BioLife Solutions CryoStor® Commercial Grade Freeze Media Embedded in TC Biopharm ImmuniCell® Clinical Trial for Various Cancers

Novel T Cell Based Immunotherapy to be Evaluated in Melanoma, Kidney, and Lung Cancer in Groundbreaking Clinical Trial Design

Sep 14, 2015, 06:00 ET from BioLife Solutions, Inc.

BOTHELL, Wash., Sept. 14, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced that UK-based TC Biopharm Ltd, a developer of anti-cancer immunotherapies, has incorporated the Company's CryoStor clinical and commercial grade freeze media in its manufacturing and clinical delivery processes of ImmuniCell, a novel T cell based immunotherapy targeting various cancers.

TC Biopharm has recently been granted a Clinical Trial Authorisation (CTA) by UK regulators to treat cancer patients with ImmuniCell. In designing the adaptive phase II/III clinical trial, TCB worked closely with the MHRA, through its Protocol Advice service, to establish a pragmatic treatment framework, which focuses on patient safety whilst maximizing the potential for an efficacious outcome.

The ground-breaking clinical trial design allows patients with melanoma, kidney and lung cancer to be treated in a single study – maximizing the potential to establish how three different cancer types respond to TCB's innovative immunotherapeutic approach.

Mike Rice, BioLife's President & CEO, said, "We are very pleased to support this groundbreaking clinical trial and congratulate Dr. Leek and the entire team at TC Biopharm on gaining authorization to commence this trial.  This product adoption further demonstrates the demand and preference for our commercial grade biopreservation media products, which have now been incorporated into more than 200 pre-clinical validation projects and clinical trials of new cell-based products and therapies." 

In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030. Pharmaceutical Commerce estimates that in 2014, $8.4 billion was spent on cold chain logistics of pharmaceuticals, with $5.6 billion for transportation and $2.8 billion for specialized packaging and instrumentation. BioLife's addressable market is comprised of the demand for small payload shipping containers and related temperature monitoring and location tracking devices.

About TC Biopharm

Incorporated late 2013, TCB was initially set up as an equally-owned joint venture partnering with Medinet (Japan), TCB receiving an exclusive license to Medinet patents for manufacture of innovative T cell therapies.

Headquartered at the Pentlands Science Park outside Edinburgh, TCB is registered in Scotland (SC 453579). Becoming operational from February 2014, the Company is developing ImmuniCell® an autologous anti-cancer immunotherapy which involves expansion of gamma delta T cells over several weeks - formulating a treatment for a wide variety of different tumor types. The technology was initially developed and commercialized by Medinet, who have successfully treated numerous cancer patients in Japan. Publicly listed on the Tokyo Stock Exchange, Medinet was founded in 1995, and is a lead contract development manufacturing organization offering a full range of cell and tissue products in Japan. Medinet has conducted collaborative worldwide research with universities, medical/academic institutions, and other companies in Japan, US and Europe.

In January 2015, TCB was awarded a Manufacturer's Authorisation for Investigational Medicinal Products MIA (IMP), which permits manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials. For more information please visit www.tcbiopharm.com.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  BioLife's enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

This press release contains forward-looking statements, including, but not limited to, statements concerning new products, the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, and, projected financial results and liquidity. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor Relations Daphne Taylor Senior Vice President, Chief Financial Officer (425) 402-1400 dtaylor@biolifesolutions.com

 

SOURCE BioLife Solutions, Inc.



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