I thought I’d give a brief summary of the conference call from a physician/researcher perspective. hydemarsh summarized the financials in an earlier post so I’ll skip that part which was pretty good to my eye but not as relevant to the company’s future and my investment as their development pipeline.
NKTR-181–> their Mu opioid receptor agonist
- All phase 3 trials were successful, over 2100 patients total studied
- Efficacy study
- Longer term safety study
- Abuse potential study in recreational drug users
- Two “highly productive” pre-NDA meetings with the FDA have occurred
- They believe they have the data to warrant approval and less restrictive scheduling for NKTR-181
based on FDA feedback
- They want it to be less than schedule 2, likely will be schedule 3 and FDA indicated the data was
adequate. NDA to be submitted Q2 2018.
- Participated in White House opioid summit
- They feel 181 is a major building block in fight against addiction (of course they do!)
- Evaluating licensing options
- 2 abstracts will be presented at upcoming College of Problems of Drug Dependence meeting
- One of these shows lack of dopamine surge in brain “reward” center unlike that observed with standard
NKTR-214 → CD122-biased agonist designed to stimulate the patient’s own immune system to fight cancer
Compelling results in clinical efficacy, safety and translational science has led to the collaboration
with Bristol Myers Squib (BMS)
Collaboration will allow rapid and broad development as backbone of cancer care across multiple
Collaboration does not prevent other collaborations with other companies/cancer agents
Nektar will book all global revenues and keep 65% of global profits
Upfront payment of $1 billion and premium equity investment of $850 million at $102.60/sh
Nektar maintains pricing nad distribution control
Collaboration commences 2Q 2018
Collaboration puts them in a very strong financial position to develop 214
Will initiate 20 studies with BMS, 15,000 patients in 9 tumor types
All will start within 14 months of collaboration commencement
First 2 Phase 3 studies will start 2Q 2018 in melanoma and renal cell carcinoma
They then gave updates on the response rates to 214 in the PIVOT study for which data had been
presented twice already, once at a meeting, next at the JP Morgan presentation this year.
They called this the 2nd phase of PIVOT (214 and Opdivo combo trial)
Response rate improved from 46% at initial presentation last year to 57% at JPM presentation but has
now increased to 71%
In all cancers studied, response rate is now 60% among all comers that are PD-L1 negative
NO DISCONTINUATION DUE TO ADVERSE EVENTS RELATED TO TREATMENT!
2nd Phase involves 330 more patients with 5 different tumor types by end of Q3 2018
Adding 3 new cohorts in 2Q 2018–> colorectal, gastric and small cell lung cancer
They plan to initiate additional collaborative agreements with other anti-cancer agents this year
Other potential uses for 214 are promising in pre-clinical studies including vaccines
They also seemed very excited about the potential combination of 214 and 262 (A TOR 78 agonist) with and without Opdivo and listening to them got me excited as well. 214/262 combo trial starts this month with plan to enroll 400 patients with 8 tumor types. Initial data expected 4Q 2018. They don’t talk much about NKTR-262. It’s difficult to find a lot of information on it.
From their website: NKTR-262 is a small molecule agonist that targets toll-like receptors (TLRs) found on innate immune cells in the body. NKTR-262 is designed to overcome the body’s dysfunction of antigen-presenting cells (APC), such as dendritic cells, which are critical to induce the body’s adaptive immunity and create antigen-specific cytotoxic T cells. In preclinical studies presented at SITC 2017, a single intra-tumoral dose of NKTR-262, administered in combination with NKTR-214, resulted in complete abscopal effects in multiple tumor models.
The REVEAL Phase 1/2 study will determine the recommended Phase 2 dose of NKTR-262 administered in combination with NKTR-214 (doublet) and in combination with NKTR-214 and nivolumab (triplet). The study will evaluate the safety, tolerability and anti-tumor effect, in patients with locally advanced or metastatic cancers including: melanoma, Merkel cell carcinoma, triple-negative breast cancer, ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, or sarcoma.
Anyway, that’s all I could find about it.
NKTR 358 - Autoimmune agent
- First in class T-cell regulator targeting autoimmune dz
- Opened IND and clinical development
- Pre-clinical success with it led to Eli-Lily partnership
- Dose escalation study in lupus patients starts in 2Q 2018, Phase 1b trial–> data expected 2019
I’m not going to review Movantic/Adenovate although they seem to be doing well with revenue from those licensing deals increasing 72% yoy.
I loved this conference call. It confirmed a few things for me. One, the deal with BMS was a great one and will allow them to develop 214 much faster than they ever could have on their own which means we will have a ton of data by the end of 2018 as opposed to seeing it in 2019 or even 2020. The deal was NOT exclusive to BMS. They can still collaborate 214 with other partners/drugs. The increasing response rates are a big deal to me as well. That’s not often seen in cancer treatment. Responses are generally seen early and fade with time. Good side effect profile with improving response rates is a big deal in oncology. Also, 181 could be a big revenue driver for them in the future once they get FDA approval. I do believe it to be a when and not an if. The only question is wether it’s schedule 2 or 3. I think the stock will take a pretty big hit if it’s not given schedule 3 status. Finally, there is a “new" kid on the block, NKTR-262. We will know a lot more about it and it’s potential by year end and I’m excited to see how it does with 214 and Opdivo.
I know Saul sold out of NKTR and I’m not sure I’d buy at the current price after today’s runup of around 20% but I’m not selling either. I almost sold today but I wanted to read/listen to the call so I didn’t pull the trigger. I’m glad I waited. The future seems very bright for this company and immuno-oncology will be a large part of eliminating the scourge of cancer. I believe Nektar is at the leading edge of that field. My 2% position has grown to 4% organically in 4 months as it is now worth over double my cost basis. I’m letting it ride for now unless something big changes.