On March 24, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that an investigator-initiated trial (IIT) will commence shortly in the US investigating 64Cu SAR-bisPSMA in prostate cancer (NCT05286840)1 (Press release, Clarity Pharmaceuticals, MAR 24, 2022, View Source [SID1234610816]).

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The X-Cancer’s investigator-led trial of SAR-bisPSMA in known or suspected prostate cancer (X-Calibur) is a Phase I/II IIT in up to 150 patients at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, sponsored by Dr Luke Nordquist. It will investigate a broad spectrum of prostate cancer patients by imaging with 64Cu-SAR-bisPSMA on the day of administration and at later timepoints. The X-Calibur trial will be assessing the safety of 64Cu SAR-bisPSMA as well as looking at the impact of the product on staging and clinical management of participants with prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to support Dr Nordquist’s trial, who has had first-hand experience with our products in the theranostic 64Cu/67Cu SAR-bisPSMA SECuRE trial (NCT04868604)2. We look forward to continuing to work together on progressing the development of our optimised SAR-bisPSMA agent in prostate cancer and exploring the many benefits of this product as part of Clarity’s Targeted Copper Theranostics (TCT) program in pursuit of our ultimate goal of improving treatment outcomes for cancer patients."

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program, where the IIT at GURN is the fourth clinical trial utilising the SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)2, has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)3, is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). The most recent diagnostic 64Cu SAR-bisPSMA trial in the US, COBRA (NCT05249127)4, has received a Study May Proceed Letter from the FDA in February 2022, with recruitment of participants with biochemical recurrence of prostate cancer planned to commence in the second quarter of 2022. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Luke Nordquist, CEO and Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very impressed with the PET imaging data collected at GURN from the SECuRE trial which indicates high tumour targeting and retention, especially compared to first-generation PSMA agents that use a single PSMA binding motif and have very short half-lives of 1-2 hours. As such, we were excited to seize the opportunity and continue the development of SAR-bisPSMA in the diagnostic IIT at GURN, continuing to further expand the clinical benefits of the product and to provide our own prostate cancer patients with the very best technologies available.

"In addition to the clinical advantages, we have also been excited about the supply and logistical benefits of SAR-bisPSMA as a TCT, which can be distributed on-demand and in large scale from central manufacturing facilities. TCT can provide universal access to radiopharmaceuticals in every zip-code in the continental US, something that is lacking with current approved agents. GURN has a significant backlog of patients who cannot access sufficient quantities of PSMA imaging agents based on gallium-68 (Ga-68) or fluorine-18 (F-18) due to the logistical issues of short half-life isotopes. We have already experienced the benefits of Cu-64 based products and their longer shelf-life of up to 48 hours with our current trial with Clarity, and we expect minimal delays and interruptions as we look to address the large backlog of treatments, providing up to 150 prostate cancer patients with the critical imaging required to improve patient outcomes."

Dr Taylor said, "This fourth clinical trial of SAR-bisPSMA will build on the exciting data to date as we progress this product towards the market. The trial will also continue to demonstrate the numerous benefits of the centrally manufactured, on-demand distribution model of ready-to use cGMP TCT products over the first-generation short half-life products using Ga-68 and F-18. We look forward to Dr Nordquist advancing the X-Calibur trial and hope it will improve cancer diagnosis and ensure that critical treatments will be available to patients and their treating staff on time and at a convenient location when and where they need it most."

This announcement has been authorised for release by the Executive Chairman.

On March 24, 2022 AstraZeneca reported that The CALLA Phase III trial for Imfinzi (durvalumab) given concurrently with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of improving progression-free survival (PFS) versus CRT alone in the treatment of patients with locally advanced cervical cancer (Press release, AstraZeneca, MAR 24, 2022, View Source [SID1234610807]).

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Bradley Monk, MD, FACOG, FACS, Professor at the University of Arizona College of Medicine and principal investigator in the CALLA Phase III trial, said: "While today’s results were not statistically significant, they underscore the need for further evaluation of novel therapeutic options and will inform future strategies to improve treatment for patients with locally advanced cervical cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "CALLA tested a novel immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress following available treatments. While the results were not what we hoped for, insights from the trial will advance our understanding and application of immunotherapy across our broad clinical development programme, exploring the benefits of Imfinzi in many tumour types."

The safety and tolerability in this trial were consistent between the two arms and no new unexpected safety findings were observed. The data will be presented at a forthcoming medical meeting.

Notes

Locally advanced cervical cancer
Cervical cancer is the eighth most common, and ninth most deadly, cancer worldwide, with approximately 600,000 people diagnosed each year.1 Approximately 40-50% of cervical cancer cases are diagnosed in the locally advanced stage.2 Following current standard-of-care treatment, platinum-based chemotherapy with radiation therapy, patients with locally advanced cervical cancer face an approximately 40% chance of disease recurrence and a five-year survival rate of about 65-70%.2,3 The standard-of-care treatment for these patients has not changed in over two decades.4

CALLA
CALLA is a randomised, multi-centre, double-blind, global Phase III trial in which 770 patients with locally advanced cervical cancer were treated with standard-of-care CRT in combination with either a 1,500mg fixed dose of Imfinzi or placebo every four weeks for up to 24 cycles or until disease progression.

The trial was conducted at 120 centres across 15 countries including in the US, Europe, Latin America, Africa and Asia. The primary endpoint was PFS and key secondary endpoints included overall survival and safety and tolerability. For more information about the trial, please visit Clinicaltrials.gov.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer based on the CASPIAN Phase III trial.

In the past year, Imfinzi has demonstrated clinical benefit in multiple additional cancer settings with positive Phase III trials in advanced biliary tract cancer (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA) and metastatic NSCLC (POSEIDON).

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with small cell lung cancer, NSCLC, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer and other solid tumours.

AstraZeneca in immuno-oncology
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On March 23, 2022 Centenaire Biosciences reported the company had attracted a total of 20 billion won in Series A investment from SD Biosensor’s affiliates Bionote and SDB Investment on the 18th (Press release, Centenaire Biosciences, MAR 23, 2022, View Source [SID1234643838]).

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Sanctnaire, which is developing an innovative antibody platform centered on the field of anti-cancer and immune disease treatment, has succeeded in attracting large-scale investment within 10 months of its establishment, and is developing, pipeline expansion, and additional platforms for clinical entry of its core pipeline ‘CTN001’. We plan to use the investment for technology development.

Centenaire, which has the goal of ‘development of innovative new drugs for the era of average lifespan of 100 years’ with the French word ‘Centenaire’ meaning 100 years as its motif, is based on its proprietary antibody platform technology to treat cancer, autoimmune diseases, and brain nerve diseases. We are building pipelines in various fields, including therapeutics.

Santnaire’s core pipeline, the next-generation HER2-targeting antibody ‘CTN001’, is indicated for HER2-low-expressing breast cancer, not HER2-positive breast cancer, which is targeted by existing HER2-targeting antibodies. HER2 low-expression breast cancer is a newly classified cancer type that accounts for more than 50% of all breast cancers, but has great market potential as there is no approved target treatment.

Yang Ki-hyuk, CEO of Sanctnaire, said, "With this Series A investment, we will begin full-scale development and expansion of the antibody pipeline using platform technology," and added, "We will develop safe and effective antibody drugs, starting with our flagship pipeline ‘CTN001’. "We will prove Nair’s differentiated value," he said.

He continued, "CTN001 showed strong efficacy in HER2-low-expressing carcinomas that do not respond to the HER2-targeting antibody Herceptin in preclinical trials," adding, "Antibody-drug complex (ADC) and T-cell engage, which have recently shown positive results and are expanding treatment options for cancer patients. "As there are limits to its use as a combination treatment for early-stage cancer due to safety issues, CTN001 will be an alternative to overcome this," he emphasized.

Meanwhile, Sanctnair is a new bio company established by researchers, including CEO Yang Ki-hyuk, who was a founding member of Medytox and oversaw R&D, to develop a next-generation antibody platform based on innovative antibody technology introduced from Medytox. Sanctnaire is discussing collaboration in various fields with BioNote, which participated in the Series A investment, along with cooperation with its affiliate Medytox, and is pursuing the establishment of a network with several domestic universities and research institutes to improve the efficiency of research and development.

On March 23, 2022 / BullFrog AI Holdings, Inc., a biopharmaceutical company focused on applying its proprietary Artificial Intelligence/Machine Learning platform to improve drug development and shorten clinical trial timelines, reported that it has entered into an exclusive license agreement with Johns Hopkins University for use of its novel formulation of mebendazole in treating cancer (Press release, Bullfrog AI, MAR 23, 2022, View Source [SID1234635364]).

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Under the terms of the agreement, BullFrog AI was granted an exclusive worldwide license to manufacture and use a novel formulation of mebendazole developed at the Johns Hopkins University (JHU) School of Medicine for treatment of cancer. This formulation is enriched in a polymorph of the drug which shows improved bioavailability, is particularly effective in crossing the blood-brain barrier, and has shown potent antitumor activity in multiple animal models of different cancers. In addition, it has been evaluated in a Phase I clinical trial in patients with high-grade gliomas (NCT01729260). The trial, an open-label dose-escalation study, enrolled 24 patients and demonstrated long-term safety and acceptable toxicity of mebendazole with adjuvant temozolomide in this population.

"We are excited to enter into this agreement with Johns Hopkins University for exclusive use of this unique formulation of mebendazole to treat cancer," said Vin Singh, Founder and CEO of BullFrog AI. "We look forward to pursuing development of this drug with Dr. Greg Riggins, Professor of Neurosurgery and Oncology at Johns Hopkins University and scientific advisor to BullFrog AI, for treatment of several devastating cancers. This drug enters our expanding pipeline as BF-222, and we will be engaging with the FDA in conversations about our clinical development plan in the near future. We are confident that bfLEAP, our proprietary AI/Machine Learning platform, provides us with an essential tool that we can leverage to efficiently develop this and other drugs that are being added to our pipeline to address unmet medical needs."

"Our Phase I clinical trial in patients with newly diagnosed high-grade gliomas showed that this novel formulation of Mebendazole is safe to use in combination with adjuvant temozolomide and provided valuable information regarding dosing," said Greg Riggins, MD, PhD. "I look forward to working with the team at BullFrog AI to pursue development of BF-222 for treating cancer."

On March 23, 2022 Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, and Arctoris Ltd. ("Arctoris"), a tech-enabled biopharma company that combines its unique automation with computational approaches to progress drug discovery, reported that they have agreed to expand their partnership to progress drug discovery programs for novel neurodegenerative targets with a focus on Alzheimer’s disease (Press release, Arctoris, MAR 23, 2022, View Source;utm_medium=rss&utm_campaign=cyclica-and-arctoris-to-expand-partnership-to-advance-drug-discovery-programs-for-alzheimers-disease [SID1234612706]). This planned expansion of the partnership follows the results from an initial engagement that yielded positive results for targets related to both oncology and neurodegenerative disease.

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"Cyclica’s platform and capabilities in combination with the biological assay development of Arctoris will enable us to yield meaningful results and advance research development for patients suffering from Alzheimers and other neurodegenerative diseases. The potential of combining our two specialities is very promising and we are extremely optimistic about the impact this partnership is expected to have on patients" shares Naheed Kurji, Co-Founder, President and CEO of Cyclica.

Dr. Martin-Immanuel Bittner, MD DPhil FRSA, CEO of Arctoris, comments by sharing, "Our joint drug discovery program focuses on dual specificity inhibitors – a very promising yet also challenging modality. Cyclica is one of the leaders in this space, leveraging their structure-based and AI-directed molecule design for polypharmacology, while at Arctoris we have built a particular expertise in complex mechanistic enzymology and advanced cell-based models in neurodegeneration. This is a highly synergistic partnership, and I am excited about what we can achieve together for patients around the world in an indication area in dire need of new and better treatment options."

Cyclica and Arctoris have long-term plans for their partnership as discussions are already underway about tackling additional therapeutic targets.