Astrazeneca plc disclosed Wall Street-pleasing phase III data from the study called Adaura with Tagrisso (osimertinib), a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. The study turned up statistically significant and clinically meaningful improvements in disease-free survival in the adjuvant treatment of patients with early stage (IB, II and IIIA) EGFR-mutated non-small-cell lung cancer after complete tumor resection with curative intent. Expectations were high for the study, since Astrazeneca had unblinded the trial for “overwhelming efficacy” at the interim analysis, but the data surpassed even what some had hoped for, said SVB Leerink analyst Andrew Berens in a report. The full results were slated for disclosure over the weekend at the virtual meeting of the American Society of Clinical Oncology.
Phio’s new data light up the company stock
Positive data from a phase II trial from Phio Pharmaceuticals Inc., of Marlborough, Mass., propelled the company stock (NASDAQ:PHIO) dramatically upward, about 86%, at midday Friday. The data come from in vivo studies showing strong antitumoral efficacy from several company programs. The results show, the company said, that intratumoral delivery of the compounds inhibited tumor growth. The compounds were designed to silence PD-1, BRD4 and TIGIT expression. Those proteins have links to cancer patient immune cell function. The company uses a self-delivering RNAi platform designed to silence tumor-induced suppression of the immune system.
Pivotal schizophrenia trial bust sends Minerva shares tumbling
A phase III test of the experimental schizophrenia drug roluperidone by Minerva Neurosciences Inc. found that it failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function. Minerva CEO Remy Luthringer attributed the outcome to a "larger than expected" placebo effect. Company shares (NASDAQ:NERV) plunged on the news, falling 81.2% by midday.
Imminent Ebola vaccine approval in Europe an historic first for J&J’s Advac platform
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of an historic first vaccine approval, having secured a positive vote today from the Committee for Medicinal Products for Human Use (CHMP) of the EMA for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo). The CHMP also voted through applications for an antiviral drug, an antibiotic and two cancer drugs at its monthly meeting this week.
Enmore Bio Conference: Chinese cell therapy developers adopt new approaches to stand out
SUZHOU, China – Chinese CAR T therapy developers from early to IPO-ready-stage are confident that they can create a strong presence in the global scene with their innovations, and they are also making strategies that will work best for their home market. One of the companies receiving a lot of attention at the EBC conference is Legend Biotech Corp. With a Nasdaq IPO coming soon, Legend Biotech has been in the spotlight at home and abroad, and it has a BCMA-targeting CAR T candidate for treating multiple myeloma nearing the NDA stage, in co-development with Janssen Biotech Inc.
Qurient to start phase I trials for triple kinase inhibitor Q-702
HONG KONG – South Korea’s Qurient Co. Ltd., located in Gyeonggi-do, is preparing to send its novel drug, Q7-02, into the clinic after receiving clearance from the U.S. FDA, roughly a month after submitting the application on April 24. Q7-02 is an oral, selective AxI/Mer/CSF1R triple kinase inhibitor that can be used in combination with anti-PD-1 antibodies. The inhibitor is designed to not only modulate innate immune components such as myeloid-derived suppressor cells and tumor-associated macrophage in the tumor microenvironment, but also to increase MHC I expression in tumor cells.
Presumption in favor of petitioner seen as most critical piece of PTO response to SAS v. Iancu
The U.S. Patent and Trademark Office has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner. However, Joseph Meara, a partner in the Madison, Wisc., office of Foley & Lardner, LLP, told BioWorld that the more significant element of the draft rule is the language questioning whether the IPR process should commence with a presumption in favor of the petitioner, a change Meara said patent owners might cheer as “a small, but potentially significant step to increase their chances of turning back petitioner challenges.”
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