On October 14, 2021 Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported the appointment of Theresa Heah, M.D., MBA as Chief Medical Officer and President of Kriya’s newly launched ophthalmology division, Kriya Ophthalmology (Press release, Kriya Therapeutics, OCT 14, 2021, View Source [SID1234591217]). Dr Heah will be responsible for advancing Kriya’s current pipeline of ophthalmology gene therapies and continuing to expand Kriya’s ophthalmology portfolio through its in-house R&D and business development engines.

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Kriya Ophthalmology is focused on the discovery and development of transformative gene therapies for ocular diseases with high unmet need. By leveraging Kriya’s computationally enabled vector design, data analytic and manufacturing technologies, Kriya Ophthalmology is uniquely positioned to accelerate the development of best-in-class gene therapies for rare and prevalent ocular diseases. Kriya Ophthalmology is currently advancing therapeutic programs in uveitis, geographic atrophy and additional undisclosed disease areas.

"Gene therapy has the potential to deliver transformative clinical benefits to address severe ocular diseases for which there are currently few effective treatment options," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya Therapeutics. "The launch of Kriya Ophthalmology, and the appointment of Theresa to lead our specialized division focused exclusively on diseases of the eye, reflects our commitment to delivering better products to patients suffering from a range of rare and prevalent ocular diseases. We believe that Kriya’s advanced technology platforms, combined with Theresa’s leadership and track record in ophthalmology, uniquely position this division to become one of the industry leaders in the development of gene therapies for ocular diseases."

"We are thrilled to welcome Theresa to lead Kriya Ophthalmology," said Ilise Lombardo, M.D., Chief Medical Officer of Kriya Therapeutics. "Her success in developing and launching treatments for ocular diseases will help Kriya play a pivotal role in the advancement of novel gene therapies that address a range of severe ocular conditions."

Dr. Heah is an accomplished executive with more than 20 years of R&D, regulatory strategy and clinical development experience. She previously served as Chief Medical Officer and Executive Vice President of Operations for AsclepiX Therapeutics where she led the company’s Series A financing and advancement of its pipeline products into the clinic. Prior to joining AsclepiX Therapeutics, Dr. Heah served as Chief Medical Officer at Applied Genetic Technologies Corporation (AGTC), where she worked to develop gene therapies in ophthalmology and rare diseases. She has also held several leadership positions with increasing responsibility in early-stage private companies (Fovea Pharmaceuticals), publicly traded companies (Aerie Pharmaceuticals, Allergan) and big pharmaceutical companies (Bayer Healthcare, Sanofi).

Dr. Heah has led multiple successful global regulatory submissions and commercialization of products including Ozurdex, EYLEA, Rhopressa and Rocklatan. While at Bayer, she launched EYLEA successfully into its eventual status as a blockbuster drug. She earned her M.D. from Guy’s, King’s and St. Thomas’ School of Medicine, King’s College, University of London, and her Executive Master’s in Business Administration from the European School of Management & Technology (ESMT), Berlin.

"My career has been dedicated to patients and the development of transformative and meaningful therapies aimed at improving their quality of life," said Dr. Heah. "Many still suffer from serious eye diseases for which there are no viable treatments. There is immense untapped potential in gene therapy, and it will be our mission to uncover and advance novel medicines for the betterment of underserved patient communities."

On October 14, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, reported that the Company will report third quarter 2021 financial results on Thursday, October 21, 2021, after market close (Press release, Cytori Therapeutics, OCT 14, 2021, View Source [SID1234591236]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

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A live webcast will be available at ir.plustherapeutics.com/events

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: 877-876-9173
International dial-in: 785-424-1667
Conference ID: PSTVQ321
Conference Call Name: Plus Therapeutics Third Quarter 2021 Results Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investor Relations’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On October 14, 2021 ARTMS Inc. (ARTMS), the global leader in developing and commercializing novel products enabling cyclotron production of the world’s most needed medical radioisotopes, reported the submission of a Type 1 Master File with the Health Products & Food Branch, Health Canada (HC) for the production of gallium-68 (Ga-68) (Press release, Point Biopharma, OCT 14, 2021, View Source [SID1234591252]). Gallium-68 is a critical medical isotope of significant clinical importance in nuclear medicine diagnostic procedures utilizing Positron Emission Tomography (PET) imaging. ARTMS’ Health Canada filing will help alleviate the current supply constraints and provide innovators the ability to advance new radiopharmaceutical drugs into development.

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On the basis of the filing, ARTMS has also entered into a tri-party co-operation with fellow industry leaders, POINT Biopharma (NASDAQ: PNT) and the Canadian Molecular Imaging Probe Consortium (CanProbe), a joint venture between the Centre for Probe Development and Commercialization (CPDC) and the University Health Network (UHN), for the development and clinical use of innovative radiopharmaceuticals in Canada.

"The Ga-68 regulatory filing in Canada is the next step in ARTMS’ goal to prevent the significant supply issues of this important medical isotope. The current supply chain of germanium/gallium generators is inefficient, high cost and at risk for interruption at any time. Any interruptions to the supply chain will negatively impact patients and drug innovators," explained Charles S. Conroy, Chief Executive Officer of ARTMS. "Our collaborative working relationship with POINT and CanProbe will leverage ARTMS’ proprietary solid target approach to bring important new medicines to Canadians."

"Increasing the availability and scale of Ga-68 supply through cyclotron production will be important in further accelerating the development and commercialization of next generation radiopharmaceutical therapies," said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. "We believe ARTMS’ solid target approach to Ga-68 production will play a key role in increasing the availability of this important isotope. We are excited to work with ARTMS and CanProbe in the creation of POINT’s new Ga-based based molecular imaging agents that will enable the development and commercialization of our next generation radiopharmaceutical therapies."

Dr. Bruno Paquin, President of CanProbe and CEO of CPDC, remarked, "Gallium-68 is the critical active component of many radiopharmaceuticals used in the diagnosis and staging of important medical conditions such as prostate cancer and neuroendocrine tumours." Dr. Paquin further commented that, "ARTMS’ QUANTM Irradiation System enables our facility a 100-fold increase in the availability of Ga-68 over the current generator supply. This significant increase in isotope supply directly impacts our ability to work with innovators such as POINT to meet end-patient needs."

ARTMS continues to drive nuclear medicine’s supply chain into the future through the QUANTM Irradiation System ecosystem by providing a pathway for large scale isotope production of Zr-89, Cu-64 and Tc-99m. Mr. Conroy concluded, "We will continue to support and work with radiopharmaceutical innovators to validate their products with the ARTMS system and have their regulatory filings reference ARTMS’ cyclotron solid target approaches."

On October 14, 2021 Neowise Biotechnology reported the company had completed Series A financing (Press release, Neowise Biotechnology, OCT 14, 2021, View Source [SID1234638951]). This round of financing was led by Taifu Capital and followed by Sinopharm Capital. This round of financing will be mainly used for the research and development of TCR-T immune cell therapy products, process development and the construction of GMP production workshops. Previously, Xinjing Zhiyuan has received angel round financing from Baidu Venture Capital and Baitu Biotechnology. In the one year since its establishment, Xinjing Zhiyuan’s cumulative financing amount has exceeded 100 million yuan.

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In recent years, cellular immunotherapy technology has developed rapidly, setting off a wave of cancer treatment. T cell immunotherapy is a hot field in cellular immunotherapy. In particular, CAR-T therapy has achieved remarkable results in the clinical treatment of blood cancer diseases. However, for solid tumors, which account for more than 90% of cancers, the industry generally believes that TCR-T cell therapy that can specifically recognize tumor intracellular antigens has greater therapeutic potential. However , how to provide patients with TCR-T cell therapy drugs quickly, accurately and effectively is a major pain point that plagues the development of the industry.

Against this background, Xinjingzhiyuan came into being in Suzhou BioBAY at the end of 2020, focusing on the development and industrialization of TCR-T cell therapy drugs for solid tumors . The company was co-founded by three Ph.D.s in the biomedical field who returned from the United States to start their own businesses full-time. The team members come from top universities such as California Institute of Technology, Carnegie Mellon University and Cornell University.

Dr. Peng Songming, founder and CEO of Xinjing Zhiyuan, was the first to directly isolate T cells capable of identifying the patient’s tumor from a tumor patient’s blood sample in 2016 while working at the California Institute of Technology, and participated in the founding of the company as one of the scientific founders. PACT Pharma, a tumor neoantigen cell therapy company, leads the R&D team to carry out personalized immunotherapy product development, IND filing and phase I clinical work. The company has received more than US$200 million in financing.

Relying on the rich experience of the founding team, Xinjing Zhiyuan hopes to analyze a large number of patient samples through independently developed high-throughput antigen-antigen receptor screening technology, thereby establishing the world’s largest antigen-antigen receptor paired relationship database (Paired Antigen- TCR library). Based on this database, Xinjing Zhiyuan can quickly select antigen receptors (TCRs) that accurately recognize solid tumors, edit, amplify and functionally identify tumor patients’ T cells, and infuse back the highly specific antigen receptors that recognize the patient’s tumor surface antigens. T cells, thereby achieving the goal of treating tumors and bringing good news to the majority of patients with solid tumors.

At present, Xinjing Zhiyuan has formed an experienced R&D team and established a R&D base in Suzhou. It has initially completed the verification of the high-throughput antigen-antigen receptor screening technology platform and begun to accumulate TCR sequences that specifically recognize tumor antigens. It has established close cooperative relationships with several well-known tertiary hospitals; at the same time, the company is also actively developing TCR-T production processes and preparing to build GMP plants to support the clinical development of subsequent pipelines.

Jiang Xiangren, managing partner of Taifu Capital , said: "Cell therapy is bringing more breakthrough therapies to patients at an unprecedented speed. The founding team of Xinjing Zhiyuan has built the world’s leading discovery platform for TCR-T cell therapy drugs. And it can well solve some key common problems in the current industrialization of TCR-T cell therapy. Taifu Capital highly recognizes Xinjing Zhiyuan’s innovative capabilities and company vision, and hopes to combine Taifu’s industrial resources and industry understanding to help the company’s development development to bring new breakthrough therapies to patients with solid tumors as quickly as possible."

Wu Aimin, founding partner of Sinopharm Capital, said: "TCR-T cell therapy has shown good potential in the treatment of solid tumors and has considerable clinical and commercial value. However, its screening barriers are high and the technology is difficult. We are highly optimistic about Xinjing Zhiyuan. The team’s global vision and R&D capabilities in this field integrate upstream bioinformatics analysis, midstream high-throughput screening, and downstream platform verification, greatly improving the success rate of R&D. We are confident that it will benefit patients in the future!"

Liu Wei, CEO of Baitu Biotechnology, said: "The breakthroughs achieved by Xinjing Zhiyuan in the past year have exceeded our expectations. Focusing on the highly expressed HLA subtypes in the Chinese population, the company has completed hundreds of pMHC-TCR tests in the past year. pairs, and in the process establish a high-throughput computing and experimental platform from discovery to verification. As an investor and strategic partner, we look forward to bringing more clinical resources and computing resources to the company, and strive to work with the company Build the world’s largest T cell antigen-antigen receptor database, improve the accuracy of current TCR-T AI design, and turn the "needle in the haystack" of solid tumor TCR-T drug discovery into "finding the picture."

On October 14, 2021 Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., reported a new study of real world data showing higher response rates than previously seen in people living with cutaneous T-cell lymphoma (CTCL) treated with POTELIGEO (mogamulizumab) (Press release, Kyowa Hakko Kirin, OCT 14, 2021, View Source [SID1234591218]). The findings, from a retrospective observational study of French CTCL patients, showed that the best overall response rate in the real-life study was 58.5 per cent, compared to 35 per cent seen in the MAVORIC trial.1,2 The MAVORIC study was the pivotal Phase 3 trial that investigated treatment with POTELIGEO compared to an active comparatora in previously treated adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

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Professor Martine Bagot of Saint-Louis Hospital, Université de Paris, France said: "The purpose of the study was to assess, for the first time, the efficacy and safety of mogamulizumab in a real-life setting. We saw a higher response in the real-life study compared to the MAVORIC trial results. The increase was also seen in both the MF and SS patient groups, compared to MAVORIC. As both the real world data and MAVORIC recruited a broadly similar set of patients, this new data underlines the value of mogamulizumab in treating these CTCL patients, whose disease causes a severe impact on their functioning, emotional and social wellbeing."

Data was collected and analysed from medical records of 124 MF and SS patients treated with POTELIGEO between February 2014 and March 2020, from 14 specialist treatment centres in France. The best overall response rate (ORR) seen in the real-life study was 47.0% in MF patients and 68.3% in SS patients. In contrast, the ORRb in MAVORIC was 21% and 37%, respectively.1,2 Of the 124 patients who received POTELIGEO treatment in the study, 44% were MF patients and 56% were SS patients. This compares to 56% and 44% in MAVORIC, respectively. In the real-life study, 49.6% of patients were at disease stage IVA1, compared to 39% in MAVORIC.1,2

POTELIGEO was also shown to have a favourable safety profile, in the real life study the most common drug-related treatment-emergent adverse events (TEAEs) were lymphopenia and asthenia. Commonly occurring TEAEs seen in both the real life study and MAVORIC were rash and infusion-related reactions.1,2

Abdul Mullick, President of Kyowa Kirin International, said: "Kyowa Kirin is committed to improving outcomes for patients with rare diseases, whose needs are often underserved. It’s heartening to see this new real world data, which reinforces what we’ve seen previously in clinical trials. Kyowa Kirin is dedicated to improve the lives of patients with CTCL, which is a chronic, debilitating disease and to deliver on our purpose, to make people smile."

MF and SS are subtypes of CTCL, a rare type of non-Hodgkin’s lymphoma that can affect the skin, blood, lymph nodes and internal organs.3 It is associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.4

The new data was presented at a poster session at the EORTC meeting in Marseille, France, which is being held on 14-16 October 2021.

a The comparator in the MAVORIC trial was vorinostat, a histone deacetylase inhibitor (HDACi) and FDA-approved standard of care option for treatment of CTCL that is licensed in the US for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies. Vorinostat is not licensed for use in Europe.

b MAVORIC ORR included only those patients with confirmed global response at two (or more) successive evaluations at least 8 weeks apart).

About Mycosis Fungoides (MF) and Sézary syndrome (SS)

Cutaneous T-cell lymphoma (CTCL) is a cancer of white blood cells (lymphocytes) that presents in the skin.5 CTCLs are rare, serious and potentially life-threatening forms of non-Hodgkin lymphoma (NHL).2 Malignant T cells in CTCL circulate in the blood and migrate to the skin6 causing lesions and itching.7

The annual incidence of CTCL in Europe is around 5.2 new cases per 100,000 population8 and it affects around 240 people per million in the region at any one time.5 The two best-studied types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS).9 Together, MF and SS account for around two thirds of all CTCLs.10,11

MF accounts for approximately 60% of all CTCLs,10 is typically indolent and is characterised by skin symptoms including patches or plaques, skin redness and tumours.12
SS is much rarer, accounting for around 5% of CTCLs,6 and is more aggressive13 with high levels of blood involvement by definition.10 It causes very severe itching, total body redness (erythroderma), intense scaling of the skin and frequent hair loss. 7
It can typically take between three and six years from CTCL disease onset for a patient to be diagnosed, in some cases it can take decades.10,12 This is sometimes due to the fact that CTCL presents very similarly to other benign skin conditions (e.g. eczema and psoriasis)7; this can mean many patients experience a long, frustrating journey before diagnosis.

CTCL can be very distressing for patients and has a significant negative life-long impact upon many aspects of a patient’s life.12,14 CTCL causes chronic skin impairment with itching, pain, recurrent infections, and disfiguring skin lesions, as well as sleep disturbance and psychosocial problems.9,12 Even in the early stages of CTCL, the disease can affect patients’ ability to meet the needs of their family, interfere with their job, and limit normal daily activities.14

About POTELIGEO (mogamulizumab) and the MAVORIC Trial

Malignant T lymphocytes in MF and SS, consistently express a molecule called CC chemokine receptor 4 (CCR4).2 POTELIGEO is a humanised monoclonal antibody that selectively binds to CCR4-expressing cells15 and helps destroy them by harnessing the body’s immune system.2 POTELIGEO is a systemic therapy, administered by intravenous infusion weekly for the first five weeks, then subsequently every two weeks.15 The registrational Phase 3 MAVORIC trial was the largest randomised study of systemic therapy in CTCL. It evaluated the safety and efficacy of POTELIGEO versus vorinostat in patients who had failed at least one previous systemic therapy.2

Following a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission (EC) granted marketing authorisation for POTELIGEO in November 2018 for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.15

Important Prescribing information and Safety Information

Refer to the full Summary of Product Characteristics (SmPC) for prescribing information and the full safety information: View Source