COVID-19 Vaccine Receives Approval in China to Begin Human Trials

March 22, 2020 — A recombinant novel coronavirus vaccine candidate (Ad5-nCoV), developed by CanSino Biologics Inc. and China’s Academy of Military Medical Sciences, received Chinese regulatory approval to start human trials against COVID-19 on March 22, 2020.

Results from preclinical animal studies of Ad5-nCoV show that the vaccine candidate induces strong immune responses in animal models. Preclinical animal safety studies demonstrate a good safety profile supporting clinical development. Multiple vaccines for the novel coronavirus (COVID-19) are expected to complete preclinical research in April and enter clinical trials in China, NMPA officials declared at a press conference on March 17, 2020.


In response to the outbreak of coronavirus (COVID-19), JOINN assembled a team of internal experts to develop study designs tailored to evaluate different types of novel therapies against COVID-19. We have established clinical sample analysis centers in Wuhan to support clinical trials. JOINN participated in the safety assessment of most anti-SARS-CoV-2 drugs in China, including DNA vaccines, mRNA vaccines, recombinant protein-based vaccines, peptide vaccines, inactivated virus vaccines and other drugs such as antibodies, stem-cell therapy drugs, etc. Most drugs are still in the pre-clinical stage, some have already been submitted to the regulatory department of the NMPA (National Medical Products Administration) of China.

ABOUT JOINN


Founded in 1995, JOINN Laboratories (JOINN, SH603127) is China’s first private nonclinical CRO. JOINN subsidiaries are located in Beijing, Suzhou, Chongqing, and Wuzhou (GuangXi Province) in China, and Richmond (CA) and Worcester (MA) in the United States. JOINN is CNAS/ILAC-MRA accredited (China National Accreditation Service for Conformity Assessment/International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement), AAALAC accredited (Association for Assessment & Accreditation of Lab Animal Care International) and OLAW accredited, and is NMPA (CFDA), US FDA, OECD and Ko-rean MFDS GLP certified/inspected/compliant. JOINN employs 1500+ pharmaceutical professionals and provides services from early-stage R&D to clinical trials and to post-approval pharmacovigilance, tailored to the sponsor’s needs.

JOINN has extensive experience on anti-virus drug safety assessment. We have participated in the drug R & D and safety assessment of SARS, H5N1, H1N1, H7N9 and Ebola virus. In response to the outbreak of coronavirus (COVID-19), JOINN developed a green channel for rapid response to antivirus non-clinical and clinical requests. We can help sponsors to communicate with local regulatory authorities, accelerating antivirus therapy development.

For the full report with language translation, see here.

JOINN Laboratories and Biomedical Research Models Inc. (“Biomere”) Finalize Deal to Merge

December 10, 2019 JOINN Laboratories (China) Co., Ltd. and Biomere announced today that it has closed on a deal to merge with Biomedical Research Models Inc., dba Biomere. The deal with Biomere will serve to launch a new and expanded North American business subsidiary and greatly enhance its global scale and international footprint while complimenting and expanding on a scientific portfolio in great demand.  The transaction was completed following CFIUS (Committee on Foreign Investment in the United States) approval.

Biomere is a rapidly growing, non-clinical contract research organization (CRO) with a unique business model specializing in services not readily available in the industry. The deal strategically leverages and combines the reputations of JOINN as a pioneer in commercial GLP services in China with Biomere’s specialty, discovery-based focus. Biomere-MA, located in Worcester, MA, will serve as the flagship site for the North American business and is in close proximity to one of the world’s premier life sciences hubs. As part of a bi-coastal initiative in the U.S. to provide the industry with better options for accelerating discovery and development, Biomere-CA will be launched in early 2020. Biomere’s west coast operations will be housed within the JOINN Innovation Park encompassing 60 acres and more than 350,000 square feet dedicated to contract research and manufacturing, located just north of San Francisco in Richmond, CA.  Mark Nedelman, Biomere’s CEO will continue to serve as CEO of JOINN’s US-based business.

JOINN Laboratories is a leading CRO in China providing comprehensive capabilities in drug development.

“As part of our global strategic plan, we have been considering site(s) within the U.S. for some time. The opportunity to have a service platform within the heart of the biomedical industry in the Boston area presents obvious advantages. Biomere’s impressive growth and reputation led by a personal approach to customer service impressed us and was a perfect fit with our plan” commented Dr. Yuxia Feng, Chair and Founder of JOINN.

The addition of Biomere to the JOINN family represents another key addition to its portfolio of services which now includes nonclinical contract testing through Phase 1 including manufacturing facilities in China and the United States and pharmacovigilance services.

Biomere CEO Mark Nedelman commented, “I am proud of our team and what we have been able to accomplish. Biomere’s continued growth will be greatly enhanced and expanded by our merger with JOINN and am excited by what the future holds for all our stakeholders”. 

About JOINN: JOINN was established in 1995 as the first privately owned Chinese nonclinical CRO. Headquartered in Beijing BDA with a “Heptagon” facility in Suzhou Taicang Biomedical Industrial Park, JOINN went public on August 25, 2017 and is traded on the Shanghai stock exchange. Both facilities have been honored with numerous qualifications and certificates for their core businesses under GLP by CFDA and many major international regulatory bodies including USFDA, OECD and AAALAC. JOINN’S “one stop service” provides its international clients a timely and efficient product aimed at becoming the standard in the industry.  www.joinn-lab.com.

About Biomere: Founded in 1996 and located in Worcester, MA, Biomere offers preclinical testing services with core competencies in a wide variety of discovery-based services including specialty services under GLP.  www.biomere.com

Contact: 
Deborah Curry
Biomere
dcurry@biomere.com
781.572.9069

Vium and Biomere announce collaboration to provide preclinical research services using Vium’s Smart Cage Technology

Biomere showcases Vium’s platform at this year’s American College of Toxicology meeting in Phoenix, AZ

San Mateo, CA, November 12, 2019 — Vium, Inc. www.vium.com, the scientific leader in delivering digital biomarker driven insights from preclinical in vivo research and Biomere www.biomere.com, a preclinical contract research organization (CRO) who delivers a personalized approach to drug discovery and development, will attend the American College of Toxicology (ACT) conference together in Phoenix, AZ.  At the conference, Biomere will feature Vium’s innovative digital biomarkers now available as part of Biomere’s unique preclinical service offering around specialty animal models.

“Collaborating with Biomere, a leading specialty preclinical CRO with deep scientific experience, will allow researchers greater access to the Vium technology enabling them to leverage our unique digital biomarkers to derive deeper insights from their preclinical studies,” said Laura Schaevitz, CSO of Vium. “Traditionally, researchers are limited in the data that can be collected from each animal on study. The Vium platform is fundamentally changing that paradigm. Digital biomarker data are collected continuously on each animal throughout the study with the goal of using these large data sets to create algorithms that more reliably and accurately predict disease and compound efficacy.

“The Vium alliance allows Biomere to enhance existing service offerings providing additional assessments in a variety of pharmacological models.  Early and accurate detection of specific biomarkers will support our clients in their drug discovery efforts” states April Hall, EVP of Biomere.

The state-of-the-art platform, including Vium’s Smart Housing™, Vium Cloud, and Research Suite is the gold-standard in vivo platform combining computer vision, artificial intelligence (AI), machine learning (ML) and sensor technology to non-invasively collect digital biomarkers from the animal in its home cage. These digital biomarkers include data on animal activity levels, breathing rate, and other behaviors. By providing continuous, rich data sets, the platform enables researchers to identify which digital biomarkers, or combinations of biomarkers, are the strongest indicators in a specific disease model. Currently, Vium, in collaboration with pharma, biotech, and academic partners, have explored digital signatures of more than 45 different animal models of disease.

“Vium is committed to bringing innovative technology to drug development,” said Wendel Barr, CEO of Vium. 5 of the top 10 global pharmaceutical companies now have Vium’s Smart housing™ system in their labs but we recognize that not all researchers have access to a vivarium.  By collaborating with a leading preclinical CRO provider like Biomere, we combine their scientific expertise in preclinical research and customer service with our advanced digital platform and insights to benefit all researchers.” 

The American College of Toxicology Conference (ACT) hosts toxicologists, pharmacologists and other preclinical researchers to discuss advancements in toxicology.  

Leveraging AI and digital sensors to replace manual monitoring improves the quality and reliability of data, while at the same time reducing stress on the animal, which can also impact experimental results. It also allows researchers the ability to collect more data than is possible using manual methods. Vium is the frontrunner in developing a full stack solution that includes hardware, software and scientific insights.

About Vium, Inc.

Vium is the first company to create a fully digital end to end Digital Vivarium® platform which is transforming in vivo research. The Vium Digital Vivarium, Vium Cloud, and online Research Suite empower scientists to optimize advances in bioengineered research models in ways previously not possible. Customers run the spectrum of biotechnology, pharmaceutical and computational drug discovery companies, academia, and novel therapeutic labs. Vium is backed by leading investors, including Lux Capital, Data Collective, Dolby Family Ventures, AME Cloud Ventures, Founders Fund, and Future Shape LLC. Vium is headquartered in San Mateo, California. Visit Vium at www.vium.com.

Media Contact:

Dwain Schenck
203-223-5230
dwain@schenckstrategies.com        

Gene Therapy for Neurological Disorder conference

Biomere will be participating in the upcoming Gene Therapy for Neurological Disorder conference December 10-12, 2019 in Boston.

The Biomere team will join the Mastermind Discussion on Thursday, December 12th as panel experts. The topic will be “Discussing Current Preclinical Animal Models for Neurological Disorders”.

Please use this link to visit the conference site: https://ter.li/i8vyfn

If you are interested in attending, please feel free to use our discount code “BIOMERE20” to receive 20% off of your registration fee.