The current generation of cell therapies has proven a game changer in terms of treating aggressive blood cancers, but the tech has its limitations. Novartis, one of the biggies in the current generation of these drugs, is now taking lessons learned from CAR-T Kymriah to supercharge a ‘second-generation’ of CAR-Ts putting superior cells into patients faster.
Novartis on Monday rolled out early Phase I data for a pair of autologous CAR-T cell therapies developed through the drugmaker’s T-Charge platform, a process designed to promote T cell ‘stemness’ — a measure of a cell’s ability to self-renew — by cutting manufacturing times and spurring cell proliferation primarily in patients’ lymph nodes.
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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.
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Frank Neumann, Kite global head of clinical development
With the cell therapy field largely pivoting to the next generation of those drugs, established players like Gilead’s Kite and Bristol Myers Squibb are still carving away at new routes into earlier lines of care. This weekend, Kite churned out more data for its CAR-T Yescarta in first-line lymphoma patients as part of a hopeful push for a greater market share.
In updated results from the Phase II ZUMA-12 study, Yescarta posted a 78% complete response rate among 37 patients with high-risk large B cell lymphoma at a median follow-up of just shy of 16 months, the drugmakers said Monday at #ASH21.
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.
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.
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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.
Helen Heslop, Center for Cell and Gene Therapy director
Tessa Therapeutics is doing CAR-T a bit differently. After reading out some positive — albeit early — results back in May showing their virus-specific T cells (VSTs) achieved three partial responses in patients with CD30-positive lymphomas, the company now says the fuller picture looks even brighter.
TT11x, Tessa’s ‘off the shelf’ CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy, achieved a 77.8% overall response rate (7 of 9 patients) in a Phase I trial, the Singapore-based company announced at this year’s ASH conference. What’s more, four of those seven patients saw a complete response, Tessa said.
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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.’
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.
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https://endpts.com/ash-novartis-rolls-out-early-data-for-a-pair-of-second-gen-car-ts-with-more-productive-cells-delivered-faster/
