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2017 JP Morgan Conference Review

January 18, 2017

The 35th annual JP Morgan Healthcare Conference was held in San Francisco, CA from January 9-12, 2017. A full list of events and catalysts that were announced or updated during the conference is included in this report. Below are select key points from the conference’s company presentations.

The meeting kicked off with the blockbuster announcement that Takeda will acquire Ariad (ARIA) and its oncology portfolio for approximately $5.2b. In March 2016, Takeda announced its strategic roadmap where it placed the oncology, gastroenterology, and central nervous system (CNS) franchises as its top R&D priority moving forward. The acquisition of Ariad reinforces Takeda’s commitment to its oncology portfolio, as the acquisition brings in multiple pipeline drugs in development for solid tumors. Specifically, the two major drugs adopted from the acquisition are brigatinib for NSCLC and the already approved Iclusig for ALL and CML. The acquisition is also aligned with Takeda’s plan announced in 2016 of rearranging R&D, in an endeavor to concentrate its efforts in the US and Japan, greatly reducing its presence in the UK. This acquisition is a step forward in the company’s restructuring goal to optimize R&D operations.
Merck (MRK) released a surprising disclosure that it had filed an sBLA for Keytruda in combination with chemotherapy for first-line NSCLC. The filing was surprising in its reliance on the Phase I/II KEYNOTE-021 study rather than the larger Phase III ‘189 study already ongoing. The move is likely designed to move quickly in the face of increased competition from other PD-1 therapies, and while it would only be a conditional approval, the move would likely help maintain the momentum for Keytruda following the high-profile approval for front-line monotherapy treatment obtained in late 2016. If approved, this combination therapy would allow Keytruda incorporation into an even larger patient population rather than just the high-PD-1 expressers on the current label. The PDUFA date is set for May 10, 2017.
Surprisingly, the new CEO of Biogen (BIIB) spent little time discussing any potential differentiators for aducanumab in Alzheimer’s disease following the high-profile failure of LLY’s solanezumab. However, he gave guidance for some data to be presented in the next 12-18 months. In the meantime, the CEO also said to expect the company to take a “calculated risk” to add to its pipeline but failed to give any additional details or list of any targeted companies.
Intra-Cellular Therapies (ITCI) provided an update on its expected meeting with FDA regarding Lumateperone (ITI-007) for the treatment of schizophrenia, but was surprisingly quiet on the Phase III development of ITI-007 for the treatment of agitation in patients with dementia including Alzheimer’s disease. The Company has requested a meeting with FDA to discuss the submission of a New Drug Application (NDA) for ITI-007 for the treatment of schizophrenia, despite the disappointing top-line results of the second Phase III trial (Study ‘302) of ITI-007 in schizophrenia. Intra-Cellular expects to provide an update on the status of discussions with FDA in Q1 2017.
Incyte (INCY) provided a roadmap for its main revenue driver, Jakafi. Specifically, officials seemed excited about advancing its development for GvHD and essential thrombocytopenia. Baricitinib will be the next revenue driver, according the the CEO, with a focus on psoriatic arthritis. IDO inhibitors have also been a new target class of intense interest, and the company’s epacadostat appears to be advancing strongly. Positive new data from the Phase I/II ECHO-202 combination study with Keytruda (MRK) in solid tumors were released with the meeting, and development will advance to Phase III in bladder, head & neck, NSCLC, and renal cell cancer in addition to the already Phase III melanoma indication. New data are anticipated at ASCO 2017. Data collection is ongoing for DLBCL and MSI-high colorectal cancer and future studies in those indications has not been decided. In ovarian and triple-negative breast cancer, there are no current Phase III plans as data does not justify moving forward at this point in time. Finally, the company initiated a collaboration with Merus to develop bispecific antibodies.
Moderna, a privately held company dedicated to developing messenger RNA (mRNA) vaccines and therapeutics, disclosed several development candidates advancing in its growing pipeline. These early stage products span across three therapeutic areas: infectious diseases, immuno-oncology and cardiovascular disease. Having established multiple key partnerships with impactful collaborators such as Merck, AstraZeneca, and Alexion, Moderna is poised to bring forth this promising novel class of medicines into reality.
Editas (EDIT) announced that it achieved the first in vivo proof-of-editing in the retina of non-human primates in the LCA10 gene editing program for Leber’s Congenital Amaurosis. The CEO noted this was a fundamental advance, given all the components that must come together and be optimized. The Company plans to file an IND by the end of 2017. The clinical program would then start with a Phase I/II dose-ranging study in adults, with the optimal dose then tested in younger children, who could probably benefit the most from treatment. A controlled Phase II/III study would likely follow.
Sarepta (SRPT) recorded $5.4 million in sales of Exondys 51 in the fourth quarter of 2016 and has received over 250 genetically verified start forms, providing some reassurance to the market about the muscular dystrophy drug's launch, given questions whether the FDA should have approved it in the first place. However, it is still quite early, and while only 8% of covered lives are in plans outright denying coverage, only 13% are in plans with a favorable policy. 79% involve plans still pending a policy decision, reviewing case-by-case, or approving with restrictions. Sarepta also presented initial data from their preclinical PPMO program (which involves addition of a peptide to improve delivery and extend dosing), showing enhanced efficacy and good tolerability. IND-enabling GLP toxicology studies expected to begin in early 2017 may lead to an IND before year-end 2017. The company also announced two gene therapy collaborations with Nationwide Children’s Hospital, to expand their portfolio of treatment options.
View more key points from the entire conference in our full report.

For the full report, download the PDF version at the top of this page.

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Disease Group Covered:

Allergy
Autoimmune/immunology
Cardiovascular
Dermatology
Endocrine
ENT/Dental
Gastroenterology (Non Inflammatory Bowel Disease)
Hematology
Infectious Disease
Metabolic
Neurology
Not Specified
Obstetrics/Gynecology
Oncology
Ophthalmology
Orthopedics
Psychiatry
Renal
Respiratory
Rheumatology (Non Autoimmune)
Urology

Additional Resources: