On January 26, 2022 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), a clinical-stage oncology-focused cell therapy company, reported that highlighted recent operational and corporate updates (Press release, Ziopharm, JAN 26, 2022, View Source [SID1234607432]). The Company also announced that it has changed its name to Alaunos Therapeutics, Inc. ("Alaunos" or the "Company").

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"We are very pleased to announce that our Phase 1/2 TCR-T library trial is now open for enrollment at MD Anderson Cancer Center. This first of its kind study, enabled by our versatile non-viral Sleeping Beauty technology, will allow us to efficiently target six solid tumor indications within this single clinical trial. In addition, our R&D efforts continue to bear fruit and we amended our IND to include four additional TCRs to the study. This further increases the number of eligible patients who could benefit from our therapies, and we look forward to dosing the first patient in this study within the first half of this year. Lastly, to support our clinical development, we have successfully opened our cGMP manufacturing facility and we are now able to manufacture our autologous cell therapy products in-house," commented Kevin S. Boyle, Sr., Chief Executive Officer.

"Over the course of 2022, the team will continue to work diligently with an execution mindset to deliver results. In addition to translating groundbreaking science into meaningful clinical progress we will work to advance our membrane bound IL-15 program with IND enabling studies. Our name change to Alaunos Therapeutics reflects the completion of our transition to a TCR-T focused company and embodies our mission of developing novel therapies for cancer patients," concluded Mr. Boyle.

Operational Updates

Phase 1/2 TCR-T Library Program Open for Enrollment: Alaunos’ phase 1/2 clinical trial is evaluating library TCR-T shared hotspot neoantigens using the Company’s Sleeping Beauty transposon/transposase technology. The Company added four additional T-cell receptors (TCRs) to its library, further increasing the number of eligible patients for the clinical trial. The study being conducted at MD Anderson Cancer Center is an open label, dose escalation study that will enroll patients who have a matched HLA and hotspot mutation that is a targeted by one of the 10 TCRs from the Alaunos library. The trial will evaluate 10 unique TCRs targeting KRAS, TP53 and EGFR mutations in patients across a broad range of solid tumors that include non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers, all in a single trial. The Phase 1 primary endpoint is maximum tolerated dose or recommended phase 2 dose. The Company expects to dose the first patient in the first half of 2022 and to provide an interim data update later this year. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735.

In-House cGMP Manufacturing Facility Operational: Alaunos completed the qualification of its state-of-the-art good manufacturing practice (cGMP) TCR manufacturing facility near the Texas Medical Center in Houston. The facility is staffed by Alaunos personnel and is fully operational for the manufacture and release of clinical product.

hunTR (human neoantigen T-cell Receptor) Platform for TCR Discovery: Alaunos’ TCR hunting process, hunTR, enables the rapid identification of new and proprietary TCRs from CD4+ and CD8+ T cells to further expand the Company’s growing TCR-T library. The platform can evaluate thousands of single T cells simultaneously using state-of-the-art bioinformatics and next generation sequencing to identify TCRs specific for neoantigens that arise from hotspot mutations. The proprietary high-throughput TCR screening process permits rapid functional validation of TCRs. Newly discovered neoantigen-specific TCRs will then undergo further development required to potentially qualify the TCR for inclusion in the Company’s TCR library and clinical evaluation.
Corporate Updates

Name Change to Alaunos Therapeutics, Inc.: The name Alaunos originates from the Celtic mythological god of healing, reflecting the Company’s commitment to developing therapies for cancer patients. The Company will trade on The Nasdaq Stock Market under the new ticker symbol "TCRT", to be effective at market open on January 27, 2022. In conjunction with the corporate name change, the Company has launched a new website, www.alaunos.com, which contains information about the Company and its innovative TCR-T platform.

Closure of Boston, MA Location: To streamline operations, the Company has closed its Boston office. Alaunos will be headquartered in Houston.

On January 26, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported that it has entered into a Global License Agreement with Xiamen Biotime Biotechnology Co., Ltd. ("Biotime") for several compounds (Press release, Adlai Nortye Biopharma, JAN 26, 2022, View Source [SID1234607423]). This includes the rights and interests of Adlai Nortye in the development, manufacturing and commercialization of AN4005 and AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. According to the terms of the agreement, the total amount of this cooperation will reach hundreds of millions of yuan, including the upfront payments, progress-dependent milestone payments and tiered royalties on sales.

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According to Jianping Yu, the chairman secretary of Biotime, "Based on independent innovation, Biotime has started involving in innovative drug business, increased R&D investment, actively integrated into the global innovation network and focused on creating an innovation engine for high-quality development. The cooperation with Adlai Nortye, a leading brand of innovative drugs, will be a win-win attempt."

Dr. Nanhai He, the head of drug discovery of Adlai Nortye, said, "We are very happy to reach this agreement with Biotime, who has strong technical capabilities and scientific and technological strength, and puts a high value on product R&D and technological innovation. This cooperation will pave the way for the development and commercialization of several products, including AN4005 and AN3025, on a global scale, and benefit patients all over the world. We firmly believe that the partnership with Biotime will greatly accelerate the R&D and commercialization of these drugs."

About AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates anti-tumor activity by the blockade of PD-1/PD-L1 interaction. In preclinical studies, AN4005 has demonstrated significant pharmacological activity, target affinity and acceptable safety profiles, which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to overcome the inhibition derived from PD-1/L1 interaction in hPBMC-based functional assays. Small molecule PD-L1 inhibitors are expected to provide several benefits over mAbs, such as, allowing for oral administration, lower production costs, improved tumor penetration, and lack of immunogenicity.

About AN3025

AN3025 is a novel humanized IgG1 (variant) anti-hTNFR2 antibody that is currently under preclinical study. This antibody binds to the extracellular domain of human TNFR2 with sub-nanomolar affinity and occludes its ligand TNFa from accessing TNFR2. Since TNFR2 is highly expressed on a subset of immunosuppressive cells, including regulatory T cells (Tregs) and MDSCs, within the tumor microenvironment, AN3025 is expected to amplify the antitumor immune response to aid in immunotherapy.

On January 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS” or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been accepted by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, JAN 26, 2022, View Source [SID1234607422]). The IND, for a small Phase I clinical trial investigating safety, was submitted by SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"). 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA will trigger a milestone payment to SELLAS. The current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $192.5 million, not including future royalties.

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"Acceptance from China’s NMPA of 3D Medicines’ IND application to initiate a Phase I clinical trial of GPS in patients with hematological malignancies in China marks an important regulatory milestone for SELLAS," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "The results of our own Phase I and II clinical trials in acute myeloid leukemia (AML), malignant pleural mesothelioma (MPM), multiple myeloma (MM), and relapsed ovarian cancer have been extremely encouraging. We look forward to expanding the reach of GPS outside the U.S. and Europe and we view 3D Medicines’ initiation of the clinical development program of GPS in China to be a key step in our plans to improve clinical outcomes for cancer patients, not only in China, but worldwide."

"In addition, we are exploring the possibility of 3D Medicines participating in SELLAS’ ongoing randomized, multi-center Phase III REGAL clinical trial currently underway in the U.S. and Europe in patients with AML who have achieved their second complete remission. Such participation would trigger a milestone payment to SELLAS. Furthermore, GPS has the potential to create synergies in combination with envafolimab, 3D Medicines’ PD-L1 product formulated for subcutaneous injection, which received marketing approval from the NMPA in China at the end of 2021. We, together with 3D Medicines, plan to explore the combination for advanced treatment for different types of cancers," concluded Dr. Stergiou.

About 3D189
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.

3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.

On January 26, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that its supervisory board created 1,000,000 subscription rights under a new subscription right plan for the benefit of a member of the personnel of the Company (Press release, Galapagos, JAN 26, 2022, View Source [SID1234607421]).

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On 26 January 2022, the supervisory board of Galapagos approved "Subscription Right Plan 2022 (B)", intended for a new member of the personnel of the Company, within the framework of the authorized capital. Under this subscription right plan, 1,000,000 subscription rights were created, subject to acceptance. Dr. Paul Stoffels will ultimately become the new Subscription Right Holder under the scheme.

The subscription rights have an exercise term of eight years as of the date of the offer and have an exercise price of €50. The subscription rights can in principle not be exercised prior to 1 January 2026. Each subscription right gives the right to subscribe to one new Galapagos share. Should the subscription rights be exercised, Galapagos will apply for the listing of the resulting new shares on a regulated stock market. The subscription rights as such will not be listed on any stock market.

Galapagos’ total share capital currently amounts to €354,582,005.11; the total number of securities conferring voting rights is 65,552,721, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights to subscribe to not yet issued securities conferring voting rights is (i) 8,595,522 subscription rights under several outstanding employee subscription right plans, which equals 8,595,522 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 1,000,000 subscription rights of Subscription Right Plan 2022 (B), which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

On January 26, 2022 Aptus Clinical reported A new trial opens in Greater Manchester which is to test cutting-edge wearable technologies involving patients who have received cancer treatment (Press release, Aptus Clinical, JAN 26, 2022, View Source [SID1234607418]).

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The commercially-available health sensors and devices produce a digital fingerprint of vital signs that could allow doctors to assess the progress of their patients.

Called, EMBRaCE, (Enhanced Monitoring for Better Recovery and Cancer Experience), the trial is a collaboration between Manchester University NHS Foundation Trust, The Christie NHS Foundation Trust and The University of Manchester.

The trial opens initially for blood cancer, lung, and colorectal cancer patients and will run across Greater Manchester.

The technologies under investigation include:

a smart ring, worn on any finger made by the company Oura
the Withings ScanWatch, a hybrid smartwatch
the Isansys system, which is worn on the chest.
The technologies can assess a range of vital signs, including electrocardiogram (ECG), heart rate, temperature, physical activity levels and sleep.

Dr Anthony Wilson, Consultant in Anaesthesia and Critical Care at Manchester Royal Infirmary (MRI), part of MFT, is the clinical lead for the project.

He said: "Cancer places a huge burden on the lives of people everywhere. This study uses cutting-edge technology that can monitor people during their treatment, with devices that they can wear all the time.

"We hope that it will provide new insights into how people cope with cancer treatment and what we can do to improve their recovery."

Dr Michael Merchant, Senior Lecturer in Proton Therapy Physics, at The University of Manchester, said: "This trial will assess if the latest wearable technology has a role in cancer care.

"It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy.

"We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic.

"It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers."

Thomas Westworth, 70, is from South Lakeland in the Lake District. Now retired, he was self-employed within the building trade for 40 years, and has been receiving care for lymphoma at Manchester Royal Infirmary, part of Manchester University NHS Foundation Trust (MFT), for three months.

Mr Westworth will be taking part in the trial in the next couple of weeks when he receives his first infusion of CAR-T (Chimeric Antigen Receptor T-cell) therapy – a personalised medicine used to treat patients with certain types of leukaemia and lymphoma.

Mr Westworth said he is ‘fascinated by technology’, and was happy to consent to taking part in EMBRaCE when he was approached by the study team.

"I said if could be of any help I’d be happy to take part," said Mr Westworth.

"I think the actual idea behind the trial is fantastic, I think it should help people.

"All the staff here at Manchester Royal Infirmary and other hospitals where I have been cared for have been fantastic, everyone is absolutely brilliant."

EMBRaCE is funded by the GM Cancer Digital Innovation Fund, UK Research and Innovation and the National Institute for Health Research (NIHR) in collaboration with Aptus Clinical and Zenzium Ltd.

This trial will assess if the latest wearable technology has a role in cancer care. It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy. We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic. It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers.
Dr Michael Merchant

Steve McConchie, CEO of Aptus Clinical, a clinical contract research organisation based in Alderley Park, Cheshire, said: "We are delighted that the clinical data collection and curation infrastructure we initially created to support an important piece of exploratory research into COVID-19 is being expanded to assess the utility of patient wearables to improve the care of cancer patients across Manchester.
"We look forward to continuing this collaboration with our partners at MFT , The Christie, and Zenzium and are pleased to be supporting research with the potential to make a real difference to patient’s care."

EMBRaCE is partnered with the health and biomedical data science company Zenzium Ltd to harness the power of Artificial Intelligence (AI) to analyse and identify key patterns within patient data.

Anthony D. Bashall, Managing Director of Zenzium, said: "We firmly believe the future of healthcare will be driven by continuous rather than episodic measurements to improve patient outcomes on an individual basis.

"We are excited to be part of this ground-breaking collaboration with some of the best entities in the field, which gives us the opportunity to bring our technology, knowledge and expertise in wearable devices enabled by AI to potentially make a real difference in the lives of patients."

Mr Steve Sweeney, cancer survivor and chair of the group of patients who have advised the project commented: "A cancer diagnosis is fraught with a variety of challenges for patients, way beyond the clinical treatment pathway itself.

"We know patients have anxiety around ongoing monitoring and the gap between GP and hospital cancer care, issues with fatigue and sleep disturbance, problems maintaining fitness and the need for greater psychological support.

"The EMBRaCE programme addresses these challenges head on, allowing participants to take more proactive control of their cancer journey through wearables and the data they provide clinicians. These patient pioneers will help shape the future of cancer care in the UK."

Professor Dave Shackley, Director of Greater Manchester Cancer Alliance and the Senior Responsible Officer for Cancer in Greater Manchester said: "We are delighted in Greater Manchester to have such a fantastic study taking place. The smart use of digital technology is going to be pivotal for high quality, personalised cancer care for our patients. We look forward to hearing the outcomes of this exciting research project and in particular implementing any key findings."