position as the leading phage company in the world and creates significant opportunities for future growth. This is especially timely now as the enthusiasm for bacteriophage-based products for controlling and treating bacterial pathogens – including multidrug resistant pathogens – is growing worldwide”

Intralytix, Inc. is a privately-held company currently headquartered in downtown Baltimore, Maryland. The company is the world’s leader in bacteriophage technology and was the first company in the world to receive FDA-approval for a phage-based product for food safety applications. Intralytix currently has the world’s largest portfolio of FDA-approved phage-based food safety products on commercial markets. The company holds several bacteriophage technology-related patents, including two U.S. patents (and additional patents pending) on the use of bacteriophages for fine tuning human or animal microbiome (US 7,459,272 B2 and US 8,003,323 B2).

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Editas Medicine and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Cell Medicines

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CAMBRIDGE, Mass. and GAITHERSBURG, Md., Oct. 07, 2019 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, and MaxCyte, Inc., the global cell-based therapies and life sciences company, today announced a new clinical and commercial license agreement. Editas Medicine will use MaxCyte’s Flow Electroporation® technology and ExPERT™ instruments for the advancement of engineered cell medicines, including EDIT-301, an experimental CRISPR medicine designed to durably treat sickle cell disease and beta-thalassemia.

Under the terms of the agreement, Editas Medicine obtains non-exclusive clinical and commercial use rights to MaxCyte’s cell engineering platform to develop up to five therapies including four immuno-oncology therapies, and in return MaxCyte will receive development and approval milestones and sales-based payments in addition to other licensing fees.

“We look forward to working with MaxCyte and using its leading technology to develop EDIT-301 as a best-in-class medicine for the treatment of sickle cell disease and beta-thalassemia, and for up to four engineered cell medicines to treat cancer,” said Charles Albright, Ph.D., Executive Vice President and Chief Scientific Officer, Editas Medicine.

“We are excited to work with Editas Medicine as it is at the forefront of developing engineered cell medicines that have the potential to change the course of disease for many patients. This agreement is also a significant business milestone for MaxCyte as we continue to invest in our technology platform and help support companies at the leading edge of cell therapy and gene editing to develop medicines for patients in need,” said Doug Doerfler, President & CEO of MaxCyte, Inc.

MaxCyte’s ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.


Adaptive Phage Therapeutics Completes $7M Financing Round with Several Strategic Investors

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October 04, 2019
Original Press Release

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 that it has closed an oversubscribed, non-brokered financing, raising approximately $7 million in proceeds. Investors include Alexandria Venture Investments as well as a large integrated healthcare delivery network currently exploring the option to implement PhageBank™ therapy within its network of more than 17 hospitals and a NYSE-listed specialty life sciences company. Proceeds will be deployed to support multi-center phase 2 clinical studies for its PhageBank® therapy for antibiotic resistant bacterial infections.

“Phage therapy is emerging as the most promising alternative to dealing with the crisis of antibiotic resistance in bacterial infection”Tweet this

“Phage therapy is emerging as the most promising alternative to dealing with the crisis of antibiotic resistance in bacterial infection,” said Greg Merril, Chief Executive Officer and co-founder of APT. “The high level of interest from strategic and financial investors in support of our expanding clinical pipeline validates the potential phage therapy holds for patients.”

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Viela Bio Rings Nasdaq Opening Bell in Highly Anticipated Biotech IPO

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October 3, 2019

It has been just 20 months since Viela Bio was founded and today Viela Bio CEO Bing Yao, surrounded by colleagues and family, rang the opening Nasdaq bell to begin their first day of trading (NASDAQ: VIE).

Their journey to IPO included more than $350 million of equity investment since its launch that fueled a rapidly advancing clinical pipeline. An experienced management team, a strong company culture, a relentless pursuit of the science and a foremost commitment to bringing new treatments to their patient community as soon as possible are the hallmarks of a company that has accomplished so much in such a short period of time.

Viela’s share price opened at $19 this morning, followed by a day of trading that did not disappoint investors. After reaching a high of $25.40 during the day, the stock closed 23% above its initial share price at $23.41.

The offering is set to close on October 7th resulting in a raise of around $150 million for the clinical-stage biotech and its investors. For AstraZeneca, Viela’s biggest shareholder who owns more than 14.2 million shares of common stock (38%), according to SEC filings, the day also brings validation to the spin-out deal that was executed nearly two years ago under, then MedImmune President, Bahija Jallal. Jallal was present for today’s ceremony.

Watch the opening bell ceremony live:

In CEO Bing Yao’s statement at the Nasdaq opening, he shared the following remarks:

“When the opportunity was presented to found Viela, spinning out of AstraZeneca, MedImmune. We understood the great responsibility ahead of us to bring this promising portfolio of autoimmune disease therapies.

We began our journey with a sharp focus on the underlining causes of autoimmune disease. Novel approaches like ours are paramount as there are over 23 million people in the US alone living with autoimmune illnesses. Currently, available therapies are rarely considered curative and many patients experience disease progression. We must do better.

In a year and a half we have assembled a team of world-class professionals who have worked tirelessly to advance our lead product inebilizumab. While its’ currently under review for approval, we are confident of its potential treat patients with AMO, a rare condition that attacks optic nerve, spinal cord and brain stem and often leads to blindness and paralysis.

Beyond AMO our team continues to innovate therapies. We believe it has the potential to target a large range of different types of autoimmune conditions. This tremendous progress is due to our experienced management team and gifted employees that I have the distinct honor to call my colleagues. I would also like to thank our investors and Board of Directors. Their support and commitment made it possible to get to this day in our companies history.

We are humbled by the importance of the work in front of us, and really excited by the potential to deliver treatments to patients who suffer from autoimmune conditions.”

Viela Bio CEO, Bing Yao

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Maryland Biotech Arcellx Just Raised $85 Million to Begin Clinicals for its Intelligent Cell Therapy Platform

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With new funding, Arcellx furthers its cell therapy platform intended to address new therapies in oncology and autoimmune disease

October 3, 2019

Arcellx, a privately-held biopharmaceutical company, today announced that it has raised $85 million in an oversubscribed Series B financing. Proceeds will be used to advance the Company’s ARC-T + sparX programs, including clinical development of a bivalent BCMA-targeted cell therapy in multiple myeloma, and a CD123-targeted therapy in acute myeloid leukemia. The Series B will also fund earlier stage ARC-T + sparX programs for patients with solid tumors and diseases outside oncology.

Arcellx was recently featured as one of Five Companies That Are Changing the Landscape for Cell and Gene Therapy and is led by founder David Hilbert, PhD and a veteran team of top-caliber scientists and executives. Earlier this year Arcellx raised $27M in Series A funding from several high caliber investment firms that include NEA, Novo, Takeda Ventures and SR One.

According to the press release;
Participants in the Series B include both existing and new investors to Arcellx. New investors Aju IB and Quan Capital co-led the round, followed by Mirae Asset Venture Investment, Mirae Asset Capital, LG Technology Ventures, JVC Investment Partners, and certain funds managed by Clough Capital Partners, L.P. Existing investors Novo Holdings, S.R. One Limited, NEA and Takeda Ventures also participated in the financing.

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GSK Opens $139M U.S. Expansion of Commercial Manufacturing Facility in Rockville, Maryland

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GSK Opens $139M U.S. Expansion of Commercial Manufacturing Facility in Rockville, Maryland

October 3, 2019

The ribbon was cut today at GSK’s recently expanded manufacturing facility in Rockville, marking the completion of a $139M project that was first announced in May 2017 to support growing demand for BENLYSTA® (belimumab), a treatment for adult patients with Lupus.

The celebration included a Governor’s Citation, presented by Secretary of Commerce Kelly Schulz, along with inspiring words from GSK leadership about the impact of the expansion project and what it means for patients around the world. GSK representatives also gave guided tours of the state of the art biomanufacturing facility.

GSK chose to expand capacity in Rockville with a new 10K scale production facility because of the existing expertise in producing the injected or infused drug that existed at the site.

In a previous statement earlier this year Craig Malzahn, Vice President & Site Director, Rockville Biopharm, shared information about the expansion project with BioBuzz. “We have a 2 x 20,000-liter value stream in our Large Scale Manufacturing facility and a 2 x 1,600-liter value stream in our neighboring Small Scale Manufacturing (SSM) facility,” Malzahan shared. “This new expansion will bring a 2 x 10,000 L value stream online in the SSM building, which will increase our production capability by almost 50% to make and supply key medicines like Benlysta to patients.”

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