Lilly expands Tyvyt collaboration with Innovent Biologics

Eli Lilly (NYSE:LLY) and China alliance partner Innovent Biologics (OTCPK:IVBIY) have agreed to expand their partnership in cancer, initiated in March 2015.

The companies currently co-commercialize PD-1 inhibitor Tyvyt (sintilimab) in China for relapsed/refractory classic Hodgkin lymphoma patients who have received at least two prior lines of systemic therapy. Other indications, including non-squamous non-small cell lung cancer, are being investigated.

Under the terms of the expanded agreement, Lilly will have an exclusive license to commercialize Tyvyt ex-China. In exchange, it will pay Innovent $200M upfront, up to $825M in milestones and tiered double-digit royalties on net sales.

Both companies retain the right to study Tyvyt in combination with other drugs as part of their respective clinical programs.

https://seekingalpha.com/news/3606573-lilly-expands-tyvyt-collaboration-innovent-biologics

ChromaDex’s Niagen shows positive effect in advanced heart failure patients

ChromaDex (NASDAQ:CDXC) announces encouraging results from a pilot study evaluating nicotinamide riboside (NR), or Niagen, in patients with Stage D (advanced) heart failure.

Results from the NIH-funded study showed that Niagen supplementation reduced signs of inflammation in a small group of end-stage heart failure patients.

A second arm of the study, conducted on peripheral blood cells, found improved mitochondrial respiration and reduced inflammatory factor expression.

https://seekingalpha.com/news/3606579-chromadexs-niagen-shows-positive-effect-in-advanced-heart-failure-patients

Kymera Therapeutics sets IPO terms

Kymera Therapeutics (KYMR) has filed an amended preliminary prospectus for an IPO of 7.36M shares at $16-18, expected to yield $125M at the midpoint.

The company plans to issue an additional 498,419 shares ($8.5M at the proposed midpoint) in a concurrent private placement to insider Vertex Pharmaceuticals.

Combined proceeds will be used for development of IRAK4 program, IRAKIMiD and STAT3 program, for preclinical studies and general corporate purposes.

2020 Financials (H1): Collaboration Revenue: $6.7M vs. $0.2M in H1 2019; Net Loss: ($24.9M) (-85.8%); Cash Burn: ($23.5M) (-157.0%).

Below is the current status of the company’s drug development pipeline:

https://seekingalpha.com/news/3606581-kymera-therapeutics-sets-ipo-terms

Vanda tradipitant shows encouraging action in hospitalized Covid patients

Preliminary data from 60 subjects in an ongoing Phase 3 clinical trial, ODYSSEY, evaluating Vanda Pharmaceuticals’ (NASDAQ:VNDA) tradipitant in hospitalized patients with COVID-19 pneumonia showed that it may accelerate clinical improvement. Treatment with tradipitant for 14 days accelerated improvement by day 7, although the proportion of those that improved was only slightly greater than placebo (both groups received standard-of-care treatment).

Specifically, 57% of patients in the treatment arm improved compared to 50% in the control arm. The mortality rate also modestly favored tradipitant, 14.2% vs. 16.6%.

In a time-to-improvement analysis, after seven days of treatment, patients receiving tradipitant recovered earlier than those receiving placebo (p=0.0375).

A larger sample size will be needed to definitively determine tradipitant’s benefit.

Tradipitant works by blocking the neurokinin-1 receptor (NK1R) that is involved in a range of neuroinflammatory processes that leads to significant lung injury.

https://seekingalpha.com/news/3606596-vandas-tradipitant-shows-encouraging-action-in-hospitalized-covidminus-19-patients

NGM Bio a stock to watch ahead of key NASH presentation

NGM Biopharmaceuticals (NASDAQ:NGM) announces that comprehensive data from its 24-week Phase 2 clinical trial evaluating aldafermin in patients with nonalcoholic steatohepatitis (NASH) will be featured in an oral plenary session at the virtual International Liver Congress on August 29.

The event could cause a significant swing in shares considering past data announcements.

In October 2019, the stock sold off after it released preliminary data from the study that were shy of Viking Therapeutics’ (NASDAQ:VKTX) VK2809 but comparable to Madrigal Pharmaceuticals’ (NASDAQ:MDGL) MGL-3196.

In February, shares rallied after the company announced positive data from cohort 4.

https://seekingalpha.com/news/3606646-ngm-bio-stock-to-watch-ahead-of-key-nash-presentation

VBI Vaccines secures manufacturing source for COVID-19 vaccine candidates

VBI Vaccines (NASDAQ:VBIV) inks an agreement with Therapure Biopharma’s manufacturing unit to produce its coronavirus vaccine candidates at the latter’s Ontario site in Canada. Therapure will be responsible for making the vaccine drug substance as well as aseptic fill.

Financial terms are not disclosed.

https://seekingalpha.com/news/3606682-vbi-vaccines-secures-manufacturing-source-for-covidminus-19-vaccine-candidates

FDA flags accuracy issue with Thermo Fisher SARS-CoV-2 test

The FDA has issued an alert to physicians and laboratory technicians using Thermo Fisher Scientific’s (NYSE:TMO) TaqPath genetic test to identify the presence of the SARS-CoV-2 virus.

Issues related to the lab equipment and software used to run the test could lead to inaccuracies. The agency advises lab techs to follow updated instructions and software developed by the company to ensure accurate results.

The warning comes almost a month after health officials in Connecticut reported at least 90 people received false positive results for the coronavirus.

One possible problem may be related to the incorrect use of a centrifuge that spins samples in preparation for processing. The other issue is software-related so labs need to upgrade top a new version.

A company spokesperson says TMO is working with the regulator to ensure that lab personnel understand the need to strictly follow the test protocol, adding that most users “follow our workflow properly and obtain accurate results.”

https://seekingalpha.com/news/3606556-fda-flags-accuracy-issue-thermo-fisher-sars-covminus-2-test