On September 21, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported it has entered into a new oncology clinical collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255, Nektar’s interleukin-15 (IL-15) receptor agonist, in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (UC) in the Phase II JAVELIN Bladder Medley study (Press release, Nektar Therapeutics, SEP 21, 2021, View Source [SID1234590105]).

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NKTR-255 is wholly owned by Nektar and is currently being evaluated in two separate clinical studies in both liquid and solid tumors. The novel IL-15 agonist is designed to activate the IL-15 pathway to expand both natural killer (NK) cells and memory CD8+ T cell populations.1 Avelumab, which is marketed in the U.S. as BAVENCIO, is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

"We are excited to partner with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the combination of NKTR-255 with avelumab in urothelial carcinoma," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "Preclinical studies suggest that avelumab may induce lysis of tumor cells via antibody-dependent cell-mediated cytotoxicity, or ADCC, indicating an additional mechanism of action, and providing an opportunity for potential synergy when combined with an NK cell stimulator, such as NKTR-255."

Under the new collaboration, Merck KGaA, Darmstadt, Germany and Pfizer Inc. will include the combination of NKTR-255 plus avelumab in the new JAVELIN Bladder Medley study. The study is a recently designed global, multi-center Phase II umbrella trial evaluating different avelumab-based combinations, compared with avelumab monotherapy, as potential maintenance therapy regimens for patients with locally advanced or metastatic UC that has not progressed with a first-line platinum-containing chemotherapy regimen. Nektar will supply NKTR-255 for the trial. Nektar and the Merck KGaA, Darmstadt, Germany-Pfizer alliance will each maintain existing global commercial rights to their respective medicines. The study is expected to begin enrolling patients in the first quarter of 2022.

BAVENCIO (avelumab) is indicated in the U.S. and Europe for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

NKTR-255 is an investigational agent in clinical development and is not approved alone or in combination with avelumab (or any other agent) for use in any country.

About Urothelial Carcinoma
Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases and 213,000 deaths.2 It is more common in men than in women, representing the 6th most common cancer and the 9th leading cause of cancer death among males. Incidence rates for men and women are respectively 9.5 and 2.4 per 100,000. Mortality rates for men and women are respectively 3.3 and 0.9 per 100,000.2 Noninvasive cancers reflect a large proportion of all bladder cancers2, and only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.3-9 In the U.S. and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.10

BAVENCIO Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

For full US Prescribing Information and Medication Guide for BAVENCIO, please see View Source

About NKTR-255
NKTR-255 is a novel polyethylene glycol (PEG)-conjugate of recombinant human interleukin-15 (rhIL-15), which was designed to retain all known receptor binding interactions of the IL-15 molecule. The investigational candidate is uniquely designed to overcome known 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. Through an extended circulating half-life and optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell populations and formation of long-term CD8+ mediated immunological memory, which may lead to sustained anti-tumor immune response.

On September 21, 2021 Zenith Epigenetics Ltd. ("Zenith" or the "Company") and Newsoara BioPharma Co., Ltd. ("Newsoara") reported the initiation of a multi-national, randomized Phase 2b clinical trial testing the combination of ZEN-3694, a leading BET bromodomain inhibitor (BETi), with Astellas Pharma Inc. ("Astellas") and Pfizer’s androgen receptor signaling inhibitor (ARSI), enzalutamide, in patients with mCRPC who had a poor response to prior abiraterone treatment (Press release, Zenith Epigenetics, SEP 21, 2021, View Source [SID1234590199]). The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

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Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer. A significant fraction of these patients, whose tumors have low androgen receptor (AR) signaling activity, have a sub optimal response to abiraterone and their subsequent treatment options are limited to cytotoxic therapies. The rationale for this study design is supported by a recent publication in Clinical Cancer Research whose authors uncovered a potential mechanism explaining the role of BETi in sensitizing tumors with low AR signaling to ARSI by blocking a treatment-emergent neuroendocrine differentiation program. This mechanistic study built on a previous clinical trial conducted by Zenith where results suggested that ZEN-3694 + enzalutamide was most active in mCRPC patient tumors who had the lowest AR activity. Furthermore, patients in that trial that had a poor response to prior abiraterone therapy had the most durable response with ZEN-3694 + enzalutamide.

"We are delighted to initiate this study in collaboration with our partners Newsoara and Astellas to continue the development of ZEN-3694 in mCRPC patients," said Donald McCaffrey, President and Chief Executive Officer of Zenith. "We are pursuing a novel approach of treating mCRPC patients whose tumors are resistant to ARSI. Other therapies, either approved or in development, are either cytotoxic or mainly target AR signaling which resistant tumors are no longer dependent on," Mr. McCaffrey further commented.

Dr. Benny Li, Chief Executive Officer of Newsoara added, "with promising data from the completed Phase 1b/2a trial, the initiation of the multi-national, randomized Phase 2b clinical study in patients with mCRPC is a significant milestone for us to pursue a novel treatment through our partnership with Zenith."

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide. Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone and to ARSIs that block AR signaling, disease progression ultimately occurs leading to mCRPC. The treatment of prostate cancer patients has evolved rapidly over the past ten years with second generation ARSIs. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates.

On September 21, 2021 Foundation Medicine, Inc. reported the appointment of Mia Levy, MD, PhD, as its Chief Medical Officer (Press release, Foundation Medicine, SEP 21, 2021, View Source [SID1234590076]). Dr. Levy is a practicing medical oncologist specializing in the treatment of breast cancer and a nationally recognized leader in biomedical informatics. She joins Foundation Medicine following an accomplished tenure as Director of the Cancer Center at Rush University Medical Center in Chicago.

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Dr. Levy has devoted her career to developing systems to support data-driven decision-making in cancer care and research. She has contributed to more than 90 publications on cancer and led the development of My Cancer Genome, an international knowledge resource for precision medicine that provides accessible information to patients and physicians around cancer-driving mutations, clinical trials, and therapies. She previously served as Associate Professor of Cancer Research, Biomedical Informatics and Medicine at Vanderbilt University, and as the Director of Cancer Clinical Informatics for the Vanderbilt-Ingram Cancer Center. She is a forum member of the National Cancer Policy Forum for the National Academies, and a member of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

"Our goal is to empower physicians and patients with the genomic information needed to make informed treatment decisions," said Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine. "Dr. Levy is uniquely positioned to lead our medical team as they work to make this information both available and indispensable at the point of care. She is an accomplished leader and a compassionate physician, and we are very excited to have her join Foundation Medicine."

Dr. Levy will lead efforts to deepen the company’s unparalleled insight into cancer genomics, generate new data to validate the use of comprehensive genomic profiling in oncology, enhance the utility of its high-quality genomic tests and bring innovative new diagnostic technology to patient care.

"We’re entering an exciting new chapter for decision-making in precision oncology as we learn more about the biology of cancer and make those learnings useful for physicians in the clinic," Levy said. "I’m proud to join Foundation Medicine’s team of world-class physicians and scientists, as we advance broader applications of its technology that can help shape treatment plans for more people living with cancer globally."

On September 21, 2021 Astellas Venture Management LLC (President: Kazunori Maruyama, Ph.D, "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), and Mission Bay Capital BioLabs ("MBC BioLabs"), a life-science incubator, reported their third collaboration on the "Future Innovator Prize" formerly known as Astellas Golden Ticket (Press release, Astellas Venture Management, SEP 21, 2021, View Source [SID1234590106]). Building on the success of the inaugural competition held in 2019, the Golden Ticket Competition offers entrepreneurial scientists or emerging biotechnology start-ups one year’s priority usage of MBC BioLabs’ state-of-the-art lab facility and access to Astellas’ research and development (R&D) capabilities and business leaders.

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With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms.

"This is the third time we have worked with MBC BioLabs to identify emerging companies that can help us achieve and realize our VISION of turning innovative science into VALUE for patients," said Maruyama, President, AVM. "The combination of Astellas’ R&D expertise and the capabilities of MBC BioLabs allow start-ups to transform exciting ideas into real businesses that could bring value and hope to patients around the world."

"We are delighted to continue our partnership with Astellas," said Douglas Crawford, MBC BioLabs General Manager. "The outstanding work of the previous winners of these Future Innovator Prize competitions is testament to what can be achieved by pairing Astellas’ ongoing support, advice and expertise with our laboratory accelerator. I’m very excited about what the next collaboration will bring."

Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 1, 2021 to enter the Golden Ticket Competition.

About the Future Innovator Prize at MBC BioLabs
Astellas is offering up to two Future Innovator Prizes for pioneering scientists with innovative research that complements Astellas’ areas of interest that fit with the Astellas Focus Area Approach and pipeline, including oncology, immunology, neuroscience including neuromuscular and sensory disorders.

Companies awarded an Astellas Future Innovator Prize will gain one year’s priority admission or renewal to MBC BioLabs’ state-of-the-art laboratory and access to Astellas’ R&D scientists and business leaders. The competition is open from September 21 to November 1, 2021. Entrepreneurial scientists, emerging life-science or biotechnology start-ups should submit their non-confidential company presentation, including a one-page executive summary, to View Source to be considered. The decision to award any Golden Ticket and the assessments underlying such decision, are solely within the judgment of Astellas and MBC BioLabs and are not subject to any objection or appeal.

The 2020 Astellas Golden Ticket winners were Keyhole Therapeutics, Inc. and Jupiter Therapeutics, Inc., chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas’ Focus Area Approach.

For further information, please go to: View Source, where you can also find submission guidance for your non-confidential company presentation and executive summary.

On September 21, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported that the China National Intellectual Property Administration has granted a new patent covering DUET-02, one of three key CpG-STAT3 inhibitors comprising the Duet Platform (Press release, Scopus BioPharma, SEP 21, 2021, View Source [SID1234590056]).

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The new patent covers the compound and composition, including phosphorothioated oligodeoxynucleotide, and methods of use for CpG-STAT3ASO, Duet’s CpG-STAT3 Antisense inhibitor.

Alan Horsager, Ph.D., President and Chief Executive Officer of Duet and President — Immuno-Oncology for Scopus, stated, "This is an important milestone for Duet Therapeutics as we continue to build our patent portfolio. The Chinese biotech market is an important and integral part of the global biotech industry. As referenced in a September 2021 Reuters article, the combined market value of Chinese biotech firms listed in Hong Kong, on Shanghai’s STAR board, and on Nasdaq had a combined value of approximately $180 billion as of May 2021, compared to just $1 billion in 2016. This rapid growth has been driven by an increasing number of Chinese biotechs raising significant amounts of capital in IPOs over the last several years."

Dr. Horsager added, "Duet continues to receive inbound inquiries regarding the Duet Platform from interested companies in Asia, including China. We believe China, as well as Asia more broadly, will be a key market for immuno-oncology therapeutics. The new patent positions Duet Therapeutics, a wholly-owned subsidiary of Scopus, to pursue opportunities arising from China’s burgeoning biotech market."

The new patent strengthens the patent portfolio for DUET-02. DUET-02 is also covered by a granted patent in the United States. Additionally, patent applications for DUET-02 are in process for the European Union, Canada, and Japan.

The patent granted in China, entitled "Compounds and Compositions Including Phosphorothioated Oligodeoxynucleotide, and Methods of Use Thereof," relates to the isolated compound, including a phosphorothioated oligodeoxynucleotide (ODN) sequence conjugated to an antisense oligonucleotide sequence (ASO), compositions of such a compound, and method of treatment of cancer and autoimmune diseases (with or without stimulating immune response), method of immune stimulation, and method of reducing activity of STAT transcription factor, by one of the disclosed compounds or compositions.

About the Duet Platform

Duet Therapeutics integrates the immunotherapy assets of Scopus and Olimmune, creating the Duet Platform. Olimmune was acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

The Duet Platform is comprised of three distinctive, complementary CpG-STAT3 inhibitors:

• RNA silencing CpG-STAT3siRNA ("DUET-01")
• Antisense CpG-STAT3ASO ("DUET-02")
• DNA-binding inhibitor CpG-STAT3decoy ("DUET-03")
DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma. Duet expects to file two INDs for DUET-02 in Q4 2022 in genitourinary and head & neck cancers, with Phase 1 clinical trials beginning in Q1 2023 in the United States. Duet is also evaluating combination therapies with checkpoint inhibitors.