On September 16, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate and present at SVB Leerink’s CybeRx Series: Vaccine Forum, taking place September 23 – 24, 2020 (Press release, Hookipa Pharma, SEP 16, 2020, View Source [SID1234565230]):

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HOOKIPA Fireside Chat: Wednesday, September 23rd at 12:00 PM ET with Joern Aldag (CEO) and Igor Matushansky (CMO)

On September 16, 2020 Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, and LabCorp (NYSE: LH), a leading global life sciences company, reported a collaboration with LabCorp’s drug development business, Covance (Press release, LabCorp, SEP 16, 2020, View Source [SID1234565229]). LabCorp will participate in Tempus’s TIME Trial Network and the companies will work together to accelerate patient enrollment for oncology clinical trials through an innovative, data-driven approach that aims to transform the clinical trial model and modernize how they are designed and executed.

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As novel therapies become increasingly targeted, identifying and enrolling patient populations have become a significant challenge for investigators and sites. Tempus offers a solution with its TIME Trial Program, which uses real-time clinical and molecular data to screen and match patients to biomarker-targeted trials. Institutions participating in The TIME Trial Network are able to initiate their trial on behalf of patients in as few as 10 days.

"The TIME Trial Program has achieved an unparalleled scale thus far, with over 50 provider networks and 2,500 oncologists included in its network," said Kim Blackwell, Chief Medical Officer of Tempus. "We’re excited to collaborate with LabCorp’s drug development business, Covance, and leverage their network of oncology sites and community physicians across the U.S., as well as their successful track record in executing some of the country’s most cutting-edge oncology trials. This collaboration furthers our mission to increase trial participation and ultimately bring the right treatment to the right patients at the right time."

"LabCorp’s drug development business has extensive experience in executing clinical trials and our leadership position in oncology, coupled with Tempus’ innovative clinical trial model, provides thousands of physicians and patients easier access to more therapeutics," said Dr. Paul Kirchgraber, CEO, LabCorp’s drug development business, Covance. "With oncology patient enrollment rates being in the single digits, it’s imperative that we find comprehensive approaches to accelerate oncology clinical trials and bring new treatments to patients faster. The combination of our capabilities will increase the ability to identify patients with specific genetic markers and link them to trial sites, thus greatly expanding access to hard-to-find patient pools for faster enrollment of the right patients for precision medicine oncology clinical trials."

To learn more about the TIME Trial Program, visit www.tempus.com/clinical-trial-matching.

On September 16, 2020 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that members of management will host a virtual investor event following the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 where they will highlight select datasets and give an overview of the company’s broad oncology portfolio on Sept. 22 at 8:00 am EDT (Press release, Merck & Co, SEP 16, 2020, View Source [SID1234565228]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On September 16, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER, eligible for the French PEA-PME personal equity plan), a company specializing in in vitro diagnostics and theranostics, reported the launch of four new i-Tracker assays designed to run on the automated IDS-iSYS analyser (Press release, Theradiag, SEP 16, 2020, View Source [SID1234565221]). These assays were developed by Theradiag to address the rapidly growing market of biologics drug monitoring.

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The four i-Tracker assays: i-Tracker Infliximab, i-Tracker Anti-Infliximab, i-Tracker Adalimumab and
i-Tracker Anti-Adalimumab were previously launched on the i-Track10 analyser, an instrument manufactured by IDS for Theradiag.

In the six months since the Theradiag launch, the assays have undergone validation on the IDS-iSYS analyser and are now available for use on the installed base of IDS-iSYS analysers in countries accepting the CE mark.

About Therapeutic Drug Monitoring (TDM) of Biologics

Biologic drugs such as Infliximab and Adalimumab have revolutionized the management of Chronic Inflammatory Diseases such as Inflammatory Bowel Disease, Rheumatoid Arthritis, and Psoriasis. A significant proportion of patients may still experience either non-response to the therapy or a loss of response over time.

TDM assays provide information for therapeutic decisions to maximize response and minimize overexposure to the drugs, and their use is included in many clinical guidelines. It is estimated that around 2 million patients worldwide are treated with Infliximab and Adalimumab.

About the i-Tracker tests

The i-Tracker tests are the first random access automated chemiluminescent (CLIA) tests for TDM of Biologics and give precise results in a very short time for an immediate adjustment of treatment by clinicians.

The drug measurement kits measure the serum/plasma levels of biologics which are used in the treatment of many inflammatory diseases. The Anti-drug kits measure the antibodies that a patient may raise against the drugs, causing a decrease in treatment efficacy. The kits are validated both on the princeps molecules and on biosimilars and are standardized according to the international standards of the World Health Organization (WHO).

Bertrand de Castelnau, CEO of Theradiag commented: "Theradiag was the first to introduce the random access approach and the CLIA technology for its range of TDM of Biologics and we are glad to now make these products available for the many users of IDS-iSYS instruments. Access to this large installed base will help increase adoption of TDM for the well-being of patients."

Jaap Stuut, CEO of IDS added: "We are pleased to see that validation of these biologics monitoring markers has been completed successfully. IDS has distribution rights for these unique assays in a number of key markets, and making the kits available to our installed base of customers is a crucial step in the distribution strategy. These tests also complement our continued focus on auto-immune diseases, as therapeutic drug monitoring is often performed by the same immunology teams."

Theradiag’s financial calendar:

– H1 2020 results, Monday, September 21, 2020

On September 16, 2020 Synaffix B.V., a biotechnology company enabling antibody-drug conjugates (ADCs) with best-in-class therapeutic index, based on proprietary GlycoConnect, HydraSpace and toxSYN technology platforms, reported promising findings from its latest in vivo benchmarking study (Press release, Synaffix, SEP 16, 2020, View Source [SID1234565220]).

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In this mouse BT-474 xenograft study, trastuzumab-based ADCs prepared using Synaffix’s proprietary SYNtecan E linker-payload demonstrated an efficacy profile equivalent to deruxtecan-based ADCs. SYNtecan E is an exatecan-based linker-payload that contains the HydraSpace polar spacer technology, a conventional dipeptide cleavable linker and is conjugated, in this study, to the native antibody glycan using GlycoConnect. Deruxtecan is the linker-payload used in Enhertu, the FDA-approved ADC indicated for previously treated, HER-2 positive unresectable or metastatic breast cancer.

Following just a single dose, both HER-2-targeting ADCs, which have the same drug-to-antibody ratio (DAR) and administered at the same dose level, achieved complete tumor regression.

A poster of the data will be presented at the World ADC Digital conference on Thursday, 17 September 2020 at 3:30p-4:00p EDT.

Floris van Delft, CSO of Synaffix said:

"Given the recent clinical and commercial success observed with deruxtecan-based ADCs, we have been very excited with our first data for ADCs with the same mechanism of action."

"Exatecan mesylate has completed Phase 3 studies as a single agent already and comes with a well-understood toxicology profile. That said, its relatively challenging biophysical properties have likely contributed to limited exploration within the ADC context to date, despite its high potency and putative bystander killing potential. We have resolved the ADC aggregation issue by combining exatecan with our highly polar HydraSpace technology, providing highly stable and efficacious ADCs. We look forward to presenting further data on this new linker-payload and introducing it to our collaborators in due course."

Deruxtecan and SYNtecan E both belong to the family of camptothecins and are potent DNA topoisomerase 1 inhibitors that release DXd and exatecan as the active catabolite respectively.

SYNtecan E represents one of multiple options within the toxSYN linker-payload platform, which spans multiple mechanisms of action and can be evaluated in combination with GlycoConnect and HydraSpace technologies. This consolidated ADC platform enables any company with an antibody to rapidly co-discover an ADC with Synaffix and then develop and market the resulting ADC as part of its own pipeline under a license agreement.