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 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 HALO Diagnostics (HALO Dx) reported that now offers men with suspected metastatic and recurrent prostate cancer another groundbreaking advanced imaging option (Press release, HALO Diagnostics, SEP 21, 2021, View Source [SID1234590104]).

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HALO Diagnostics, known for pioneering MRI-guided Laser Focal Therapy for the treatment of prostate cancer, reported the adoption of imaging agent, PYLARIFY (piflufolastat F-18) Injection for use with targeted positron emission tomography (PET) imaging.

"PYLARIFY is a game-changer for early detection of metastasis and recurrence in men previously treated for the disease."

PYLARIFY, developed by Lantheus, targets a prostate-specific membrane antigen (PSMA) protein overexpressed on the surface of 95 percent of prostate cancer cells circulating in a man’s blood. It is the first commercially available, FDA approved PSMA PET imaging agent for prostate cancer.

"PYLARIFY is a molecular imaging game changer for early detection of metastasis in newly diagnosed prostate cancer patients, and for recurrence in men previously treated for the disease," said Dr. John Feller, HALO Diagnostics Chief Medical Officer. "Early and more precise detection gives patients multiple treatment options."

Prostate cancer is the second most common form of cancer affecting American men. An estimated one in eight will be diagnosed in their lifetime.

Of men with localized prostate cancer who undergo initial treatment, as many as 50 percent may experience recurrence within ten years. Recurrent disease is often detected by rising PSA levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in most cases.

PYLARIFY enables visualization of microscopic amounts of cancer that have metastasized beyond the prostate by binding to PSMA and causing the cancer cells to "light up" on a PET scan, allowing the reader to better detect and locate the disease. Early detection saves lives.

The radiotracer is now included in the National Comprehensive Cancer Network (NCCN) guidelines for imaging prostate cancer.

To make an appointment with a HALO Diagnostics doctor, visit HALODx.com.

On September 21, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development reported their participation at the World Bispecific Summit occurring virtually September 29 – October 1, 2021 (Press release, Applied BioMath, SEP 21, 2021, View Source [SID1234590099]).

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Alison Betts, PhD, Vice President of Scientific Collaborations and Fellow of Modeling & Simulation at Applied BioMath will present "Mechanistic Strategies for Modeling Avidity: Application in the Design of Tumor Selective Bispecific Antibodies in Oncology" on Thursday, September 30th at 8:50 a.m. ET. In this presentation, Dr. Betts will discuss the importance of avidity in designing tumor selective bispecific antibodies and how modeling can help interpret titration curves and optimize single-site binding affinities. She will also explain a case study about optimizing a 2+1 format T-cell engager for binding selectivity to tumor cells.

"Mechanistic modeling strategies can help understand complexities innate in bispecific design that are not often straightforward or intuitive," said John Burke, PhD, Co-founder, President and CEO of Applied BioMath. "Dr. Betts will explain how an avidity binding systems pharmacology model provided guidance about bispecific molecules and how the model was expanded and translated into a collaboration."

Learn more about Applied BioMath’s work in bispecifics at View Source

On September 21, 2021 LIPAC Oncology LLC., a pharmaceutical company utilizing its liposome-bound nano-technology platform to provide precision targeted cancer drugs for the treatment of multiple tumor types, reported that management will participate in the following investor conferences, which will all be held virtually:

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Thursday, September 23, 2021 at 2:55 p.m. E.T.
A.G.P. Biotech & Specialty Pharma Conference on Wednesday, October 13, 2021
BMO Life Sciences Private Company Showcase on Thursday, October 14, 2021 at 9:00 a.m. E.T.
A live webcast of the Oppenheimer and BMO presentations can be accessed by visiting the home page of the Company’s website: View Source

About LiPax

LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). Its liposome-bound nano-technology platform achieves targeted tissue penetration with undetectable systemic exposure, toxicity or chemo-related side-effects. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), thoracic cancers (mesothelioma and malignant pleural effusion) and peritoneal and ovarian cancers. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal followed by intravesical instillation using a typical urinary catheter. LIPAC Oncology completed a Phase 2a clinical trial in August 2020 and intends to initiate a Phase 2b study in the second half of 2021 to further investigate LiPax in the treatment of this condition.