Bionest

Setting (Financial) Records in I/O

 On February 14, Bristol-Myers Squibb (BMS) and Nektar announced the largest-ever deal in history involving a single development-stage drug in a partnership that greatly expands combination testing of BMS’s checkpoint inhibitor Opdivo (nivolumab) and Nektar’s T-cell stimulating molecule NKTR-214.   Many recent immuno-oncology collaborations have involved cost sharing but no other financial transactions, and the...

Bionest

Welcome to 2018! What we are watching for JPM18 and the coming year…

Now that the holidays have wound down, we look forward to catching up with many of you in person as the Bionest team and many others from across the healthcare business world descend on San Francisco next week for the three-ring circus of conferences, one-on-one meetings and social gatherings that is JPM18. Here are some...

Bionest

Giving Thanks in IO

The immuno-oncology (IO) field has a lot to be thankful for as the year comes to a close.   Not only are PD-1/PDL-1 inhibitors being rapidly approved, their use is being extended into new indications and tumor types well beyond what people expected. From melanoma and lung cancer to bladder, gastric and liver cancer, drugs...

Bionest

Kite Gains First Adult CAR-T Approval

Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval, which came more than a month ahead of the expected FDA decision date, is for...

Bionest

ESMO 2017 — Recent Developments in the Oncology Arena — Part One

We recently returned from the European Society for Medical Oncology (ESMO) 2017 meeting, which is the major meeting for oncology professionals in Europe, attracting over 24,000 participants from 131 countries.  This fall meeting saw a lot of news, notably in the areas of lung cancer, breast cancer, and melanoma as well as immuno-oncology generally, including...

Bionest

New Big Data Initiatives in Oncology

As cancer therapy moves towards the concept of “real-time” oncology — the ability to constantly monitor changes in a patient’s disease and adjust treatment accordingly — we see big data and high powered analytical approaches increasingly playing a key role. The aim of such efforts will be to find novel biomarkers and a new understanding...

Bionest

Advances and Set Backs for CAR-T Therapy

Late August and early September was a period of big news — both positive and negative — on the CAR-T front. On the positive side, Novartis’ received the first FDA approval of a CAR-T therapy for Kymriah (tisagenlecleucel), for the treatment of children and young adults with B-cell precursor acute lymphoblastic leukemia that is refractory...

Bionest

Recent Developments in IO – Our Take on a Couple of Key Events

On July 27, AstraZeneca (AZ) disappointed their investors and many immuno-oncology watchers with the results of their MYSTIC trial combining two immunotherapies targeting PD-L1 (durvalumab/Imfinzi) and CTLA-4 (tremelimumab) in newly diagnosed Stage-IV lung cancer patients.  The AZ combination therapy failed to show a benefit compared to chemotherapy in a primary endpoint of “Progression-free Survival (PFS).”...

Bionest

CAR-T Nears the Marketplace, with Unanimous Approval Recommendation – but Challenges Remain

On July 12, Novartis’ CAR-T therapy, CTL019 (tisagenlecleucel), received a unanimous recommendation for approval from the reviewing U.S. Food and Drug Administration’s advisory panel for use in the treatment of children and young adults with advanced acute lymphoblastic leukemia (ALL). The FDA is now expected to make its final decision by October 3.   CTL019...

Bionest

FDA: Thinking “Outside the Box”

On May 17, the U.S. Food and Drug Administration granted an expanded approval to Vertex’s Kalydeco (ivacaflor), tripling the number of mutations in the cystic fibrosis (CF)-associated gene CFTR that the drug can treat, from 10 to 33. The agency’s action was unusual in that, for the first time ever, they based their decision on...