R&D Pipeline

Nektar Therapeutics has a deep and diverse portfolio of investigational medicines in different stages of clinical development. We are focused on using new chemistry approaches to make better medicines to treat cancer, chronic pain and auto-immune disease.

Nektar Therapeutics also has a number of strategic partnerships ranging from joint discovery and co-development to licensing and royalty arrangements with numerous companies.

ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated]

Indication: Hemophilia A in pediatric, adolescent and adult patients and for use during surgery

Partner
Partner

Filed for approval in the EU

ADYNOVI is an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for pediatric, adolescent and adult patients with hemophilia A and for use during surgery. Currently licensed in the U.S. and Japan as ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] and under regulatory review in the EU, Canada and Switzerland, ADYNOVI is the only rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of ADVATE [Antihemophilic Factor (Recombinant)].

ONZEALD (etirinotecan pegol)

Indication: Advanced breast cancer and brain metastases

Discovered by Nektar

Partner
Partner

FILED FOR CONDITIONAL APPROVAL IN EU

Amikacin Inhale (BAY41-6551)

Indication: Gram-negative pneumonia

Partner
Partner

Phase 3
  • Aerosolized antibiotic in both on and off ventilator setting

Amikacin Inhale is a drug-device combination product, comprised of a specially formulated Amikacin Inhalation Solution with Nektar's Pulmonary Drug Delivery System (PDDS). It is being developed in partnership with Bayer HealthCare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. The unique areosolization system, PDDS, was designed to achieve optimal lung penetration of the specially formulated Amikacin Inhale Solution, delivering antimicrobial agent directly to the site of infection in the lungs.

Ciprofloxacin Dry Powder for Inhalation (DPI)

Indication: Non-cystic fibrosis bronchiectasis

Partner
Partner

Phase 3

Under development by Bayer Healthcare, Ciprofloxacin Dry Powder for Inhalation (DPI) is an innovative drug-device combination being investigated in non-CF bronchiectasis (NCFB). The investigational product candidate is currently in Phase 3 clinical trials in patients with NCFB and features a small, hand-held inhaler for ease-of-use. Nektar is entitled to royalties on sales of Ciprofloxacin DPI upon commercialization.

The first of the Phase 3 efficacy studies, RESPIRE 1 assessed the safety and efficacy of Cipro DPI in NCFB patients and met both primary endpoints. Cipro DPI 14 day on/off regimen significantly prolonged time to first exacerbation vs pooled placebo (p=0.0005) and significantly reduced frequency of exacerbation vs matched placebo (0.0061). The frequency of treatment emergent adverse events was similar across groups. The data were presented at the 26th International Congress of European Respiratory Society in September 2016. Click here for more detail.

NKTR-181

Indication: Treatment of moderate to severe chronic low back pain

Discovered and wholly owned by Nektar

Unpartnered

Phase 3

PEGPH20

Indication: Pancreatic cancer

Partner
Partner

Phase 3

PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan (HA). Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor that rapidly changes the tumor microenvironment and metabolism, which may render the tumor more vulnerable to therapy as well as inhibit tumor growth. PEGPH20 is being evaluated in a Phase 3 HALO 301 study as a first-line therapy for patients with metastatic pancreatic cancer. The trial will be conducted at approximately 200 sites with two co-primary endpoints of progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Additional clinical studies for PEGPH20 include a Phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA® (pembrolizumab) in relapsed lung and gastric cancer patients; and a Phase 1b/2 clinical collaboration with Eisai evaluating eribulin in combination with PEGPH20 in women with advanced or metastatic, HER2-negative, HA-high breast cancer.

Nektar has an exclusive worldwide license agreement with Halozyme for PEGPH20. As part of the agreement, Nektar is entitled to development and commercial milestones and royalties on product sales of PEGPH20.

ONZEALD (etirinotecan pegol)

Indication: Advanced breast cancer and brain metastases

Discovered and wholly owned by Nektar

Unpartnered

Phase 3 IN US

Dapirolizumab Pegol (Anti-CD40L)

Indication: Systemic lupus erythematosus (SLE)

Partner
Partner

In partnership with Partner

Phase 2

Systemic lupus erythematosus (SLE) is a chronic inflammatory disease that occurs when the body's own immune system mistakenly attacks healthy tissue in skin, joints, kidneys, the brain and other organs. It is a difficult disease to diagnose because it resembles several other conditions.

CD40L is a protein in B and T cells, which helps regulate the immune system. Dapirolizumab pegol (Anti-CD40L) is an antibody that blocks CD40L, potentially lessening disease activity in SLE patients. Dapirolizumab pegol is being developed by Biogen and UCB, Inc. in a Phase 2 clinical trial to evaluate the efficacy and safety of dapirolizumab pegol in patients with moderately to severely active systemic lupus erythematosus. For more information about this study, visit clinicaltrials.gov.

NKTR-214 in combination with OPDIVO® (nivolumab)

Research Focus: Immuno-oncology

Discovered and wholly owned by Nektar

In clinical collaboration with Collaborator

Phase 1/2

NKTR-214 in combination with TECENTRIQ® (atezolizumab) or KEYTRUDA® (pembrolizumab)

Research Focus: Immuno-oncology

Discovered and wholly owned by Nektar

Unpartnered

Phase 1

NKTR-214 (single agent)

Research Focus: Immuno-oncology

Discovered and wholly owned by Nektar

Phase 1

NKTR-358

RESEARCH FOCUS: Autoimmune Disease

Discovered by Nektar

Partner
Partner

Phase 1

NKTR-214 in combination with Takeda oncology compounds

Research Focus: Immuno-oncology

Discovered and wholly owned by Nektar

In research collaboration with Collaborator

Preclinical

NKTR-255

RESEARCH FOCUS: Immuno-oncology

Discovered and wholly owned by Nektar

Unpartnered

Preclinical

NKTR-255 is a memory T cell stimulating cytokine designed to engage the IL-15 pathway to enhance and sustain long-term T cell memory response to treat cancer.

NKTR-262

RESEARCH FOCUS: Immuno-oncology

Discovered and wholly owned by Nektar

Unpartnered

Preclinical

NKTR-262, which is entering the clinic in 2017, 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. NKTR-262 is being developed as a single intra-tumoral injection to be administered at the start of therapy with NKTR-214 in order to induce an abscopal response and achieve the goal of complete tumor regression in cancer patients treated with both therapies.


ONZEALD is a trademark of Nektar Therapeutics; ADYNOVI is a trademark of Baxalta Incorporated, a wholly owned subsidiary of Shire plc; OPDIVO® is a registered trademark of Bristol-Myers Squibb; TECENTRIQ is a registered trademark of Genentech, Inc.