CTI: Phase 1 Trial Has Encouraging Clinical Benefit, Safety for Preventing Graft-V-Host Disease

 CTI BioPharma Corp. (Nasdaq: CTIC), today announced that Clinical Cancer Research, a journal of the American Association for Cancer Research, has published results from a Phase 1 study led by Joseph Pidala, MD, PhD (Moffitt Cancer Center), and Brian C. Betts, MD (Masonic Cancer Center at the University of Minnesota), evaluating pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, for the prevention of acute graft-versus-host disease (GVHD). The results demonstrated that pacritinib, combined with sirolimus and low-dose tacrolimus (PAC/SIR/TAC), has a promising safety profile and exhibits preliminary therapeutic activity in preventing acute GVHD after allogeneic hematopoietic cell transplantation. The article, titled "Pacritinib Combined with Sirolimus and Low-Dose Tacrolimus for GVHD Prevention after Allogeneic Hematopoietic Cell Transplantation: Preclinical and Phase 1 Trial Results," is available online (http://clincancerres.aacrjournals.org/content/early/2021/03/17/1078-0432.CCR-20-4725). The Phase 2 portion of the trial (NCT02891603) designed to evaluate the therapeutic effect of pacritinib in combination with sirolimus and low-dose tacrolimus for GVHD prevention is ongoing at Moffitt Cancer Center and the Masonic Cancer Center at the University of Minnesota.

The Phase 1 portion of the trial (NCT02891603) evaluated the safety of pacritinib when administered with sirolimus plus low-dose tacrolimus after allogeneic hematopoietic cell transplantation (alloHCT). A 3+3 dose escalation design identified PAC 100 mg twice a day as the minimum biologically active and well-tolerated dose for further study. At this dose, one out of six study participants treated with the investigational regimen had Grade 2-4 acute GVHD. Chronic GVHD was rare, with only two participants developing mild disease per NIH consensus criteria, which resolved without systemic immune suppression.

https://finance.yahoo.com/news/phase-1-trial-demonstrates-encouraging-140100342.html

ENDO 2021: 89bio Presents Additional Analysis of Phase 1b/2a NASH Study

 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced additional positive data from its Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). The data will be presented in an on-demand poster presentation at ENDO 2021, the Endocrine Society’s annual meeting taking place virtually from March 20-23, 2021.

“Excess liver fat is an important driver of disease progression for people living with NASH and can be associated with increased risk for cardiovascular events and even death,” said Hank Mansbach, chief medical officer of 89bio. “We are encouraged by new analyses from our Phase 1b/2a study that show BIO89-100 demonstrated clinically meaningful reductions in both liver fat volume and liver volume overall across all dosing groups. The data continues to highlight the promising clinical profile of BIO89-100 and supports further development of BIO89-100 in NASH and also severe hypertriglyceridemia.”

New analyses of the Phase 1b/2a study data showed BIO89-100 treatment resulted in significant reductions in liver volume of up to 15% and liver fat volume of up to 65% in treated patients at 13 weeks compared to baseline, as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). These data extend the previously reported MRI-PDFF data in which BIO89-100 treatment resulted in up to 70% relative reduction in liver fat fraction relative to placebo treatment. Additionally, BIO89-100, as previously reported, demonstrated a favorable safety and tolerability profile, with rates of gastrointestinal side effects such as nausea, diarrhea and vomiting similar to placebo.

https://finance.yahoo.com/news/89bio-presents-additional-analysis-phase-150000143.html

Thai-developed COVID-19 vaccine starts human trials

 Thailand started human trials on Monday of a domestically developed coronavirus vaccine and expects to deploy it next year, which its health minister said could give the country more freedom with its vaccine policy.

Thailand’s vaccination drive is targeting the inoculation of half of its adult population by the end of the year using 61 million doses of AstraZeneca’s vaccine, which will be locally produced from June.

The home-grown vaccine candidate is being developed by state drug maker, the Government Pharmaceutical Organization (GPO), with Mahidol University’s Tropical Medicine Department and an American non-profit and uses an inactivated virus to trigger immunity.

“The vaccine, produced by Thais for Thais, is expected to be used next year,” Piyasakol Sakolsatayadorn, chairman of the Mahidol University Council, told a news conference.

Thailand’s progress comes as countries including Japan and Taiwan speed up domestic vaccine development programmes amid tight global supply and concerns about new COVID-19 variants.

Vietnam last week said its locally developed vaccine would be available by the fourth quarter of this year.

Mahidol University’s dean, Bangjong Mahaisavariya, said 460 volunteers would be accepted for the human trials, 210 of whom would be used in the first phase. Phase two is expected to begin in July, with results by year-end.

The Thai vaccine candidate modifies the avian Newcastle Disease virus with a COVID-19 spike protein and is replicated using egg-based technology, the GPO said.

Health Minister Anutin Charnvirakul said the vaccine would give Thailand more options with less constraints.

“Even though we can produce vaccines in the country, it is from technology transfer and under management of brands,” he told the news conference.

“But today, if we are successful we can set our own direction.”

Another homegrown vaccine is being developed by Chulalongkorn University and uses Messenger RNA (mRNA) technology. It is expected to start human trials soon.

Thailand has recorded 27,876 coronavirus cases in total, with 91 deaths.

https://www.reuters.com/article/us-health-coronavirus-thailand-vaccine/thai-developed-covid-19-vaccine-starts-human-trials-idUSKBN2BE0UD

Russia says clinical trials for 1-shot Sputnik Light vaccine complete

 Russia has completed clinical trials for its one-shot “Sputnik-Light” version of its COVID-19 vaccine, the health minister said on state television on Monday.

Russia said in January that it would trial the slimmed-down vaccine as a possible “temporary” solution to help countries with high infection rates make the vaccine go further.

Moscow has said that its two-dose Sputnik V vaccine will remain the main version used in Russia.

President Vladimir Putin said on Monday that 4.3 million Russians had received both shots of the vaccine and also announced that he would get vaccinated on Tuesday.

https://www.reuters.com/article/us-health-coronavirus-vaccine-russia-lig/russia-says-clinical-trials-for-one-shot-sputnik-light-vaccine-are-complete-idUSKBN2BE1YO

Russia says unnamed U.S. firm violated patent rights on Sputnik V vaccine

 Russia’s RDIF sovereign wealth fund said on Monday a U.S. firm had violated Russian patent rights on its Sputnik V vaccine against COVID-19.

RDIF, which actively markets Sputnik V abroad, did not disclose the name of the U.S. firm.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-rig/russia-says-unnamed-u-s-firm-violated-patent-rights-on-sputnik-v-vaccine-idUSKBN2BE1VH

India to increase interval between doses of AstraZeneca shot

 

India's health ministry on Monday wrote to states asking them to administer second AstraZeneca coronavirus vaccine doses to recipients within four to eight weeks, from the current guideline of four to six weeks.

"The recommendation has been revised to provide the 2nd dose of COVISHIELD at 4-8 weeks' interval after the 1st dose, instead of earlier practiced interval of 4-6 weeks," the ministry said in a statement, using the brand name for the vaccine made locally by the Serum Institute of India.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-India-to-increase-interval-between-doses-of-AstraZeneca-shot-32751826/

Daiichi takes mRNA COVID-19 vaccine into clinic as Japan R&D belatedly fires up

 Daiichi Sankyo has begun (PDF) a phase 1/2 clinical trial of an mRNA vaccine against COVID-19. The vaccine is set to come to market well after leading prophylactics but gives Japan a chance to establish its own countermeasures for COVID-19 and future health crises. 

Japan has played a small role in the development of COVID-19 vaccines so far. AnGes took a vaccine candidate into the clinic last year, but the rest of the local industry has lagged well behind. Japanese companies have struck deals to make foreign vaccines, such as Daiichi’s deal with AstraZeneca, but home-grown innovation has been lacking.

Daiichi signaled its intent to bring a home-grown vaccine to market in August when it was selected to take part in government initiatives to develop COVID-19 prophylactics and build production capacity. The vaccine covered by the agreements, DS-5670, is now in the clinic.

Investigators are enrolling 152 healthy adults, including elderly individuals, in the phase 1/2 trial. The study will assess the safety and immunogenicity of the mRNA vaccine to determine a recommended dose for further development. 

Daiichi is yet to share a timeline for further development of the vaccine but, based on the speed at which other products came to market, the product is unlikely to win approval until late this year at the earliest. Japan’s vaccination campaign has ramped up relatively slowly—0.44% of people had received at least one dose as of March 19—but with jabs from AstraZeneca and Moderna waiting to join the Pfizer-BioNTech product on the market, it is possible Daiichi will arrive too late to play a big role in the initial immunizations.

By then, attention may have turned to protecting the population against variants. Japan has reported cases of infection with variants featuring E484K, the mutation that is thought to make the virus more resistant to antibodies. E484K is found in the variants first identified in Brazil and South Africa. The start of work on DS-5670 predates the emergence of the variants, suggesting it may be less effective against them than it is against the original coronavirus. 

In the longer term, the development of DS-5670 may ensure Japan is equipped to respond faster to new or mutated pathogens. Vaccines from Moderna and Pfizer-BioNTech have pointed to the power of mRNA to protect against pathogens, suggesting Daiichi’s technology could be used in response to future health crises if validated against COVID-19. The capacity Daiichi is establishing is intended for use in the responses to infectious diseases other than COVID-19.

The Daiichi trial is part of a flurry of studies of Japanese COVID-19 vaccines. Shionogi became the second company to trial a Japan-originated COVID-19 vaccine late last year, and KM Biologics disclosed the initiation of its study on the same day as Daiichi. 

https://www.fiercebiotech.com/biotech/daiichi-takes-mrna-covid-19-vaccine-into-clinic-as-japanese-r-d-belatedly-fires-up