On October 14, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2021 financial results will be released on Thursday, October 28, after the market closes (Press release, Gilead Sciences, OCT 14, 2021, View Source [SID1234591255]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s third quarter 2021 financial results and will provide a business update .

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

On October 14, 2021 Tizona Therapeutics, Inc., a privately held, clinical-stage company developing first-in-class cancer immunotherapies, reported that its lead investigational therapy, TTX-080, a novel antibody targeting HLA-G, has advanced to Phase 1b (Press release, Tizona Therapeutics, OCT 14, 2021, View Source [SID1234591254]). This phase includes expansion tumor arms to evaluate the safety and efficacy of TTX-080 as monotherapy and combination regimens in patients with advanced malignancies.

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The Phase 1b is a dose expansion study designed to assess TTX-080 as monotherapy and in combination with either pembrolizumab or cetuximab in patients with advanced refractory or resistant solid tumor malignancies, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and triple negative breast cancer. In addition to evaluating the anti-tumor activity of TTX-080, the study will continue to evaluate the safety, pharmacokinetics, and immunogenicity of TTX-080. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

"The initiation of the Phase 1 dose expansion study is an important milestone for the TTX-080 clinical development program," said Christine O’Brien, Chief Executive Officer, Tizona. "As a novel checkpoint inhibitor, the TTX-080 program offers an opportunity to apply new understandings of immune regulation within the tumor microenvironment in solid tumor indications where patient outcomes remain a major unmet medical need."

The Phase 1b expansion study follows the Phase 1a study, an open label, multicenter, dose escalation clinical trial designed to assess the safety and tolerability of TTX-080 as monotherapy. The Phase 1a stage of the study, which has completed enrollment, determined a recommended Phase 2 dose of TTX-080 when administered as a single agent.

About TTX-080

TTX-080 is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. By blocking the interaction of HLA-G with its receptors, TTX-080 prevents the suppression of both innate and adaptive immune activity and has the potential to enhance anti-tumor responses. Tizona is currently enrolling patients in a Phase 1b clinical trial (NCT04485013) evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.

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).