On May 9, 2016 Incyte Corporation (Nasdaq: INCY) reported 2016 first-quarter financial results, including strong revenue growth driven by increased Jakafi (ruxolitinib) sales in the U.S. as well as continued growth in ex-U.S. Jakavi (ruxolitinib) royalties from Novartis (Press release, Incyte, MAY 9, 2016, View Source [SID:1234512105]).

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Incyte’s broad portfolio of development candidates includes immuno-oncology as well as targeted anti-cancer therapies and is made up of both small and large molecules. The recent presentations at the 2016 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) showcased the depth of Incyte’s discovery and development expertise, including both monotherapy and combination therapy approaches.

As also announced today, Incyte has agreed to acquire the European operations of ARIAD Pharmaceuticals and the development and commercialization rights to Iclusig (ponatinib) in Europe. The acquisition of a fully-integrated and established pan-European team, including medical, sales and marketing personnel, will help Incyte optimize clinical development and maximize the potential of future European launches for its portfolio of products.

"Incyte has a unique profile within the biopharmaceutical industry. Our revenue growth and the underlying demand for Jakafi are strong, and we also have the potential for a second important source of revenue should baricitinib be approved in 2017," stated Hervé Hoppenot, Incyte’s Chief Executive Officer. "We have a fast-moving and rapidly expanding portfolio of exciting development projects, and we also look forward to the initiation of two new pivotal programs – epacadostat for the 1st line treatment of advanced melanoma and ruxolitinib for the treatment of graft versus host disease – during 2016."

2016 First-Quarter Financial Results
Revenues For the quarter ended March 31, 2016, net product revenues of Jakafi were $183 million as compared to $115 million for the same period in 2015, representing 59 percent growth. For the quarter ended March 31, 2016, product royalties from sales of Jakavi outside of the United States received from Novartis were $22 million as compared to $16 million for the same period in 2015. For the quarter ended March 31, 2016, contract revenues were $58 million as compared to $28 million for the same period in 2015. We earned $55 million in milestone payments from Lilly during the quarter ended March 31, 2016 and a $25 million milestone payment from Novartis during the quarter ended March 31, 2015. For the quarter ended March 31, 2016, total revenues were $263 million as compared to $159 million for the same period in 2015.

Year Over Year Revenue Growth
(in thousands, unaudited)

Three Months Ended
March 31, %
2016 2015 Change
Revenues:
Jakafi net product revenue $ 183,267 $ 115,330 59%
Product royalty revenues 21,903 15,673 40%
Contract revenues 58,214 28,214 -
Other revenues 80 58 -
Total revenues $ 263,464 $ 159,275

Research and development expenses Research and development expenses for the quarter ended March 31, 2016 were $157 million as compared to $118 million for the same period in 2015. Included in research and development expenses for the quarter ended March 31, 2016 is the previously announced $35 million upfront payment to acquire the rights from Lilly to develop ruxolitinib for the treatment of patients with GVHD and non-cash expenses related to equity awards to our employees of $13 million. In addition to the $35 million upfront payment to Lilly, the increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter ended March 31, 2016 were $65 million as compared to $45 million for the same period in 2015. Included in selling, general and administrative expenses for the quarter ended March 31, 2016 were non-cash expenses related to equity awards to our employees of $8 million. Increased selling, general and administrative expenses are driven primarily by additional costs related to the commercialization of Jakafi.
Unrealized loss on long term investment Unrealized loss on long term investment of $3 million for the quarter ended March 31, 2016 represents the fair market value adjustments of the Company’s investment in Agenus.

Net income / (loss) Net income for the quarter ended March 31, 2016 was $24 million, or $0.13 per basic and $0.12 per diluted share, as compared to net loss of $18 million, or $0.11 per basic and diluted share for the same period in 2015.

Cash, cash equivalents and marketable securities position As of March 31, 2016, cash, cash equivalents and marketable securities totaled $811 million, as compared to $708 million as of December 31, 2015.

2016 Financial Guidance
The Company has updated its full year 2016 financial guidance, as detailed below.

Incyte

ARIAD EU

Combined
Jakafi net product revenues
$815-$830 million
(previously $800-$815 million) - $815-$830 million
Iclusig net product revenues
- $25-$30 million $25-$30 million
Research and development expenses
$620-$640 million
(no change) $15-$20 million $635-$660 million
Selling, general and administrative expenses
$255-$275 million
(previously $255-$270 million) $30-$35 million $285-$310 million

Corporate Update
In May 2016, Dr. Vijay Iyengar joined the Incyte Executive Management team as Head of Global Product Strategy, a position from which he will also lead Incyte’s business development, licensing and strategic planning teams. Vijay was previously President, Genoptix Corporation, a Novartis Company, and has significant international biopharma experience in building and managing teams in the U.S. and in Europe.

Portfolio Update
Targeted Cancer Therapies
In April, preliminary data from an open-label Phase 1 dose escalation trial of INCB50465, Incyte’s second-generation, highly selective PI3K delta inhibitor, was presented at AACR (Free AACR Whitepaper) 2016. INCB50465 showed promising efficacy in B-cell malignancies and was generally well tolerated at all doses tested.

Indication Status Update
INCB50465 (PI3Kδ) B-cell malignancies Phase 1/2 as monotherapy and in combination with INCB39110 (JAK1); expansion cohorts initiating
INCB39110 (JAK1) Lung cancer Phase 1/2 in combination with osimertinib (EGFR) expected to initiate mid-year 2016
INCB52793 (JAK1) Advanced malignancies Phase 1/2 dose-escalation
Capmatinib (c-MET, licensed to Novartis) Non-small cell lung cancer, glioblastoma, liver cancer Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation
INCB54828 (FGFR) Advanced malignancies Phase 1/2 dose escalation; expansion cohorts in genetically-defined tumor types now underway
INCB54329 (BRD) Advanced malignancies Phase 1/2 dose-escalation
INCB53914 (PIM) Advanced malignancies Phase 1/2 dose-escalation
INCB59872 (LSD1) Acute myeloid leukemia, small cell lung cancer Phase 1/2 dose-escalation

Immune Cancer Therapies
The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016. The trial, randomized, double-blind and placebo controlled, is planned to enroll 600 patients and to have dual-primary endpoints of overall survival and progression-free survival. Updated data from the dose-escalation portion of ECHO-202, initial data from which was presented at SITC (Free SITC Whitepaper) 2015 and drove the decision to initiate the Phase 3 trial, are expected to be presented in the second half of 2016. In addition, initial data from the ongoing Phase 2 dose-expansion cohorts investigating the safety and efficacy of epacadostat in combination with anti-PD-1 and anti-PD-L1 agents are anticipated to become available in the second half of 2016.
Driven by preclinical data presented at the AACR (Free AACR Whitepaper) annual meeting in 2015, Incyte has launched two clinical platform studies to investigate a series of therapeutic doublet combinations on the tumor microenvironment. The PD-1 platform study will investigate the effects of adding either INCB39110 (JAK1) or INCB50465 (PI3Kδ) to pembrolizumab (PD-1). The JAK1 platform study will investigate all-oral doublets combining either INCB50465 (PI3Kδ) or epacadostat (IDO1) with INCB39110 (JAK1).

Indication Status Update
Epacadostat First line, advanced melanoma Phase 3 (ECHO-301) expected to begin in the first half of 2016 in combination with pembrolizumab (PD-1)
Multiple tumor types Phase 2 (ECHO-202) expansion cohorts now recruiting in combination with pembrolizumab (PD-1)
Multiple tumor types Phase 2 (ECHO-204) expansion cohorts now recruiting in combination with nivolumab (PD-1)
Multiple tumor types Phase 2 (ECHO-203) expansion cohorts now recruiting in combination with durvalumab (PD-L1)
Non-small cell lung cancer Phase 1/2 (ECHO-110) dose-escalation ongoing in combination with atezolizumab (PD-L1)
INCSHR1210 (PD-1,
licensed from Hengrui) Solid tumors Phase 1/2 dose-escalation
INCAGN1876 (GITR,
co-developed with Agenus) Solid tumors Phase 1/2 expected to initiate in the first half of 2016
INCAGN1949 (OX40,
co-developed with Agenus) Solid tumors Phase 1/2 expected to initiate in the second half of 2016

PD-1 platform study Solid tumors Phase 1/2, pembrolizumab (PD-1) in combination with INCB39110 (JAK1) or INCB50465 (PI3Kδ)
JAK1 platform study Solid tumors Phase 1/2, INCB39110 (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ)
Non Oncology

During the first quarter of 2016, Eli Lilly and Company began a series of global submissions seeking regulatory approval for baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Lilly. The submissions of the New Drug Application (NDA) and the Marketing Authorization Application (MAA) to the U.S. Food and Drug Administration and the European Medicines Agency, respectively, generated milestone payments from Lilly to Incyte. Incyte is eligible to earn further regulatory milestones and, if baricitinib is approved, will also become eligible for commercial milestones as well as royalties on global net sales. Baricitinib is also in Phase 2 trials for the treatment of atopic dermatitis and systemic lupus erythematosus.

Incyte recently announced an agreement with Lilly enabling Incyte to develop and commercialize ruxolitinib in the U.S. for the treatment of GVHD, and an agreement granting Novartis exclusive research, development and commercialization rights for ruxolitinib in GVHD ex-U.S. Incyte intends to initiate a U.S. registration program for ruxolitinib in GVHD in the second half of 2016. A proof-of-concept trial of INCB39110, a selective JAK1 inhibitor, in patients with GVHD is already underway.

Indication Status Update
Baricitinib (JAK1/JAK2, licensed to Lilly) Rheumatoid arthritis NDA & MAA submitted
Psoriasis Phase 2 studies completed
Atopic dermatitis, systemic lupus erythematosus Phase 2
Ruxolitinib (JAK1/JAK2) Graft versus host disease Phase 3 to begin in the second half of 2016
INCB39110 (JAK1) Graft versus host disease Phase 1/2
Topical ruxolitinib (JAK1/JAK2) Alopecia areata Phase 2

On May 9, 2016 BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS, reported financial results for the first quarter ended March 31, 2016 and provided a business update (Press release, BIND Therapeutics, MAY 9, 2016, View Source [SID:1234512102]).

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"Despite our financial challenges, we remain committed to advancing our new R&D strategy of applying our ACCURINS technology to develop innovative medicines and we have made significant progress during the first quarter," said Andrew Hirsch, president and chief executive officer at BIND Therapeutics. "In order to address these challenges, we took difficult but necessary steps to substantially reduce our operating expenses, focus the business, and explore strategic and financial alternatives. Despite these efforts, we filed for Chapter 11 protection to provide the necessary time to pursue these alternatives to the benefit of all stakeholders. While the Chapter 11 process can be distracting, we don’t anticipate any major disruptions in our business operations during this process."

Scientific Highlights:

Discovery Pipeline:

During the quarter, BIND initiated in vivo studies aimed at characterizing the ability of ACCURINS to affect pharmacokinetic, biodistribution, cellular uptake and gene silencing activity of oligonucleotide therapeutics. In addition, the Company has initiated formulation efforts to develop ACCURINS containing small molecule inhibitors of TGF-beta signaling.

In addition, BIND has recently entered into several strategic research collaborations to quickly and efficiently evaluate novel targeting ligands as part of our strategy to develop ACCURINS that incorporate combinations of targeting ligands and therapeutic payloads, including a variety of biologically active ligands. These collaborations include:

Synergy Pharmaceuticals, for access to ligands that can target gastrointestinal malignancies;
PeptiDream, to incorporate biologically active targeting ligands; and
Affilogic, to secure access to biologically active immuno-oncology related targeting ligands.
"We have an opportunity to formulate ACCURINS with oligonucleotides or potent kinase inhibitors while functionalizing the surface of our particles with a variety of biologically active targeting ligands," said Jonathan Yingling, Ph.D., chief scientific officer for BIND. "This has the potential to create ACCURINS that act as combination therapy within a single particle."

BIND-014

The Company released data from multiple phase 2 trials of BIND-014, ACCRUINS formulated with the approved cytotoxic cancer agent docetaxel. The iNSITE 1 trial is squamous histology non-small cell lung cancer exceeded the protocol defined endpoint of greater than 65 percent 6-week disease control rate. The data suggest BIND-014 continues to provide meaningful improvements in safety and tolerability, and at least similar efficacy in comparison to historical studies with docetaxel. As a result, BIND believes the new data further validate the ACCURINS platform and justify further development where improved safety and tolerability may be valuable. The company is seeking a collaborator to fund further development of BIND-014.

AZD2811

In collaboration with AstraZeneca, BIND developed AZD2811, which became the first nanoparticle containing a kinase inhibitor to begin clinical testing. The kinase inhibitor targets the Aurora B protein, which can contribute to the growth of tumor cells, and is currently in a phase 1 clinical trial. In the first quarter, preclinical data for AZD2811 was published in The Journal of Science Translational Medicine. The data highlighted the ability of ACCURINS to control release kinetics and provide increased concentration of nanoparticles to tumor sites.

Anticipated upcoming milestones and activities include:

Report initial in vivo POC data for discovery programs, with preclinical pharmacokinetic and efficacy data expected in second half of 2017
In vivo POC data for targeting guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies
In vivo POC data for anti-tumor immunity targeted ACCURINS
Additional in vivo POC data for delivering single and double stranded RNA fragments and achieving target knock-down in tumor models
Demonstrate in vitro and in vivo POC for achieving endosomal escape with double stranded RNA
Expand pre-clinical pharmacology for KSP ACCURINS (BIND-267), including combinations with immune-oncology biologics
Additional rodent and potentially non-rodent safety evaluation of BIND-267
Identify first ACCURINS-based immuno-oncology product concept
Identify development and commercialization partner for BIND-014
Continue to support AstraZeneca’s clinical trial activities for AZD2811
Advance the Pfizer compound toward the clinic by initiating IND-enabling studies
Key Business Developments

Implemented a restructuring plan designed to streamline operations and reduce the Company’s operating expenses
Announced shift in R&D strategy to leverage the platform to develop innovative medicines and initiate a review of financial and strategic alternatives
Initiated voluntary Chapter 11 bankruptcy protection proceedings to provide for an orderly process and additional time to pursue the strategic and financial alternatives that were previously underway
First Quarter 2016 Financial Results

Cash, cash equivalents and short-term investments were approximately $21.5 million as of March 31, 2016. Given the fact that the Company is operating under Chapter 11 bankruptcy protection, the Company is suspending financial runway guidance until further notice.

Development revenue for the first quarter of 2016 was $1.9 million, compared to $4.4 million for the first quarter of 2015. The decline was primarily due to lower reimbursed collaboration expenses related to clinical trial manufacturing activities for AZD2811, which were performed in the first quarter of 2015 to support initial clinical testing as part of the Company’s collaboration with AstraZeneca.

Research and development expenses totaled $11.2 million for the first quarter of 2016, compared to $8.2 million for the first quarter of 2015. The increase was primarily related to BIND-014 expenses of approximately $7.2 million. In addition, there was an increase in manufacturing costs related to an engineering manufacturing run of ACCURINS completed at the 15kg scale at our contract manufacturer in Germany.

General and administrative expenses totaled $3.6 million for the first quarter of 2016, compared to $4.8 million for the first quarter of 2015. The decline was partially due to one-time severance and stock-based compensation charges for our former chief executive officer in the first quarter of 2015 as well as a decrease in general consulting expenses of $0.4 million.

Net loss for the first quarter of 2016 was $12.7 million, compared to a net loss of $8.3 million for the first quarter of 2015. The increase in net loss was mostly the result of the aforementioned increase in clinical trial activities and the decrease in collaboration revenue during the first quarter of 2016.

On May 9, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported the U.S. Food and Drug Administration (FDA) updated the IMBRUVICA (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, AbbVie, MAY 9, 2016, View Source [SID:1234512091]).[1] The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATETM-2 (PCYC-1115) trial.

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The IMBRUVICA label has also been updated with safety and efficacy data from the Phase 3 HELIOS (CLL3001) trial assessing the use of IMBRUVICA in combination with bendamustine and rituximab (BR) versus placebo plus BR in relapsed/refractory patients with CLL/SLL. As well, following a review of the November 2015 supplemental New Drug Application (sNDA), the FDA has approved a new IMBRUVICA indication to include the treatment of patients with SLL with or without the deletion of chromosome 17p (del 17p).1 IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.

The RESONATE-2 trial served as the basis for the March 2016 FDA approval of IMBRUVICA for the first-line treatment of CLL patients. Notably, the OS data now included in the IMBRUVICA PI provide a longer-term update to results published in The New England Journal of Medicine, with a median follow-up of 28.1 months. The label updates based on HELIOS represent the first-ever data demonstrating an improvement in progression-free survival (PFS) and overall response rate (ORR) with IMBRUVICA when combined with BR versus placebo plus BR in patients with relapsed/refractory CLL/SLL.

"This update helps to affirm the established efficacy, safety and tolerability of this therapy for treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents," said Jan Burger, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX and the RESONATE-2 lead study investigator.* "It reflects the growing body of clinical evidence supporting this therapy as a potential treatment option for people living with CLL/SLL."

"We are pleased the FDA has added the survival data observed with IMBRUVICA as a first-line therapy for CLL to its Prescribing Information and that the indication has been expanded to include patients with SLL. Moreover, the positive results seen in the HELIOS study provide additional evidence supporting the compelling safety and efficacy seen with IMBRUVICA in CLL and SLL patients," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics. "We believe the IMBRUVICA label is very strong for the treatment of certain hematologic malignancies and is now reinforced not only by data evaluating its use as a single agent, but also in combination with other commonly used chemotherapy regimens."

On May 09, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, and Gritstone Oncology, a private cancer immunotherapy company developing next-generation, personalized cancer therapeutics, reported a clinical collaboration for development of novel, personalized immunotherapies combining both companies’ leading technologies (Press release, Immune Design, MAY 9, 2016, View Source [SID:1234512088]).

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The collaboration will involve the application of Immune Design’s ZVexTM discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies. Immune Design and Gritstone will be jointly responsible for development activities, with an initial likely focus in non-small cell lung cancer. The first clinical trial is expected to commence in 2017.

"The emerging tumor neoantigen field holds great potential for the successful application of cancer immunotherapies, and we are pleased to be working with Gritstone, a company that we believe is a pioneer in the field," said Carlos Paya, M.D., Ph.D., president and chief executive officer of Immune Design. "Having validated our two platforms in clinical trials targeting conserved tumor antigens, we believe their application to patient specific tumor antigens is a natural next step."

For the first trial of their technologies, the companies are evaluating combining the Gritstone and Immune Design neoantigen vaccine with a checkpoint inhibitor, to optimize the vaccine-induced immune response at several levels and maximize the likelihood of clinical efficacy.

"We are excited to work with Immune Design and their novel immunotherapy approach," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "There is good evidence that viral vectors are one of the most effective means of generating high titer CD8+ T cells that recognize encoded antigens, and so this is a logical move for our company, as our neoantigen prediction platform starts to deliver immune targets for individual patients with lung cancer."