A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
The phase III failure of Blueprint Medicines Corp.’s avapritinib to meet its primary endpoint of improving progression-free survival (PFS) in patients with locally advanced unresectable or metastatic gastrointestinal stromal tumors (GIST) pummeled the company stock on Tuesday but boosted shares and hopes at Deciphera Pharmaceuticals Inc.
CYBERSPACE – At a series of new drugs on the horizon sessions at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, a variety of companies presented preclinical and clinical data for promising early stage oncology products.
DUBLIN – Thrive Earlier Detection Corp. and its academic and clinical collaborators have provided a first glimpse at the utility of a liquid biopsy test as a screening tool for picking up cancers in an asymptomatic population. In an interim one-year readout of data from the prospective five-year DETECT-A study in 10,000 women, an early version of Thrive’s Cancerseek test picked up 26 cancers ahead of standard-of-care screening, while the latter modality picked up another 24 cancers that Cancerseek missed.
Blincyto (blinatumomab, Amgen Inc.), the first FDA-approved bispecific antibody, gained regulatory approval in 2014, but the intervening years have been fairly bleak for bispecific antibodies as companies worked through technical challenges.
BEIJING – Pre-revenue Chinese biotech Akeso Inc., of Zhongshan, Guangdong province, launched a high-profile IPO on April 24 in Hong Kong to reap HK$2.4 billion (US$314 million), even though the economy is taking a hard hit from the COVID-19 pandemic.
Oric Pharmaceuticals Inc. stepped into a tough economic climate on Friday when it priced its IPO of 7.5 million shares of common stock at $16 each and won the day as shares (NASDAQ:ORIC) closed at $25.77 each, 61.06% higher than they started.
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call.
Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints.
Although the product pipeline for vaccines and therapeutics targeting COVID-19 is top of mind right now, investors are also keeping a close eye on companies involved in the development of medicines targeting cancer and the central nervous system. According to financings tracked by BioWorld and deals and grants logged in Cortellis, the therapeutic areas of cancer, neurology and psychiatric attracted the highest amounts of investments last year with a collective $101.9 billion and $27.5 billion raised, respectively.
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