AACR: Kintara updates on glioblastoma trials

  Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company's lead compound, for the treatment of glioblastoma multiforme (GBM). The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) Annual Meeting, which is taking place virtually from April 10-15, 2021.

Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston, Texas. The second poster, CT172, updates the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China.

"These interim data updates at the AACR Annual Meeting continue to demonstrate VAL-083's potential as a game-changing treatment option for GBM patients," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "Furthermore, it's important to note that both trials have provided valuable insights as we prepared to initiate the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which commenced patient enrollment in February 2021."

https://finance.yahoo.com/news/kintara-presents-updates-two-phase-120000968.html

Regeneron to seek U.S. OK for COVID-19 cocktail to be used for prevention

 Regeneron is pursuing U.S. approval for its COVID-19 monoclonal antibody cocktail as a preventative treatment after it helped cut the risk of symptomatic infections in households where someone else is ill, the U.S. drugmaker said on Monday.

REGEN-COV, a combination of casirivimab and imdevimab, protected household contacts from exposure to SARS-CoV-2, with 72% protection against symptomatic infections in the first week, and 93% after that, according to trial data released by the company.

In a separate trial, Regeneron also said the treatment reduced overall risk of progressing to symptomatic COVID-19 by 31%, and by 76% after the third day.

Regeneron has enlisted Switzerland’s Roche and its massive biotech facility in South San Francisco to make around 2 million doses annually. The cocktail already has emergency U.S. approval for mild to moderate COVID-19 patients, and the companies are hoping the latest trials convince regulators to expand deployment.

“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection,” said Myron Cohen, who leads monoclonal antibody efforts for the U.S. National Institutes of Health-sponsored COVID Prevention Network.

A challenge in breaking infection chains, he said, is that some 10% of unvaccinated people in the study who didn’t get the Roche-Regeneron drug while living in a household with an infected individual developed symptomatic infection even with efforts to reduce transmission.

‘HIGH-RISK SETTINGS’

“REGEN-COV could help control outbreaks in high-risk settings” where people haven’t been vaccinated, Cohen said.

In the separate trial, Regeneron said the cocktail also cut symptomatic infection risk and helped nearly halve the total weeks that patients experienced symptoms, with the viral burden -- the amount of virus present -- cut by more than 90%.

“These data pave the way for REGEN-COV to be used before patients become symptomatic,” Katharine Bar, co-principal investigator and a professor at the University of Pennsylvania hospital, said.

https://www.reuters.com/article/health-coronavirus-roche-regeneron-pharm/update-2-regeneron-to-seek-us-ok-for-covid-19-cocktail-to-be-used-for-prevention-idUSL8N2M526F

Spectrum Pharma Presents Additional Twice Daily Dosing Data for Poziotinib at AACR

 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented a data update on the safety and tolerability of twice daily (BID) administered poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations. These preliminary data, from Cohort 5 of the ZENITH20 clinical trial, continue to show improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrate improved anti-tumor activity with 8mg BID dosing. The presentation is part of the AACR Virtual Meeting 2021 taking place April 10-15, 2021.

“The 8mg BID dosing arm is showing the best performance we have seen across the various dosing arms for a mixed population of EGFR and HER2 exon 20 insertion mutations in NSCLC patients. There is clearly an improved therapeutic effect and a lower adverse event rate which is highly encouraging,” said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “We are currently expanding the 8mg BID dataset and look forward to evaluating this dose in additional NSCLC patients and other solid tumors.”

A copy of the AACR presentation titled “Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations” is available on Spectrum’s website at https://investor.sppirx.com/events-and-presentations.

https://www.businesswire.com/news/home/20210410005020/en/Spectrum-Pharmaceuticals-Presents-Additional-Twice-Daily-Dosing-Data-for-Poziotinib-at-the-AACR-Virtual-Meeting-2021

Lilly ends supply agreement with U.S. govt for COVID-19 antibody drug

 Eli Lilly and Co said on Monday it had terminated a supply agreement with the U.S. government for its COVID-19 antibody drug and would now focus on selling it in combination with another therapy.

Lilly and the U.S. government have agreed to modify the purchase agreement for the drug, bamlanivimab, and focus on its supply with etesevimab, the company said.

https://www.reuters.com/article/healthcoronavirus-lilly-antibody-idUSL4N2M52P3

Kiniksa: Positive Results for Mavrilimumab Phase 2 Trial in Severe COVID

 – Primary endpoint achieved: the proportion of patients alive and free of mechanical ventilation at Day 29 was 12.3 percentage points higher with mavrilimumab versus placebo (p=0.1224 met predefined statistical threshold of p<0.2) –

– 65% reduction in risk of mechanical ventilation/death with mavrilimumab versus placebo (p=0.0175) –
– 61% reduction in risk of death with mavrilimumab versus placebo (p=0.0726) –
– Clinical improvement was observed on top of steroids and/or antivirals –
– Enrollment in the Phase 3 portion of the trial ongoing –

https://www.globenewswire.com/news-release/2021/04/12/2208144/0/en/Kiniksa-Announces-Positive-Results-for-Mavrilimumab-Phase-2-Trial-in-Non-Mechanically-Ventilated-Severe-COVID-19-Patients.html

Biogen, Sage Phase 2 meets primary endpoint

 Statistically significant reduction in tremor score compared to placebo at Day 29 in adults with essential tremor

SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population; in a more severe population (baseline TETRAS Upper Limb Item 4 >12), SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline

SAGE-324 demonstrated a safety profile generally consistent with previously reported data

Sage Therapeutics to host conference call today at 8 a.m. ET

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET). The study (n=67 full analysis set) achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 upper limb tremor score on Day 29 (P=0.049), which corresponded to a 36% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to a 21% reduction in patients receiving placebo. Activities of daily living (ADL) scores showed a statistically significant correlation with upper limb tremor score at all timepoints. While not powered to fully examine TETRAS ADL, SAGE-324 was numerically superior to placebo at all time points. Reported treatment-emergent adverse events (TEAEs) were generally consistent with the safety profile of SAGE-324 to date.

In the KINETIC Study, patients (n=47) with a more severe tremor at baseline (at or above the median TETRAS Performance Subscale upper limb tremor Item 4 score of 12) who received SAGE-324, demonstrated a statistically significant reduction (P=0.007) from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score compared to placebo at Day 29, corresponding to a 41% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to an 18% reduction for placebo. Study patients were not taking other medications for ET during the 28-day treatment period.

Sage will host a conference call and webcast today, Monday, April 12, at 8:00 a.m. ET to discuss the KINETIC Study topline results. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.

https://finance.yahoo.com/news/sage-therapeutics-biogen-announce-sage-110000150.html

iRhythm Call to Discuss Medicare Administrative Contractor Novitas’s Updated Rates

 iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced that it will host a conference call to discuss the recent publication by Novitas Solutions (“Novitas”) of rates applicable to the Current Procedural Terminology (CPT) codes 93243 and 93247.

On April 10, 2021, Novitas published updated reimbursement rates for codes 93243 and 93247 at $103 and $115, respectively. The updated rates are retroactive to January 1, 2021 and replace rates initially published on January 29, 2021. iRhythm is assessing the impact of the updated Novitas rates on its business and will provide comments on a conference call on April 12, 2021.

Webcast and Conference Call Information
iRhythm will host a conference call on April 12, 2021 at 5:30 AM PT / 8:30 AM ET to provide commentary on the newly published rates by Novitas. Investors interested in listening to the conference call may do so by accessing the live and archived webcast of the event available on the “Investors” section of the company’s website at: www.irhythmtech.com.

https://finance.yahoo.com/news/irhythm-technologies-announces-conference-call-182000006.html