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Cantrixil positive Phase I trial data published in the journal Cancers

On June 30, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that the results from a Phase I open-label study (NCT02903771) of the investigational drug candidate Cantrixil (TRX-E-002-1) have been published in Cancers, a peer-reviewed, open access journal of oncology (Press release, Oasmia, JUN 30, 2021, View Source [SID1234584496]).

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The paper entitled ‘Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results’ can be accessed online at the following link: View Source

Oasmia acquired the exclusive global development rights for the Cantrixil ovarian cancer program from Kazia Therapeutics Ltd earlier this year. Top-line data from the Phase I study previously reported by Kazia Therapeutics Ltd in December 2020 and presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021 confirmed that the Phase I study met its primary endpoints, establishing clinical proof of concept.

The study was conducted at sites in the USA and Australia under the leadership of clinical trial’s Principal Investigator, Jermaine Coward, Associate Professor, ICON Cancer Centre, located in Brisbane, Australia. The study aimed to define the maximum tolerated dose, tolerability, and antitumor activity of Cantrixil when administered via an intraperitoneal (IP) port. Cantrixil was well tolerated even in patients with heavily pre-treated disease.

The study demonstrates the potential for prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy with IP-administered Cantrixil.

Dr. Heidi B. Ramstad, CMO of Oasmia, commented: "These data are encouraging and has demonstrated the potential for prolonged survival in some patients with advanced ovarian cancer. By inducing ovarian cancer stem cell death and sensitizing cancer cells to standard chemotherapy, Cantrixil may improve survival outcomes in this patient population. Ovarian cancer remains one of the most aggressive cancers and are proven difficult to treat in advanced stages. We look forward to the forthcoming Phase 2 trial investigating Cantrixil in combination with first-line chemotherapy with an aim to improve survival rates in ovarian cancer."

Alligator Bioscience AB and Scandion Oncology A/S present promising preclinical data

On June 30, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) and Scandion Oncology (Nasdaq Stockholm: SCOL) reported that promising preclinical data from their ongoing collaboration exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology’s drug candidate SCO-101 and Alligator Bioscience’s candidate drug mitazalimab.

The collaboration explores the anti-tumor efficacy of the CD40 antibody mitazalimab in combination with SCO-101 as an addition to chemotherapy (FOLFIRINOX) in chemotherapy-resistant preclinical tumor models. The hypothesis is that SCO-101 will revert chemotherapy resistance and thereby facilitate a strengthening of the anti-tumor effects of mitazalimab.

The combination of mitazalimab and FOLFIRINOX demonstrates a strong anti-tumor response in FOLFIRINOX resistant cancer cells. Importantly, the current data indicate that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. The studies are still ongoing and further monitored for anti-tumor effects and survival.

The data further validate the potential of mitazalimab in combination with standard of care chemotherapy such as FOLFIRINOX.

"We are pleased to see that the preliminary results strengthen and expand the preclinical efficacy data for mitazalimab, by demonstrating synergy with FOLFIRINOX even in tumors resistant to chemotherapy. This bodes well for our OPTIMIZE-1 phase II study where we are assessing the efficacy of mitazalimab in combination with FOLFIRINOX in pancreatic cancer. Once we have the full data we will evaluate the possibility of testing of the triple combination in clinical trials," said Søren Bregenholt, CEO of Alligator Bioscience.

The data support the basic concept that SCO-101 in combination with chemotherapy and immuno-oncology is well tolerated and has a very potent anti-tumor effect in vivo on drug resistant cancer cells.

"The very first set of in-vivo data is encouraging. The studies will continue to draw the final conclusions, but this first assessment is supporting our hypothesis and opens for a novel opportunity in our R&D strategy. We are pleased that the collaboration with Alligator Bioscience has enabled us to explore the potential of SCO-101 in the setting of immuno-oncology and are committed to explore the potential of SCO-101 in immuno-oncology further," said Bo Rode Hansen, CEO of Scandion Oncology.

Defence therapeutics signs a collaboration agreement with the curie institute for testing the accum-t-dm1 adc therapeutic in pdx models of breast cancer

On June 29, 2021 Defence Therapeutics reported that the establishment of a collaboration with the Curie Institute (Paris, France) to evaluate the therapeutic efficacy of Accum-T-DM1 ADC in patient-derived xenograft (PDX) models of breast cancer (Press release, Defence Therapeutics, JUN 29, 2021, View Source [SID1234626243]).

The Curie Institute is a worldwide renowned center engaged leader in fundamental and applied scientific research to better serve humankind in fighting illnesses such as cancer. Their scientific team has a wide expertise in the field of medical and experimental pharmacology with PDX models of cancer.

T-DM1 (Kadcyla) is currently used to treat women with metastatic HER2-positive breast cancer. The efficacy of the treatment remains limited due to sub-optimal drug delivery to tumor cells resulting in some treatment resistance, recurrence, and side effects.

The agreement between the Curie Institute and Defence Therapeutics stipulates the following objectives related to the breast cancer:

– To perform a head-to-head toxicology profile comparisons of T-DM1 versus Accum-TDM1 in mice.
– Complete a dose escalation study in mice bearing PDX that are T-DM1 resistant.
– Conduct a complete breast cancer efficacy study on PDX mice undergoing the ADC therapy, including in 3 HER2+ and in 1 triple-negative PDX.

"The AccumTM technology has been very efficient at enhancing protein-/or cell-based vaccination and ADCs potency. This studies objective in demonstrating enhanced efficacy and the refined treatment regiment of Accum-T-DM1, can lead to an enhanced ADC platform for the AccumTM technology. This serves as a strong foundation for a panoply of other therapeutics endowed with limitations known to impairing their therapeutic potency. AccumTM enhanced efficacy opens up a broad opportunity in the ADC market to address this," mentioned Sebastien Plouffe, CEO of Defence Therapeutics.

Currently, the T-DM1 regiment is long and tedious. The use of the AccumTM in this context is expected to increase significantly the efficiency as well as to lower the treatment cycle, which would highly lower the side effects triggered by the current ADC therapies.

US Breast Cancer Antibodies immunotherapy Therapeutics Market Offers USD 20 Billion Opportunity by 2026 according to Kuick research.

The first time in China! Two indications of Disitamab Vedotin have been granted breakthrough designations in the United States and China for three times

On June 29, 2021 Remegen reported that National Medical Products Administration (NMPA), China’s first novel antibody-drug conjugate (ADC)- Disitamab vedotin, which was just approved to market has been officially included in the breakthrough treatment category for HER2-positive late-stage breast cancer patients with liver metastasis who have received Trastuzumab and taxane therapy in the past (Press release, RemeGen, JUN 29, 2021, View Source [SID1234594765]). The indication is currently in phase Ⅲ clinical trials in China.

This is the third time that Disitamab vedotin has been granted breakthrough therapy. In September and December 2020, Disitamab vedotin was granted breakthrough designation by the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) respectively for the treatment of urothelial cancer, becoming the first ADC drug to be dual recognized by both the US and China as breakthrough therapy and Disitamab vedotin is so far the only ADC from China that recieved breakthrough designation from US FDA .

The criteria for breakthrough designation are significantly higher than the other accelerated review pathways of FDA, such as Fast Track, Accelerated Approval, and Priority Review. However, since breakthrough designation emphasizes on significant improvement over currently available treatment, the application drugs must have clinical data with clear advantages, and approvals in the United States are extremely hard, making it very rare for a single drug to be granted both in the United States and China.

QIAGEN Partners with Verogen to Offer Broadest Portfolio for Human Identification, Including Next Generation Sequencing Solutions

On June 29, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a commercialization partnership with San Diego-based human identification specialist Verogen that will provide customers of both companies with superior tools and comprehensive support for human identification (HID) workflows in their laboratories (Press release, Qiagen, JUN 29, 2021, View Source [SID1234586594]).

The deal enables QIAGEN to offer Verogen’s preeminent HID sequencing and analysis solutions that run on MiSeq FGx sequencers from Illumina, decisively expanding QIAGEN’s forensics leadership that already covers sample collection and preparation, genetic testing analysis and workflow automation. The agreement grants QIAGEN the rights to distribute the Verogen portfolio globally – including kits based on the proprietary Verogen ForenSeq assay, the Verogen MiSeq FGx Sequencing System and the Universal Analysis Software – and covers an expansion of the partnership through future ForenSeq-based assays.

Verogen and QIAGEN will also cooperate to commercialize a menu of forensically validated workflows for next-generation sequencing (NGS) that combine Verogen’s library-prep products with QIAGEN’s QIAseq products, automation solutions and expertise. QIAGEN will market Verogen products globally alongside its portfolio of forensics instruments, kits and services. Financial details of the deal are not being disclosed.

"This combination brings together Verogen’s innovative NGS workflows with QIAGEN’s leading portfolio of Sample to Insight solutions, creating the most comprehensive product offering for forensics applications," said Thierry Bernard, Chief Executive Officer at QIAGEN. "The partnership will drive the adoption of NGS in human identification as it will enable our customers to gain even better insights from their casework samples. This will ultimately strengthen justice systems all over the world."

"Our mission is to empower the human identification community with innovative tools that can deliver an identification, not just a DNA profile," said Brett Williams, Chief Executive Officer at Verogen. "This partnership with QIAGEN will make it easier for laboratories to provide more impactful answers. By combining Verogen’s industry-leading NGS-based product portfolio with QIAGEN’s gold-standard extraction, assay and automation solutions, we will accelerate adoption and use of NGS in forensics."

NGS is used in many biotechnological fields, from cancer research to rare-disease testing. In forensics, it opens completely new opportunities for criminal casework, missing persons and disaster-victim identification. While traditional STR-profiling requires a suspect or a database hit to compare with a crime sample, NGS provides additional intelligence options such as estimation of externally visible characteristics like hair or eye color, thereby elevating DNA testing from a passive forensic support to a proactive investigational technique.

Experts expect the market for NGS in forensics to grow at a double-digit rate annually because of its promising applications.

This collaboration of market leaders addresses important hurdles in areas like workflow integration, automation and vendor support that have slowed adoption of NGS in forensics. The partnership bolsters the workflow solutions offered by QIAGEN and Verogen by offering forensic customers a new level of end-to-end support across the globe, from sample collection to data interpretation and analysis.

QIAGEN is a world leader in HID and forensic testing. It offers a full range of forensic-grade chemistries and high-quality instruments, such as the new EZ2 Connect Fx that address the challenges of crime scene investigation and more. Covering every step from sample to insight, QIAGEN has shaped the development of forensic standards, supporting criminal justice and missing persons identification. QIAGEN’s top-quality forensics products and services are helping customers unlock vital molecular insights to make improvements in life possible.