U.S. likely to start COVID-19 vax in children late spring, early summer - Fauci

 The United States will likely start vaccinating children by late spring or early summer, top U.S. infectious disease expert Anthony Fauci said on Friday, as studies are underway to test the safety and effectiveness of Pfizer Inc and Moderna Inc's COVID-19 vaccines in children under 16.

"Over the next couple of months, we will be doing trials in an age de-escalation manner so that hopefully by the time we get to the late spring and early summer we will have children being able to be vaccinated according to the FDA guidance," Fauci said, speaking at a White House press briefing. 

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-U-S-likely-to-start-COVID-19-vaccination-in-children-by-late-spring-or-early-summer-Fauc-32311950/

Russia to launch 'Sputnik-Light' COVID vaccine in February

 Russia will launch the one-dose “Sputnik-Light” version of its coronavirus vaccine in February, the vaccine’s producers said on Twitter on Friday.

Russia has described “Sputnik-Light”, which could be used for export, as a possible temporary solution to help countries with high infection rates make their vaccine supplies go further.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-spu/russia-to-launch-sputnik-light-covid-vaccine-in-feb-sputnik-v-twitter-idUSKBN29Y1WD

European regulator gives green light for Astra-Oxford COVID-19 vaccine

 Europe’s medicines regulator on Friday approved AstraZeneca and Oxford University’s COVID-19 vaccine for people over the age of 18, the third vaccine to be cleared for use in the European Union.

The AstraZeneca vaccine demonstrated an efficacy of around 60% in the trials on which the decision was based, the European Medicines Agency (EMA) said in a statement bit.ly/3pwGYlx.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA.

Europe urgently needs more shots to speed up its inoculation programme with suppliers such as AstraZeneca, Pfizer and Moderna facing difficulties in delivering the quantities promised for the early months of the year.

There were not yet enough results for people over the age of 55 to determine how well the vaccine would work for this group, EMA said. However, it said protection was expected and that the vaccine can be given to older people.

AstraZeneca CEO Pascal Soriot welcomed the decision.

“Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” he said in a statement.

https://www.reuters.com/article/us-health-coronavirus-europe-vaccine-ema/european-regulator-gives-green-light-for-astra-oxford-covid-19-vaccine-idUSKBN29Y23E

RedHill Gets Positive Review for Phase 2/3 COVID-19 Study of Opaganib

 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib^[1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.

https://www.biospace.com/article/releases/redhill-biopharma-announces-positive-dsmb-futility-review-for-phase-2-3-covid-19-study-of-opaganib/

Karyopharm: CHMP Gives Nod to NEXPOVIO® (selinexor) for Multiple Myeloma

 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for NEXPOVIO® (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm's marketing authorization application (MAA). An EC marketing authorization through the centralized procedure is valid in all 27 European Union member countries as well as the European Economic Area countries Iceland, Liechtenstein and Norway.

https://www.biospace.com/article/releases/karyopharm-receives-positive-chmp-opinion-for-nexpovio-selinexor-for-the-treatment-of-patients-with-refractory-multiple-myeloma/

Turning Point Updates on Interim Data in Phase 2 of Repotrectinib in Non-Small Cell Lung Cancer

  Turning Point Therapeutics Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, announced updated interim findings from the ongoing TRIDENT-1 registrational study of lead drug candidate repotrectinib in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC).

In a total of 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed the confirmed objective response rate (ORR) by physician assessment was 93% (95% CI: 68-100) and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99).

The findings will be presented in a mini-oral presentation by Dr. Byoung Chul Cho, Division of Medical Oncology, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer.

https://www.biospace.com/article/releases/turning-point-therapeutics-reports-updated-interim-data-from-registrational-phase-2-trident-1-study-of-repotrectinib-in-patients-with-ros1-positive-tki-naive-non-small-cell-lung-cancer/

Puma: Interim Phase 2 Results for Neratinib in Lung Cancer at WCLC 2020

 The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response, which included 4 patients (40%) with a confirmed partial response. 8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression-free survival was 9.1 months. The success criteria for both the 1^st stage and the 2^nd stage of the Simon’s 2-stage design were met and enrollment in the 2^nd stage of this cohort continues.

The safety profile observed in the subgroup of patients with EGFR exon 18-mutated NSCLC showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. 4 patients (36%) reported grade 1 and 1 patient (9%) reported grade 2 diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.

Dr. Boni, an investigator of the trial, said, “We are very excited about these early study results in EGFR exon 18 mutant lung cancer, for whom very few effective treatment options are available once they fail first-line FDA approved EGFR TKI therapy.”

https://www.biospace.com/article/releases/puma-biotechnology-presents-interim-results-from-the-phase-ii-summit-trial-of-neratinib-for-egfr-exon-18-mutated-metastatic-non-small-cell-lung-cancer-at-wclc-2020/