Although 2020 is the highest money-making year on record for the biopharma industry, a direct comparison of the first five months indicates that the amount raised so far in 2021 is 22% ahead of last year, while the number of financings climbed 26%. The beginnings of the COVID-19 pandemic likely slowed activity during the early months of 2020, as 64% of the year’s $134.5 billion total was collected June or later. So far this year, the industry has raised $58.5 billion through 751 financings, up from $48 billion through 596 financings by this point last year.

Stemirna raises nearly $200M to advance mRNA COVID-19 vaccine

Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature.

Pfizer vaccine less effective against India variant of SARS-CoV-2

LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10. Blood samples taken from healthy volunteers at different time points after receiving one or two doses of the Pfizer vaccine had lower levels of neutralizing antibodies against the India variant than against the Kent and South Africa variants of concern. Levels of neutralizing antibodies were lower with increasing age and levels decline over time, suggesting that third, booster doses of vaccine will be needed later in the year.

ASCO 2021: Harpoon’s interim phase I/II data shows HPN-424 is generally well-tolerated

Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the prostate-specific membrane antigen-targeting T cells were active and generally well-tolerated in treating metastatic castration-resistant prostate cancer. There was antitumor activity detected, including a confirmed partial response, prostate-specific antigen declines and circulating tumor cell reductions. The fresh results, from an April 23 cutoff date, are being presented this weekend at the 2021 American society of Clinical Oncology’s annual meeting. The South San Francisco-based company, however, saw its stock (NASDAQ:HARP) sag 24% at midday June 4.

ASCO 2021: Cullinan's Pearl: EGFR inhibitor shines in early stage NSCLC trial

Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 15.2% by midday as an update on its EGFR inhibitor, CLN-081, suggested it may eventually prove competitive with Johnson & Johnson's recently approved treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, Rybrevant (amivantamab). The phase I/IIa update, offered by Cullinan during the American Society of Clinical Oncology, pointed to a "clean safety profile" and strong efficacy, SVB Leering analyst Andrew Berens said. Testing of the candidate, in-licensed from Taiho Pharmaceutical Co. Ltd. in 2018, is led by one of Cullinan's five subsidiaries, Cullinan Pearl Corp.

ASCO 2021: Merus reports ‘important and clinically meaningful’ responses to zenocutuzumab in NRG1+ cancers

DUBLIN – The latest update from Merus NV’s phase I/II trial of zenocutuzumab (MCLA-128) – and its early access program – in patients with solid tumors harboring an NRG1-fusion offered a slight improvement on the data disclosed in an abstract released last month, in the run-up to the 2021 American Society of Clinical Oncology meeting. The earlier disclosure had concerned 33 patients, who were evaluated by Jan. 12, 2021. Earlier today, clinical collaborator Alison Schram, of Memorial Sloan Kettering Cancer Center, in New York, delivered an oral presentation on 45 patients who were evaluable by the April 13 cut-off date.  Thirteen of them (29%) attained a partial response, according to RECIST criteria. The effect was most pronounced in 12 patients with pancreatic cancer, five of whom (42%) attained a partial response.

Sanofi eyeing adjuvant market as it advances oral SERD candidate in breast cancer

Sanofi SA is hoping an oral successor to Astrazeneca plc’s Faslodex (fulvestrant) could be a significant moneyspinner as it seeks to re-establish itself as a major player in oncology – and is pushing ahead with clinical trials to get it to market ahead of rivals. The Paris-based pharma has announced it is to start a new phase III trial of its second-generation oral selective estrogen receptor degrader (SERD) drug, amcenestrant, targeting high-risk patients with early breast cancer who need adjuvant drugs to suppress formation of secondary tumors after surgery. But as it unveiled taster phase I data ahead of the American Society of Clinical Oncology conference, Sanofi said the drug’s potential goes further and could form the basis of a “backbone” treatment that could be used along the treatment pathway for estrogen receptor-positive cancer.

With GI trifecta by way of Astrazeneca deal, Redhill improving Movantik picture

Redhill Biopharma Ltd.’s takeover of peripherally acting mu-opioid receptor antagonist Movantik (naloxegol) from Astrazeneca plc in February 2020 has helped turn the drug’s marketing prospects around. The company has global rights to Movantik, indicated for opioid-induced constipation in adults with chronic noncancer pain, in a deal that excluded Europe, Canada and Israel (though Israel was added later). Movantik joined Talicia and Aemcolo to provide a “triple-threat product lineup” in gastrointestinal diseases, Wainwright analyst Raghuram Selvaraju said in a recent report.

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