SkylineDx | December 22, 2021
SkylineDx announced it received a capital investment from USA based investment and advisory firm Novalis LifeSciences, and one of Benelux' largest biotech investors Van Herk Investments, to further solidify its position in the USA dermatology diagnostics market. SkylineDx is at a critical growth stage in their development now that the first products are introduced to the USA market, and Novalis LifeSciences has demonstrated impressive successes with their strategic and operational advice to their portfolio companies. Marijn E. Dekkers, founder and chairman of Novalis LifeSciences, will be named board member of SkylineDx' Board of Directors. He brings a long track record of industry-related strategic leadership experience as the former CEO of Bayer AG, CEO of Thermo Fisher Scientific and his role in the recent 600M USD acquisition of Decipher Biosciences by Veracyte.
SkylineDx' dermatology program, often referred to as the Falcon R&D Program, currently overarches four dedicated dermatology initiatives, focused on prognostic and predictive biomarker development covering two skin cancers: melanoma and squamous cell carcinoma. These indications affect approximately 1.9 million patients annually in the United States only. One of these initiatives generated its first commercially available product, branded as Merlin Test, for which SkylineDx aims to accelerate the clinical adoption with this joint investment.
"It is a great honor to have Marijn and Novalis LifeSciences as our first specialized USA investor on board, with all their incredible experience and know-how. Together we aim to further extend SkylineDx' USA investor base and continue expanding our strong footprint there. Our mission is to improve a patient's quality of life by enabling them to benefit from personal insights at the genomic level of their disease. We are excited to be working with Marijn and his team to continue fulfilling this mission."
Dharminder Chahal, CEO SkylineDx
Marijn Dekkers comments: "I have monitored the progress of SkylineDx for several years now, and I am excited about the leading edge position the company has built in predictive biomarkers for melanoma and various other cancers. I very much look forward to working with the SkylineDx team to bring these sophisticated diagnostic tests to patients around the globe."
SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient.
About Novalis LifeSciences
Novalis LifeSciences LLC is a boutique investment and advisory firm that was founded in 2017 by Marijn E. Dekkers, and is based in Hampton, NH, USA. With a team of experienced operating executives from the Life Science industry, Novalis funds and advises visionary Life Science entrepreneurs. The firm has approximately USD 500M under management in two investment funds.
BigHat Biosciences, Inc. | January 12, 2022
BigHat Biosciences, Inc., a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform, announced the successful completion of the first stage of a previously undisclosed research collaboration and licensing agreement with Amgen applying BigHat’s platform for multi-objective optimization of a next-generation antibody.
BigHat’s antibody design platform integrates a high-speed characterization with AI/ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease. BigHat’s experimental platform massively speeds up candidate discovery and validation.
“This is an important milestone for BigHat, and the AI/ML biologics drug discovery field more broadly, as it demonstrates the ability of their platform to quickly and significantly optimize next-generation antibodies,” said Steve Doberstein, BigHat Independent Board Member and former Chief R&D Officer at Nektar Therapeutics, Inc.
Achievement of this first milestone shows that BigHat’s platform has the potential to design high-quality therapeutic antibodies effectively and efficiently. Its platform can synthesize, express, purify, and characterize antibodies in a fraction of the time compared to traditional labs to guide the search for better molecules.
“BigHat's platform for data-driven antibody design generated several antibodies significantly better than the starter molecules found using traditional technologies. Now that Amgen has validated the capabilities of BigHat's unique approach to antibody development, we're excited to continue working with them towards a lead antibody for their discovery research.”
Vineeta Agarwala, MD, PhD, General Partner at Andreessen Horowitz and BigHat Board Director
This successful milestone triggers the initiation of work to create a lead panel of VHH antibodies for patients in need. “We are excited to show the power of our platform to rapidly improve biophysical characteristics and function by directing and learning from each cycle of our AI/ML-enabled experimental platform. We are looking forward to continuing our productive collaboration,” said Peyton Greenside, BigHat’s CSO and Co-Founder.
About BigHat Biosciences, Inc.
BigHat Biosciences is reimagining antibody discovery and engineering with an AI-first experimental platform that integrates a high-speed wet lab with machine learning to create better antibodies faster and undertake novel designs far beyond what’s possible today. BigHat applies these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is a Series A stage biotechnology company based in the San Francisco Bay Area with a team-oriented, inclusive, and family-friendly culture. BigHat is backed by a16z, 8VC, AME Cloud Ventures, and Innovation Endeavors and counts among its employees and advisors a Nobel Laureate, a serial life-science entrepreneur, and leaders in fields from antibody development to machine learning.
CELL AND GENE THERAPY
Gracell Biotechnologies Inc | January 13, 2022
Gracell Biotechnologies Inc. a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its newly established research facility, the Innovation Center, is scheduled to open in San Diego, California, during the first quarter of 2022.
As a pivotal part of Gracell's global strategy, the company is fully committed to expanding its operations in the U.S. to enhance and diversify its in-house drug discovery, pre-clinical research, and translational capabilities to further complement its proprietary platforms and extensive early-stage pipeline. After a thorough nationwide search, Gracell chose to establish its Innovation Center within the Cornerstone Research Center in San Diego. The new hub includes a state-of-the-art laboratory, along with office space. Gracell is also expanding its R&D team through the recruitment of high-caliber biotech talent in the San Diego area.
"We are delighted to start 2022 with the opening of our U.S. Innovation Center in San Diego, which will strengthen our R&D capabilities and further expand our presence in the U.S. market. This marks another solid step in Gracell's journey of becoming a leading global cell therapy company. By innovating and expanding upon our proprietary FasTCAR and TruUCAR platforms, we remain focused on solving the challenges of conventional CAR-T cell therapies and advancing innovative, highly differentiated programs from our robust pipeline to benefit cancer patients all around the world."
Dr. William (Wei) Cao, Founder, Chairman and Chief Executive Officer of Gracell
Gracell Biotechnologies Inc. is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR, TruUCAR and SMART CARTTM technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.
Sorrento Therapeutics, Inc. | December 28, 2021
Sorrento Therapeutics, Inc. announced that initial testing of COVISTIX on recombinant N proteins demonstrated its ability to detect the Omicron variant, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as the delta and delta-plus strains. The COVISTIX detection levels were similar for all variants. The ease of use and timely detection of Omicron infection was demonstrated by a recent case report of a Mexico patient infected with the Omicron variant detected first with COVISTIX in about 15-minutes test time. This result was confirmed a day later by RT-PCR and sequence verified a few days later to be Omicron infection.
In a laboratory setting, Sorrento has also studied the ability of COVISTIX to detect the Omicron variant compared to other Emergency Use Authorization approved, commercially available COVID-19 virus rapid antigen tests. Initial lab results demonstrate that COVISTIX was able to detect the Omicron N protein at a significantly lower level than other commercially available tests. With a difficulty to detect the Omicron N protein at low levels, some of the EUA-approved and marketed rapid tests may have a tough time detecting the Omicron infection at a reasonable sensitivity. False negative readings for infected asymptomatic patients could lead to a false sense of security and the inability to control outbreaks and achieve normal social and business routines.
Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests a month and is currently building up its manufacturing capacity in the US. The company anticipates having a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month up and running in Q1 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million monthly in 2022.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain, autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies, immuno-cellular therapies , antibody-drug conjugates, and oncolytic virus. Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class non-opioid pain management small molecule, resiniferatoxin, and SP-102 corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.