On September 21, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported completion of the Phase 1/2 dose expansion studies evaluating its lead asset VT1021 in recurrent glioblastoma (rGBM) and pancreatic cancer (Press release, Vigeo Therapeutics, SEP 21, 2021, View Source [SID1234590109]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

VT1021 is a first-in-class, dual-modulating compound that both blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis and inhibit angiogenesis. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated in subjects enrolled in both dose escalation and dose expansion cohorts. The escalation cohort included all-comers, and the expansion cohorts focused on rGBM and pancreatic cancer, among other indications.

Phase 1/2 Results in Recurrent Glioblastoma and Pancreatic Cancer

In the rGBM expansion cohort, single-agent VT1021 demonstrated complete tumor regression in multiple subjects and partial response in other subjects, with multiple subjects remaining on trial for well over 9 months. While the expansion study has concluded, these subjects will continue to receive VT1021 in an open label extension study.

In the pancreatic cancer expansion cohort, single-agent VT1021 demonstrated tumor reduction in multiple subjects with measurable disease. Moreover, VT1021 was able to reprogram the tumor immune microenvironment from immune-suppressive to immune-responsive.

Vigeo plans to present the results of both of these studies at medical meetings during the fourth quarter of 2021. The company is expected to initiate a global, Phase 2/3 registration study evaluating VT1021 in newly diagnosed and recurrent GBM patients by the end of 2021. In parallel, Vigeo plans to initiate efficacy studies in additional solid tumor indications, including pancreatic cancer, during the first half of 2022.

Jim Mahoney, Chief Executive Officer of Vigeo, commented, "VT1021 is a first-in-class anti-cancer agent that works by stimulating the expression of Tsp-1 which then binds with high affinity to CD47, blocking the "do not eat me" signal, and to CD36, which leads to a cascade of beneficial changes within the tumor microenvironment (TME) that further enhance anti-tumor effects. We, along with the PI’s who conducted the trials, are very excited by what we have observed to date in the two expansion studies."

Mr. Mahoney was appointed Chief Executive Officer in February of this year. Jing Watnick, PhD, MBA, Vigeo founder and previous CEO, is remaining on as the COO and will focus her efforts on developing the clinical and preclinical assets.

Prior to joining Vigeo as CEO, Mr. Mahoney served as a member of the Vigeo Board of Directors since 2015. In his new role, Mr. Mahoney will lead the development of Vigeo’s corporate strategy and will drive a disciplined growth strategy as Vigeo executes on its clinical programs.

Mr. Mahoney has over 30 years of senior executive experience at various biotechnology, healthcare and specialty chemicals companies. Most recently, he was an Operating Partner at Ara Partners, a private equity investment firm. Prior to that he served as CEO and President at Novomer Inc., Surface Logix Inc., and Prolinx Inc. and was a founding senior executive at Dade Behring Inc. Earlier, he held executive positions at Baxter International and FMC Corporation. Mr. Mahoney received his BS degree from the University of Massachusetts, Amherst, and holds an MBA from Northwestern University’s J.L. Kellogg School of Management and an MMA in international economics from the University of Southern California.

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

On September 21, 2021 HemoShear Therapeutics, Inc., a privately held clinical stage biotechnology company, reported that it has earned a milestone payment for the advancement of potential lead product candidates for the treatment of gout under its collaboration with Horizon Therapeutics plc (Nasdaq: HZNP) (Press release, Horizon Therapeutics, SEP 21, 2021, View Source [SID1234590108]). This milestone marks the fourth payment that HemoShear has earned, following previous payments for the identification and validation of two novel gout drug targets in accordance with the Horizon exclusive drug discovery agreement established in January 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Horizon has been a great partner throughout this collaboration," said Brian Wamhoff, PhD, chief operating officer of HemoShear. "By combining Horizon’s expertise in gout with HemoShear’s REVEAL-TxTM drug discovery platform, we are managing a research program that has generated new insights into the disease process, identified novel gout targets and generated several first-in-class modulators of these targets."

Under the terms of the agreement, HemoShear received an upfront payment and R&D funding, and Horizon received exclusive access to HemoShear’s proprietary disease modeling platform, to discover new therapeutics for gout. Successful development and commercialization of multiple therapies by Horizon will make HemoShear eligible to receive milestone payments of potentially more than $500 million plus royalties. Further financial terms were not disclosed.

Gout is a chronic, progressive inflammatory form of arthritis affecting more than nine million people in the United States that is caused by excess uric acid in the body and needs to be managed aggressively. If uric acid levels in the blood remain elevated, crystals can form and deposit in the joints, which can lead to severe pain, tenderness, stiffness, swelling and joint damage. In addition to the joint damage, urate crystals can also deposit in other organs of the body, and if left unmanaged, gout can lead to significant tissue damage. Uncontrolled gout occurs when people living with gout continue to have high levels of uric acid and gout symptoms despite the use of standard oral urate-lowering therapies.

On September 21, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, chairman, president and chief executive officer, will present virtually at the JP Morgan 12th Annual U.S . All Stars Conference on Wednesday, September 22, 2021 at 9:00 a.m. (EDT) (Press release, Thermo Fisher Scientific, SEP 21, 2021, View Source [SID1234590107]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

You can access the webcast of the presentation via the Investors section of our website, www.thermofisher.com.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.