Gilead and Vir Biotechnology Establish Clinical Collaboration 

Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to assess novel therapeutic combination strategies to develop a functional remedy for chronic hepatitis B virus (HBV).

The companies schedule to initiate a Phase 2 trial assessing combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will gauge various combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. 

People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The study’s primary result will be the proportion of patients attaining a functional treatment, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.

Both companies retain full rights to their product candidates and discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial.

Tessera Therapeutics scores USD 230 Million to cure disease

Technologists are getting better at coding biology, and venture firms are flooding a new generation of startups with cash to commercialize their technology bringing in the next wave of genetic innovation.

Tessera Therapeutics, the Boston-based spin-up from Flagship Pioneering, is the latest company to enter the mix with USD 230 million in new financing to build up its platform for better biological programming.

The round was led by Alaska Permanent Fund Corp., Altitude Life Science Ventures, and the second SoftBank Vision Fund, with participation from the Qatari Investment Authority and other undisclosed investors.

Last year, the company disclosed its gene-writing service, which combined various gene editing, manufacturing, and synthesizing technologies to provide more tailored therapeutic instructions to genetic code.

By providing more instructions to genetic material, the company aims to increase the precision of therapies while expanding the number of potential pathogens or mutations they can target, the company said in a statement.

Teladoc Health, Dexcom offers CGM-powered insights to Type 2 Diabetes patients

Teladoc Health, Inc., the first and only complete virtual care system, and DexCom, Inc., the leader in real-time continuous glucose monitoring (CGM), announced that joint Livongo for Diabetes and Dexcom members will now get CGM-powered insights, a new set of features and reports, which help members more easily visualize their health information and comprehend how lifestyle decisions affect their blood glucose levels. 

Combining Dexcom CGM data with more signals from Teladoc Health, comprising activity data and food intake, CGM-powered insights proffer members a complete health profile and recommendations that back ongoing diabetes management. 

In January 2020, Livongo merged with Teladoc Health in October, and Dexcom announced the first phase of their strategic relationship, a data-sharing deal for Livongo for Diabetes members using Dexcom CGM technology. 

Teladoc Health and Dexcom will launch a pilot exhibiting the impact of CGM-powered insights for people affected with Type 2 diabetes. Eligible members will get an integrated product experience, comprising the Livongo for Diabetes program, Dexcom CGM technology, and CGM-powered insights at no cost. Through the pilot, members will receive a new experience that examines their health data and trends with the mutual goal of improving health outcomes. Teladoc Health and Dexcom plan to launch the pilot more broadly throughout 2021.

Verve Therapeutics unveils its lead program for treating genetically high cholesterol 

Verve Therapeutics has an aim to bring one-and-done gene editing treatments to heart disease. Now, the company is moving toward the clinic to treat a genetic form of high cholesterol.

The treatment, VERVE-101, is a base editor; that is, it does not cut DNA as CRISPR gene editing systems do. Instead, it changes one base, or letter, in the genome to a different one without affecting the letters around it. Its first target is an inherited form of high cholesterol called heterozygous familial hypercholesterolemia, or HeFH.

People affected by HeFH have a gene mutation in the liver that causes very high cholesterol levels and leads to heart attacks or strokes relatively early in life. VERVE-101 is designed to cut those cholesterol levels by hindering the PCSK9 gene.

The treatment is a lipid nanoparticle involving a guide RNA to search the target letter on the PCSK9 and an mRNA that changes an A base in the gene to a G, hence inactivating the gene and lowering cholesterol.