BioNTech bought a Novartis manufacturing facility to accompany its Asia-Pacific headquarters in Singapore. Astellas has reported a first-in-class phase 3 win for its anti-CLDN18.2 drug in stomach cancer. Daiichi Sankyo said its mRNA vaccine, when used as a booster, works better than existing COVID shots available in Japan. And more.
1. BioNTech buys Novartis plant in Singapore, will retrofit for mRNA vaccine production
Last May, BioNTech unveiled a plan to establish its Asia-Pacific headquarters in Singapore. Now, the German company has purchased a manufacturing facility in the country from Novartis. The plant will be fully operational by late 2023 and will have the capacity to produce several hundred million doses of mRNA-based vaccines annually, BioNTech said.
2. Astellas' $1.3B antibody strikes first in hot cancer field, extending survival in phase 3
In a first for the emerging anti-CLDN18.2 class of drugs, Astellas’ zolbetuximab posted a phase 3 win in stomach cancer. The drug, used in combination with chemo, topped chemo alone at staving off tumor progression or death. Astellas is now waiting on an imminent readout from a second phase 3 trial to file for approvals. Astellas picked up the drug through an acquisition of Ganymed Pharma in 2016.
3. Daiichi-Sankyo, playing COVID catch up with Pfizer and Moderna, says its mRNA booster stands out
Daiichi Sankyo said its mRNA COVID-19 vaccine, DS-5670, increased higher levels of neutralizing antibodies than existing shots did when used as a booster. The phase 1/2/3 trial enrolled about 5,000 Japanese people. The company said it will ask for a Japanese approval in January 2023, and it’s working on launching clinical trials of a bivalent vaccine.
4. Hutchmed, NightHawk and NexImmune are latest biotechs to drop R&D programs in Q3 cleanout
Hutchmed's fruquintinib posts China trial win in 2nd-line gastric cancer
Hutchmed has launched a strategic pivot, saying it will focus on late-stage and registrational studies while de-prioritizing some early-stage programs. The company will look for partners to commercialize its drugs outside of China. After an FDA rejection for surufatinib, Hutchmed’s focus is now on fruquintinib, which is angling for the U.S. colorectal cancer market. The drug also just posted a Chinese trial win in stomach cancer.
5. Takeda's Iclusig delivers a win in rare subtype of acute lymphoblastic leukemia
Takeda’s Iclusig could become the first targeted therapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in the U.S. The drug, compared with Novartis’ first-generation tyrosine kinase inhibitor Gleevec, helped more patients achieve complete remission with no minimal residual disease.
6. GSK debuts new $33M high-potency Singapore plant focused on cancer treatments
GSK has opened a new $33 million plant in Singapore that will produce the toxic chemo payloads used in antibody-drug conjugates. GSK has a BCMA-targeted ADC, Blenrep, that just failed a confirmatory phase 3 in third-line multiple myeloma.
Other News of Note
7. Another day, another FDA reprimand for troubled Indian manufacturer Lupin
8. Temasek reportedly considering billion-dollar sale of Advanced MedTech: Reuters