On April 25, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported a new strategic plan focused on prioritizing key research and development efforts that will be most impactful to the company’s future, including its NKTR-358, NKTR-255 and several core research programs (Press release, Nektar Therapeutics, APR 25, 2022, View Source [SID1234612904]). In connection with this new strategic plan, Nektar also announced a cost restructuring plan aimed at ensuring Nektar has significant capital to fund key programs through value-enhancing data and other milestones without a need to raise incremental capital for at least 3 years.

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Nektar’s strategic plan going forward is built upon three core pillars:

Success-based development funding of NKTR-358 for maximum royalty participation: In partnership with Eli Lilly, the NKTR-358 program has continued to advance. Built upon early promising data, the Phase 2 program for NKTR-358 includes the ongoing 280-patient Phase 2 study in lupus, a second Phase 2 study planned to start shortly in 300 patients with atopic dermatitis and a third Phase 2 study being planned in a yet to be announced autoimmune indication to potentially start in 2023. Under the terms of its agreement with Eli Lilly, Nektar is eligible for up to $250 million in development and regulatory milestones. Nektar will have the option to participate in Phase 3 development up to 25% on an indication-by-indication basis and can receive significant double-digit royalties on global sales of NKTR-358 with the first tier in the mid-teens and the second tier in the low twenties of global sales of NKTR-358. Lilly is responsible for all costs of global commercialization and Nektar has an option to co-promote NKTR-358.
Prudently develop NKTR-255 in its areas of strength and differentiation: Nektar’s development plan for 255 is focused on key preclinical and emerging clinical data driven areas of differentiation of this unique IL-15 agonist. The company will continue the Merck KGaA-sponsored JAVELIN Bladder Medley Study. In addition, new development efforts will focus on the potential to use NKTR-255 as a cell therapy potentiator, based upon clinical observations and preclinical models suggesting NKTR-255 has great potential to enhance CAR-T cell persistence. Nektar currently has two studies underway with external collaborators to evaluate NKTR-255 in combination with CAR-T therapies and is also currently designing a Nektar-sponsored comparative study, which it aims to initiate in the second half of 2022. The company will also continue its dose-escalation development work in combination with antibody-dependent cell mediated cytotoxicity (ADCC) agents and plans to evaluate potential next steps once these data mature.
Invest in core research programs to complement Nektar’s pipeline: Nektar is currently cultivating several new research programs. The first, a collaboration with Biolojic Design, is for a unique bivalent agonistic antibody targeting TNFR2, and is an example of Nektar’s ability to bring in external candidates and new modalities into the pipeline. The additional two programs were invented in Nektar’s laboratories and are focused in the areas of auto-immune disease and oncology.
"Over the past several weeks, the Nektar executive team has made decisions to prioritize key research and development efforts that will be most impactful to the future of our company," said Howard W. Robin, President and CEO of Nektar. "This new strategic plan focuses on important pipeline programs – NKTR-358, NKTR-255 and preclinical candidates – each of which we believe presents an opportunity to create significant value for our shareholders."

To reflect these new strategic priorities, Nektar also announced several changes to its executive team. Dr. Dimitry Nuyten, Nektar’s Chief Medical Officer (CMO), will step down from his position following a transition through June 2022. He will be succeeded by Dr. Brian Kotzin, Nektar’s Head of Immunology, who brings over 30 years of drug development experience to the role and is an expert in the areas of immunology and inflammatory diseases. Dr. Kotzin had previously served as Nektar’s interim CMO. John Northcott, Nektar’s Chief Commercial Officer, who led the pre-commercialization activities for BEMPEG, will depart the company in June following a transition period, but will remain as a strategic consulting advisor to the company through the end of 2022. The company thanks Dr. Nuyten and Mr. Northcott for their contributions.

Cost Restructuring Plan
Nektar also announced that it is implementing a cost restructuring plan, extending the company’s cash runway into the first half of 2025. The restructuring plan is designed to ensure Nektar has sufficient working capital to fund key R&D programs to value-enhancing data and other milestones without a need to raise external capital. In connection with this restructuring, Nektar will reduce its workforce by approximately 70%. The scale and scope of this reduction aligns with the substantial work Nektar did to conduct late stage registrational studies of bempegaldesleukin and prepare for its widespread distribution and commercial launch.

Robin continued, "Our new operating plan is designed to ensure we have at least three years of cash runway to support the advancement of our key programs through a steady stream of data catalysts that we expect will begin in the second half of 2022. On behalf of our entire Nektar management team and Board, I want to express my deep and humble gratitude to the employees who will be departing Nektar. We are immensely grateful for the contributions you have made to our company, your dedication to our mission and your efforts to work to bring new medicines to patients with debilitating diseases."

After accounting for BEMPEG wind-down and restructuring costs, Nektar now expects to end the year with approximately $440 million to $450 million in cash and investments and no debt on the company’s balance sheet. In connection with the business restructuring and reduction in workforce, Nektar expects to take a charge of between $150 million and $160 million, a substantial portion of which will be recorded in the company’s financial results for the quarter ending June 30, 2022.

Webcast Conference Call for Analysts & Investors
Nektar executives will host an analyst and investor conference call to discuss the new strategic plan and the company’s research and development pipeline beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on Monday, April 25, 2022.

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.

On April 25, 2022 Laboratoires DELBERT reported the signature with Sanofi on March 31st, 2022 of the acquisition of Teralithe 250mg, divisible tablet and Teralithe LP 400mg, prolonged-release tablet (lithium carbonate) in France (Press release, Sanofi, APR 25, 2022, View Source [SID1234612921]).

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Laboratoires DELBERT (View Source) is a French Pharmaceutical company specialized in the « Revival of essential medications » : Marketing discontinuation, stock shortages …affect more and more essential medications especially in crisis periods with the consequence of narrowing the therapeutic arsenal of doctors that may force well-controlled patients to switch to other therapies.

With this acquisition Laboratoires DELBERT reinforces the execution of their strategy in order to ensure safe and continuous availability of Essential Medications to patients and reinforce their CNS portfolio.

"This acquisition demonstrates our ongoing commitment to invest in Major Therapeutical Interest Medications (MITM). Maintaining these medications available for patients in need is our priority," said Marc Childs, & Thierry Hoffmann co-founders of Laboratoires DELBERT, « Laboratoires DELBERT built up over the time a portfolio of MITM that is anchored in 3 specific therapeutic areas : Antiinfectives, CNS and Oncology. »

Laboratoires DELBERT will reach over 30m€ sales by 2022 with double digit growth every year and already commercializes 14 products (out of which 13 princeps) for hospitals/specialists prescriptions.

Laboratoires DELBERT financed this acquisition thanks to very strong relationship with its financial partners who strongly believe in their values focused on patients access to MITM.

On April 25, 2022 Hoffmann-La Roche reported its first quarter results 2022 (Presentation, Hoffmann-La Roche, APR 25, 2022, View Source [SID1234612941]).

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On April 25, 2022 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that it will report financial results for the quarter ended March 31, 2022, on Monday, May 9, 2022 after the close of the market, and provide a corporate update (Press release, Aptose Biosciences, APR 25, 2022, View Source [SID1234612889]).

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Conference Call & Webcast:

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website here. An archived version of the webcast will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended March 31, 2022 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On April 25, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that the first participants have been enrolled in a study that is part of an 800-site master protocol trial for non-small cell lung cancer (NSCLC) (Press release, ImmunityBio, APR 25, 2022, View Source [SID1234612905]). The Lung Cancer Master Protocol trial (Lung-MAP) includes a study of Anktiva (N-803) plus Keytruda (pembrolizumab) versus investigator choice of standard-of-care chemotherapy in patients with non-small cell lung cancer (NSCLC) whose cancer has progressed after prior checkpoint-inhibitor-containing regimens. The study, which opened in March and currently includes nearly 200 sites across the U.S., will involve 478 patients when fully enrolled.

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"The Lung-MAP master protocol is an important and innovative national multicenter trial and we’re grateful to be working with this national network to validate our hypothesis that both NK and T cells are needed to establish durable responses in patients with lung cancer," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "This large trial will provide valuable information on the role Anktiva could potentially play in bolstering the effectiveness of checkpoint inhibitors such as Keytruda. Since Anktiva acts by activating and proliferating both NK and memory T cells, the combination with a checkpoint inhibitor that takes the brakes off T cells could result in improved durable outcomes. This combination therapy will be offered as a treatment option to patients with tumors that do not have druggable mutations, which is the case for the majority of NSCLC patients."

About the Anktiva (N-803) Lung-MAP Trial

The trial protocol is enrolling patients to a randomization schema of N-803 + pembrolizumab versus investigator choice of standard-of-care chemotherapy (docetaxel, gemcitabine, pemetrexed, or docetaxel + ramucirumab). The two cohorts are being studied independently: 1. Primary checkpoint inhibitor resistant patients, 2. Previous responders to checkpoint inhibitors who then subsequently progress.

The current standard-of-care for NSCLC without targetable mutations is pembrolizumab (Keytruda). This Lung-MAP study will look at how N-803 could potentially bolster the effectiveness of Keytruda for patients with non-targetable cancer cell mutations. The current standard of care for patients who progress on Keytruda is chemotherapy, which has significant toxicities associated with its use. Data presented by Wrangle and colleagues at ASCO (Free ASCO Whitepaper) 2021 showed the N-803/Keytruda combination as a chemotherapy-free alternative that has produced lower rates of adverse events than chemotherapy in the second-line setting View Source

To learn more about the Lung-MAP study, please visit View Source or clinicaltrials.gov (NCT05096663).

"We are incredibly excited to begin a randomized trial of N-803 plus pembrolizumab compared to second line chemotherapy," said John Wrangle, M.D., a researcher at the Medical University of South Carolina who developed the study. "Lung-MAP S1800D will let us study if we can prolong the duration of benefit a patient experiences from immunotherapy while delaying use of cytotoxics. We have already observed that the combination is safe and that it can shrink tumors that have progressed on immunotherapy. Now it’s time for a rigorous trial to determine if that means patients experience prolonged survival in the real-world setting that the Lung-MAP mechanism provides."

Incidence of Lung Cancer

According to the American Cancer Society, lung cancer is the second most common cancer in the U.S. and remains a significant cause of death. It is estimated that nearly 237,000 new cases of lung cancer will be diagnosed in the U.S. this year, leading to some 130,000 deaths attributed to the disease. Non-small cell lung cancer accounts for about 80% to 85% of all lung cancer diagnoses; there are very few successful treatment options for these patients once the cancer spreads beyond the lungs. The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient response may be short lived, due to late response and/or progression after achieving an initial response.

ImmunityBio’s IL-15 superagonist Anktiva (N-803)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. Anktiva is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. Compared to native, non-complexed IL-15 in vivo, Anktiva has better pharmacokinetic properties, due to longer persistence in lymphoid tissues, and enhanced anti-tumor activity.

Anktiva is currently being studied in 21 clinical trials across 14 indications.

About Lung-MAP

Launched in 2014, Lung-MAP, or the Lung Cancer Master Protocol, is a precision medicine clinical trial for people with advanced non-small cell lung cancer that has continued to grow after treatment. As the largest "umbrella" lung cancer trial in the U.S., Lung-MAP is simultaneously studying how well multiple investigational or new drugs work in NSCLC with specific gene mutations or biomarkers. Open at almost 800 sites across the U.S., Lung-MAP is a unique public-private collaboration among the National Cancer Institute (NCI), which is part of the National Institutes of Health, SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), and 13 pharmaceutical companies.