Li Ning, Junshi Biosciences CEO
Four months after its first upbeat interim analysis, Shanghai’s Junshi Biosciences and California biotech Coherus BioSciences are touting a statistically significant improvement in overall survival for patients treated with toripalimab plus chemotherapy as a treatment for advanced squamous or non-squamous NSCLC.
The drug, an anti-PD-1 mAb already approved in China as Tuoyi, previously beat placebo as a first-line treatment when combined with chemotherapy. Among 465 advanced NSCLC patients who have never received therapy (both squamous and nonsquamous), investigators observed a ‘significant improvement in progression-free survival.’
Today’s interim analysis goes one step further with the OS announcement, and the trial also met the primary endpoint of PFS compared to chemotherapy alone.
According to a joint statement, the biotechs plan to submit the results of the trial for publication, and then request a meeting with the FDA to discuss a BLA submission for an advanced NSCLC indication.
If the FDA accepts that BLA, it would not be the only one for toripalimab in the US. Another BLA for toripalimab — from the same biotechs — is currently under priority review in combination with chemotherapies gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, with an April 2022 PDUFA date.
‘We are working to register toripalimab for a broad array of indications in China and the United States. In 2022, we look forward to clinical data from additional Phase 3 studies in NSCLC, small cell lung cancer, triple negative breast cancer, and hepatocellular cancer,’ said Junshi CMO Patricia Keegan in a statement.
Shortly after Keytruda and Opdivo wrestled their way to the top of the PD(L)-1 food chain, they’ve been followed by a long list of rivals. Alongside Coherus’s $150 million cash upfront deal earlier this year for the rights to Junshi’s toripalimab, other players including Eli Lilly, EQRx and Novartis, which paid out $650 million upfront to BeiGene for ex-China rights to its PD-1 inhibitor tislelizumab, have been lining up.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
Roberto Bellini, Bellus Health CEO
Do investors want the good news, or the bad news first? Bellus went with the good news, sharing that its chronic cough contender hit the primary endpoint in a Phase IIb trial, lining it up for a Phase III study in the second half of next year where it could pose stiff competition for Merck.
Amidst all the commotion, the Canadian biotech also revealed that the same candidate flunked a proof-of-concept trial in atopic dermatitis, and the company will now steer the program away from pruritic conditions.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
Rumors have swirled around a potential buyout of Switzerland’s Vifor Pharma by Australia’s CSL since the start of December, and now the gossip reportedly has some truth to it.
Vifor confirmed to Reuters early Monday that it is in discussions to be acquired by CSL for more than $8.5 billion, sending its shares up more than 15% in overseas trading. The deal is expected to be finalized Tuesday, according to Australian media, with one large investor reportedly willing to pay more than $173 per share — about $60 more than Vifor’s price before the rumors began circulating on Dec. 2.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
Precision CMO Alan List (Diane Bondareff/AP Images for Moffitt Cancer Center)
The next generation of cell therapies have focused in large part on the development of allogeneic — better known as ‘off-the-shelf — drugs that can cut manufacturing times and hopefully evade a patient’s immune system. One of the early players in that race has new data at #ASH21 that show deep responses but will also raise fresh concerns about these therapies’ durability.
Precision Biosciences’ PBCAR0191, a CD19-directed allogeneic CAR-T cell therapy, posted a complete response rate of 59% in 22 heavily pretreated patients with various forms of relapsed or refractory non-Hodgkin’s lymphoma and acute lymphocytic leukemia, six of whom had previously received an autologous CAR-T before dosing, the biotech said.
Stéphane Bancel, Moderna CEO (Endpoints JPM20/Jeff Rumans)
Last fall, as their Covid-19 vaccine crossed the finish line, Moderna unveiled plans to take its newly proven mRNA platform and use it to effectively change how the world blocks humanity’s most persistent viral foes.
In addition to their pre-existing vaccine programs, executives announced new ones for flu, where vaccines have chronically underperformed, and HIV, which has eluded every inoculation effort over nearly 40 years. In flu, the other mRNA vaccine companies — BioNTech (with Pfizer), Translate Bio (under Sanofi), and CureVac (with GSK) — all had similar ambitions, hoping to make shots that were as high as 80% effective.
Gene therapy biotech Intellia Therapeutics has dosed its first patient with genome editing candidate NTLA-2002, its drug candidate for hereditary angioedema, a rare genetic condition that causes swelling under the skin.
The drug candidate has been under development as a single-dose gene therapy to prevent HAE attacks by inactivating the target gene kallikrein B1 (KLKB1). That would, Intellia hopes, reduce plasma kallikrein activity and thus prevent HAE attacks.
AbbVie’s Migraine Relief-Tok on TikTok
Relaxation apps have nothing on AbbVie migraine med Ubrelvy’s TikTok. Ocean waves and birds chirping offer respite and a quiet scrolling break on the more typically frenetic social media app.
AbbVie calls it Migraine Relief-Tok and in a series of ads feature different calming sounds of nature with the advice: ‘Take a Break. Breathe in, Breathe out.’
The unexpected quiet in what can be an overstimulating experience of music, dancing, pop culture and politics is intentional. AbbVie knows that like many people, the 40 million people who suffer from migraine, are also on social media and TikTok.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
In the face of short attacks, it is not uncommon these days for companies to cry foul and defend themselves against what they call false and misleading statements. But are these short sellers involved in something more nefarious? The Department of Justice is reportedly trying to find out through a sweeping criminal investigation.
Federal investigators are scrutinizing an unknown number of hedge funds and research firms — alongside their trading of at least several dozen shorts — to see if any kind of deception or manipulation was involved, Reuters and Bloomberg reported.
https://endpts.com/junshi-and-coherus-plan-to-hustle-the-latest-pd-1-to-the-fda-after-an-upbeat-phiii-assessment/
