2019 Biotech Showcase Developments of Note, with a Particular IVD Focus

From a credit card-sized clinical chemistry system to a spectrometry-based monoclonal measurement system, to phages that eat harmful bacteria, there are some interesting developments at the upcoming Biotech Showcase meeting that the Kalorama team is excited about that could directly or indirectly impact the clinical diagnostics markets.

“JPM Week” will begin next week in San Francisco. The event has become a significant launch pad for new products and start-up companies, and a place where large concerns discuss their results and future plans for curious investors and journalists. Kalorama Information will be there, previewing new innovations and speaking with customers at the related Biotech Showcase at the Hilton Union Square, January 7-9.

The Science and Medicine Group (parent company of Kalorama Information) is looking forward to the JP Morgan HC Conference, BioTech Showcase, and Digital Medicine Showcase next week in San Francisco. If you will be attending, reach out to our team to discuss how we can support your 2019 objectives in life science, clinical Dx, imaging, and radiation therapy with our commercial services including product promotion, market sizing, business intelligence, M&A advisory, and pricing-product launch. Reach out to our attending team: Craig OverpeckBruce Carlson, and Brian Casey (#jpm19).

The meeting comes amid good news: according to Biotech Showcase’s survey, a majority (65 percent) of life science investors and executives expect to see an increase in investment during 2019. Biotech leaders think cell and gene therapy are poised to have the biggest breakthroughs in 2019 among the major categories. China is predicted to see the biggest percentage increase in 2019 biotech investment dollars compared to other global biotech hot spots.  Kalorama Information has a principal diagnostic focus, and our team has taken note of the following developments:

CBC and CMP Testing on a Credit Card-Sized Device?

That got our attention.  Getting point-of-care (POC) right has been a goal for healthcare for some time, and every serious advance is worth watching. Chronus Health will present at the meeting; their credit card reader-sized instrument and credit card-sized test strip are their main offerings. A complete blood count (CBC) is a routine but critical test. Red blood cells, which carry oxygen among other important functions, can disclose a wide range of disorders including anemia, infection, and leukemia. Comprehensive metabolic panels (CMPs) are on the more complex side of routine testing and offer a lot more information. While the devices still need clinical testing and approvals, the possibility of both on a POC device is intriguing. The company’s technology replaces chemical testing, and does so without optical sensors or microfluidics.

 “A majority (65%) of life science investors and executives expect to see an increase in investment during 2019.”

Chronos uses electrical measurements and pumps with electrostatic forces. Their technology does not require optics (for measurements), reagent bottles (for storage), or pumps (for moving liquids). The entire analysis happens on a disposable test strip where sample preparation, fluid movement, and sensors are embedded. The company says the technology will be in place in 2020 and will cost $400.

Using Microphages to Get Around Antibiotic Resistance

– Antimicrobial Resistance (AMR) is a major problem in all healthcare systems and a major expense for hospitals. Microphages that attack pathogens specifically instead of broadly affecting a range of pathogens have been known for many years and have received passing interest. That interest will increase in 2019 as the stakes of AMR increase. There are two companies of note presenting at Biotech Showcase. Adaptive Phage Therapeutics (APT) announced it has entered into a collaboration agreement with the Paul Turner Lab at Yale University to manufacture and supply therapeutic bacteriophage (phage) for use in clinical trials. Through this collaboration, APT is committed to leveraging the exquisite specificity and potency of phage in the fight against the global rise of MDR infections. The company maintains an automated companion diagnostic systems capability of rapid matching of a patient’s bacteria to the world’s largest collection of therapeutic phage, what the company calls PhageBank. Another microphage-related concern, Phagelux, Inc., will also present at the Showcase. The biotechnology company signed an agreement with Johnson & Johnson Consumer, Inc., in 2017 to collaborate on the development of one or more skin care products. The company’s HumanHealth intellectual property revolves around sustained release microencapsulation technologies that the company adapts to different therapeutic problems.

Smaller-Than-a-Penny Dx and Treatment Devices?

These days, it might be possible to imagine a sensor that can be the size of a penny. But how about a sensor that can fit on the mint date on the penny? This is the promise of iota Biosciences. iota holds exclusive license to millimeter-sized, ultrasonic-powered bioelectronic devices developed at UC Berkeley. Also known as “neural dust” because of their small size and ability to interface directly with the central nervous system, these battery-free implantable devices empower doctors to safely get closer than ever to the internal causes of disease. The devices are powered by ultrasound. Per the company, the platform enables production of devices the size of a grain of sand that avoid the dangers associated with wire- and battery-powered implantables. Because they are smaller and can be implanted deeper into the human body than traditional technologies, neural dust can interface directly with specific nerve clusters, enabling more precise diagnostics and treatments. iota’s devices can simultaneously record information and stimulate nerves, offering near instantaneous closed-loop therapies that could better treat complex disease from the inside out.

Cannabis-Related Companies

– A product that has been locked away for decades is now available, and it can be expected to be featured at Biotech Showcase as anywhere. CV Sciences, Inc., makes Cannabidiol – CBD – a cannabis compound that has significant medical benefits, but does not have physiological effects associated with use of the product as a drug. The company operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD and a consumer product division focused on manufacturing, marketing, and selling plant-based CBD products. GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that GW’s CEO Justin Gover will present a company update at the J.P. Morgan 2019 Healthcare Conference. For market information on cannabis related analytical instrumentation, see Strategic Directions International’s report: https://strategic-directions.com/cannabis-testing/.

Measuring mAbs

Monoclonal Antibiodies are effective for testing and therapeutic purposes, but they need to be created and once created, measured to be sure the desired mAb is indeed produced. Forced degradation studies, for example, are needed to test mAb-based products for conditions including high temperature, freeze-thaw, high pH, low pH, light exposure, and glycation. IonDx uses an electrospray ion mobility spectrometer to provide customers with a rapid means of surveying not only intact mAbs, but their non-specific aggregates and other higher order structures formed in solution.

 Liquid Biopsy Updates

– Guardant Health has emerged as one of the leading liquid biopsy companies, and so watching what the company does is one way of assessing the performance of the sector. Kalorama will have a report on liquid biopsy this year – our schedule is here. Guardant has launched multiple liquid biopsy-based tests, including Guardant360 and GuardantOMNI for advanced stage cancer patients. The company says that since launch Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers. Guardant Health developed 500 gene test GuardantOMNI in partnership with several leading pharmaceutical companies. The company is expected to update its performance, clinical results, and development of its programs for recurrence and early detection – LUNAR-1 and LUNAR-2, respectively. Trovagene is another established precision medicine player presenting at the meeting. The company has intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP-accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. Recently Trovagene announced that it has entered into an exclusive patent license agreement with the Massachusetts Institute of Technology (MIT). The exclusive license agreement is part of the company’s strategy to explore the efficacy of Onvansertib, its oral PLK1 inhibitor, in combination with anti-androgen drugs in cancers including prostate, breast, pancreatic, lung, and gastrointestinal.

“It might be possible to imagine an ultrasound device that can be the size of a penny. But how about one that can fit on the mint date on the penny?”

 Aural Measurement of Neurological Issues

– Aural Analytics uses an iPhone app to analyze speech for motor and cognition changes, which can be a sign of neurodegeneration. Mobile applications empower their partners to accurately and efficiently collect information from their patients anywhere at any time. Speech, fine motor and linguistic samples are automatically uploaded to their HIPAA compliant secure cloud server where their AI engine analyzes each sample for finite but clinically relevant information and delivers results in real-time.

Concentrated Biomarker Sample Prep

– Veravas offers a novel biomarker diagnostic platform. The system, according to the company, can quickly commercialize low abundance biomarkers to meet unmet clinical needs, reduce the effects of troublesome sample interferences, and can dramatically reduce the cost of diagnostic testing. VERAPrep™ is based on a technology that selectively captures, cleans, and concentrates multiple biomarkers prior to a test. VERAPrep™ is unique because it pretreats human samples to (i) remove many complicating factors that can interfere with test results, capture low abundance biomarkers and concentrate the targets to create large improvements in sensitivity over existing methods.

Microbiome-based C. difficile Treatment

– Glasgow-based life sciences firm MGB Biopharma will present at the meeting. The firm has created a microbiome-based treatment, DNA Minor Groove Binders (MGBs), as a novel treatment method for C. diff-associated diseases. Their anti-bacterial agents interact with microbial cell DNA and interfere with its replication. MGB-BP-3 was invented at the University of Strathclyde and MGB Biopharma hopes it can go on to become a new gold standard for treatment of C. difficile – the bacteria responsible for most cases of hospital-acquired infection. The bacteria are able to take over the gut when a course of antibiotics kills off the bugs that normally live there.

Rydapt Companion Assay

Invivoscribe Technologies, Inc., recently announced premarket approval of LeukoStrat® CDx FLT3 Mutation Assay. The company says its test is the first companion diagnostic for acute myeloid leukemia and detects internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene. The tool includes software that interprets data, generates mutant and wildtype signal ratios for ITD and TKD mutations, and predicts response to the drug gilteritinib fumarate (Xospata). Due to current labeling for the FDA-approved test, FLT3 mutation testing with LeukoStrat® CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt in newly diagnosed FLT3+ AML. Invivoscribe previously released a CE-marked IVD version of the LeukoStrat assay in August 2017.

Kalorama Information is a publisher of market research in in vitro diagnostics and biotechnology.  Kalorama’s report on the in vitro diagnostic market can be found here: https://www.kaloramainformation.com/Worldwide-In-Vitro-Diagnostic-Tests-11th-Edition-11723890/.

Rare TNBC Assay in Development

Phoenix Molecular Designs (PhoenixMD) will discuss its lead program, PMD-026, the first RSK inhibitor to demonstrate potential disease-modifying properties in triple-negative breast cancer (TNBC). In preclinical studies, PMD-026 is shown to unlock the potential of tumor resistance by synergizing with chemotherapies such as paclitaxel. PMD-026 also has the potential to reprogram the way that TNBC is recognized by the immune system. The first in human clinical trial for PMD-026 is a Phase 1/1b that is scheduled to initiate in mid- 2019. Importantly, the clinical trial will include a companion diagnostic that links PMD-026 to RSK2 activation in tumors. Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies.

Colposcopy-Enhancing Diagnostic

ZedScan is a diagnostic system that is used alongside colposcopy to provide an objective assessment of the cervical epithelial tissue in real time to enhcance detection of cervical cancer.  ZedScan uses Electrical Impedance Spectroscopy (EIS) to differentiate between normal, pre-cancerous and cancerous tissue on the cervix according to its electrical properties.  Zilico Limited’s CEO, Sameer Kothari, will be presenting at the annual Digital Medicine and Medtech Showcase.  2018 saw Zilico continue global expansion and growth with two investments totalling $19million for their lead product, ZedScan As part of this growth Zilico secured a strategic deal with the MaxHealth Medicine Group (China), which permits MaxHealth to sell and market ZedScan™, Zilico’s cervical cancer diagnostic system, to the Chinese market. The deal will see Zilico receive minimum royalties of $12million. In addition to the Chinese deal, Zilico has also announced investments totalling $7M from Deepbridge Capital (UK). Both investments continue to help Zilico further drive the adoption of ZedScan™ across the UK and Europe as well as taking the product through its regulatory trials in the US.

Keytruda Companion

BriaCell Therapeutics Corp.will attend the meeting. The company offers a proprietary targeted immunotherapy technology. The company recently announced the imminent clinical use of a new novel, frozen formulation for its lead product candidate, Bria-IMT™, which is currently being tested in a Phase I/IIa clinical trial with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. The company is also promoting its BriaCell’s recent clinical and research-focused development of Bria-IMT™ and BriaDX™, the corresponding companion diagnostic which helps identify those patients most likely to benefit from Bria-IMT™ and Bria-OTS™.