Oppenheimer analyst Kevin DeGeeter raised his price target for Invitae to $30 from $21 based on improved long-term competitive positioning for the company’s patient-initiated testing given data presented at the ACMG meeting demonstrating poor performance for a leading DTC genetic test and potential consolidation in DTC market as industry matures and economies of scale, quality/clinical data and regulatory oversight drive market share. The analyst reiterates an Outperform rating on the shares.
Monday, April 8, 2019
Tyme Technologies says SM-88 first in-human study published in IND
Tyme Technologies announced that the results of its first human study, completed as of September 15, 2017 and designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with advanced metastatic cancers, was published online on March 30th 2019 in the peer-reviewed journal Investigational New Drugs. The article, titled “A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer,” is available online. Based on these proof-of-concept clinical findings, TYME is developing new approaches, including SM-88, that target cancer metabolism. As metabolic changes in tumor cells are nearly universal, TYME believes that targeting these mechanisms creates the possibility of delivering potent therapeutic benefit across a broad spectrum of solid tumors and blood cancers. The SM-88 first human study was a TYME-sponsored, open-label, single-center first in human study of 30 patients with metastatic cancers who had failed or refused all available therapeutic options. In this study, SM-88 was used with low doses of melanin, melanotan 2, phenytoin, and sirolimus. Based on results from the study, clinical researchers observed that patients reached a median overall survival of 29.8 months and 13 months of progression free survival without additional therapy. 33% of patients achieved RECIST complete response and partial response with median time to best response of greater than 3 months. 57% of patients achieved RECIST stable disease with a median duration of 11 months.
Sanofi makes milestone payment to Schrodinger
Schrodinger announced receipt of a milestone payment from Sanofi to mark the advancement into the clinic of an autoimmune therapy discovered as part of a multi-year, multi-target collaboration between the two companies. Under the terms of the collaboration, Schrodinger provides advanced molecular simulation and computational design expertise to Sanofi across multiple stages of drug discovery, from target analysis and lead optimization to identification of a development candidate. The companies are currently advancing programs in oncology and autoimmune disease.
Medtronic: study shows TDD is associated with lower cost for cancer patients
Medtronic announced results of a study published in JAMA Network Open that demonstrates a reduction in health care utilization and cost for cancer pain patients using targeted drug delivery, or TDD and conventional medical management, or CMM, vs. CMM alone. The study found cost savings to payors, with fewer inpatient visits, shorter inpatient length of stay and fewer emergency department, or ED, visits for the TDD and CMM group. Over 12 months, TDD therapy was associated with a significant mean overall cost savings of $63,498 and fewer oral opioid prescriptions per patient. TDD, delivered via the Medtronic SynchroMed II infusion system, is an alternative to oral opioids for patients and provides pain relief at a fraction of the oral dose with fewer side effects and may help reduce the use of oral opioids. The paper reports the results of a retrospective propensity-score matched analysis conducted using a large U.S. claims database comparing mean total commercial payer costs and health care utilization at two, six, and 12 months. Researchers matched commercial insurance beneficiaries with patients with severe uncontrolled cancer pain receiving TDD and CMM or CMM alone. Participants were matched on age, sex, cancer type, comorbidity score and pre-enrollment characteristics. After matching, each group included 268 patients. The study showed that TDD and CMM is a cost-saving therapy to treat cancer pain, and based on these findings, increased use of TDD may have the potential to reduce future health care cost and utilization. As cancer rates continue increasing with the aging population, the authors concluded that considering more patients with significant cancer-related pain for TDD may result in substantial cost savings alongside improved quality of life.
Reveal Biosciences Gets Intel’s Backing on ‘AI-Powered’ Pathology
A 25-person startup developing advanced computing tools to speed up pathology work has raised its first institutional financing from a group of investors led by Intel Capital, the corporate investment arm of the chipmaker.
The San Diego-based company, Reveal Biosciences, is among 14 early-stage companies with business plans that include artificial intelligence, a catchall term for a wide range of “intelligent” computer programs, that the tech giant recently selected to back.
Intel (NASDAQ: INTC) said it invested a total of $117 million in the group of companies as part of a new strategy to make larger, “more strategic” investments in the startups it adds to its portfolio, but didn’t say how much it invested in each. The companies receiving funding were announced at Intel’s annual Global Summit, held this year in Phoenix, AZ.
Reveal isn’t disclosing the amount it raised either. GNI Group, a pharmaceutical company based in Japan, and PP Capital, an Austrian investment company, also invested in the round, CEO Claire Weston said.
Weston, who started Reveal in late 2012, said the Series A round will fund further development of its AI-powered pathology software, called ImageDx, moving it closer toward use in clinical settings. The software, which analyzes images of tissue samples, is intended to provide pathologists with data that can help them characterize and detect disease with greater speed and accuracy, with the subsequent goals of improving both drug development and patient care.
The company to date has been funded by revenue from laboratory services conducted for pharmaceutical and biotech companies. It was one of two healthcare companies included in the latest batch of startups in which Intel Capital announced it would invest.
“These companies are shifting the way we think about artificial intelligence, communications, manufacturing and healthcare—areas that will become increasingly essential in coming years as the linchpins of a smarter, more connected society,” said Wendell Brooks, Intel senior vice president and president of Intel Capital, in a statement.
Under the terms of the Reveal deal, Intel senior director Ranjeet Alexis, who led the investment, will join the company’s board of directors.
Since 1991, Intel Capital has invested about $12 billion in more than 1,500 companies, including big names in the tech world such as Broadcom (NASDAQ: AVGO), Red Hat (NYSE: RHT), and VMware (NYSE: VMW). The division puts $300 million to $500 million annually into emerging companies, according to Intel.
GSK adds to COPD pipeline as Exscientia deal bears fruit
AI drug research firm Exscientia has delivered the first candidate molecule to its partner GlaxoSmithKline following an R&D tie-up signed in 2017.
Under the deal Exscientia will develop small molecule drugs for up to 10 disease targets nominated by GSK, and is worth up to £33 million if all these milestones are met.
The Oxford biotech gave no details about how much it got paid for submitting this first active lead molecule for development by GSK, but said it is a highly potent in vivo molecule targeting a novel pathway for chronic obstructive pulmonary disease (COPD).
Developing new respiratory disease drugs is a priority for GSK, which is under pressure after generics of its ageing blockbuster COPD and asthma inhaler Advair have finally been launched in the US market.
Mylan in February launched its Advair generic at a 70% discount to Advair, and although GSK has a new generation of respiratory drugs on the market, none of them have gained as much traction as Advair.
The company saw sales peak at more than $8 billion in 2013 and still managed to bring in around $3 billion in 2018 despite competition from newly approved competitors.
The molecule delivered by Exscientia is light years away from the market, but demonstrates that GSK is focused on trying to get ahead of its competitors in this tough market by finding new ways to treat COPD.
The molecule was developed through the application of Exscientia’s Centaur Chemist AI-driven automated drug discovery platform.
Exscientia said the approach has delivered a lead molecule with fewer compounds synthesised in comparison to conventional industry benchmarks. The in vivo lead was identified de novo from 85 project compounds and was synthesised and tested within five iterative design and screening cycles.
The company uses AI algorithms that learn from a bank of biological and chemistry data resources to design novel molecules, when given exacting criteria by clients.
Exscientia last month signed a $25m cancer drug development deal with Celgene, and is also working with clients such as Roche, Sanofi, and Evotec.
Celltrion Partners with Canada’s iProgen for Biotherapeutics
- Celltrion signs a partnership deal with the Canada-based iProgen Biotech Inc. to bolster its pipeline for novel biotherapeutics.
- The deal aims to co-develop up to 4 ADCs including a novel ADC (Antibody-drug conjugate) that targets breast cancers expressing low levels of HER2 using iProgen’s proprietary antibody drug delivery technology.
On April 8, Celltrion (KRX:068270) and the Canada-based iProgen Biotech Inc. announced to agree to partner for the development of novel ADCs against validated antibody targets, including HER21 and CD202.
The terms of the partnership agreement include: (1) Celltrion manufactures and supplies four recombinant antibodies to iProgen, among which two are HER2 and CD20 targeting, selected by Celltrion, and two additional targets to be selected by iProgen, (2) Celltrion provides supports for the Chemistry, Manufacturing, and Control (CMC) activities for the IND application and the Phase-1 clinical trial, (3) iProgen conducts the Phase-1 clinical trial using these drug candidates, and (4) upon completion of Phase 1, Celltrion has the right of first negotiation on these drug candidates for global in-licensing.
The antibodies encompassing iProgen’s proprietary delivery technology, Antibody Delivery Enhancing Domain (ADED) is expected to increase anti-tumor efficacy by enhancing the drug delivery and internalization to cancer cells. The ADED technology is applied to anti-HER2 ADCs to potentially treat not only the breast cancer patients with high levels of HER2 expression more effectively but also those with low levels with no approved targeted therapies. In addition to HER2, other tumor antigens may be therapeutically targeted by ADCs that embody this technology.
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