Kalvista Pharmaceuticals Inc.’s phase II win with KVD-900 against hereditary angioedema (HAE) attacks pushed shares (NASDAQ:KALV) to $31.84, up $16.23, or 103%, in midday trading, having reached a high of $45. The study turned up statistically and clinically significant efficacy of KVD-900 as an oral, on-demand treatment for HAE. Cambridge, Mass.-based Kalvista said the kallikrein inhibitor significantly reduced use of rescue (p=0.001) therapy, with 15% of KVD-900-treated attacks rescued compared to 30% on placebo at 12 hours.

Heat Biologics shares sizzle as new phase II NSCLC data put it on path to possible pivotal trial

New interim phase II data in advanced non-small-cell lung cancer has shown that a combination of Heat Biologics Inc.'s cell therapy candidate, HS-110, and Bristol Myers Squibb Co.'s Opdivo (nivolumab) delivered a median overall survival of 24.6 months in 47 previously treated, checkpoint inhibitor-naïve patients. An evaluation of potential phase III registration pathways for the combination is now underway, CEO Jeff Wolf said. After hitting an all-time low about a year ago, Heat's shares (NASDAQ:HTBX) continued an ongoing recovery, rising 53% by midday.

Intermediary host species likely introduced SARS-CoV-2 virus, says WHO

LONDON – The World Health Organization’s (WHO) mission to Wuhan has rejected accidental laboratory escape as the source of SARS-CoV-2, but failed to uncover satisfactory evidence of its exact origin. The chair of the WHO investigation into the source of the virus, Peter Ben Embarek, said the most probable hypothesis is that rather than a direct zoonotic spillover from horseshoe bats, the likely route was through an intermediary animal species. “Our initial findings suggest that the introduction through an intermediary host species is the most likely pathway; [confirming] that will require more studies,” Embarek told attendees of a press briefing held in Wuhan at the conclusion of his group’s four-week field trip to China.

Celltrion wins first conditional Korean approval for COVID-19 antibody Regkirona

HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s is the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.

Savings from complex generics remain elusive in U.S.

Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration, formulation or dosage form. For the past two decades, lawmakers and FDA officials have recognized that getting more complex generics on the market could significantly help reduce the price of what are often expensive drugs. A report released today puts a number to the savings – a median $1.3 billion a year if just seven off-patent complex drugs faced generic competition in the U.S. Generics referencing those drugs are being marketed in the EU or Canada, but they’re still awaiting FDA approval in the U.S.

Interna closes $22M series B round as it enters the clinic

DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first micro-RNA (miR)-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages.

ASCO GU: Janssen and Bayer

Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13. In the final analysis of Janssen’s phase III study of Erleada (apalutamide), the selective androgen receptor inhibitor showed improved overall survival in patients with metastatic castration-sensitive prostate cancer and in those with metastatic hormone-sensitive prostate cancer. Exelixis, of Alameda, Calif., also posted a retrospective analysis in advance of the conference of the effect of Cabometyx (cabozantinib) activity in brain metastases in patients with renal cell carcinoma. The data showed an intracranial response rate of 61% for patients with metastatic renal cell carcinoma, including a complete response rate of 13% for patients with progressing intracranial metastases. The virtual ASCO GU conference offers abstracts and symposia on adrenal, penile, prostate, renal cell and testicular cancers along with urothelial carcinoma.

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