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CTI BioPharma Reports Second Quarter 2016 Financial Results

On August 4, 2016 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the second quarter ended June 30, 2016 (Press release, CTI BioPharma, AUG 4, 2016, View Source [SID:1234514251]).

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"The interest from oncologists generated by the Phase 3 PERSIST-1 long-term safety and efficacy results of pacritinib showing durable reduction in spleen volume and symptom burden including in patients that crossed over to pacritinib from best available therapy, presented at ASCO (Free ASCO Whitepaper), supports our belief that pacritinib may play an important role in the treatment of myelofibrosis," said James A. Bianco, M.D., President and Chief Executive Officer of CTI BioPharma. "We are now in the process of preparing for the release of top-line results from the second Phase 3 trial of pacritinib, PERSIST-2, which we expect to report in the third quarter of 2016. The results from the full analysis of the PERSIST-2 trial are a key requirement as we continue to work with the FDA to seek to address their recommendations for getting pacritinib off clinical hold."

Second Quarter Event

In June 2016, researchers presented long-term safety and efficacy results from the pivotal Phase 3 trial, PERSIST-1, evaluating pacritinib versus best available therapy, excluding treatment with JAK2 inhibitors (BAT), in patients with myelofibrosis. As previously reported, the PERSIST-1 trial met its primary endpoint in the intent-to-treat population with statistically significant reduction in spleen volume when compared to patients receiving BAT. The results presented were an update on the efficacy and safety for all patients regardless of their initial platelet count, including patients with very low platelet counts at study entry, a condition known as severe or life-threatening thrombocytopenia. A planned analysis of the study up to 72 weeks demonstrated treatment with pacritinib led to durable reductions in spleen volume and symptom burden, two key measures of disease control, in patients with myelofibrosis, including patients with low platelets at baseline. These and other findings were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

Second Quarter Financial Results

Total revenues for the second quarter and six months ended June 30, 2016, were $7.4 million and $43.8 million, respectively, compared to $1.1 million and $3.8 million for the respective periods in 2015. The increase in total revenue for the six month period in 2016 is primarily due to recognition of $32 million in milestone payments and reimbursement of development costs from Baxalta, which is now part of Shire plc, related to pacritinib. CTI BioPharma had previously received a cash advance for these milestone payments from Baxalta in the second quarter of 2015 that was accounted for as long-term debt until the achievement of the associated milestones in the first quarter of 2016. Net product sales of PIXUVRI for the second quarter and the six months ended June 30, 2016, were $1.1 million and $2.3 million, respectively, compared to $0.8 million and $1.7 million for the respective periods in 2015.

GAAP operating loss for the second quarter and six months ended June 30, 2016, was $19.1 million and $14.9 million, respectively, compared to GAAP operating loss of $31.0 million and $58.5 million for the respective periods in 2015. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the second quarter and six months ended June 30, 2016, was $16.7 million and $8.8 million, respectively, compared to the non-GAAP operating loss of $28.3 million and $51.4 million for the respective periods in 2015. The decrease in CTI BioPharma’s operating loss for the six month period ended June 30, 2016 is primarily due to recognition in the first quarter of 2016 of $32 million in milestone payments as license and contract revenue related to pacritinib as mentioned above. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2016, was $2.3 million and $6.2 million, respectively, compared to $2.8 million and $7.1 million for the respective periods in 2015. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the second quarter of 2016 was $19.8 million, or ($0.07) per share, compared to a net loss of $32.6 million, or ($0.19) per share, for the same period in 2015. Net loss for the six months ended June 30, 2016 was $16.5 million, or ($0.06) per share, compared to a net loss of $61.2 million, or ($0.35) per share, for the same period in 2015. The decrease in net loss for the second quarter and the six months ended June 30, 2016 compared to the respective periods in 2015 is primarily due to increased net product sales and license and contract revenue and decreased operating expenses.

As of June 30, 2016, cash and cash equivalents totaled $76.7 million, compared to $128.2 million as of December 31, 2015.

Juno Therapeutics Announces Multiple Myeloma Partnership with Memorial Sloan Kettering Cancer Center and Eureka Therapeutics for Developing CAR T Cell Immunotherapy Against Multiple Novel Targets

On August 4, 2016 Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported that it has entered into an exclusive license agreement with Memorial Sloan Kettering Cancer Center (MSK) and Eureka Therapeutics, Inc. for a novel, fully-human binding domain targeting B-cell maturation antigen (BCMA), along with binding domains against two additional undisclosed multiple myeloma targets to be used for the potential development and commercialization of chimeric antigen receptor (CAR) cell therapies for patients with multiple myeloma (Press release, Juno, AUG 4, 2016, View Source [SID:1234514265]). The binding domains were developed under a collaboration agreement between Eureka Therapeutics and MSK. The parties expect the BCMA CAR to enter human testing as early as 1H2017.

"We are optimistic that CAR T therapy can be an important component in treating patients with multiple myeloma, and we are pleased to bring additional fully-human binding domains against BCMA and other targets into our program," said Hy Levitsky, M.D., Juno’s Chief Scientific Officer. "We believe that a multi-pronged approach may be necessary to treat this disease, and we will pursue more than one target against myeloma. The MSK and Eureka constructs are promising additions to our portfolio that will accelerate our efforts and provide additional opportunities to combat this disease."

"We are pleased to work with Juno Therapeutics on developing CAR T therapies against multiple myeloma," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "Multiple myeloma is a devastating disease. For the past three years, we have been working with MSK to develop CAR T therapies against multiple myeloma, and we are delighted that Juno is able to use their broad expertise to bring these therapies to patients faster."

MSK and Eureka Therapeutics are eligible to receive an undisclosed upfront payment, additional payments upon the achievement of undisclosed clinical, regulatory, and commercial milestones, and royalties on net sales.

Momenta Discontinues Further Accrual of its Phase 2 Trial of Necuparanib in Patients with Pancreatic Cancer Following Planned Interim Futility Analysis

On August 4, 2016 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, reported that the Company has discontinued further accrual in its Phase 2 trial evaluating necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer (Press release, Momenta Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514227]).

The decision to discontinue enrollment into the study was based on the recommendation from the independent Data Safety Monitoring Board (DSMB) following a planned interim futility analysis conducted once 57 deaths (50% of the target number of 114 events required for trial completion) had occurred. Data were assessed from 120 randomized patients as of July 20, 2016. While no new safety signals were observed and the toxicity profile was considered manageable, the DSMB determined that necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment. Additionally, no new toxicities were observed that necessitate immediate discontinuation of study drug in patients currently active on protocol. The DSMB also recommended that the company consider unblinding the data to provide more information to determine how best to address ongoing patients.

"We are extremely disappointed with the outcome of the futility analysis – in particular, for those patients with pancreatic cancer where there is still so much unmet need for safe and effective therapy," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "We agree with the DSMB recommendations and plan to confirm the futility analysis and determine next steps for the necuparanib program."

"We are saddened that necuparanib did not produce the outcome we had hoped for in this patient population," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We would like to thank the investigators and their brave patients for participating in this trial as well as our staff and external advisors for their support throughout this program."

The Phase 1/2 necuparanib trial is a two-part study in patients with advanced metastatic pancreatic cancer. Part A was a Phase 1, open-label, multiple ascending dose study of necuparanib given first as a single dose and then daily in combination with Abraxane and gemcitabine; final data from Part A was reported at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. Part B is a Phase 2, randomized, placebo-controlled, double-blind study investigating the antitumor activity of necuparanib combined with Abraxane and gemcitabine compared with placebo combined with Abraxane and gemcitabine.

About Necuparanib
Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins.

Calithera Announces Enrollment of First Patient in CB-839 in Combination with Checkpoint Modulator

On August 4, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the first patient has been enrolled in a Phase 1/2 clinical trial assessing the safety and efficacy of CB-839, a first-in-class glutaminase inhibitor, in combination with nivolumab for the treatment of renal cell carcinoma, malignant melanoma and non-small cell lung cancer (Press release, Calithera Biosciences, AUG 4, 2016, View Source [SID:1234514226]).

"In preclinical models, glutaminase inhibition with CB-839 substantially increased the number of tumor regressions in combination with PD-1 and PD-L1 antibodies by overcoming a metabolic checkpoint blocking T-cell activation," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We have demonstrated that CB-839 can safely be added to standard of care therapeutics to treat solid tumors with the potential to improve clinical outcomes, and we look forward to the results of this trial testing an immuno-oncology therapy in combination with our first-in-class glutaminase inhibitor."

The Phase 1/2 study will assess the safety, pharmacokinetics and pharmacodynamics of CB-839 and nivolumab. The study will enroll patients with clear cell renal cell carcinoma who are either naïve to checkpoint inhibitors, or were recently treated with nivolumab without tumor response, as well as melanoma and non-small cell lung cancer patients who have received anti-PD-1 monotherapy as their most recent line of therapy without tumor response.

Surprise! Allergan sheds generics unit for branded focus in $40.1B Teva deal

Under the terms with TEVA, Allergan retains the branded pharma business and medical aesthetic business, as well as its biosimilars development programs, including its collaboration with Amgen Inc, inherited in the 2012 merger of Actavis with Watson Pharmaceuticals) (Article, BioWorld, AUG 3, 2016, View Source [SID1234516258]).
President and CEO Brent Saunders said biosimilars remain a strategic fit for the company, adding that "we made substantial investments over the years that will pay out" in the future, both in terms of the Amgen collaboration and Allergan’s internal biosimilars programs