December 10, 2018
GlaxoSmithKline is getting back into the cancer business in a big way, with a proposed $5.1 billion takeover of Tesaro, maker of cancer gene therapy Zejula (niraparib).
Glaxo officials say they expect to close the deal — pending approval by the Federal Trade Commission — in the first quarter of 2019.
If given the nod, the move will give Glaxo rights to Zejula — approved for treatment of some forms of ovarian cancer and in trials for other types — and at least 14 other cancer drugs in the clinical trial pipeline.
This marks a dramatic return to oncology for Glaxo, which sold off most of its cancer assets to Novartis in 2014 for $16 billion. The sale followed the Phase III failure of Glaxo’s MAGE-A3 melanoma immunotherapy.
Glaxo CEO Emma Walmsley said the acquisition “will strengthen our pharmaceuticals business by accelerating the build of our oncology pipeline and commercial footprint.”
Earlier this year, Glaxo hired Hal Barron from Calico, a subsidiary of Alphabet (Google’s parent company), to run its R&D department. He said he was tasked with helping to rebuild the company’s oncology biz and take an aggressive approach to immunotherapy, broadly.
Drug Helps Cut Sickle Cell Burden
A daily pill used to fight cancer has been found effective in protecting children against malaria as well as the painful and sometimes deadly effects of sickle cell disease.
Researchers gave 606 African children, ages one to 10, daily doses of hydroxyurea, an antimetabolite approved to treat some forms of leukemia, for six months.
They found pain dropped by an average of 55 percent and patients suffered 38 percent fewer infections, required 67 percent fewer transfusions and were 70 percent less likely to die. They were also 51 percent less likely to develop malaria.
The Phase I/II, dose-escalation trial, dubbed REACH, was led by researchers from the University of Cincinnati and the Centre Hospitalier Monkole; it was conducted at sites in four countries — the Democratic Republic of Congo, Uganda, Kenya and Angola.
The findings were published in the in the New England Journal of Medicine and presented at last week’s annual meeting of the American Society of Hematology (ASH).
Successful Non-Hodgkin’s Lymphoma Clinical Trial
Novartis’ Kymriah has been approved to treat non-Hodgkin’s lymphoma — and the lead researcher behind the pivotal trial that led to its OK is showing his work.
Stephen J. Schuster, director of the Lymphoma Program at the University of Pennsylvania’s Abramson Cancer Center, presented findings from the so-called JULIET trial at last week’s annual meeting of the American Society of Hematology (ASH).
JULIET was a Phase II, single arm trial involving 27 sites in 10 countries that began in July 2015.
During the trial, researchers gave 115 patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) Kymriah (tisagenlecleucel). Overall, 54 percent of patients responded to the treatments, and 40 percent went into complete remission.
The current treatment involves high-dose chemo and an autologous stem cell transplant. But only half of patients are candidates for this approach — and the three-year, event-free survival rate for those who do qualify for chemo/stem cell treatment is just 20 percent.
AI Biotech Launches Research Collaboration Platform
An artificial intelligence biotech has created its own AI-based research collaboration platform and is now open for business.
Rockville, Md.-based Insilico Medicine’s MOSES system is designed to serve as a machine-learning based benchmarking platform for molecular degeneration to help standardize data on age-related diseases for clinical trials and other research.
MOSES, an acronym for “molecular sets,” offers open-sourced models and its own metrics to evaluate data that’s entered into it.
The company formally announced the new platform at the NIPS Expo in Montreal last week.
Keytruda Aces Another Trial
Merck’s blockbuster drug Keytruda, already forecast to reach $7 billion in sales this year alone, has passed another clinical test — this time for patients with late-stage head and neck cancers.
During a clinical trial (spanning 20 countries), researchers from the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust gave 247 patients with platinum-chemo resistant head and neck cancers Keytruda (pembrolizumab) and another 248 chemotherapy or cetuximab, the two standards of care.
On average, the patients who took Keytruda survived 8.4 months compared to 6.9 months for those in the standard therapy group. But researchers say the most promising finding was that the cancers disappeared in 36 of the Keytruda patients — and they were still cancer-free three years after their treatments began.
The scientists said they’ll seek regulatory approval to use Keytruda for advanced head and neck cancers but called for more research to help identify which patients could benefit most from it.
Late last month, Merck, which sponsored the trial, announced that it was raising the price of Keytruda by an average of 1.5 percent.
New Owner, Clinical Trial Media
Clinical Trial Media, a patient recruiting and retention firm, has a new boss.
Officials announced that Cara Brant, who began her career at Clinical Trial Media in 2001 as a project coordinator, is the new owner and CEO of the Jericho, NY-based company.
Brant, who had risen to become chief operating officer — Clinical Trial’s first female, c-suite executive — left the company in 2016. Terms of her acquisition of the company weren’t disclosed.
Brant said she’s “thrilled to be at the helm” and is looking “forward to bridging the gap between healthcare, advertising and technology.”