Title of Study. ☐Full title of study listed. ☐Short title contains the words “SHELL STUDY” before the title. ☐Brief description
Title of Study. A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR‑214 and Nivolumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies [***] [***] Phase of Development: Phase 1/2 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Exhibit A ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 [***]NKTR-214 Exhibit A ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 EXHIBIT B FORM OF PRESS RELEASE Please refer to Nektar Therapeutics’ Current Report on Form 8-K filed with the Securities and Exchange Commission on September 27, 2016. Exhibit B ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 EXHIBIT C EXCLUSIVITY The Parties desire to agree on the following terms in order to develop innovative medicines as promptly as reasonably practicable, to avoid IP and other conflicts with Third Parties in related subject matter transactions, and to better ensure that each Party focuses its efforts on the development of appropriate Combined Therapy Trials and that the agreed-upon Combined Therapy Trials proceed in an effective, cost-efficient and timely manner:
Title of Study. A Phase 1 Open-Label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or Non-Hodgkin’s Lymphoma Study Name: PANAMA: PAK4 and NAMPT in Patients with Solid MAlignancies or NHL Name of Active Ingredient: (E)-3-(6-aminopyridin-3-yl)-N-((5-(4-(4,4-difluoropiperidine-1-carbonyl)phenyl)-7-(4- fluorophenyl)benzofuran-2-yl)methyl)acrylamide Objectives and Endpoints: This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin’s lymphoma (NHL). Objectives Endpoints Primary Parts A and B • To assess the maximum tolerated dose (MTD) in each Part • To establish a recommended phase 2 dose (RP2D) Dose Expansion (if conducted) • Preliminary evidence of anti-tumor activity of KPT-9274 at the RP2D ± niacin ER Parts A and B • MTD/RP2D • Dose limiting toxicities (DLTs) • The occurrence of Grade ≥3 adverse events (AE), all serious adverse events (SAEs), and all AEs leading to treatment discontinuation Dose Expansion (if conducted) • Overall response rate (XXX), duration of response (DOR), disease control rate (DCR), duration of disease control, progression-free survival (PFS), overall survival (OS), time to progression (TTP)
Title of Study. A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR‑214 and Nivolumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies [***] [***] Phase of Development: Phase 1/2 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] NKTR-214 Please refer to Nektar Therapeutics’ Current Report on Form 8-K filed with the Securities and Exchange Commission on September 27, 2016.
Title of Study. A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients with Severe COVID-19 Infection Protocol Number: XPORT-CoV-1001 Study Name: XPORT-CoV-1001
Title of Study. A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients with Military-Related PTSD (Protocol No. TNX-CY-P301) Studied period (years): 1.5 Estimated date first patient enrolled: February 2017 Estimated date last patient completed: January 2019 Studied period (months) for the post-study pharmacogenomic assessment: 3 Estimated date first patient enrolled: November 2019 Estimated date last patient completed: January 2020 Phase of development: 3
Title of Study. A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis Coordinating Investigator: This study will be conducted at approximately 15 study centers in the United States (US) and China. The Coordinating Investigator is Xxxxx Xxxxxx, MD, University of California, San Diego, CA. Studied period (years): Estimated date first subject enrolled: April 2019 Estimated date last subject completed: August 2021 Phase of development: 2
Title of Study. Type of research ☐ UG/ PG Academic Study ☐ Exempt Academic Study* ☐ Staff Academic Study ☐ Regulatory Clinical Trial *Studies that do not require CDSCO approval Reference Number Date received: Review Date: Outcome: ☐ Approval Applicant Informed ☐ Yes ☐ No ☐ Conditional Approval Date: ☐ Deferral ☐ Approval Declines Version No. Effective Date Page Please complete form and select YES/NO options as appropriate. An application will only be accepted for review by MNR-MC IEC if it is completed fully and the relevant enclosures are received. Complete the checklist on the next page before submitting the form. Where you have received permission to do this, please provide evidence of permission with this application. Please ensure that all copies of the same document are collated together in sets: • Application form • Study Protocol • Participant Consent Document • CRF • Questionnaire(s), if any • Investigator Brochure. Address to send application: The IEC Chair, MNR-MC Institutional Ethics Committee.
Title of Study. (SK-FAN) An Open-Label Study Assessing Subject Satisfaction with A-101 (Hydrogen Peroxide) Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Xxxx, Xxxx, and Décolletage. Studied period (months): 3 Estimated date first subject enrolled: March 5, 2018 Estimated date last subject completed: September 5, 2018 Phase of development: IV
Title of Study. A Phase II, Randomized, Active-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination with Peginterferon alfa-2b, with and without Ribavirin, for 12 Weeks in Patients with Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-based Therapy. Study Period (Planned): Start – August 2005 and End – April 2006 Phase of Development: II
