Nektar and Collaborators Present Preclinical Data on NKTR-255, a Novel IL-15 Receptor Agonist, in combination with CAR Cell Therapies at the 2022 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR®

On April 23, 2022 Nektar Therapeutics (Nasdaq: NKTR) announced that collaborators from the Cairo Laboratory at New York Medical College reported data from several preclinical studies demonstrating the potential of NKTR-255 to enhance the anti-tumor activities of different CAR-T therapies in a variety of cancer preclinical models (Press release, Nektar Therapeutics, APR 23, 2022, View Source;transplantation–cellular-therapy-meetings-of-astct-and-cibmtr-301531360.html [SID1234612877]). Presentations include an oral presentation by Wen Luo, Ph.D., assistant professor of pediatrics at NYMC, on in vivo and in vitro efficacy of NKTR-255 combined with anti-MCAMa CARb modified Natural Killer (NK) cells in several tumor models, and a poster presentation by Yaya Chu, Ph.D., assistant professor of pediatrics at NYMC, presenting studies of NKTR-255 in combination with ex vivo expanded anti-CD19 CAR NK cells and anti-CD20 or anti-CD79 antibodies in models of Burkitt Lymphoma (BL).

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"Our research builds on the body of knowledge for the role of an agent which activates the full IL-15 biology pathway in the field of cell therapy," said Mitchell S. Cairo, M.D., director of the Cairo Laboratory, chief of pediatric hematology, oncology and stem cell transplantation, director of the Children and Adolescent Cancer and Blood Diseases Center, associate chairman of the Department of Pediatrics and professor of pediatrics, medicine, pathology, microbiology and immunology and cell biology and anatomy at NYMC. "My lab’s findings show that NKTR-255’s ability to expand and proliferate NK cells resulted in the enhancement of the efficacy of two different CAR therapies in our preclinical models."

The oral presentation will be virtually live streamed on Saturday April 23rd, 2022 at 3:00 PM MT and is accessible through the meeting organizer’s website at View Source These presentations are available for download at View Source

Key details and takeaways from the two collaborator presentations include:

Abstract 27: "Targeting Ewing sarcoma, Osteosarcoma and Neuroblastoma with Anti-MCAM Chimeric Antigen Receptor Modified Natural Killer Cells" Luo, W., et al.
Presentation Type: Oral Presentation
Presenting Author: Wen Luo, Ph.D.
Session: Oral Abstract – Session C – Immune and Gene Therapy
Virtual Live Stream of the presentation will begin at 3:00 PM MT on Saturday April 23rd, 2022

NKTR-255 enhances expression of NK cell-activating receptors, stimulates NK cell proliferation and sustains NK cell expansion
NKTR-255 enhances anti-MCAM CAR NK cell cytotoxicity against Ewing sarcoma, osteosarcoma and neuroblastoma in vitro
Anti-MCAM CAR NK alone or in combination with NKTR-255 significantly decrease lung metastasis and prolong animal survival in an Ewing sarcoma orthotopic mouse model
Abstract 201: "Optimizing Chimeric Antigen Receptor (CAR) Engineered NK Cell- Mediated Cytotoxicity Combined with anti-CD20 or anti-CD79 Therapeutic Antibodies and NKTR-255 in Burkitt Lymphoma (BL)" Chu, Y., et al.
Presentation Type: Poster

NKTR-255 + obinutuzumab, a humanized type II anti-CD20 monoclonal antibody (mAb) glycoengineered to enhance Fc receptor affinity, significantly enhanced the in vitro cytotoxicity of anti-CD19 CAR NK compared to controls against multiple Burkitt lymphoma model (Raji) (p<0.0081) as well as release of perforin (p<0.05), IFN-g (p<0.001) and granzyme B (p<0.01)
These results were further confirmed utilizing Raji-2R and Raji-4RH cells
NKTR-255 + polatuzumab vedotin (PV), an anti-CD79 mAb glycoengineered to enhance Fc receptor affinity, significantly enhanced the in vitro cytotoxicity of anti-CD19 CAR NK cells compared to control groups such as expanded NK cells +NKTR-255 + PV against Raji (p<0.0001), Raji-2R (p<0.0003), and Raji-4RH (p<0.0311), as well as enhanced release of Interferon gamma (IFN-γ) and perforin
Posters will be on display Sunday, April 24, 2022 from 11:00 am to 7:15 pm; Monday, April 25, 2022 from 7:00 am to 7:00 pm; Tuesday, April 26, 2022 from 7:00 am to 12:00pm (all times MDT)

Poster Receptions are on Sunday, April 24, 2022 from 6:30 pm to 7:15 pm MDT

About NYMC
Founded in 1860, New York Medical College is one of the oldest and largest health sciences colleges in the country with nearly 1,500 students and 330 residents and clinical fellows, more than 2,600 faculty members and 23,200 living alumni. The College, which joined Touro University in 2011, is located in Westchester County, New York, and offers degrees from the School of Medicine, the Graduate School of Basic Medical Sciences, the School of Health Sciences and Practice, the Touro College of Dental Medicine at NYMC, and the Touro College School of Health Sciences’ nursing program at NYMC. NYMC provides a wide variety of clinical training opportunities for students, residents, and practitioners. For more information, visit www.nymc.edu.

About NKTR-255
NKTR-255 is an investigational IL‐15 receptor agonist designed to boost the immune system’s natural ability to fight cancer. NKTR-255 increases the proliferation and survival of cancer-killing natural killer (NK) cells and memory CD8+ T cells. NKTR-255 engages the entire IL-15 receptor complex (IL‐15Rα/IL‐15Rβγ) to enhance the formation of long-term immunological memory, which may lead to sustained antitumor immune response.

NKTR-255 is specifically engineered using Nektar’s expertise in polymer chemistry to mimic the natural biological activity of the body’s own IL-15, resulting in optimal activation of the IL-15 pathway. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15, which has to be given in high doses due to rapid clearance from the body, limiting its utility due to toxicity and lack of convenience and use.

BioLexis Reorganization Results in GMS Holdings as Largest Shareholder in Outlook Therapeutics

On April 22, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. ("BioLexis"), a strategic shareholder in Outlook Therapeutics, reported that BioLexis is being reorganized (Press release, Outlook Therapeutics, APR 22, 2022, View Source [SID1234616058]). The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.

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Pursuant to an agreement among BioLexis, GMS Ventures & Investments ("GMS V&I"), and certain of GMS V&I’s affiliates (GMS V&I and its affiliates, "GMS Holdings"), on April 21, 2022, GMS V&I has taken direct ownership of all of the shares of Outlook Therapeutics that were indirectly owned by GMS Holdings through BioLexis.

As the next step in the reorganization, GMS Holdings will cease to be a shareholder in BioLexis and BioLexis will be renamed "Tenshi Healthcare Pte Limited" (or such other name as may be approved by the regulatory authorities in Singapore). GMS Holdings does not have an economic interest in, or voting rights with respect to, the shares of Outlook Therapeutics that are held by BioLexis. BioLexis directly holds the shares beneficially owned by the minority shareholder in BioLexis, Tenshi Life Sciences Private Limited and Tenshi Life Sciences Pte Limited.

Since the initial investment by BioLexis in 2017, Outlook Therapeutics has undergone a significant transformation and has successfully completed three clinical trials which recently culminated in a BLA submission to the U.S. FDA on March 30, 2022. As the largest investor, GMS Holdings actively supported Outlook Therapeutics by leading and participating in multiple capital raises to support the Outlook Therapeutics growth strategy.

"The submission of a Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg) with FDA is a significant milestone to achieve and places Outlook Therapeutics on a path to potential marketing approval for a very promising therapy," said Faisal Sukhtian, Executive Director of GMS Holdings and a member of the Board of Directors of BioLexis. "With this milestone accomplished, the shareholders of BioLexis have fully realized their intended objectives for the joint venture. This reorganization will see the existing partners translate their joint ownership positions in Outlook Therapeutics into direct stakes."

"We appreciate the longstanding support we have received from BioLexis and look forward to executing on our priorities to create value for all shareholders," added Russell Trenary, President and CEO of Outlook Therapeutics.

In connection with the reorganization, Outlook Therapeutics and GMS Holdings entered into an Amended and Restated Investor Rights Agreement, which replaces the previous Investor Rights Agreement among Outlook Therapeutics, BioLexis and GMS V&I. BioLexis no longer has any rights under the Amended and Restated Investor Rights Agreement.

Nektar Therapeutics to Host Webcast Conference Call for Analysts & Investors to Outline New Strategic Plan

On April 22, 2022 Nektar Therapeutics (NASDAQ:NKTR) reported that it will host an analyst and investor conference call with Nektar executives on Monday, April 25, 2022, at 2:00 p.m. Pacific Standard Time (PST), to outline a new strategic plan for the company and provide updates for the company’s research and development pipeline (Press release, Nektar Therapeutics, APR 22, 2022, https://www.prnewswire.com/news-releases/nektar-therapeutics-to-host-webcast-conference-call-for-analysts–investors-to-outline-new-strategic-plan-301530770.html [SID1234612879]).

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through May 27, 2022.

CEL-SCI Announces Acceptance of Abstracts to ASCO 2022

On April 22, 2022 CEL-SCI Corporation (NYSE American: CVM) reported that two abstracts related to CEL-SCI’s pivotal Phase 3 head and neck cancer clinical trial were accepted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting being held June 3-7, 2022 in Chicago, IL (Press release, Cel-Sci, APR 22, 2022, View Source [SID1234612875]). After a two-year hiatus, ASCO (Free ASCO Whitepaper) comes alive in June 2022 under the theme, "Advancing Equitable Cancer Care Through Innovation." ASCO (Free ASCO Whitepaper) is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.

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About Multikine

Multikine* (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain a mixture of natural human proinflammatory cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf, non-autologous biological investigational product, Multikine is manufactured using a proprietary process following Current Good Manufacturing Practice (cGMP) at CEL-SCI’s manufacturing facility near Baltimore, Maryland.

About Head and Neck Cancer

Approximately 890,000 new cases of head and neck cancer are diagnosed each year globally, of which approximately 68,000 are in the U.S. and 150,000 in Europe.

Novartis receives positive CHMP opinion for Tabrecta® for patients with METex14 advanced non-small cell lung cancer

On April 22, 2022 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy (Press release, Novartis, APR 22, 2022, View Source [SID1234612866]).

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"Patients with alterations leading to METex14 skipping have an urgent need for treatment options, as this form of lung cancer is aggressive, often diagnosed in an advanced stage and frequently comes with a poor prognosis," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, Germany, and lead investigator of the GEOMETRY mono-1 trial. "The positive CHMP opinion for Tabrecta brings an option to patients for a treatment specific to their tumor. If approved by the European Commission, new targeted therapies like Tabrecta—supported by early and broad molecular testing of patients’ tumors—can better guide treatment decisions and ensure patients receive the appropriate therapy for their cancer."

The CHMP opinion is based on results from the Phase II GEOMETRY mono-1 trial that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors had alterations leading to METex14 skipping1. Based on data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, among 31 patients who received Tabrecta as second-line therapy in the METex14 skipping pretreated population, a confirmed ORR of 51.6% (95% CI, 33.1-69.8) was achieved, and the ORR across all 100 previously-treated patients, which included patients who received one or two prior lines of systemic therapy, was 44.0% (95% CI, 34.1-54.3)1. The most common treatment-related adverse events (AEs) (incidence ≥20%)were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

"Every 30 seconds, someone dies of lung cancer—the need for more treatment options is critical. Through research and targeted therapies like Tabrecta, we are working to change that statistic and make a positive impact on the lives of people affected by cancer around the world," said Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis. "Today’s announcement represents an important step forward for people in the European Union with previously-treated advanced NSCLC having alterations leading to METex14 skipping."

In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC5. METex14 skipping, a recognized oncogenic driver, occurs in approximately 3-4% of NSCLC cases3,4.

About Tabrecta (capmatinib)
Tabrecta (capmatinib) is approved in several countries including the US, Switzerland and Japan. It is the number one prescribed targeted therapy for patients with advanced NSCLC with alterations leading to METex14 skipping globally2.

Tabrecta is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

About GEOMETRY mono-1
GEOMETRY mono-1 is a Phase II multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, advanced NSCLC with alterations that lead to MET exon-14 skipping who received 400 mg of capmatinib orally twice daily1.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC1.

Mature data from the trial, including from an expansion cohort analysis, showed Tabrecta demonstrated a median duration of response of 9.7 months (95% CI, 5.6-13.0) in all previously-treated patients (n=100)1. In addition, Tabrecta demonstrated a median overall survival of 13.6 months (95% CI, 8.6-22.2) in previously-treated patients (n=69)1. The median progression-free survival was 5.5 months (95% CI, 4.2‑8.1) for all previously-treated patients (n=100) and 6.9 months (95% CI, 4.2-13.3) for patients who received Tabrecta as second-line therapy (n=31)1. The Disease Control Rate across all previously-treated patients was 82.0% (95% CI, 73.1-89.0)1. The expansion cohort analysis enrolled 160 patients with MET alterations and included previously-treated cohorts (n=100) who had been treated with one or two prior lines of systemic therapy for advanced disease, as well as treatment-naive cohorts (n=60)1.

Overall, Tabrecta demonstrated a manageable safety profile and there were no new safety signals or unexpected safety findings1. The most common treatment-related adverse events (AEs) (incidence ≥20%) were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

About MET exon 14 skipping
MET (mesenchymal-epithelial transition), a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival3. Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions and deletions that lead to skipping of exon 14. MET exon 14 (METex14) skipping is an oncogenic alteration in NSCLC that can result in overstimulation of the MET pathway3.

Patients with alterations that lead to METex14 skipping often have a poor prognosis due to the aggressiveness of the cancer and limited treatment options6-8.

Novartis and lung cancer
The needs in lung cancer are urgent and significant. Each year, more than 2 million people are newly diagnosed globally, and lung cancer remains the number one cause of cancer-related death worldwide9. There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC accounts for approximately 85% of lung cancer diagnoses10.

Novartis is making bold investments in advancing the science to drive treatment and make an impact for patients around the world. The company is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer.

With one of the most diverse lung cancer development programs in the industry, Novartis is developing therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between unregulated inflammation and tumor growth and recurrence; and exploring the potential for advanced nuclear medicine to fight the disease. Through these programs, Novartis aims to redefine possibilities in lung cancer and pursue a trajectory to make lung cancer history.