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New Radioisotope for Cancer Therapy – A new Collaboration to produce copper-67

On August 25, 2021 Iotron Medical Inc. (Iotron) and Canadian Isotope Innovations Corp. (CIIC) reported a collaboration to produce the radioisotope copper-67 (Cu-67) for new cancer therapies (Press release, Iotron Medical, AUG 25, 2021, View Source;a-new-collaboration-to-produce-copper-67-301362227.html [SID1234586898]). This investment will increase the production capacity of the CIIC-operated facilities in Saskatoon, making Cu-67 more widely available to international cancer researchers.

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Iotron Medical, a spin-out business of Iotron Industries, has been providing innovative solutions using electron beam technology for more than 25 years. CIIC is a startup company, producing medical radioisotopes using a novel linear accelerator-based method initially developed at the Canadian Light Source.

Cu-67 has long been known for its excellent properties for personalized cancer therapy but has been extremely difficult to produce with sufficient quantity and purity using nuclear reactors or cyclotrons. Lack of an adequate and reliable supply of this radioisotope has prevented medical researchers from exploring the potential of Cu-67 in new targeted cancer therapies.

"Iotron is excited about the future for Cu-67 and the opportunity to work with CIIC to make the benefits of this radioisotope available to the wider market, and positively impact the lives of so many people," said Mike Scott, Iotron Board Chair.

CIIC and Iotron are proud to establish the world’s first private sector producer and supplier of this valuable radioisotope, building on the application innovations and accelerator expertise of both parties. This novel production method for high purity Cu-67 is needed by researchers and pharmaceutical companies developing new drugs for a variety of cancers including neuroendocrine tumors, prostate and neuroblastoma. When linked to a suitable targeting agent, Cu-67 delivers highly localized radiation to tumor cells.

"CIIC looks forward to working with our partner Iotron to bring this important radioisotope to market and to produce it in the volume needed for researchers and the broader pharmaceutical community," said Dr. Mark de Jong, Chief Technical Officer of CIIC.

Iotron and CIIC have committed to a five-year agreement that will establish a stable and reliable source of Cu-67, with plans to expand production further as market demand grows. The first shipments of Cu-67 have been made to a US research group in July demonstrating the ability of Iotron-CIIC to make and supply this critical isotope. Batches of Cu-67 are being produced biweekly for researchers, and by the end of 2021, more will be available to support clinical trials in North America and around the world.

For more information about the CIIC-Iotron collaboration or to order Cu-67 radioisotope please refer to the website at www.copper67.com.

Senhwa Biosciences Announces Dose Escalation Initiation of the Phase I Trial of Pidnarulex as a Treatment for Advanced Hematological Malignancies

On August 25, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported the initiation of Dose Escalation within the Phase I Investigator Initiated Trial (IIT) of Pidnarulex for the treatment of advanced hematological malignancies (Press release, Senhwa Biosciences, AUG 25, 2021, View Source [SID1234586897]). After evidence of human efficacy was observed in patients with specific biomarkers and resistant to standard treatments, including chemotherapeutics, the Phase I study was redesigned to further determine the Recommended Phase II Dose.

This open-label dose escalation Phase I IIT study of Pidnarulex is sponsored by the Peter MacCallum Cancer Center (PMCC), in Australia, focusing on various haem cancers, including multiple myeloma, T-cell non-Hodgkin lymphoma, acute myeloid leukaemia and myelodysplastic syndrome. Senhwa is providing the study supplies and the Investigational Product, Pidnarulex, which is intravenously administered on 4-week cycles.

The preliminary results from the preceding portion of the Phase I study, completed in 2017, demonstrated that among the 16 evaluable patients, one patient experienced a partial response after the Pidnarulex treatment, while five patients had stable disease. The PMCC was invited to the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting on 11th December, 2017, and presented a poster on these findings.

"The multiple myeloma patients enrolled in the initial portion of the Phase I study were resistant to other therapies; however, fifty percent of the multiple myeloma patients treated with Pidnarulex were able to stabilize their conditions. We here at Senhwa will continue to work at providing alternative therapeutics for treatment resistant cancers," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

"We look forward to the outcome of this study and we hope that the findings may inspire more collaborative opportunities to determine if Pidnarulex is effective in treating various forms of haem cancers," said Tai-Sen Soong, the Chief Executive Officer of Senhwa Biosciences.

Hematological cancers affect populations worldwide, notably, there are more than 160,000 new cases of multiple myeloma worldwide per year. The global drug market for multiple myeloma is expected to reach USD 37.5 billion by 2024, according to the forecast of Grand View Research, a leading market research firm.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.

BioMarin to Participate in Three Upcoming Virtual Investor Conferences

On August 25, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in three upcoming virtual investor conferences (Press release, BioMarin, AUG 25, 2021, View Source [SID1234586896]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

First patient treated in Clarity’s Cu-64/Cu-67 SAR-bisPSMA theranostic prostate cancer trial

On August 25, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that the first US patient has been dosed with 64Cu SAR-bisPSMA in the dosimetry phase of the SECuRE clinical trial (NCT04868604)[1] investigating Targeted Copper Theranostics (TCTs) in patients with metastatic castrate resistant prostate cancer (mCRPC) at the Urology Cancer Center and GU Research Network in Omaha, Nebraska (Press release, Clarity Pharmaceuticals, AUG 25, 2021, View Source [SID1234586895]).

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to have treated our first US patient in the SECuRE trial for mCRPC using our optimised PSMA agent, 64/67Cu SAR-bisPSMA, and look forward to recruiting additional patients and opening all seven clinical sites selected for this trial in the US. We believe the central manufacture, logistical and treatment advantages of TCTs using copper-64 and copper-67 in large patient populations such as prostate cancer will benefit both clinicians and patients.

The SECuRE trial is a Phase I/IIa theranostic trial for identification and treatment of PSMA-expressing mCRPC using TCT. 64Cu SAR-bisPSMA is used to image and select patients for 67Cu SAR-bisPSMA therapy. The initial dosimetry phase utilises 64Cu SAR-bisPSMA to determine biodistribution and dosimetry over multiple time points. The entire trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA as a therapy.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, who treated the first patient with 64Cu SAR-bisPSMA in the trial, commented on this milestone, "64/67Cu SAR-bisPSMA products hold great promise of improving prostate cancer diagnosis and treatment and have the potential to provide significant supply benefits in comparison to current products in the market. We look forward to working together with Clarity to explore these benefits and utilise them to improve the lives of men with this insidious disease."

Dr Taylor said: "The prostate cancer market is a key focus for Clarity. The news of the SECuRE trial recruitment milestone comes shortly after treating our first patient in the PROPELLER trial, a diagnostic 64Cu SAR-bisPSMA clinical trial in patients with confirmed prostate cancer (NCT04839367)[2]. We are excited to now have two clinical trials in prostate cancer actively recruiting and treating patients and to build on the compelling results from our therapeutic and diagnostic preclinical studies. We look forward to progressing these trials and getting closer to achieving our ultimate goal of developing better treatments for children and adults with cancer."

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide[3]. In 2021, the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease[4]. Annually, there are around ~34,000 men in the US who are diagnosed with mCRCP[5], ~90% of whom have tumours which express PSMA[6].

References

[1]. ClinicalTrials.gov Identifier: NCT04868604 View Source
[2]. ClinicalTrials.gov Identifier: NCT04839367 View Source
[3]. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries View Source
[4]. American Cancer Society, Cancer Statistics Center,
View Source!/cancer-site/Prostate
[5]. American Cancer Society, Cancer Statistics Center,
View Source!/cancer-site/Prostate
[6]. D. A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

This announcement has been authorised for release by the Board.

FDA Approves NGS-Based Companion Diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma

On August 25, 2021 Thermo Fisher Scientifi reported that The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for Servier Pharmaceuticals’ TIBSOVO (ivosidenib tablets) (Press release, Thermo Fisher Scientific, AUG 25, 2021, View Source [SID1234586894]). TIBSOVO is an IDH1 inhibitor that is approved for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test.

CCA is a rare, aggressive cancer of the bile ducts within and outside of the liver. IDH1 mutations occur in up to 20 percent of CCA cases in the Unites States and are not associated with prognosis.1 Prior to the approval of TIBSOVO on August 25, 2021, there were no approved targeted therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting.2

TIBSOVO is also approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutated AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval of TIBSOVO in previously treated IDH1-mutated CCA is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated CCA.

"Prior to today, patients with IDH1-mutated cholangiocarcinoma did not have an approved targeted therapy treatment option," said Susan Pandya, M.D., vice president, clinical development, head of cancer metabolism global development, Servier Pharmaceuticals. "The FDA approval of TIBSOVO (ivosidenib tablets) for patients with previously treated IDH1-mutated cholangiocarcinoma is a major milestone for the cholangiocarcinoma community. I’d like to acknowledge and thank all the patients, their families and the investigators and research teams who took part in the ClarIDHy study, as well as Thermo Fisher Scientific for their partnership."

The Oncomine Dx Target Test is a next-generation sequencing (NGS) based test that delivers robust and reproducible results in the IDH1 gene clinically associated with CCA. The FDA first approved the test as a CDx in 2017, and it is now approved for four targeted therapies for non-small cell lung cancer (NSCLC) and one targeted therapy for CCA in the U.S. The test is currently approved and reimbursed by government and commercial insurers in over 15 countries, including U.S., Europe, Japan, South Korea and the Middle East, covering more than 550 million lives globally.

"With the FDA approval of Oncomine Dx Target Test as a companion diagnostic for TIBSOVO, healthcare providers across the U.S. can now match patients with this critically needed therapy," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Advances in genetic profiling through NGS have enabled identification of an increasing number of cancer-driving genomic variations, opening the door for the development of more targeted treatment options. By continuing to work with our pharmaceutical partners to co-develop diagnostics for these life-changing therapies and expanding the clinical utility of our tests, we hope to help more cancer patients around the world receive more targeted and effective treatment."

Thermo Fisher also has an agreement with Servier to develop and commercialize a CDx leveraging the Oncomine Precision Assay* to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). The Oncomine Precision Assay runs on the Ion Torrent Genexus* System, the first fully integrated NGS platform featuring an automated specimen-to-report workflow that delivers results economically in a single day.

*This assay and instrument are currently For Research Use Only. Not for use in diagnostic procedures.