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 [SID1234591253]). 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 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 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, highlighted ImmunityBio, Inc.’s (NASDAQ: IBRX) ("ImmunityBio") reported completion of enrollment in its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) – which includes aldoxorubicin – in advanced metastatic pancreatic cancer (Press release, CytRx, OCT 14, 2021, View Source [SID1234591251]).

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CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.

According to ImmunityBio, the majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. On the strength of this early data and significant unmet medical need, ImmunityBio has submitted an amendment to increase enrollment in Cohort C.

Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, commented:

"Patients with advanced metastatic pancreatic cancer who have failed all standards of care have very grave prognoses with few treatment options. This study was to explore if the Nant Cancer Vaccine could address this unmet need. It is gratifying to note that patients in this study, who had progressed after up to six lines of prior therapy, have exceeded historical survival rates despite having very advanced pancreatic cancer upon enrollment. Achieving robust enrollment in this patient group and early promising efficacy evidence are important milestones in ImmunityBio’s effort to develop this therapeutic with the potential to improve survival rates and provide a replacement for toxic chemotherapy. As the historical survival rate for third- to sixth-line pancreatic cancer patients is approximately two months, we are encouraged by this early data and have decided to open this cohort to more patients with advanced metastatic disease who have no further treatment options."

Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:

"With each of our licensing agreements, CytRx’s primary goal is to put greater energy and resources behind innovative clinical programs working to combat cancer and rare diseases. We are highly encouraged by ImmunityBio’s milestone achievement of robust enrollment in its QUILT-88 study and early evidence of promising efficacy of the Nant Cancer Vaccine, which includes our licensed aldoxorubicin drug, to treat severe cases of pancreatic cancer. We look forward to continuing to monitor the trial’s progress when mature data is released in Q1 2022, ahead of ImmunityBio’s plans to meet with the U.S. Food and Drug Administration in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer."

QUILT-88 Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which serves patients in the tri-state area (Iowa, Nebraska and South Dakota).

On October 14, 2021 Pillar Biosciences, an innovative, next-generation sequencing (NGS) solutions, in-vitro diagnostics company, reported that it has entered into an agreement with Labcorp (NYSE: LH), a leading global life sciences company, to provide genomic testing for people with cancer (Press release, Pillar Biosciences, OCT 14, 2021, View Source [SID1234591250]).

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Under the agreement, Pillar Biosciences will provide the oncoReveal Essential Myeloproliferative Neoplasm (MPN) panel. Using NGS, the test simultaneously measures for DNA mutations across multiple genes.

"Collaborating with Labcorp makes available a targeted NGS testing solution to accurately diagnose and monitor people with cancer who are suspected of having myeloproliferative neoplasms, which are diseases of the blood and bone marrow," said Laura Beggrow, Chief Business Officer at Pillar Biosciences. "This collaboration presents a broad market opportunity and bolsters our mission to make precision medicine accessible to all by providing high-quality, affordable specialty NGS testing capabilities."

"Our collaboration with Pillar Biosciences allows us to provide an accurate, efficient and scalable solution to patients with blood and bone marrow diseases through a multiplex targeted gene panel," said Dr. Marcia Eisenberg, Chief Scientific Officer at Labcorp and a Member of the Scientific Advisory Board of Pillar Biosciences. "Offering this specialty oncology assay will enable patients and health care providers to make the most-informed and best-possible treatment decisions."

On October 14, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that it has raised an additional $6.2 million in an equity offering at $8/share (Press release, MAIA Biotechnology, OCT 14, 2021, View Source [SID1234591249]). The proceeds of the financing will advance the company’s programs and will support the initiation of a Phase 2 clinical trial (THIO-101) evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The THIO-101 trial is expected to begin this year.

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"We are excited to have closed this latest financing round, which brings MAIA additional capital as we continue to advance our THIO program," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We appreciate the continued support of our high-quality investors who share our vision developing novel cancer therapies aimed at overcoming treatment resistant diseases."

About the Phase 2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)

This trial (THIO-101) will be the first to test THIO’s immune system activation by administering THIO in advance of administration of the checkpoint inhibitor (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.

The THIO-101 trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 41 evaluable patients.

About THIO

THIO (6-thio-dG, 6-thio-2’-deoxyguanosine) is a potentially first-in-class small molecule that, to our knowledge, is the only cancer telomere targeting agent currently in development. THIO is believed to selectively target telomerase-positive cancer cells, which account for more than 85% of human cancers. Data from pre-clinical studies showed that THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. Studies to date also showed that telomerase recognizes THIO and selectively incorporates it into the telomeres in tumor cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends, which results in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in pre-clinical models and produced cancer cell-specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results support the hypothesis that demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, and provides a strong rationale for sequentially combining telomere-targeted therapy with immunotherapy. THIO is investigational and has not been approved yet for any use by regulatory authorities.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. It is estimated that, in 2020, more than 2.2 million new cases were diagnosed globally, including 228,000 new cases in the U.S. Approximately 85% of all lung cancers are NSCLC and an estimated 80% of these cases are telomerase positive. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains a significant unmet need to optimize treatment of patients and offer additional clinical options.