On September 9, 2020 TScan Therapeutics, a biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies in oncology, reported plans to file two Investigational New Drug (IND) applications in their liquid tumor program in 2021 (Press release, TScan Therapeutics, SEP 9, 2020, View Source [SID1234564844]). Their first product, TSC-100, targets HA-1 and is designed to treat patients receiving hematopoietic stem cell transplant therapy with the goal of preventing relapse, a high unmet need in this setting. TScan announced selection of their lead TCR and its advancement to IND-enabling activities. Simultaneously, TScan announced selection of their second target, HA-2, with plans to file a second IND in 2021. These products are the first two TCRs in a multi-TCR program designed to provide treatment options for the majority of patients receiving stem cell therapy.

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"We are excited to progress this T cell therapy solution for patients receiving stem cell transplant therapy," said David Southwell, Chief Executive Officer at TScan. "TScan’s goal in both its liquid and solid tumor programs is to learn from patients who respond well to therapy to treat those who are less fortunate. This represents a significant step in the progression of TScan as a TCR therapy company. Our lead TCR, TSC-100, was discovered internally using our TCR discovery platform, R-Scan, and was significantly derisked using our proprietary genome-wide safety screening platform, T-Scan. By extending our liquid tumor program to also include HA-2, we are one step closer to providing a comprehensive solution for patients receiving stem cell therapy. We also remain on track to nominate solid tumor targets in 2021."

Leveraging its core TCR discovery platform, R-Scan, TScan identified its lead HA-1 TCR after screening over 100,000,000 T cells from HA-1-negative donors. In preclinical experiments, TSC-100 showed strong activity against HA-1-positive leukemia cells and a clean safety profile, with minimal off-target interactions or alloreactivity. TSC-100 will be used to engineer donor T cells in the context of a stem cell transplant, with the goal of preventing relapse in HA-1-positive patients with AML, MDS, or adult ALL. To expand this program to patients not expressing HA-1, TScan is developing a second TCR specific for HA-2, termed TSC-101.

"Our goal is to provide a therapeutic option for every patient," said Gavin MacBeath, Chief Scientific Officer. "Our discovery team is already identifying TCRs that will allow our products to address an even broader patient population. Expanding our repository of therapeutic TCRs also enables us to develop multiplexed TCR therapies, which better mimic natural immune responses and provide more robust treatments for heterogeneous cancers like AML, as well as a diverse range of solid tumors. Using our two core platforms, we remain on track to nominate our first solid tumor candidates in early 2021."

About HA-1

HA-1 is a well-characterized minor histocompatibility antigen that is expressed on all blood cells, including leukemia cells, but is not expressed at appreciable levels in other normal tissues. It is associated with clinical benefit by generating a ‘graft vs. leukemia’ effect in the context of hematopoietic stem cell transplants in which the patient is HA-1-positive and the donor is HA-1-negative. Over half of all patients express the HA-1 target.

About HA-2

Similar to HA-1, HA-2 is a minor histocompatibility antigen expressed specifically on blood cells and is associated with clinical benefit through a ‘graft vs. leukemia’ effect. Addition of TSC-101, an HA-2-specific TCR, will expand the pool of eligible patients for TScan’s liquid tumor program.

On September 9, 2020 Phosplatin Therapeutics, a clinical stage pharmaceutical company focused on oncology therapeutics, reported the addition to its growing team of Joseph F. O’Donnell, MD, as Interim Chief Medical Officer and Jason Summa in the newly created role of Vice President of Clinical Development (Press release, Phosplatin, SEP 9, 2020, View Source [SID1234564877]).

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"We welcome both Dr. O’Donnell and Jason to our rapidly growing clinical team. As a long-standing member of our Scientific Advisory Board from Phosplatin’s early days, Dr. O’Donnell is uniquely qualified to oversee the strategy, direction and execution of our clinical development program. Jason brings deep knowledge as a biotechnology and pharmaceutical executive with many years of clinical trial experience in a variety of solid tumors, including ten years in the prostate cancer space," said Robert Fallon, President and Chief Executive Officer of Phosplatin Therapeutics. "As Phosplatin continues to advance PT-112 to the next stage of development, having successfully completed our second and third Phase 1 clinical trials earlier this year, the clinical development expertise brought to these roles by both Dr. O’Donnell and Jason will be invaluable in our continued efforts in Phase 2 development of PT-112."

Dr. O’Donnell is a deeply experienced clinical oncologist who began his career at the National Cancer Institute, and after that had a long-standing academic career at the Geisel School of Medicine at Dartmouth, where he most recently served as the Elizabeth Decamp McInerney Professor of Medicine. He also served for many years as an Associate Dean and Senior Scholar of the C Everett Koop Institute at Dartmouth. He is on the editorial board of the Journal of Cancer Education, where he also served for years as Editor-in-Chief and the Journal of Palliative Care, as well as being an editorial referee for six journals and grants referee for the National Cancer Institute. He has published more than 100 studies and four books related to oncology and medical education.

Dr. O’Donnell is the recipient of millions of dollars in grants from the National Institutes of Health, the American Cancer Society, and the Corporation for National and Community Service, among others. He has served on countless committees, and is a respected lecturer and a member of many professional societies, including the American Association of Cancer Education, the European Association for Cancer Education, and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper). He graduated with an A.B. in biology summa cum laude from Harvard College and an MD from Harvard Medical School.

"The unique potential of PT-112 has intrigued me from my early involvement with Phosplatin. I am eager to draw on my years of experience in the oncology field to lead the clinical development team to an FDA approval to make this potentially highly impactful therapy available to cancer patients," said Dr. O’Donnell.

Mr. Summa most recently served as Oncology Director and Clinical Project Scientist with the Janssen Pharmaceutical Division of Johnson & Johnson where he was responsible for the clinical program for developing niraparib, a PARP-inhibitor under development in metastatic castration-resistant prostate cancer patients with DNA repair defects, including successfully procuring Breakthrough Therapy Designation. Previously he spent nine years with BIND Therapeutics in a variety of clinical roles in the area of oncology, including oversight of the clinical department. He began his career with Alkermes and served in drug development roles with Corixa Corporation and Momenta Pharmaceuticals as well. Mr. Summa has authored more than 15 publications, developed protocols for eight clinical trials and holds a patent for inhalable epinephrine. He is a member of six professional oncology-related organizations.

"I am looking forward to following my passion and offering my experience in oncology clinical trial development to contribute to the commercial availability of this unique therapy, and to working alongside the talented Phosplatin team, with its deep expertise and strategic vision," said Mr. Summa.

The Company’s previous Chief Medical Officer, Jose Jimeno, MD, PhD, has recently taken on new responsibility as VP Global Head, Virology and Inflammation, in a newly created division of PharmaMar (Madrid, Spain) and has become a member of the Phosplatin Therapeutics Scientific Advisory Board in order to continue his involvement with the PT-112 development program.

About PT-112

PT-112 is the first small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs) that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death, and is under Phase 2 development. The first-in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients, and won "Best Poster" at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress within the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in bone, or frequently lead to metastatic bone involvement, such as metastatic castrate-resistant prostate cancer (mCRPC). The first human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium on February 13, 2020.

On September 9, 2020 Alkermes plc (Nasdaq: ALKS) reported that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 p.m. BST) (Press release, Alkermes, SEP 9, 2020, View Source [SID1234564903]). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On September 9, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported updated timelines indicating 3-6 months delay for the planned Phase Ib study with ATOR-1015, its tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer (Press release, Alligator Bioscience, SEP 9, 2020, View Source [SID1234564803]).

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As previously communicated, preliminary data from the ongoing Phase I study have shown that ATOR-1015 is well tolerated at doses up to 600 mg (about 10 mg/kg), which is believed to be a clinically relevant dose range. At the current dose of 750 mg (~12.5 mg/kg), some grade 3 infusion related reactions have been reported which is expected to result in further dose evaluations.

"While the infusion related reactions will lead to the selection of a Phase Ib dose below 750 mg, we are still considerably higher in dose than our competitors and well within clinically relevant dose levels", commented Per Norlén, CEO at Alligator Bioscience.

The ongoing Phase I dose escalation will be completed during the fourth quarter 2020 as previously communicated. The start of the Phase Ib expansion in malignant melanoma will be pushed into 2021 due to study amendments to adjust for the observed reactions. Recruitment will start as soon as regulatory approval has been obtained.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 1:40 p.m. CEST on September 9, 2020.

About ATOR-1015
ATOR-1015 is a tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer. Promising data from the ongoing ATOR-1015 Phase I clinical trial was presented at ASCO (Free ASCO Whitepaper) in June 2020 and dose escalation continued at the higher dose 750 mg. The next step in the ATOR-1015 clinical development plan is a Phase Ib study for demonstration of single-agent activity.

On September 9, 2020 Varian (NYSE: VAR) reported the German Cancer Research Center (DKFZ) in Heidelberg has ordered Germany’s first Ethos therapy, an Adaptive Intelligence solution (Press release, Varian Medical Systems, SEP 9, 2020, View Source [SID1234564824]). This artificial intelligence (AI)-driven holistic solution is designed to increase the capability, flexibility, and efficiency of radiotherapy. Ethos therapy delivers an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery. The first Ethos therapy in Germany is scheduled to be installed and start treating patients by early 2021.

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"Adaptive therapy is one of the most important developments in the field of radiotherapy," said Prof. Dr. Michael Baumann, CEO and scientific director at DKFZ. "At DKFZ, cancer researchers and oncologists are closely cooperating to get the latest research findings rapidly from bench to bedside, as well as transfer the insights gained from the treatment back from clinic to the lab. Ethos therapy will complement both our research and treatment activities at DKFZ, and we are looking forward to applying adaptive radiotherapy in this context."

"We are very proud that DKFZ, the largest biomedical research center in Germany, has selected Ethos to conduct both research into adaptive radiotherapy and to put this research directly into practice," said Chris Toth, president, Varian Oncology Systems. "Since its introduction in September 2019, Ethos therapy has been recognized by leading clinics around the world as a game changer that is unlocking a new era of personalized adaptive radiation therapy."

DKFZ is among the most renowned cancer research facilities in the world, with 3,000 employees working tirelessly to gain a better understanding of cancer and putting their research findings to medical use for patients. Located on the Heidelberg biomedical campus, DKFZ scientists are engaged in a large number of national and international partnerships and research alliances and cooperate closely with several university hospitals in translational networks. The DKFZ Ethos therapy was financed by the Dieter Morszeck Foundation.

Ethos Therapy

The streamlined workflow of Ethos therapy is enabled by its AI-driven planning and contouring capabilities. Physicians define their clinical intent from predefined templates and the initial treatment plan is generated based on the physician’s pre-defined clinical objectives. The treatment is adapted in response to changes in the patient’s anatomy and the tumor’s shape and position, at the time of treatment. The ability of Ethos to deliver on-couch adaptive treatment puts the patient at the center of care.

Ethos therapy offers the use of multimodality images (MR, PET, CT) registered with daily iterative CBCT images at the console. By providing an up-to-date view of the patient’s anatomy, Ethos therapy provides clinicians the confidence to make more informed adaptive treatment decisions. The solution is built on Varian’s latest treatment delivery technology and provides fast imaging and treatment delivery without compromising quality.

Ethos therapy has obtained CE mark, as well as 510(k) clearance. Its availability is rapidly expanding across multiple markets worldwide. For more information on Ethos, visit www.varian.com/ethos.