New Immunotherapy Treatment Removes All Tumors In Woman With Advanced Metastatic Breast Cancer

T-cells extracted from a tumor, expanded and then re-introduced into the body have resulted in the disappearance of tumors in a woman with metastatic breast cancer. (from forbes.com article: New Immunotherapy Treatment Removes All Tumors In Woman With Advanced Metastatic Breast Cancer)

T-cells extracted from a tumor, expanded and then re-introduced into the body have resulted in the disappearance of tumors in a woman with metastatic breast cancer. (from forbes.com article: New Immunotherapy Treatment Removes All Tumors In Woman With Advanced Metastatic Breast Cancer)

Another remarkably promising immunotherapy. Read the full article in forbes.com HERE

Research published today in Nature Medicine by scientists at the National Cancer Institute (NCI) has described a new immunotherapy approach, which led to a complete disappearance of tumors in a woman with advanced metastatic breast cancer who only had months to live.

The findings show how naturally-occurring tumor infiltrating lymphocytes (TILs) were extracted from the patient’s tumor, grown outside of her body to boost their numbers and injected back into the patient to tackle the cancer. The patient had previously received several treatments including hormone therapies and chemotherapy, but nothing had stopped the cancer progressing. After the treatment, all of the patient’s tumors disappeared and 22 months later, she is still in remission.

Researchers are particularly enthusiastic about the potential of TILs to treat a group of cancers termed ‘common epithelial cancers’, which include those of the colon, rectum, pancreas, breast and lung, together accounting for 90% of all deaths due to cancer in the U.S, around 540,000 people annually, most of these from metastatic disease.

“Once these cancers spread, most people die. We have no effective ways of eliminating metastatic cancers,” said Steven A. Rosenberg, M.D., Ph.D., chief of the Surgery Branch at NCI’s Center for Cancer Research (CCR).

“This is an illustrative case report that highlights, once again, the power of immunotherapy,” said Tom Misteli, Ph.D., director of CCR at NCI
— https://www.forbes.com/

We Are Joining The BioLife Team!

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This morning a press release was issued announcing BioLife’s intention to purchase the 56% share of Savsu that they do not currently own.   We expect the deal to close in 45 days.   We are very excited to be joining the BioLife team!

You can read the press release HERE.

You may know BioLife Solutions for their work as the leading supplier of biopreservation media and automated cell thawing devices for the cell and gene therapy industry.    BioLife is a public company, listed on the NASDAQ exchange (Stock symbol: BLFS), and recently included in the Russell 3000 stock index.  They have built a great team and a fast growing, well run, exciting  business.   (website: https://www.biolifesolutions.com)

Importantly, we have been working with BioLife since 2014 when we first joined together to begin development of our evo.is system and to continue the development of our evo hardware.   We have regularly coordinated on marketing and sales efforts periodically during the past 6 years.  Mike Rice (CEO - BioLife) and Rod DeGreef (CFO - BioLife) currently serve on our Board of Directors.  We have had a really long time to get to know the BioLife team, and we like and respect them.

We are excited about joining the BioLife team at this moment in time for a number of reasons:   First, and foremost, we are joining a company who’s values and vision strongly matches our own.  Second, as activity at Savsu is rapidly increasing, we are joining a team that has the resources and capability to help us reach our full potential.

The entire Savsu team is moving in to this next phase together.   We will continue our base of operations in our new Albuquerque facility which houses design, engineering, testing, and fabrication.   Our evo.is software team (currently based in the greater Seattle area) will co-locate with BioLife at their headquarters facility in Bothell, WA.

We look forward to talking to you about the next phase of our journey!

Dana

Congratulations, AveXis! FDA Approves the First Gene Therapy!

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AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)!

“In the START clinical trial we conducted with Zolgensma, all children were alive at the conclusion of the study and many were able to sit, roll, crawl, play and some could walk. This level of efficacy, delivered as a single, one-time therapy, is truly remarkable and provides a level of unprecedented hope for families battling SMA Type 1. ...”
— Jerry Mendell, M.D., principal investigator at the Center for Gene Therapy at The Abigail Wexner Research Institute of Nationwide Children's Hospital in Columbus, OH
“We are grateful to the tenacious researchers, partners and families who participated in the Zolgensma clinical trials that helped us achieve this incredible milestone,” said Dave Lennon, president of AveXis. “We are proud to bring this one-time gene therapy to pediatric patients with SMA and remain committed to advancing the science behind Zolgensma to transform SMA, as well as other rare genetic diseases.”
— Dave Lennon, President of AveXis

Savsu is really proud to have been selected to help protect this pioneering, life saving, gene therapy with our evo system.

Read announcement HERE

See You at the Allogeneic Cell Therapies Summit! (May 7-9, Boston, USA)

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We are a conference partner and will be exhibiting. Conference venue: Hilton Boston Back Bay.

Goal of the conference:

Advance the clinical translation of commercially viable allogeneic cell therapies to improve efficacies and create simpler manufacturing processes to ensure global patient accessibility”

We look forward to meeting you and talking about our evo system and successfully moving allogeneic therapies.

Conference information HERE

Global Availability

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Very interesting post on World Courier’s blog by Simon Ellison highlighting their global LN2 charging and operations support network. World has been managing cryo shipments for 20 years operating within their global quality system.

World Courier now offers our evo DV products in all major markets. They are a strong partner able to deliver and service evo’s anywhere in the world.

Read full post HERE

“We need to be bold..."

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“We need to be bold, we think it’s important to be bold for these kids who need this therapy.”
— Mustang Bio, Chief Executive Officer Manny Litchman -- bloomberg.com

“Shares of the tiny biotechnology company Mustang Bio Inc. more than tripled Thursday, following a scientific breakthrough that cured eight infants suffering from the devastating “Bubble Boy” immune system disorder.”

Fantastic development in gene therapy for a rare but, well known disease. Cool company. Well done, MustangBio team!

Read full article in Bloomberg HERE



Bruce Speaking at World Vaccine Congress

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Bruce McCormick, President and CTO of Savsu, will be speaking at the World Vaccine Congress on April 16 @ 15:10. Announcement and bio below. Link to conference home page is HERE

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Savsu Opens First European Office in Wil, Switzerland!

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Savsu now has a home in Europe!

Savsu is really excited to announce the opening of our new sales and customer service office in Wil, Switzerland (just outside of Zurich)!   We have an increasing level of activity in Europe and with this office we can provide local support to our business partners without the time delay.     

With the opening of our new office, we also get to announce the addition of two great professionals to our team: Andreas Giger (Business Development Director) and Monika Egli (Business Development Manager) who will be in charge of our Swiss operation.   Both Andreas and Monica have extensive experience in critical temperature recording and data management for pharma and other industries.  

Andreas Giger

Andreas Giger

Monika Egli

Monika Egli

Andreas and Monika will be representing us at Meeting On The Med in Barcelona (April 23-25) so, please schedule a meeting if you are attending.  If you would like direct contact info for Andreas and Monika, please contact us and we will connect you.

Office address:

Savsu Technologies

Ringstrasse 15/Stelz

Wil 9500

Switzerland

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Allogeneic Supply Chain Challenges

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Interesting article in BioProcess Online, written by Carla Reed (Founder/CEO, NewCreedLLC) from February 25, 2019: “Recalibrating The Supply Chain For Allogeneic Cell Therapies”. You can read the whole article at BioProcess Online HERE.

Allogeneic therapies offer some obvious advantages from the production perspective. However, unlike autologous therapies — where the patient and their location are known from the outset — allogeneic therapies can be distributed to patients across a wide geographic area. In many cases, the point of care for a commercial allogeneic therapy is in a different location than the product’s clinical trials sites. This presents challenges that are unique to allogeneic therapies, not the least of which is identifying where to position product inventory and distribution channels for delivery to an undefined network of caregivers.
— Carla Reed, New Creed LLC, in BioProcess Online, February 25, 2019
image from: https://www.bioprocessonline.com/doc/recalibrating-the-supply-chain-for-allogeneic-cell-therapies

image from: https://www.bioprocessonline.com/doc/recalibrating-the-supply-chain-for-allogeneic-cell-therapies

At Savsu, we working with clients preparing allogenic products for trials and commercialization and, we agree, the supply chain challenges are unique. Our hardware sizing flexibility, partnership with the leading specialty couriers, evo DV access to regional jets, and powerful communications module in evo.is help to build a robust, efficient, flexible supply chain. Contact us if you would like to explore this topic.

Note: If you missed her previous article on designing a successful supply chain for autologous therapies, “Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies” (November 15, 2018), you can read it HERE. “

And…you can visit Carla’s NewCreed LLC website HERE.

See You In Barcelona!

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We will be attending Cell and Gene - Meeting On The Med in Barcelona, Spain this year.   Meeting is April 23-25.  Great opportunity to meet, talk and learn in a wonderful setting.   Please reach out directly or, using the conference app or partnering website, if you would like to talk about using our evo system to protect your live cell therapies during transport.

Partnering website: HERE

Venue:

Hotel Arts Barcelona 
Marina 19-21
08005 Barcelona, Spain

U.S. proposes Medicare coverage for CAR-T cancer therapies

© Can Stock Photo / kgtoh

Good news for getting CAR-T cell therapies out to more patients (as reported in Reuters today)

HEALTH NEWS

FEBRUARY 15, 2019 / 7:20 AM 

(Reuters) - The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient’s immune system to fight cancer. 

The proposal would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment, CMS said. 

The evidence from these studies and registries would help the agency identify the patients that benefit from CAR-T cell therapies. 

“Today’s proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it,” CMS Administrator Seema Verma said in a statement. 

Chimeric antigen receptor T-cell therapy, known as CAR-T, harnesses the body’s own immune cells to recognize and attack malignant cells. 

Approved CAR-T therapies include Novartis AG’s Kmyriah treatment for leukemia and Gilead Sciences Inc’s Yescarta.

Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur

J&J Signals Bigger Move Into Gene Therapy

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Gene therapy has come of age over the past few years. And Johnson & Johnson this morning gave its biggest signal yet that it wants in on the emerging field.
— xconomy new york. Ben Fidler. January 31, 2019
The deal comes at a time in which gene therapies have, at long last, made their way to the U.S. markets. In 2017, the FDA approved the first treatment to fix a faulty gene with a patient’s body— voretigene neparvovec (Luxturna), from Spark Therapeutics (NASDAQ: ONCE), for a rare form of inherited blindness. Another, known as Zolgensma, from Novartis (NYSE: NVS), could be approved in the U.S. this year, for the rare disease spinal muscular atrophy. And others are making clinical progress in blood diseases like hemophilia and beta-thalassemia, rare disorders such as Duchenne muscular dystrophy, and more. Two gene therapies were approved earlier in Europe.

These developments are the culmination of decades of scientific research on how to effectively and safely deliver genes to cells. Gene therapies shuttle DNA material into the body, typically with the help of an engineered virus, to help the body produce a critical protein—in perpetuity, theoretically. In hemophilia patients, for instance, experimental gene therapies help people make proteins that clot blood. Luxturna helps patients produce a protein that makes light receptors work in the eye.

With $100M MeiraGTx Deal, J&J Signals Bigger Move Into Gene Therapy

Good article from Xconomy site (Author: Ben Fidler) about J&J and field of gene therapy. You can read it HERE.

Here you go! SAVSU Technologies Launches Two New evo® Smart Shipper Models!

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SAVSU Technologies Launches Two New evo® Smart Shipper Models to Improve Apheresis Collection Shipments and Cryopreserved Cell and Gene Therapies 

  • evo ACS™ Extends Thermal Protection During Shipment of Patients' T Cells for Downstream Manufacturing of CAR T-Cell Therapies

  • DV7™ Liquid Nitrogen Dewar Offers 7 Days Frozen Storage in a Compact, Non-palletized Form Factor Supporting Use on Regional Aircraft'

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Phacilitate, Miami, January 2019: Team Savsu introduces two new models: the DV7 (temp range: -196c) and the ACS (temp range 2-8c). Interest in the new models was fantastic and, we want to thank everyone for stopping by to talk.

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The evo ACS is a category-breaking 2-8°C shipper specifically designed for shipping apheresis collections of live cells intended for downstream manufacturing of autologous cell therapies. A smart system with thermal autonomy of 15+ days, the ACS allows cell therapy companies to safely source incoming materials globally while providing a high degree of supply chain control. Built for the challenges of commercialization, the ACS, connected to the evo.is, is "always on" and does not require special training or "button pushing" by hospital staff to turn the device on, as is the case with other shipping containers.

The ACS is a game changer. It gives our cell and gene therapy customers an unprecedented degree of flexibility in designing systems for their fresh cells that reduce risk, increase intelligence, and can scale through commercialization. With the current awareness of the impact variability of apheresis collections can have on final cell quality and therapeutic efficacy, we believe evo ACS will be very well received and preferred by the leading cell therapy developers.
— Bruce McCormick, President, Savsu Technologies
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The new evo DV7 extends SAVSU's dry vapor shipper product line, which maintains biologic payloads at a temperature of -196°C during storage and transport. Positioned between the DV4 and the DV10, the DV7 offers 7 days of thermal autonomy in a compact unit, while maintaining a large payload size similar to the DV10. Like all other SAVSU DV shippers, the DV7 is built with SAVSU's proprietary Fusion Core™, Smart Cap™, and Autonomous Payload Extractor™ technologies. 

Our customers have been asking for a compact evo DV shipper with 7 days of autonomy. The DV7 retains the advantages of the DV10 unit in a more compact form factor. It’s easier to handle, easier to store, and less expensive to ship. Since we design and build our evo shippers and evo.is cloud software, these new products represent our ability to respond to customer needs and quickly bring innovative products to market. Based on feedback from our early focus group customers, the DV7 could capture a significant share of the market for dry vapor shippers.
— Caitlin Rice, evo Product Manager, Savsu Technologies


Please contact us if you are interested in the DV7, ACS, or any of our products and services.

You can read our full press release HERE








See you in Miami! (January 22-25, 2019)

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“Welcome to the world’s largest advanced therapies partnering event!”

We will be exhibiting at Phacilitate Leader’s World & World Stem Cell Summit, January 22-25 in Miami.   Savsu’s President, Bruce McCormick is giving a presentation on “Site Handling Challenges of Cryogenic Shippers” (see image for time and location)

Please contact us (directly or through the app) if you would like to set up a meeting while we are in Miami. Or stop by Booth 804 and chat.

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Venue: Hyatt Regency, 400 South East Second Avenue, Miami, FL, 33131

Stay tuned! We will be making some exciting business and product announcements prior to the show.  

CAR-T Cancer Fighters in the Real World

From Economy:  NCI T cell attack cancer —  National Cancer Institute \ Duncan Comprehensive Cancer Center at Baylor College of Medicine

From Economy: NCI T cell attack cancer

National Cancer Institute \ Duncan Comprehensive Cancer Center at Baylor College of Medicine

An interesting, detailed article from Alex Lash at Xconomy reviewing the progress of the first two CAR-T therapies approved, Kymriah (from Novartis) and Yescarta (from Gilead Sciences). While the article may seem a bit negative, we think it simply reflects the normal difficulties of introducing a brand new, radically different, medical technology in to a complicated world.

A generation ago, cancer treatments made from a patient’s own living immune cells would have been science fiction. Now they’re here. The first two products, approved in 2017 and known in shorthand as CAR-T, have brought some people with otherwise untreatable blood cancers back from the brink of death.

The experimental results that led to approval for each product were remarkable. But outside the cautious, tightly controlled bubble of clinical studies, the products and their owners have had different experiences in the real world.

Read the full article at Xconomy HERE

Welcome 2019!...(we're not in the office today due to snow and ice...but, still online and doing business)

image from visit albuAlbuquerquequerque (https://www.visitalbuquerque.org/things-to-do/outdoors/ski/)

image from visit albuAlbuquerquequerque (https://www.visitalbuquerque.org/things-to-do/outdoors/ski/)

Hi All,

Nature happens … which is why we built the evo system! Snow and ice combination blew into Albuquerque yesterday (New Year’s Day). The city and Savsu are largely shut down today due to hazardous driving conditions. However, most of us are working on-line so, call and email like normal, and we can all pretend that we are in our offices. (We just aren’t shipping or receiving.)

Weather, customs, strikes, airport issues…there are a million reasons why your critical shipments might be delayed, or potentially delayed (just like today). The evo system keeps your payload thermally safe in these circumstances, lets all parties know exactly where your evo unit is and what the operating conditions are (internal and external), and allows our fantastic, specialty courier partners to show off their stuff (and maybe avoid the delay all together). So, Savsu’s headquarters may be closed today but, just like our evo system, our company is online and doing business.

Local conditions - KOB TV website: https://www.kob.com