Daiichi Sankyo has been busy the past few days. The drugmaker launched a front-line breast cancer trial for its AstraZeneca-partnered Enhertu, scored a Japanese nod for oncolytic virus therapy Delytact, and nixed development of a COVID-19 candidate. Meanwhile, Celltrion’s coronavirus antibody posted a win in mild-to-moderate patients who weren’t hospitalized. Zai Lab in-licensed four cancer bispecifics from old partner MacroGenics. And more.
1. AstraZeneca, Daiichi Sankyo launch Enhertu head-to-head trial with eyes on a new breast cancer standard
AstraZeneca and Daiichi Sankyo aim to set their blockbuster-to-be Enhertu as a new standard in newly diagnosed metastatic HER2-positive breast cancer. The pair has launched the Destiny-Breast09 trial, pitting the antibody-drug conjugate—with or without Roche’s Perjeta—against a triplet of Perjeta, Herceptin and chemotherapy. Phase 3 data from the second-line setting are expected later this year.
2. Celltrion’s COVID-19 antibody gets a phase 3 win as virus variants snare existing therapies
Celltrion’s COVID-19 antibody, regdanvimab (CT-P59), reduced risk of hospitalization or death by 70% compared with placebo in mild-to-moderate COVID-19 outpatients after 28 days of treatment. The drug also helped patients recover more quickly than placebo did. The antibody already has conditional authorization in South Korea.
3. Zai Lab to pay MacroGenics $25M upfront with $1.4B in potential biobucks for bispecific immuno-oncology antibodies
Zai Lab already holds rights in China for three of MacroGenics’ drugs, including the newly FDA-approved breast cancer med Margenza. Now, the Chinese biotech is paying $25 million up front and making an equity investment of $30 million in its old partner for the rights to four CD3- or CD47-based bispecific antibodies. The milestone payments could go up to $1.4 billion.
4. EHA: Watch out, Imbruvica. BeiGene’s touting Brukinsa efficacy, safety wins in a key leukemia battleground
BeiGene has detailed Brukinsa’s head-to-head win against AbbVie and Johnson & Johnson’s market-leading BTK inhibitor Imbruvica in previously treated chronic lymphocytic leukemia. By investigator analysis of the phase 3 Alpine trial, Brukinsa triggered a response in 78.3% of patients, significantly more than Imbruvica’s 62.5% after a median 15 months of follow-up. The BeiGene drug also showed a significantly lower rate of atrial fibrillation.
5. Heartseed collects new venture round after $598M heart failure stem cell deal with Novo Nordisk
Tokyo-based Heartseed has raised JPY 4 billion ($37 million) in a series C round to fund a global clinical trial of its lead therapy, a stem cell-based treatment to repair heart damage. It comes shortly after a collaboration and licensing agreement with Novo Nordisk. For $55 million upfront, the Danish company is getting exclusive ex-Japan rights to the therapy.
6. Lilly-backed Terns tees up combo trial as oral NASH drug shows promise in phase 2
Terns Pharmaceuticals has reported positive phase 2 data for its NASH candidate TERN-101. The drug was well tolerated, and patients who got it showed improved results on liver enzyme and imaging tests. The company now aims to combine the FXR agonist with TERN-501, its TR-beta agonist that’s in a phase 1 trial.
7. HiFiBiO gets high-five from investors with $75M series D to bring 2 programs into clinic
U.S.-China biotech HiFiBiO has completed an oversubscribed $75 million series D led by Mirae Asset Financial Group. The money will move its two lead oncology assets—an anti-TNFR2 antibody and an OX-40 inhibitor—into phase 1 clinical trials. The firm also has a SARS-CoV-2 neutralizing antibody in the works.
8. Daiichi Sankyo wins Japan nod for oncolytic virus therapy Delytact for brain cancer (release, PDF)
Daiichi Sankyo has won conditional nod from Japanese authorities for Delytact, an oncolytic virus, for the treatment of patients with malignant glioma. The company’s initial goal is to develop the drug for the Japanese market. Now that’s been achieved, “we will explore potential steps for development in other regions of the world,” a company spokesperson told Fierce Pharma.
9. Daiichi Sankyo drops development of early-stage inhaled COVID-19 drug
Also this week, the Japanese pharma pulled the plug on developing DS-2319, an inhaled version of nafamostat, for COVID-19. The company launched a phase 1 trial in March with the hope that the drug might block fusion between the coronavirus and host plasma cell.
News of Note:
10. Bristol Myers, Eisai and Lundbeck ally to bring down blood-brain barrier
11. Verona sells Chinese rights to inhaled drug for $40M upfront
12. Cadila’s Viona Pharmaceuticals pulls 2 metformin lots in U.S. over carcinogen fears
13. Symptom checking platform developer Ada Health inks partnerships with Sanofi, Takeda, Alnylam
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