On June 25, 2021 Cambridge start-up Lucida Medical has reported that it has joined the Edison Accelerator, a programme designed by GE Healthcare in partnership with innovation organisation Wayra UK, to support early-stage and technologically advanced businesses developing AI applications for healthcare (Press release, GE Healthcare, JUN 25, 2021, View Source [SID1234584375]).

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Participation in the Edison Accelerator programme is a major advance towards Lucida Medical’s goal to disrupt the cancer diagnostic pathway with technology that finds prostate cancer more accurately by analysing MRI, enabling radiologists to save time and patients to receive the best possible diagnosis and treatment.

Prostate cancer is the most common cancer in men in Europe, Africa and North and South America, with 1.4 million diagnosed worldwide each year and 375,000 deaths. Earlier and better detection saves lives.

The Edison Accelerator creates a collaborative environment for start-ups, research centres, hospitals, clinicians and large corporations across the EMEA region. It aims to foster open innovation and digital transformation of healthcare.

Lucida Medical was invited to join the Edison Accelerator programme for its pioneering work in helping identify prostate cancer and its exceptional development team led by Prof Evis Sala and Dr Antony Rix, both highly experienced in artificial intelligence, or AI, medical technology.

In joining the Edison Accelerator programme, Lucida Medical will:

Receive mentoring on problem validation, business, regulatory and clinical validation, and deployment.
Participate in joint pilots between start-up and healthcare partners.
Access support in customer discovery and product validation.
Access support in adapting, integrating and launching solutions on the Edison marketplace.
Access GE Healthcare global commercial force and customers in various markets.
Receive support for clinical studies and regulatory preparation in target geographies.
Catherine Estrampes, President and CEO, Europe, Middle East & Africa, GE Healthcare, said: "The future of innovation will be about working across silos and collaborating across the healthcare ecosystem, including start-ups, research centres, hospitals and clinicians. The Edison Accelerator brings together leading technology providers, developers and academic institutions under a single, connected ecosystem to create real impact from the bottom line to better patient outcomes."

Dr Antony Rix, CEO and Co-founder, said: "That Lucida Medical has been chosen to join the prestigious Edison Accelerator programme is both a demonstration of confidence in the technology and our team. This development comes soon after our Prostate Intelligence technology received a CE mark. The support of GE Healthcare and Wayra will help us develop further our technology and access new partners and markets."

Co-founder and Chief Medical Officer Prof Evis Sala, Professor of Oncological Imaging at the University of Cambridge, said: "We are tremendously excited by our ability to support radiologists to detect cancer accurately and early. The Edison Accelerator programme will now help us bring our technology into clinical use."

XTX Ventures, the venture capital arm of XTX Markets, provided Lucida Medical with early-stage investment capital from a group of investors in March 2021.

On June 24, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported that it is set to join the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021 (Press release, Aileron Therapeutics, JUN 24, 2021, View Source [SID1234584309]).

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Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

"Protection against chemotherapy-induced toxicities represents a significant, largely unaddressed need in the oncology space, and one for which there is now increasing progress and momentum," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "Precision medicine has truly revolutionized cancer treatment. In line with that transformation, our use of the p53 biomarker gives us the potential to selectively chemoprotect healthy cells in a very large number of patients given that nearly one million cancer patients are annually diagnosed with a p53-mutated cancer in the United States alone. Our inclusion in the Russell Microcap Index will expand our investor base as we work to transform the experience of cancer patients undergoing chemotherapy."

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

On June 24, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that dose administration for the first patient in a Phase 1 U.S. clinical study for liver cancer treatment, with the company’s siRNA (small interfering RNA) drug candidate, STP705 (Press release, Sirnaomics, JUN 24, 2021, View Source [SID1234584326]). STP705 takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression.

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This Phase 1 trial is a multicenter, open-Label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705, with an intratumoral administration. In this "basket study" of up to 50 subjects suffering from cholangiocarcinoma, hepatocellular carcinoma, or liver metastases from colorectal cancer, the patients with advanced/metastatic or surgically unresectable solid tumors and are refractory to standard therapy will be treated with STP705. This therapeutic regimen is designed to take advantage of a dual-targeted inhibitory property of siRNAs and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expressions. Early pre-clinical and clinical studies using STP705 have shown an increase of active T cell infiltration into the tumor microenvironment. In addition, knocking down TGF-β1 and COX-2 gene expressions in animal fibrosis tissue can activate fibroblast apoptosis with significant antifibrotic efficacy.

"Advancing STP705 from skin cancer to liver cancer is a major milestone for Sirnaomics’ clinical programs, especially with a basket study design that consists of multiple tumor types. We are particularly interested in learning whether the mechanism of action validated in the skin cancer clinical study can be further verified in this liver cancer study," said Patrick Lu, Ph.D., founder, President and Chief Executive Officer of Sirnaomics. "We are expecting that the combination of anti-fibrotic effects and enhanced tumor immunity will provide a novel approach for the treatment of cholangiocarcinoma and hepatocellular carcinoma using our novel siRNA therapeutics. Sirnaomics is committed to advancing our polypeptide nanoparticle delivery system for innovative RNAi-based cancer therapy."

"Liver cancer is a devastating disease for patients with high mortality and high unmet medical need," stated Michael Molyneaux, MD, Chief Medical Officer of Sirnaomics. "The company is excited to announce first dosing, as we hope to gain important insight into the potential safety and efficacy of STP705 in this Phase 1 trial and build on the data from this study to expand into other oncology indications."

Sirnaomics expects to report initial clinical data from the Phase 1 trial in the second half of 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04676633

Wechat 01
About Liver Cancer

Liver cancer is a global health problem, with liver neoplasms representing the second-most frequent cause of cancer-related death. There are many different types of liver cancers including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), liver angiosarcoma, hepatoblastoma and others. Additionally, liver is a highly metastasis-permissive organ. It is the most frequently afflicted organ by metastasis and liver metastases are much more common than primary hepatic tumors. The distinctive biology of the liver renders it intrinsically susceptible to metastases. The true prevalence of liver metastasis is unknown, but between 30% and 70% of patients dying of cancer have liver metastases and most patients with liver metastases will die of their disease.

STP705 and Liver Cancer

Over expressions of TGF-β1 and COX-2 have been well-characterized as playing key regulatory roles in tumorigenesis. TGF-β is produced by different liver cells and is demonstrated to induce tumor cell migration and survival. TGF-β has been found to be overexpressed in metastatic HCC tissues. Overexpression of TGF-β is generally accepted to be associated with metastasis and poor prognosis. COX-2 is reported to be highly expressed in cancer stem cells and promotes cell migration in HCC cell lines. Additionally, inhibition of COX-2 suppresses cell migration and induces apoptosis. As such TGF-β1 and COX-2 are excellent therapeutic targets for treatment of liver cancer.

STP705 is composed of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed several pre-clinical studies that demonstrate that inhibition of TGF-β1 and COX-2 is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerous oncology targets.

Additional immunohistochemistry and image analyses of the liver and tumor tissues demonstrated that animals treated with STP705 resulted in increased CD4+ and CD8+ T cell infiltration within the tumor microenvironment. Using STP705 for treatments of hepatocellular carcinoma and cholangiocarcinoma have been designated as Orphan Drug indications by U.S. FDA. STP705 has also been evaluated in a Phase 2a clinical trial for treatment of Non-melanoma skin cancer.

On June 24, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported dose administration for the first patient in a Phase 1 U.S. clinical study for liver cancer treatment, with the company’s siRNA (small interfering RNA) drug candidate, STP705 (Press release, Sirnaomics, JUN 24, 2021, View Source [SID1234584342]). STP705 takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This Phase 1 trial is a multicenter, open-Label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705, with an intratumoral administration. In this "basket study" of up to 50 subjects suffering from cholangiocarcinoma, hepatocellular carcinoma, or liver metastases from colorectal cancer, the patients with advanced/metastatic or surgically unresectable solid tumors and are refractory to standard therapy will be treated with STP705. This therapeutic regimen is designed to take advantage of a dual-targeted inhibitory property of siRNAs and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expressions. Early pre-clinical and clinical studies using STP705 have shown an increase of active T cell infiltration into the tumor microenvironment. In addition, knocking down TGF-β1 and COX-2 gene expressions in animal fibrosis tissue can activate fibroblast apoptosis with significant antifibrotic efficacy.

"Advancing STP705 from skin cancer to liver cancer is a major milestone for Sirnaomics’ clinical programs, especially with a basket study design that consists of multiple tumor types. We are particularly interested in learning whether the mechanism of action validated in the skin cancer clinical study can be further verified in this liver cancer study," said Patrick Lu, Ph.D., founder, President and Chief Executive Officer of Sirnaomics. "We are expecting that the combination of anti-fibrotic effects and enhanced tumor immunity will provide a novel approach for the treatment of cholangiocarcinoma and hepatocellular carcinoma using our novel siRNA therapeutics. Sirnaomics is committed to advancing our polypeptide nanoparticle delivery system for innovative RNAi-based cancer therapy."

"Liver cancer is a devastating disease for patients with high mortality and high unmet medical need," stated Michael Molyneaux, MD, Chief Medical Officer of Sirnaomics. "The company is excited to announce first dosing, as we hope to gain important insight into the potential safety and efficacy of STP705 in this Phase 1 trial and build on the data from this study to expand into other oncology indications."

Sirnaomics expects to report initial clinical data from the Phase 1 trial in the second half of 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04676633

About Liver Cancer
Liver cancer is a global health problem, with liver neoplasms representing the second-most frequent cause of cancer-related death. There are many different types of liver cancers including hepatocellular carcinoma (HCC), cholangiocarcinoma, liver angiosarcoma, hepatoblastoma, and others. Additionally, the liver is a highly metastasis-permissive organ. It is the most frequently afflicted organ by metastasis and liver metastases are much more common than primary hepatic tumors. The distinctive biology of the liver renders it intrinsically susceptible to metastases. The true prevalence of liver metastasis is unknown, but between 30% and 70% of patients dying of cancer have liver metastases and most patients with liver metastases will die of their disease.

STP705 and Liver Cancer
Over expressions of TGF-β1 and COX-2 have been well-characterized as playing key regulatory roles in tumorigenesis. TGF-β is produced by different liver cells and is demonstrated to induce tumor cell migration and survival. TGF-β has been found to be overexpressed in metastatic HCC tissues. Overexpression of TGF-β is generally accepted to be associated with metastasis and poor prognosis. COX-2 is reported to be highly expressed in cancer stem cells and promotes cell migration in HCC cell lines. Additionally, inhibition of COX-2 suppresses cell migration and induces apoptosis. As such TGF-β1 and COX-2 are excellent therapeutic targets for treatment of liver cancer.

STP705 is composed of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed several pre-clinical studies that demonstrate that inhibition of TGF-β1 and COX-2 and is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerous oncology targets.

Additional immunohistochemistry and image analyses of the liver and tumor tissues demonstrated that animals treated with STP705 resulted in increased CD4+ and CD8+ T cell infiltration within the tumor microenvironment. Using STP705 for treatments of hepatocellular carcinoma and cholangiocarcinoma have been designated as Orphan Drug indications by U.S. FDA. STP705 has also been evaluated in a Phase 2a clinical trial for treatment of non-melanoma skin cancer.

On June 24, 2021 Bio-Techne Corporation (NASDAQ: TECH) and Catamaran Bio reported an expansion of their collaboration for the development of cell engineering and cell process technologies for use by Catamaran in the manufacturing of CAR-NK cell therapy products (Press release, Bio-Techne, JUN 24, 2021, View Source [SID1234584311]).

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The companies have now broadened the scope of their collaboration to include the development of novel cell expansion technologies for use in the manufacturing of CAR-NK cell therapy products. In addition, Catamaran has secured a broad worldwide license to Bio‑Techne’s rights related to the TcBuster transposon system for use in the research, clinical and commercial manufacturing of next generation allogeneic cell therapy products. Catamaran has integrated the TcBuster transposon system, a non-viral cell engineering technology that enables multiple gene editing and efficient delivery of large genetic payloads, into its TAILWIND Platform for CAR-NK cell therapies.

The initial collaboration between Catamaran and Bio-Techne, which began in 2020, has been focused on optimizing the application of the TcBuster transposon system to CAR-NK cell engineering. The TcBuster transposon system was developed at B-MoGen Biotechnologies by a team that included Catamaran’s scientific co-founder, Branden Moriarty, PhD, Assistant Professor in the Department of Pediatrics, Division of Hematology/Oncology at the University of Minnesota. Bio-Techne acquired B-MoGen Biotechnologies in 2019.

"Our agreements with Catamaran open the path for Bio-Techne’s cutting-edge cell engineering and process technologies to deliver gene-modified CAR-NK cell therapies for cancer," said Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "We are delighted to expand our relationship with Catamaran and increase our impact in the cell therapy space."

"We have established a successful track record of collaborating with Bio-Techne to optimize technologies for use in CAR-NK cell engineering and manufacturing. This collaboration and license exemplify our strategy to access technologies that provide important advantages in the cell therapy manufacturing process, as we position Catamaran as a leader in developing off-the-shelf CAR-NK cell therapies for solid tumors," said Alvin Shih, MD, President and Chief Executive Officer of Catamaran Bio.

Through the collaboration, the Catamaran and Bio-Techne teams are focused on developing and enhancing technologies for scalable and robust manufacturing of allogeneic CAR-NK cell therapies. Bio-Techne will contribute innovative cell expansion technologies and both companies will contribute know-how to enable large-scale production of functional CAR-NK cells.

"We are excited to be making advances with innovative technologies that enable Catamaran to achieve scalable and robust manufacturing processes for our CAR-NK cell therapies. We are committed to incorporating transformative technologies into our TAILWIND Platform as we advance our product candidates toward the clinic and enable allogeneic CAR-NK cell therapies to reach their therapeutic potential," said Vipin Suri, PhD, Chief Scientific Officer of Catamaran Bio.