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Nektar Therapeutics Announces Dosing of First Patients in Phase 1/2 Study of its IL-15 Agonist, NKTR-255, in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma or Colorectal Cancer

On December 15, 2020 Nektar Therapeutics (NASDAQ:NKTR) reported that the first patient has been dosed in the Phase 1/2 trial of NKTR-255, Nektar’s investigational IL-15 pathway agonist, in patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC) at the START Center for Cancer Care in San Antonio, TX (Press release, Nektar Therapeutics, DEC 15, 2020, View Source [SID1234572897]). The study is evaluating NKTR-255 plus cetuximab in up to 80 patients at approximately 15 investigator sites in the United States and European Union.

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NKTR-255 is designed to activate the IL-15 pathway and expand Natural Killer (NK) cells as well as promote the survival and expansion of CD8+ T cells without inducing suppressive regulatory T cells. Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR) and is approved for the treatment of advanced HNSCC and CRC.

"An NK-cell agent such as NKTR-255 is a perfect and unique complement to monoclonal antibody therapies which induce antibody-dependent cellular cytotoxicity," said Wei Lin, MD, Head of Development at Nektar. "Our body of preclinical and clinical data for NKTR-255 demonstrates that this novel agent not only induces NK cell proliferation but also enhances their cytotoxic immune effector function. With this new Phase 1/2 study in HNSCC and CRC, we are excited to expand our NKTR-255 development program beyond the hematological setting into solid tumors."

Nektar recently presented the first clinical data for NKTR-255 at the most recent 2020 Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. The data demonstrated that NKTR-255 was well tolerated and biologically active, and treatment resulted in consistent expansion of lymphocytes, with durable and sustained increases in NK and CD8+ T cells in a highly refractory population of patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).

The new Phase 1b/2 study will test the combination of NKTR-255 with cetuximab in two groups of patients. One group will consist of R/R head and neck cancer patients who have progressed after treatment with platinum-based chemotherapy and a checkpoint inhibitor. The second group will include patients with metastatic colorectal cancer who have received two prior treatments for metastatic disease. The trial will begin with a dose-finding portion for the combination, which will then be expanded into dedicated cohorts for head and neck and colorectal cancer patients.

About NKTR-255

NKTR-255 is an investigational IL-15 receptor agonist designed to activate the IL-15 pathway and expand NK cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell population and formation of long-term immunological memory, which may lead to sustained anti-tumor immune response. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses.1 NKTR-255 is wholly-owned by Nektar.

NCCN Announces Research Projects Exploring Axitinib in Various Cancers, in Collaboration with Pfizer

On December 15, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported four projects selected to receive funding for clinical evaluation of axitinib (Press release, NCCN, DEC 15, 2020, View Source [SID1234572895]). Axitinib, a small molecule indazole derivative, is an oral multi-targeted tyrosine kinase inhibitor of Vascular Endothelial Growth Factor (VEGF) Receptors 1, 2, and 3. NCCN issued the initial Request for Proposals and convened a Scientific Review Committee from across NCCN Member Institutions to select projects. The studies will receive funding and oversight from Pfizer.

The following projects were selected:

Phase II Study of Axitinib + Ipilimumab in Advanced Melanoma
Zeynep Eroglu, MD, Moffitt Cancer Center
Single-arm Phase II Study of Axitinib, Avelumab, and Bavituximab in Advanced HCC
David Hsieh, MD, UT Southwestern Simmons Comprehensive Cancer Center
Phase II Study of Axitinib + PD-1 Blockade in Mucosal Melanoma with Adaptive Phase I Escalation in Select Progressors
Alexander Shoushtari, MD, Memorial Sloan Kettering Cancer Center
Phase I-II Study of Hepatic Chemoembolization With Irinotecan-Loaded Drug-Eluting Microspheres (DEBIRI) Plus Axitinib and Hydrochlorquine for Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum
Michael Soulen, MD, Abramson Cancer Center at the University of Pennsylvania
"We’re particularly interested in learning more about the efficacy of axitinib in combination with various other anti-cancer agents, that may exploit its specific pharmacokinetics," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "These innovative studies will add to our knowledge base for treating challenging cancer presentations, as part of our ongoing exploration into how to improve patient outcomes. All of the selected researchers should be commended for their meritorious proposals."

The projects are set to begin by August 2021.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

Qualigen Therapeutics Announces Issuance of U.S. Patent for Expanded Applications of ALAN Anticancer Platform Technology

On December 15, 2020 Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, reported that the United States Patent and Trademark Office has issued a patent entitled "Anti-Nucleolin Agent-Conjugated Nanoparticles as Radio-Sensitizers and/or MRI Contrast Agents" regarding the Company’s ALAN (Aptamer-Linked Anti-Nucleolin) technology (Press release, Qualigen, DEC 15, 2020, View Source [SID1234572894]). This patent issued to the University of Louisville (UofL) protects the ALAN technology for use with cancer radiation therapy and for imaging tumors utilizing magnetic resonance imaging (MRI). The novel ALAN technology has several other potential applications, including its use as a monotherapy for the treatment of cancer and as a vehicle to deliver other anticancer compounds directly to tumors. In 2018, Qualigen obtained exclusive worldwide rights from the UofL for the use of the ALAN technology.

The gold nanoparticle component of ALAN is believed to enhance radiation therapy by "magnifying" the effects of radiation on the targeted tumor cells with the potential to justify lower radiation exposure and, in turn, decrease side effects. ALAN may also potentially be used in combination with MRIs to provide higher-resolution images of solid tumors and tumor cells as special imaging dyes attach to the gold nanoparticle compound.

"With the issuance of this patent, we continue to build our intellectual property portfolio as a key component to protect our technologies under development," stated Michael Poirier, Qualigen’s Chairman, Chief Executive Officer and President. "ALAN is a valuable therapeutic platform technology that may be applied in numerous indications. Currently, we are evaluating strategic options on how to develop and monetize these additional applications while we continue to advance ALAN in our development pipeline against acute myeloid leukemia."

ALAN is a DNA aptamer-based anticancer drug candidate that combines the DNA aptamer AS1411 with a gold nanoparticle to dramatically increase its potency. This drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company plans to commence Phase 1 human trials with ALAN in 2021 in patients with acute myeloid leukemia, its lead indication.

"The issuance of this patent for ALAN further protects this technology’s potential broad applicability as a treatment for cancer," added Paula Bates, PhD, Professor of Medicine at UofL. "We look forward to our continued collaboration with Qualigen as we plan to enter this drug candidate into clinical trials as a therapeutic next year. We believe ALAN has the potential to be more targeted than available cancer treatments with the ability not to harm normal healthy cells resulting in less side effects for the patient."

Qualigen currently has 58 issued and pending patents and has in-licensed rights to a further 42 issued and pending patents.

Singlera Genomics raises $150 million in Series B financing to promote the development and commercialization of early cancer screening products

On December 15, 2020 Singlera Genomics Inc. reported that it raised $150 million in Series B financing (Press release, Singlera Genomics, DEC 15, 2020, View Source [SID1234572893]). This round of financing was led by the CICC Kai Tak Innovative Biomedicine Fund, and co-led by Detong Capital and Furong Investment. The new group of investors also include Huamei International, Linden Asset Group, Wuxi Capital, FutureX Skyline Capital, Shanghai Free Trade Zone Fund, and initial investors from the Series A round such as Greenpine Capital, Prosperico Ventures, and Proxima Ventures joined with follow-on investment. Singlera will utilize this round of financing mainly to expand the company’s early cancer screening product research and development pipeline and focus on promoting product registration and commercialization, as well as expanding prospective studies into pan-cancer early screening.

Singlera was established in 2014 with a commitment to develop the next generation of genetic testing and molecular diagnostic technologies. By focusing on the development and application of non-invasive early screening and diagnosis technology, the company developed a patented methylation detection platform for early tumor diagnostics and prevention. The series B round of financing demonstrates Singlera’s strong scientific technology research and development strength and broad commercial development prospects.

In July 2020, Singlera and Fudan University published groundbreaking scientific research results, which used Singlera’s circulating tumor DNA (ctDNA) methylation multi-cancer screening technology PanSeer to validate early cancer detection in a large population cohort. After this round of financing, Singlera Genomics will continue to carry out large-scale pan-cancer early screening prospective studies.

Mr. Johny Zhang, co-founder and CEO of Singlera, said in a statement "we thank investors for their trust and support. I am honored that the innovative R&D, clinical transformation, and commercialization capabilities of Singlera have been recognized by top investors. This round of financing will help us further expand our product system and strengthen our strategic advantages and marketing capabilities in the field of early tumor screening and liquid biopsy. Cancer has been a major disease that impacts the entire world. Since its establishment 6 years ago, Singlera has been aiming to overcome early cancer screening and diagnosis. It has made a series of major breakthroughs in cancer early screening and early diagnostic technology. The next priority is to accelerate the commercialization of products so that these innovations can be applied to cancer prevention and treatment for hundreds of millions of people."

"Singlera has been committed to building an open and diversified ‘industry-university-research-medicine’ collaborative innovation ecosystem. In the past few years, we have cooperated with dozens of domestic and international scientific research institutes, hospitals and Pharmaceutical companies have carried out extensive cooperation, which has laid a huge advantage for us in basic research and application results transformation of early tumor screening and liquid biopsy," Professor Yuan Gao, co-founder and scientific advisor of Singlera, said in a statement. "We have developed early cancer screening and diagnostic technologies and products covering a variety of cancer types including lung, colorectal, liver, stomach, esophageal, pancreatic, and thyroid. This round of financing will help us carry out large-scale prospective studies and clinical trials".

Clarity Pharmaceuticals closes $25m capital raising

On December 15, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has completed a capital raising of $25,000,410 (Press release, Clarity Pharmaceuticals, DEC 15, 2020, View Source [SID1234572891]).

Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "It has been a pivotal year for Clarity with numerous critical milestones achieved in the development of our main products, advancement of our platform, as well as accelerated corporate and strategic activities despite facing an unprecedented global environment.

"The money raised will enable us to keep the momentum from 2020 going and provide financial resources to progress the following important initiatives:

– SARTATE

Progress the Cu-64/Cu-67 SARTATE Neuroblastoma trial at the Memorial Sloan Kettering Cancer Center in children with neuroblastoma;
Expand the Cu-64/Cu-67 SARTATE Neuroblastoma trial to additional clinical sites across the US with the ultimate goal of developing better treatment options for children with cancer; and
Commence patient recruitment in Phase II Cu-64 SARTATE Neuroendocrine trial.
– SAR-Bombesin

Progress and expand the Cu-64 BOmbesin in Breast CAncer Trial (C-BOBCAT) led by A/Prof Louise Emmett, Director of Theranostics and Nuclear Medicine, at St Vincent’s Hospital in Sydney with an aim of developing better treatment options to women with metastatic breast cancer, an area currently with a high unmet need;
Expand the C-BOBCAT trial to include prostate cancer patients; and
Seek US Food and Drug Administration’s (FDA) approval for an Investigational New Drug (IND) Application.
– SAR-bisPSMA

Commence a clinical trial in the US for Cu-64/Cu-67 SAR-bisPSMA (theranostic) and in Australia for Cu-64 SAR-bisPSMA (diagnostic) to build on the promising pre-clinical data with the help of an internationally recognised team of key opinion leaders in the prostate cancer field; and
Seek US FDA approval for an IND Application.
– Develop new targeted theranostic products for a broad range of cancer types, utilising Clarity’s SAR Technology Platform and the Cu-64/Cu-67 pairing."

Dr Taylor continued, "Clarity has a strong focus on getting its lead product SARTATE to market, supported by the US FDA granting both Cu-67 SARTATE and Cu-64 SARTATE Orphan Drug Designations and Rare Paediatric Disease Designations for the treatment and clinical management of neuroblastoma, as well as developing the copper platform in large and unmet clinical indications."

"It has been a very exciting year for Clarity" Dr Taylor added. "We would like to sincerely thank our long-term shareholders for their continued support of Clarity, as well as welcome and thank a broad range of new shareholders including institutions, family offices, high net-worth individuals and others who wanted to be part of the Clarity story. We would also like to thank Blue Ocean Equities for their contribution in assisting us with the capital raise."