J&J's Erleada/Zytiga combo hits PhIII endpoint — but what about OS?; Targovax loses prostate cancer partner after enrollment struggles
J&J says a combination of Erleada and Zytiga, two of its big prostate cancer drugs, has met the primary endpoint of radiographic progression-free survival in a Phase III study — but fell short of helping patients live longer.
Specifically, the ACIS study recruited patients with chemotherapy-naïve metastatic castration-resistant prostate cancer receiving androgen deprivation therapy. Investigators found that adding Erleada to a regimen of Zytiga plus prednisone extended median rPFS by 6 months (22.6 versus 16.6 months).
At a median follow-up of 54.8 months, J&J reported at ASCO GU, they observed a 30% reduction in the risk of radiographic progression or death.
When it comes to the secondary endpoints, though, no statistically significant difference between treatment arms was demonstrated, either on OS, time to initiation of cytotoxic chemotherapy, chronic opioid use or pain progression.
For its part, J&J noted that among the heterogeneous overall population, certain cohorts — including patients aged 75 or older, those with visceral metastasis, luminal type in PAM50 test and tumors with average or high AR activity — had better rPFS and better OS results, suggesting they may derive clinical benefit from the new combo.
“Insights from the ACIS study regarding differences in benefit for specific patient subgroups treated with the combination warrant additional evaluation,” Dana Rathkopf, principal investigator and a medical oncologist at Memorial Sloan Kettering, said in a statement. — Amber Tong
Targovax loses prostate cancer partner after enrollment struggles
Norwegian biotech Targovax said Tuesday that its partner on a prostate cancer program has dropped out of the collaboration.
The Czech biotech company Sotio had been running a Phase I safety study for ONCOS-102 to see if it could enhance the efficacy of its dendritic cell vaccine. However, due to the strict inclusion criteria in the study and challenges related to the Covid-19 pandemic, the duo was not able to complete enrollment.
As such, Sotio decided to walk away from the partnership. Only four patients ended up enrolling, and Targovax said the decision will not impact further development of ONCOS-102.
Targovax is also researching the program’s use in treating melanoma and mesothelioma. In data released last November, the company said an 18-month analysis showed that median overall survival was at least 18.2 months for first-line mesothelioma patients receiving the drug plus chemotherapy. That compared to 14.2 months or less for the control group. — Max Gelman
WuXi backs $56M launch round of trans-Pacific biotech
Transpacific biotech startup Drug Farm is launching with $56 million, a focus on hepatitis B virus, and promises to uncloak new targets and pathways in innate immunity.
Dually based in Shanghai and Guilford, CT, the company says its tech platform allows it to generate and directly assess genetic mutations in living animals with intact immune systems. The AI-directed medicinal chemistry then points them to first-in-class small molecule immune-modulating candidates, added Tian Xu, founder and chairman.
Outside of its lead drug, DF-006, which is also being positioned for other liver diseases, Drug Farm has also set its sights on autoimmune diseases and cancer.
BioVeda China Fund, WuXi AppTec’s corporate venture fund, South China Venture Capital, Detong Capital and Zhejiang United Investment Group invested in the round. — Amber Tong
Cambridge expansion gets the OK for £65 million project
The Cambridge Biomedical Campus, the largest center of medical research and health science in Europe, has been given the green light on a £65 million expansion project.
Cambridge announced the plans last Friday, noting that this is part of a massive expansion planned to increase the total area of the campus by 400,000 square feet. Friday’s project specifically will provide 103,000 square feet of laboratory and office space in a five-story building.
The go-ahead was granted to developers Liberty Property Trust and Countryside Properties, who had been in charge of the previous renovations as well.
“The new development will be the latest building on the biomedical campus which has seen extraordinary growth with the delivery of over 1.7 million square feet of new space for occupiers in less than 10 years,” Liberty managing director Andrew Blevins said in a statement. — Max Gelman
Hengrui bets $20M on fellow Chinese biotech and its PI3kδ inhibitor
After vaulting itself to the ranks of global biopharma, Hengrui Medicine is scouting the local biotech scene for new assets.
Its latest bet is on fellow Shanghai biotech Yingli Pharma, which is scoring a $20 million equity investment in exchange for joint development and commercialization rights for its PI3kδ inhibitor in China.
“This collaboration will further enrich the layout of Hengrui Medicine in the field of hematological tumor and oncology and supplement the existing product line,” Zhang Lianshan, senior deputy general manager and president of global R&D of Hengrui Medicine, said.
Like a number of peers in its generation, Yingli has a lofty vision to go global with its small molecule drug research, eyeing both cancer and kidney-related metabolic diseases. — Amber Tong