Gilead’s Kite Forms AML Collaboration With HiFiBiO Therapeutics

Gilead Sciences Inc. on Thursday said its Kite unit signed a two-year research collaboration and license agreement with biotherapeutics startup HiFiBiO Therapeutics targeting acute myeloid leukemia, or AML.

The Foster City, Calif., biopharmaceutical company said HiFiBiO will use its proprietary technology platforms to identify novel AML targets and anti-AML specific antibodies for Kite’s use in cell therapies.

Financial details weren’t disclosed, but Gilead said it will make an upfront payment to HiFiBiO, and that the startup will be eligible for additional payments based on Kite’s opt-in on targets discovered through the collaboration, along with development, regulatory and commercial milestone.

HiFiBiO, which is developing drugs that harness the immune system’s ability to treat autoimmune disorders and cancer, raised $67 million in a Series C funding round in August 2019.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-Kite-Forms-AML-Collaboration-With-HiFiBiO-Therapeutics-31226580/

Xencor teams up with MD Anderson on XmAb cancer treatments

September 3, 2020

Xencor (NASDAQ:XNCR) will collaborate with The University of Texas MD Anderson Cancer Center to investigate treatments for a range of cancers leveraging the company’s line-up of XmAb drug candidates, including novel bispecific antibodies and engineered cytokines.

The company will fund and support clinical studies over an initial five-year term.

https://seekingalpha.com/news/3611417-xencor-teams-up-md-anderson-on-xmab-cancer-treatments

Soligenix to host investor webcast

On September 10, beginning at 4 ET (webcastlink), Soligenix (NASDAQ:SNGX) will be hosting an investor webcast event on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax.

https://seekingalpha.com/news/3611419-soligenix-to-host-investor-webcast

Akebia down as vadadustat misses safety endpoints in late studies in CKD anemia

Following up on its announcement of positive data in May, Akebia Therapeutics (NASDAQ:AKBA) announces mixed final results from two open-label Phase 3 clinical trials, PRO₂TECT-CONVERSION and PRO₂TECT-CORRECTION, evaluating vadadustat in adult chronic kidney disease patients with anemia not on dialysis.

Both studies met the primary and key secondary efficacy endpoints demonstrating non-inferiority (NI) to darbepoetin alfa [Amgen’s (NASDAQ:AMGN) Aranesp] but they missed the primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE) (all-cause mortality, non-fatal myocardial infarction, non-fatal stroke). Specifically, the upper bound of the 95% confidence interval was above the prespecified NI margin of 1.25 (hazard ratio = 1.17, 95% CI: 1.01, 1.36).

The incidence of treatment-emergent adverse events (TEAEs) in CORRECTION was 90.9% compared to 91.6% in patients receiving darbepoetin alfa. The most common were: end-stage renal disease (34.7%/ 35.2%), hypertension (17.7%/ 22.1.%), hyperkalemia (12.3.%/ 15.6%), urinary tract infection (12.9%/ 12.0%), diarrhea (13.9%/ 10.0%), peripheral oedema (12.5%/ 10.5%), fall (9.6%/ 10%) and nausea (10%/ 8.2%). The rates of serious TEAEs were 65.3% and 64.5%, respectively.

In CONVERSION, the rates of TEAEs were 89.1% and 87.7%, respectively. The most common were: end-stage renal disease (27.5%/ 28.4%), hypertension (14.4%/ 14.8%), urinary tract infection (12.2%/ 14.5%), diarrhea (13.8.%/ 8.8.%), peripheral oedema (9.9%/ 10.1%) and pneumonia (10.0%/ 9.7%). The rates of serious TEAEs were 58.5% and 56.6%, respectively.

The company plans to present the full dataset from both INNO2VATE and PRO2TECT programs at an upcoming medical conference and submit for publication.

Confident with the totality of the data, it expects to file a U.S. marketing application as early as possible in 2021. It is working with collaboration partner Otsuka Pharmaceutical Co., Ltd. (OTCPK:OTSKF) on an application in Europe.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3611381-akebia-down-big-after-vadadustat-misses-safety-endpoints-in-late-stage-studies-in-ckd-anemia

Dr. Reddy’s launches generic Concerta in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) commences the U.S. commercial launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a therapeutic equivalent generic version of Johnson & Johnson’s (NYSE:JNJ) ADHD med Concerta (methylphenidate Hydrochloride) Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg.

Per IQVIA, the U.S. market is ~$1.16B.

https://seekingalpha.com/news/3611343-dr-reddys-launches-generic-concerta-in-u-

Fulgent Genetics, NYC Health and Hospitals partner on back-to-school Covid testing

September 3, 2020

Fulgent Genetics (NASDAQ:FLGT) and New York City Health and Hospitals will provide COVID-19 testing to hundreds of thousands of students across approx. 1600 locations as they return to school in September and over the next several months.

The company will provide its FDA EUA-approved at-home test, Picture Genetics, an RT-PCR test that provides results within 24-48 hours from the time of specimen collected.

Fulgent’s at-home test was chosen due to its convenient self-administration, which can be used on-site at schools as well as at home.

https://seekingalpha.com/news/3611335-fulgent-genetics-nyc-health-and-hospitals-partner-on-back-to-school-covidminus-19-testing

China offers coronavirus vaccine candidates to aviation industry workers

China has offered experimental coronavirus vaccines to aviation industry workers, according to a regulatory notice seen by Reuters, in a push to inoculate high-risk groups to prevent a possible resurgence as economies reopen.

China, which has four COVID-19 vaccines in the final stage of human trials, launched the emergency use vaccine programme in July, hoping to boost the immunity of groups such as border inspectors or medical industry workers.

Frontline workers at Chinese airlines, airports, China National Aviation Fuel Group and TravelSky Technology Limited will be provided a candidate vaccine on a voluntary basis, the notice from China’s aviation regulator shows.

The Civil Aviation Administration of China has asked these sectors and firms to compile a list of personal information of employees willing to take the vaccine, the notice adds.

The vaccination is “in response to a possible second wave of infections erupting in the fall and winter, and to the huge pressure facing our work of preventing imported cases as western countries reopen despite the pandemic”, according to the notice.

While the regulator did not immediately respond to a Reuters request for comment, several staffers at Air China, China Southern Airlines and Juneyao Airlines confirmed they had received such a notice.

Juneyao said it had submitted a list of employees willing to take the vaccine. The other airlines did not immediately reply to requests for comments.

It is not clear yet which candidate vaccine will be given and how many people will be vaccinated.

At least two experimental vaccines, one from Sinovac Biotech Ltd and the other from China National Biotec Group, have been approved for emergency use in China.

No vaccine has yet passed final, large-scale trials to prove it is effective enough to protect people from contracting the virus that has led to over 860,000 deaths globally.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china/china-offers-coronavirus-vaccine-candidates-to-aviation-industry-workers-notice-idUSKBN25U0OD