FDA accepts Athenex application for oral paclitaxel for breast cancer

Under Priority Review status, the FDA has accepted Athenex’s (NASDAQ:ATNX) marketing application seeking approval of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer.

The agency’s action date is February 28, 2021.

https://seekingalpha.com/news/3610363-fda-accepts-athenex-application-for-oral-paclitaxel-for-breast-cancer

Dosing underway in Annovis Bio’s mid-stage Alzheimer’s and Parkinson’s trial

Annovis Bio (NYSEMKT:ANVS) announces dosing of the first three patients in its new Phase 2a clinical trial targeting early Alzheimer’s disease (AD) and Parkinson’s disease (PD).

The two-part study is designed to treat a combined total of 28 AD and PD patients for four weeks with lead compound ANVS401.

The study compares how nerve cells die by measuring all the steps in the toxic cascade leading to nerve cell death and how ANVS401 might reverse the toxic cascade and recover normal brain function.

In addition, the study also examines safety and tolerability, as well as the effect of ANVS401 on motor and non-motor symptoms in early PD patients and the effect on memory and cognitive function in early AD subjects.

Initial data are expected in early 2021. The study will be followed by a dose response study in 40 PD patients, with final data readout expected by late summer 2021.

https://seekingalpha.com/news/3610358-dosing-underway-in-annovis-bios-mid-stage-alzheimer-s-and-parkinson-s-trial

Jounce inks license deal with Gilead valued up to $805M

Jounce Therapeutics (NASDAQ:JNCE) enters into an agreement with Gilead Sciences (NASDAQ:GILD) under which the latter will have exclusive global rights to preclinical immuno-oncology candidate JTX-1811, a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells via targeting a chemokine receptor called CCR8. An IND, a regulatory application seeking sign-off for clinical trials, should be filed in H1 2021.

Under the terms of the deal, Jounce will receive $85M upfront, a $35M equity investment at a premium, up to $685M in milestones and high single-digit-to-mid-teen royalties on net sales.

The transaction should close this year.

https://seekingalpha.com/news/3610422-jounce-inks-license-deal-gilead-valued-up-to-805m

Altimmune reports favorable ALT-801 data in rats and monkeys in NASH

Altimmune (NASDAQ:ALT) has successfully completed its multiple dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH).

ALT-801 was well tolerated in both rats and cynomolgus monkeys and no-observed-adverse-effects were seen.

The most remarkable finding was significant weight loss versus the control groups in both species. No evidence of significant GI toxicity or intolerability, including vomiting, was observed in the animals.

Recently completed toxicology studies also suggest that ALT-801 can be well tolerated in humans and not require dose titration, potentially enabling higher levels of weight loss and liver fat reduction than existing GLP-1 receptor agonist-based compounds.

The nonhuman primate data also showed an ALT-801 pharmacokinetic profile that is expected to support weekly dosing in humans.

Based on these preclinical toxicology studies, Altimmune plans to initiate first-in-human studies of ALT-801 in Q4, with data readouts on safety, pharmacokinetics, and important measures of activity such as weight loss and liver fat reduction in the Spring of 2021.

https://seekingalpha.com/news/3610384-altimmune-reports-favorable-altminus-801-data-in-rats-and-monkeys-in-nash

Humanigen’s lenzilumab shows positive effect in COVID-19 in study

Results from a 39-patient case-control study in hospitalized COVID-19 patients showed a significant treatment benefit from Humanigen’s (OTCQB:HGEN) lenzilumab, its Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. The data were just published in Mayo Clinic Proceedings.

12 severely ill patients received lenzilumab and 27 contemporaneous matched control patients, identified from an electronic registry of COVID-19 patients matched for age, sex, disease severity and baseline oxygen requirements, received standard-of-care (SOC) treatment.

The relative risk of invasive mechanical ventilation (IMV) and/or death was reduced 80% in the lenzilumab group. Specifically, the risk of IMV and/or death was 8% in lenzilumab-treated patients compared to 41% in the control group (p=0.07).

Median time to resolution of acute respiratory distress syndrome (ARDS) was one day in lenzilumab patients versus eight days in the control group (p<0.01). Median time to discharge was shorter in the lenzilumab group, five days versus 11 days (p=0.008).

Lenzilumab was also associated with a significant reduction in an inflammatory marker called c-reactive protein and improved lymphocyte counts.

The antibody is currently being evaluated in a Phase 3 NIH study called COVID-19 Big Effect.

https://seekingalpha.com/news/3610392-humanigens-lenzilumab-shows-positive-effect-in-covidminus-19-in-case-control-study

Plus Therapeutics rallies on Orphan Drug tag for glioblastoma treatment

Nano cap Plus Therapeutics (NASDAQ:PSTV) jumps 24% premarket on robust volume in reaction to U.S. Orphan Drug status for lead drug Rhenium NanoLiposomes (RNL) for the treatment of recurrent glioblastoma, an aggressive type of cancer of the brain or spinal cord.

RNL, designed to deliver a very high dose of radiation (up to 25x more than external beam radiation therapy) directly into the brain tumor, is currently being tested in a Phase 1 dose-finding study called ReSPECT.

https://seekingalpha.com/news/3610403-plus-therapeutics-rallies-on-orphan-drug-tag-for-glioblastoma-treatment

Inspire Medical Systems’ Inspire therapy to be covered by Humana

Inspire Medical Systems (NYSE:INSP) announced today that Humana will provide coverage for its Inspire therapy; effective August 27, 2020.

Humana is a national healthcare company that provides health insurance coverage to ~16.7M individuals in the U.S.

“With the addition of Humana, we now have 59 coverage policies, representing over 207M lives, that cover Inspire therapy,” president & CEO Tim Herbert commented.

A quick look at its annual revenue growth with FY20 guidance:

Humana coverage decision includes the expanded age range approved by the U.S. FDA in April 2020 to include patients 18 years and older.

Since its IPO launch in May 2018, the company has recorded a significant growth in covered lives:

https://seekingalpha.com/news/3610405-inspire-medical-systems-inspire-therapy-to-be-covered-humana