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Sorrento Therapeutics CAR-T Manufacturing Capacity Expanded With Opening of East Coast GMP Site in Addition to Primary West Coast Facility

On January 24, 2018 Sorrento Therapeutics, Inc. (NASDAQ:SRNE) ("Sorrento"), reported the expansion of its Good Manufacturing Practices (GMP) CAR-T manufacturing capacity, with an exclusive agreement to operate the "Cellular Immunotherapy and Gene Therapy Facility" at Roger Williams Medical Center (Providence, RI) under Sorrento management (Press release, Sorrento Therapeutics, DEC 24, 2018, View Source [SID1234532248]).

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Sorrento estimates that the combination of its East and West Coast manufacturing capacity will allow the company to process CAR-T treatments for over 300 patients a year without the use of a third-party contract manufacturer. Sorrento believes that the current capacity should be sufficient to meet its lead candidate CD38 CAR-T multiple myeloma development needs through and up to FDA approval, and support other upcoming CAR-T development programs.

This latest facility addition brings the total GMP manufacturing sites of Sorrento and its subsidiaries to 5 separate facilities: Judicial Facilities (San Diego, CA) for CAR-T therapies and antibody production, Providence Facilities (RI) for CAR-T therapies, Camino Santa Fe Facilities (San Diego, CA) for oncolytic virus production, Suzhou Facilities (China) for antibody-drug conjugate (linker toxin synthesis and bio conjugation) production and Bioserv Corporation (San Diego, CA) for small molecule and biologics fill and finish, medical devices and high potency compound fill and finish (expected completion later in the year).

"We decided a long time ago that internal manufacturing capability would be a strategic asset for Sorrento," stated Henry Ji, Chairman and CEO. He also noted, "Many biotech companies learned the hard way the risks of entering into a new therapeutic area without internal manufacturing capabilities and having to compete with other companies for limited numbers of third party manufacturers. With all the recent activity in the CAR-T space we are extremely pleased to be in control of our own GMP manufacturing and not have to rely on outside parties for our supply needs for our current and future development work."

As Sorrento moves towards non-viral CAR manufacturing, it also expects both the Judicial and Providence Facilities to be able to increase their capacity throughput and handle multiple CAR-T development programs in parallel.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Novartis, 2017, JAN 24, 2018, View Source [SID1234523540])

SELLAS Life Sciences Group to Present Complete Phase 2 Correlative Results for its Lead Cancer Immunotherapy Candidate, galinpepimut-S (GPS), in Treatment of Multiple Myeloma: Oral Presentation at the 2018 European Society for Blood and Marrow Transplantation Meeting

On January 24, 2018 SELLAS Life Sciences Group, Inc. (SELLAS; NASDAQ: SLS) reported that an abstract highlighting the detailed description of antigen-specific immune responses and correlation thereof with clinical effects over time has been accepted for oral presentation at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting taking place March 18-21 in Lisbon, Portugal (Press release, Sellas Life Sciences, JAN 24, 2018, View Source [SID1234523569]).

"The abstract to be presented at the EBMT Conference highlights the depth of our clinical program exploring the potential of GPS as an innovative immunotherapeutic for multiple cancer types," said Angelos M. Stergiou, MD, ScD h.c., President and CEO of SELLAS. "There has been great interest in immuno-oncology approaches for the treatment of MM and GPS offers an exciting opportunity by directly immunizing the host against a key immune target in multiple myeloma, namely WT1, particularly in view of strong differentiating attributes of our hetereoclitic immunotherapeutic as well as the other indications we are carefully pursuing."

Multiple myeloma (MM) patients with high-risk cytogenetics at baseline who also remain positive for minimal residual disease post-frontline autologous stem cell transplantation continue to experience poor clinical outcomes, despite maintenance with immunomodulatory drugs, such as lenalidomide. This is a population segment that represents approximately 15-20% of first-line MM patients. In previous reports, such patients immunized with GPS in a Phase 2 study (n=18) experienced a median progression-free survival of 23.6 months and an 18 month overall survival of 88%.

The presentation at the EBMT Conference will entail detailed correlative analyses between clinical benefit, as reflected by the rate of achievement of complete response/very good partial response, per International Myeloma Working Group criteria, and antigen-specific immuno-responses of the complete dataset from this Phase 2 study.

Details for the presentation are as follows:

Title: Clinical Benefit after Galinpepimut-S (GPS), a WT1 Immunotherapeutic, Correlates With Antigen-Specific Immune Responses in High-Risk Multiple Myeloma: Complete Analysis of the Phase 2 GPS Maintenance Study.
Presenter: Guenther Koehne, MD, PhD, Miami Cancer Institute, Baptist Health South Florida
Session: Oral Session 4 – Multiple Myeloma; Room 5B
Abstract Number: A-947-0029-01047
Date/Time: March 19, 2018, 3:50 p.m WET/ 10:50 a.m. EST
Location: Centro de Congressos de Lisboa / Lisbon Congress Centre (LCC), Room 5B
The presentation will be made available on the Presentations section of Sellas’ website at www.sellaslifesciences.com/publications immediately following the presentation.

About galinpepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immunotherapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer antigens for immunotherapy. Importantly, because the WT1 antigen is over-expressed in many malignancies, and is not found in most normal tissues, GPS has the potential to be a broad immunotherapy, effective across a multitude of diverse cancer types and patient populations.

Pfizer Announces Positive Top-Line Results For Potential Biosimilar To Rituxan®/MabThera®

On January 24, 2018 Pfizer Inc. reported that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-US)/MabThera1 (Press release, Pfizer, JAN 24, 2018, View Source [SID1234523567]).

The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.

"We are pleased to report on our fifth proposed biosimilar monoclonal antibody (mAb) with positive study results. These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients," said Amrit Ray, MD, global president, Pfizer Essential Health Research and Development. "As a global leader in novel biologics, and with one of the broadest global portfolios in oncology, we are delivering on our commitment to advancing high-quality medicines for the millions of patients with cancer around the world today and in the future."

Pfizer’s biosimilars pipeline consists of seven distinct biosimilar molecules in mid to late stage development, with three of these in oncology, as well as several others in early stage development.

About the REFLECTIONS B3281006 Study

REFLECTIONS B3281006 is a randomized, double-blind clinical trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus MabThera (rituximab-EU)for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma. The primary endpoint measure, ORR, is defined according to the revised response criteria for malignant lymphoma [Time Frame: Week 26]. Results of the study will be presented in full at a future medical meeting or summarized in publication.

More information about the PF-05280586 REFLECTIONS B3281006 study can be found at www.clinicaltrials.gov.

About PF-05280586

PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin’s lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with Polyangiitis and Microscopic Polyangiitis; and other region-specific indications.

PF-05280586 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.

Iovance Biotherapeutics Announces Preliminary Phase 2 Data for TIL Treatment in Head and Neck and Cervical Cancers

On January 24, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported preliminary clinical results from two ongoing open-label Phase 2 studies in head and neck and cervical cancers (Press release, Iovance Biotherapeutics, JAN 24, 2018, View Source;p=RssLanding&cat=news&id=2328242 [SID1234523547]).

The company reported preliminary data from C-145-03, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Three of the eight patients treated with LN-145 had a reduction in tumor size of at least 30% and qualified as a Partial Response (PR) as per RECIST 1.1 criteria. The Objective Response Rate (ORR) in the study is 38% to date. These patients had a median of 4 prior treatments for their cancer and had all received prior anti-PD-1 therapy. Two of eight had also received prior anti-CTLA-4. The most common side effects were pyrexia, chills, and hypotension. Iovance will continue to enroll patients in this study to the full sample size of 47 per protocol.

The company also reported preliminary data from C-145-04, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Two patients are currently evaluable. One treated with LN-145 had a confirmed PR and one patient had stable disease.

"These early data from the head and neck study show the potential safety and efficacy of TIL therapy in tumor types other than melanoma, and demonstrate the broad utility of TIL therapy in various solid tumors. Recently approved anti-PD-1 therapies have resulted in overall response rates of 13-16% in head and neck cancer patients with a median of 2 prior therapies or similar disposition. We are therefore excited by this early data and believe that LN-145 may offer patients who have failed prior therapies, including anti-PD-1 checkpoints, an important treatment alternative," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also encouraged by the preliminary data reported today in cervical cancer. Previously published data from the National Cancer Institute (NCI) had shown a response in three of nine cervical cancer patients treated with TIL therapy. Patients with metastatic cervical cancer have limited effective treatment options, with no transformative new systemic therapies having been approved over the last several decades."