On November 9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and nine-months ended September 30, 2016 (Press release, Eagle Pharmaceuticals, NOV 9, 2016, View Source [SID1234516517]). Highlights of and subsequent to the third quarter of 2016 include:

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Business Highlights:

Bendeka total market share rose to 88%, as of November 6, 2016;
The Centers for Medicare & Medicaid Services (CMS) established a unique J-Code (J9034) for Bendeka effective January 1, 2017;
Positive initial results of animal study exploring use of Ryanodex in MDMA (Ecstasy) induced hyperthermia conducted at the National Institutes of Health (NIH);
Extended our licensing agreement with Teva Pharmaceutical Industries Ltd. (Teva) to include certain territories outside the US and Canada; and
Repurchased $18.0 million of Eagle common stock during the third quarter for a total of $32.0 million since commencing the Share Repurchase Program on August 9, 2016.
Financial Highlights:

Total revenue was $37.8 million during the third quarter of 2016 compared to $5.7 million for the three months ended September 30, 2015;
Product sales increased to $7.8 million during the third quarter of 2016 compared to $3.3 million for the prior year period;
Royalty income increased to $26.2 million during the third quarter of 2016 compared to $2.4 million for the prior year period;
License and other income was $3.8 million during the third quarter of 2016;
Sales of Ryanodex grew 92% to $2.5 million during the third quarter of 2016 compared to $1.3 million for the prior year period;
Net income was $12.0 million, or $0.77 per basic and $0.73 per diluted share, compared to a net loss of $10.2 million, or $(0.65) per basic and diluted share, for the three months ended September 30, 2016 and 2015, respectively; and,
Cash and cash equivalents were $59.3 million and accounts receivable were $47.1 million as of September 30, 2016.
"We had another strong quarter delivering results for our shareholders, reflecting our ability to execute Eagle’s strategy to develop and commercialize improved formulations that enhance patients’ lives. Bendeka market share continues to ramp up and is approaching our joint goal with Teva of 90%. We believe the CMS final ruling to establish a unique J-Code for Bendeka will not only aid further adoption, but also provide greater access for patients and facilitate reimbursement. We remain confident in our ability to drive continued growth in our bendamustine franchise well beyond 2019," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We are also particularly excited about the multiple opportunities within our pipeline to drive substantial value beyond 2020. We are very encouraged by early results of clinical testing to explore the potential of Ryanodex for the treatment of both exertional heat stroke and MDMA (Ecstasy) induced hyperthermia. If approved, both indications would address the needs of very significant new patient populations for whom no pharmaceutical treatment options are currently available. Our development work on additional product candidates continues, providing us with a robust pipeline from which to create long term value," added Tarriff.

"We remain focused on optimizing the deployment of our capital on behalf of shareholders and continue to evaluate opportunities to do so. As part of that effort, since August 9, we purchased a total of $32 million through our stock buyback program and are pleased with our solid financial position," concluded Tarriff.

Third Quarter 2016 Financial Results

Total revenue for the three months ended September 30, 2016 was $37.8 million, as compared to $5.7 million for the three months ended September 30, 2015. A summary of total revenue is outlined below:

Three Months Ended
September 30,

Increase
2016 2015
(in thousands)
Product sales $ 7,837 $ 3,314 $ 4,523
Royalty income 26,246 2,422 23,824
License and other income 3,750 3,750
Total revenue $ 37,833 $ 5,736 $ 32,097

Product sales increased $4.5 million to $7.8 million driven by due to increases in Bendeka, Non-Alcohol Docetaxel Injection, Argatroban, and Ryanodex net product sales of Ryanodex, offset by a decrease in net product sales of diclofenac-misoprostol. Royalty income increased $23.8 million to $26.2 million, as a result of the launch of Bendeka in January 2016.

Cost of revenue increased by $6.7 million to $10.4 million in the three months ended September 30, 2016 from $3.8 million in the three months ended September 30, 2015. This $6.7 million net increase resulted from $0.8 million in cost of revenue for Non-Alcohol Docetaxel Injection, an increase of $0.8 million in the cost of Argatroban, and an increase of $5.3 million related to the cost of Bendeka product sales: $2.4 million of product sales, $2.4 million of royalties and $0.5 million of other expense, and a decrease of $0.2 million in cost of revenue for Ryanodex.

Research and development expenses decreased by $3.7 million to $3.2 million in the three months ended September 30, 2016, compared to $6.9 million in the prior year quarter. The decrease resulted from certain cost reimbursements from one of our suppliers, non-recurrence of project spending for Ryanodex (dantrolene sodium) for exertional heatstroke related to the completion of the clinical treatment portion of the safety and efficacy study, and lower project spending for pemetrexed, offset by the increase in project spending for bivalirudin, and other projects, and higher salary and other personnel-related expenses due to increased headcount.

SG&A expenses increased $6.4 million to $11.9 million in the third quarter of 2016 compared to $5.5 million in the three months ended September 30, 2015. Personnel-related expenses accounted for the bulk of the $6.4 million increase and were due to overall expansion of the business.

Net income for the third quarter was $12.0 million, or $0.77 per basic share and $0.73 per diluted share, compared to a net loss of $10.2 million, or ($0.65) per basic and diluted share in the three months ended September 30, 2015, as a result of the factors discussed above.

Liquidity

As of September 30, 2016, the Company had $59.3 million in cash and cash equivalents; $47.1 million in receivables, with approximately $30.9 million due from Teva; and no debt.

Events Subsequent to the End of the Third Quarter

The Centers for Medicare & Medicaid Services (CMS) established a unique, product-specific billing code, or J-code (J9034), for Bendeka (bendamustine hydrochloride) Injection. The J-code will become effective on January 1, 2017.

The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that administer Bendeka, facilitating access for patients and Medicare, Medicaid and commercial insurance reimbursement.

The J-Code decision triggered a $40 million milestone payment from Teva and an increase in Eagle’s royalty from 20% to 25% of net sales of Bendeka.

On November 9, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended September 30, 2016, and provided an overview of recent corporate developments and upcoming milestones for its research and development programs (Press release, CytRx, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2220972 [SID1234516514]).

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"This month we expect to report additional data from our pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line soft tissue sarcomas (STS)," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We then plan to schedule a pre-NDA meeting with the FDA. Additionally, we recently completed enrollment in the aldoxorubicin Phase 2b clinical trial in second-line small cell lung cancer in September. We now estimate that top-line results will be available in the first half of 2017 as the number of progression events has not yet been reached."

Third Quarter 2016 and Recent Developments

Presented Positive Aldoxorubicin Combination Clinical Trial Results at ESMO (Free ESMO Whitepaper) 2016. On October 10, 2016, CytRx presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress featuring interim clinical data from its on-going clinical trial of aldoxorubicin in combination with ifosfamide and mesna in patients with soft tissue sarcomas. Of 36 evaluable patients, 13 of 36 (36%) achieved a partial response of the target lesion by RECIST 1.1 criteria, 22 of 36 (61%) had stable disease, and one patient had progressive disease. Median progression-free survival has not yet been reached. While the combination did have certain toxicities, none were treatment-limiting.

Completed enrollment in its Global Phase 2b Clinical Trial in Second-Line Small Cell Lung Cancer. On September 6, 2016, CytRx announced that it completed enrollment in its global, randomized Phase 2b clinical trial comparing aldoxorubicin to topotecan in 135 patients with small cell lung cancer (SCLC) who have progressed or relapsed to prior chemotherapy. The primary endpoint is progression-free survival. The number of progression events has not yet been reached, and CytRx currently expects to announce top-line data in the first half of 2017.

Strengthened the Balance Sheet with an Equity Financing. On July 20, 2016, CytRx completed a public offering of common stock and one-year warrants for total net proceeds of aproximately $18.3 million. If exercised in full, the warrants would provide up to an additional $20 million in capital.

Reported Initial Analysis of its Pivotal, Global Phase 3 Aldoxorubicin Trial in STS. On July 11, 2016, CytRx reported interim results from its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory STS. The Company also previously announced that it expects to report additional data from the trial in the fourth quarter. Following the subsequent analysis, CytRx plans to schedule a pre-NDA meeting with the FDA to seek marketing approval. In addition, patients in the Phase 3 clinical trial continue to be followed for overall survival, a secondary endpoint of the trial.

Capital Conservation. During the third quarter, CytRx embarked on a plan to reduce spending until additional results from the aldoxorubicin Phase 3 STS clinical trial are available and the Company meets with the FDA. This included reducing headcount, stopping pre-commercialization activities for aldoxorubicin and suspending further development of DK049.

Pipeline Generation Activities. CytRx’s expanded its drug discovery efforts to create a pipeline of oncology candidates utilizing the Company’s LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.

Upcoming Milestones

Present interim data from the on-going Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/mesna at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held on November 9-12, 2016, in Lisbon, Portugal.
Announce additional data from CytRx’s pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line STS in November 2016.
Report top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin versus topotecan in patients with second-line SCLC in the first half of 2017.
Schedule and hold a pre-NDA meeting with the FDA regarding aldoxorubicin as a treatment for patients with relapsed or refractory advanced STS.
Third Quarter 2016 Financial Results

CytRx reported cash and cash equivalents of $58.9 million as of September 30, 2016.

Net loss for the quarter ended September 30, 2016 was $12.2 million, or $0.13 per share, compared with a net loss of $7.1 million, or $0.11 per share, for the quarter ended September 30, 2015. During the third quarter of 2016, CytRx recognized a non-cash gain on warrant derivative liability of $0.2 million, compared to a non-cash gain of $3.5 million for the three-month period ended September 30, 2015.

Research and development (R&D) expenses were $8.9 million for the third quarter of 2016, and included development expenses of $6.7 million for the aldoxorubicin program. R&D expenses were $8.5 million for the third quarter of 2015.

General and administrative (G&A) expenses were $2.8 million for the third quarter of 2016, compared to $2.2 million for the third quarter of 2015. G&A expenses for the third quarter 2016 included non-cash employee stock-compensation expense of $0.6 million, compared to $0.5 million for the same period in 2015.

On November 9, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor and tumor immune cell metabolism targets for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2016 (Press release, Calithera Biosciences, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2221119 [SID1234516512]). As of September 30, 2016, cash, cash equivalents and investments totaled $56.3 million.

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"During the third quarter, we continued enrolling the two cohorts evaluating our glutaminase inhibitor CB-839 in triple negative breast cancer and in renal cell carcinoma. We expect to be in a position to provide additional updates at medical meetings in the fourth quarter," said Susan Molineaux, Ph.D., President and Chief Executive Officer of Calithera. "In addition, we opened two new immuno-oncology trials in the quarter, both of which should have an initial read out in 2017."

Third Quarter 2016 and Recent Highlights

CB-839: First patient enrolled and dosed in combination with checkpoint modulator. In August 2016, we enrolled the first patient in a Phase 1/2 clinical trial assessing the safety and efficacy of CB-839, in combination with Opdivo for the treatment of renal cell carcinoma (RCC), malignant melanoma and non-small cell lung cancer. The Phase 1/2 study will assess the safety, pharmacokinetics and pharmacodynamics of CB-839 and Opdivo. The study will enroll patients with clear cell RCC who are naïve to checkpoint inhibitors, as well as clear cell RCC, melanoma, and non-small cell lung cancer patients who are receiving anti-PD-1 monotherapy as their current therapy without having a tumor response.
CB-839: Data in renal cell carcinoma selected for oral presentation. In September, we announced that clinical data for CB-839 will be presented in a plenary session at the 28th Annual EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, November 29 to December 2, 2016 in Munich, Germany. The clinical presentation will be focused on data from Calithera’s CB-839 Phase I RCC combination trial with everolimus.
CB-839: Data in triple negative breast cancer selected for presentation. Clinical data for CB-839 will be presented at the San Antonio Breast Cancer Symposium in San Antonio, December 6 to 10, 2016 in San Antonio, Texas. The clinical presentation will be focused on data from Calithera’s CB-839 Phase I triple negative breast cancer combination trial with paclitaxel.
CB-1158: First patient dosed in a phase 1 study of our first-in-class inhibitor of the immuno-oncology target arginase. In September 2016, we announced dosing of the first patient in a Phase I clinical trial assessing the safety and efficacy of our drug candidate as a treatment for advanced solid tumors. Arginase is an enzyme in myeloid-derived suppressor cells (MDSCs), which prevents T-cell and natural killer (NK) cell activation in tumors.
Board of Directors. In August 2016, Suzy Jones was appointed to our Board of Directors, and added to the Audit committee. Ms. Jones is currently Founder and Managing Partner of DNA Ink, a boutique life sciences advisory firm.
Selected Third Quarter 2016 Financial Results

Research and development expenses were $6.3 million for the three months ended September 30, 2016, compared with $6.8 million for the same period in the prior year. The decrease of $0.5 million was primarily due to the timing of manufacturing clinical supply to support our CB-839 and CB-1158 clinical trials, partially offset by increased personnel-related costs primarily due to higher headcount, salary increases and stock-based compensation expense, and costs associated with our licensing arrangements.

General and administrative expenses were $2.3 million for the three months ended September 30, 2016, compared with $2.2 million for the same period in the prior year. The increase of $0.1 million was primarily due to higher personnel-related costs as a result of higher headcount, salary increases and stock-based compensation expense.

Net loss for the three months ended September 30, 2016 was $8.5 million, or $0.44 per share.

Based on the results for the first nine months of 2016 and our current expectations for the remainder of the year, we are raising our guidance and expect cash, cash equivalents and investments will be at least $50 million at the end of 2016.

On November 9, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the third quarter ended September 30, 2016 (Press release, Bellicum Pharmaceuticals, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2221084 [SID1234516507]).

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"We are pleased with recent progress, as the pediatric trial of our lead product candidate BPX-501 continues to enroll at a strong pace. We are preparing for a comprehensive data update of this program at ASH (Free ASH Whitepaper) 2016, and are working with regulators in the European Union and the U.S. to finalize registration pathways for BPX-501 and rimiducid," said Tom Farrell, President and Chief Executive Officer of Bellicum. "In the coming weeks, we expect to initiate the Phase 1 clinical trials of our BPX-601 GoCAR-T and BPX-701 TCR product candidates. We continue to build upon our differentiated technology platform and believe its potential to address the safety and efficacy issues of adoptive cell therapies will provide competitive advantage."

Third Quarter and Recent Highlights

Bellicum continued to advance its BPX-501 lead program and will provide a clinical update at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. The BP-004 pediatric clinical trials in the U.S. and Europe have enrolled over 100 patients with orphan inherited blood disorders and blood cancers. Three abstracts, including an oral presentation focused on pediatric patients with immune deficiencies, were accepted for presentation at ASH (Free ASH Whitepaper) 2016. Bellicum will also host an investor and analyst luncheon on Monday, December 5, 2016. A full schedule can be found in the News & Events section of the Company’s website.
The Company is completing preparations for the start of Phase 1 clinical trials for BPX-601 and BPX-701. BPX-601 GoCAR-T contains Bellicum’s proprietary iMC activation switch and is designed to treat solid tumors expressing prostate stem cell antigen, with the initial clinical trial in non-resectable pancreatic cancer to be conducted at Baylor Sammons Cancer Center. BPX-701 incorporates the CaspaCIDe safety switch and is designed to target malignant cells expressing the preferentially-expressed antigen in melanoma (PRAME), with the initial clinical trial in Refractory or Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes, to be conducted at Oregon Health and Science University and Leiden University Medical Center.
Bellicum expanded its collaboration with Ospedale Pediatrico Bambino Gesù (OPBG) to develop novel CAR T and TCR cell therapies engineered with the CaspaCIDe safety switch. Under the agreement, the organizations agreed to jointly develop CARs and other cell therapies discovered by OPBG, with a clinical trial for a CaspaCIDe-enabled CD19 CAR T cell therapeutic anticipated to begin in 2017.
Bellicum continued to innovate and build upon its differentiated cellular control technologies; will present data highlighting preclinical results from the application of its GoCAR-T and GoTCR technologies in two poster presentations at ASH (Free ASH Whitepaper) 2016.
Third Quarter and Nine Months Ended September 30, 2016 Financial Results

Bellicum reported a net loss of $17.7 million for the third quarter of 2016 and $49.3 million for the nine months ended September 30, 2016, compared to a net loss of $13.4 million and $31.7 million for the comparable periods in 2015. The results included non-cash, stock-based compensation charges of $3.1 million and $9.2 million for the third quarter and nine months ended September 30, 2016 and $2.3 million and $5.9 million for the comparable periods in 2015.

As of September 30, 2016, cash and investments totaled $129.1 million, which included $5.0 million borrowed in September under the agreement with Hercules Capital. Bellicum now expects that it will end 2016 with at least $100 million in cash, cash equivalents and investments, and continues to expect that current cash resources will be sufficient to meet operating requirements through 2017.

Research and development expenses were $13.3 million and $36.5 million for the three and nine months ended September 30, 2016, respectively, compared to $9.8 million and $23.5 million during the comparable periods in 2015. The higher expenses in the 2016 periods were primarily due to an increase in manufacturing and clinical expenses as a result of increased patient enrollment in the BPX-501 clinical trials, increased expenses for the IND-enabling activities for product candidates BPX-601 and BPX-701, and increased personnel and infrastructure costs.

General and administrative expenses were $4.3 million and $12.7 million for the three and nine months ended September 30, 2016, respectively, compared to $3.9 million and $8.9 million during the comparable periods in 2015. The higher expenses in the 2016 periods were primarily due to the growth of the organization, including an increase in costs related to personnel, higher facility costs and increased legal, accounting and travel related expenses.

On November 9, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported that new Phase 1 clinical data for Nektar’s lead immuno-oncology agent, NKTR-214, were presented at the SITC (Free SITC Whitepaper) 2016 Annual Meeting (Press release, Nektar Therapeutics, NOV 9, 2016, View Source [SID1234516469]). NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and Natural Killer (NK) cell abundance directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. The results were presented by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in an oral presentation during today’s session entitled "New Cancer Immunotherapy Agents in Development."

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Interim results presented were from the ongoing Phase 1 dose-escalation, first-in-human, trial of single-agent NKTR-214 in patients with locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), bladder, colorectal and other solid tumor cancers. A total of 20 patients were treated in four separate every three-week (q3w) dose cohorts (ranging from 0.003 mg/kg q3w to 0.012 mg/kg q3w) with 18 of these patients evaluable for anti-tumor activity. Based upon encouraging anti-tumor activity and tolerability of NKTR-214 observed at the 0.006 mg/kg q3w dose, an every two week (q2w) cohort of the 0.006 mg/kg dose began enrolling in September 2016 with an additional 5 patients enrolled to this cohort, all of which are continuing on therapy.

"NKTR-214 resulted in robust activation of the immune system and encouraging anti-tumor activity, including a partial response observed in a patient who continues to be treated with NKTR-214," said Dr. Ivan Gergel, Senior Vice President, Drug Development & Chief Medical Officer of Nektar. "NKTR-214 was also well tolerated in patients when administered as an every two-week or every three-week outpatient therapy. We are very encouraged by the clinical profile emerging for NKTR-214 and the totality of the data from this ongoing single-agent trial of NKTR-214."

Preliminary encouraging evidence of anti-tumor activity has been observed to date in the ongoing study:

12/18 (67%) evaluable patients had stable disease at the initial 8 week scan
7/18 (39%) evaluable patients had radiographic reductions in tumor size per RECIST 1.1 on NKTR-214
One patient with metastatic melanoma (prior treatment with ipilimumab and a BRAF inhibitor) has received 13 cycles of treatment (0.003 mg/kg q3w) with stable disease and continues on therapy with NKTR-214
In the 18 evaluable patients, a total of 5 patients with metastatic RCC who had progressed on 1 prior tyrosine kinase inhibitor (TKI) were treated with NKTR-214 at the 0.006 mg/kg q3w dose level:
1/5 (20%) of these RCC patients had a uPR per RECIST 1.1 (at 16 week scan) and treatment with NKTR-214 is ongoing
2/5 of these RCC patients had additional tumor reductions of 6% and 10% per RECIST 1.1 while on NKTR-214
NKTR-214 also demonstrated a favorable safety and tolerability profile with convenient, outpatient q2w or q3w administration in 25 patients evaluable for safety to-date:

No immune-related AEs were observed (e.g. colitis, dermatitis, hepatitis pneumonitis, adrenal insufficiency)
No deaths or grade 4 AEs related to NKTR-214
No capillary leak syndrome was observed at any dose
One patient experienced a dose-limiting toxicity (DLT) of hypotension/syncope at 0.012 mg/kg q3w and continued on treatment at 0.006 mg/kg q3w
3/25 patients experienced grade 3 hypotension, which was rapidly reversed with fluid administration and all patients continued on treatment with NKTR-214
Most common grade 1-2 adverse events were fatigue, pruritis, cough, decreased appetite, pyrexia, and hypotension
Immune pheno-typing was conducted and biomarkers of immune activation were measured in patients with evaluable tumor biopsies and blood samples. Treatment with NKTR-214 produced a robust elevation in immune cell frequency and activation, including:

Increase in total and newly proliferating (Ki67+) CD4+ T cells, CD8+ T cells, and Natural Killer (NK) cells in 9/9 patients with blood samples evaluated in the trial to-date, with increases of up to 30-fold observed
Increase in frequency of PD-1+ T cell subsets of up to 9-fold in the blood
Increase in CD8+ T cells and Natural Killer (NK) cells of up to 10-fold in the tumor micro-environment in patients with evaluable tumor biopsies (pre-dose and post-dose at week 3), with minimal intratumoral changes to T regulatory cells
Increase in expression of cell-surface PD-1 on T cell subsets of up to 2-fold in the tumor micro-environment
Induction of an activation gene signature in the tumor micro-environment, including increases of 5-fold or greater in expression of interferon γ, perforin and granzyme B genes
Changes in T cell repertoire (TCR), which is a measure of T cell clonality, in the tumor micro-environment
"We are extremely pleased with the single-agent activity of NKTR-214 and the potential of NKTR-214 to transform the immuno-oncology landscape," said Howard W. Robin, President & CEO of Nektar Therapeutics. "As the first I-O agent to demonstrate that it can increase tumor-infiltrating lymphocytes (TILs) and increase PD-1 expression on immune cells in humans, NKTR-214 complements not only existing checkpoint inhibitors, such as nivolumab, but also other I-O mechanisms in development."

In September 2016, Nektar entered into a clinical collaboration with Bristol-Myers Squibb to evaluate NKTR-214 as a potential combination treatment regimen with Bristol-Myers Squibb’s Opdivo (nivolumab) in five tumor types and seven potential indications. The Phase 1/2 clinical trials will enroll up to 260 patients and will evaluate the potential for the combination of Opdivo (nivolumab) and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, triple-negative breast cancer, bladder and non-small cell lung cancer patients. The initial dose-escalation trial is underway with Opdivo (nivolumab) and NKTR-214.

NKTR-214 is an experimental therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and Natural Killer (NK) cells. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. A Phase 1/2 clinical study is ongoing to evaluate single-agent NKTR-214 in cancer patients.