Fergene, the gene therapy company formed by Ferring Pharmaceuticals SA and Blackstone Life Sciences, unveiled positive data from the pivotal phase III study with nadofaragene firadenovec (rAd-IFN/Syn3) for the treatment of high-grade Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer. The multicenter study met its primary endpoint with 53% of CIS ± Ta/T1 patients achieving a complete response (CR) at three months, and 24% continuing to show a CR at 12 months, Fergene said. Findings also show 73% high-grade recurrence-free (HGRF) survival in patients with papillary disease at three months and 44% HGRF survival at 12 months. Safety and tolerability also look favorable for the compound, given intravesically once every three months. The FDA has already validated the BLA for the product, granting priority review, fast track status and breakthrough therapy designation.

Are the savings of H.R. 3 worth the sacrifice of potential new cures? 

It may be winter in the U.S., but the 2020 campaign season is heating up, especially in swing states that could determine political and ideological control of Congress. Those states are being stormed with ads picking up on public outrage over prescription drug prices. The ads, sponsored by Democratic-leaning groups, characterize lawmakers opposed to H.R. 3, the Lower Drug Costs Now Act, as being in the pockets of big pharma. The partisan bill, drafted behind the closed doors of House Democratic leadership, mandates that Medicare annually negotiate prices on 250 of the costliest prescription drugs in the U.S., with that number escalating over the years, and it imposes a steep inflationary rebate designed to end hefty price increases. In an attempt to weather the storm, House Republicans have launched the #FewerCures Facts video series to highlight the human cost of H.R. 3 by emphasizing the new cures that may never materialize if H.R. 3 were to become law.  

Emphasizing synergy and efficiency, EOC Pharma raises $71M series C to fight breast, gastric cancers

BEIJING – EOC Pharmaceutical Group, of Shanghai, completed a series C financing round, bagging $71 million to advance its lead programs EOC-103 and EOC-315 for breast and gastric cancers. The round was led by Hangzhou Tigermed Consulting Co. Ltd. and its affiliated funds, TF Capital and Yingke PE. Hanne Capital and Everest Venture Capital also participated. In 2017, EOC raised $32 million in a series B round. All funding participants are China-based. “Most of the proceeds will be used to advance our existing clinical programs. A major part will go to late-stage development of our assets, while a small portion will be used to advance the early stage programs into clinical studies,” EOC CEO Xiaoming Zou told BioWorld.

New PCa treatment strategy may overcome resistance

Targeting prostate cancer (PCa) neuroendocrine (NE) cells via inhibition of the C-X-C motif chemokine receptor 2 (CXCR2) is an androgen receptor (AR)-independent therapeutic strategy that can improve the efficacy of treatment for PCa, a leading cause of male cancer mortality. Reported in the Dec. 4, 2019, edition of Science Translational Medicine, that novel strategy may overcome treatment resistance due to tumor cell heterogeneity, according to a study led by Jiaoti Huang, chairman and professor in the Department of Pathology at Duke University School of Medicine in Durham, N.C.

Newco news: Dyno to scale the heights of AAV vector engineering

DUBLIN – In rock climbing lingo, a “dyno” is a bold, dynamic move the climber executes to reach a new handhold. It requires courage and coordination as well as athleticism – a miss can have very serious consequences. The reward is a precious gain in altitude and a new position, from which to plot the next move. In an analogous fashion, startup firm Dyno Therapeutics Inc. is attempting to engineer a new generation of adeno-associated virus capsids by navigating its way across what it calls the “capsid fitness landscape,” in order to optimize the key parameters that affect capsid performance: production, delivery efficiency, biodistribution, immunogenicity and thermostability.

Newco news: With another $26M, Japan’s Heartseed aims to advance iPSC-derived regenerative medicine for heart failure

BEIJING – Tokyo-based biotech firm Heartseed Inc., which focuses on regenerative medicine, has closed a series B financing round to pocket $26 million that will go to its lead drug candidate, HS-001, for treating heart failure. The $26 million came from investors such as SBI Investment, JMDC, Gene Techno Science, Nissay Capital, SMBC Capital and an existing investor Astellas Venture Management LLC. Heartseed was founded in 2015, and the startup, which has grown to a team of 30 members, has raised $35 million from investors so far.

Also in the news

3DBio Therapeutics, Alexion, Amgen, Applied Therapeutics, Aptevo, Arcutis, Aslan, Basilea, Biohaven, Cassava, Codexis, Curis, Dynavax, EIP Pharma, Enzychem, Fergene, Galapagos, Galectin, Galera, Gemphire, Innovent, Intellipharmaceutics, Intercept, Ipsen, Iveric, Midatech, Nicox, Novartis, UCB, Oncolytics, Onconova, Rocket, Summit, Sunesis, Y-mabs