On March 29, 2022 Mursla, a novel multi-omics exosome characterisation company, reported that it has secured mentorship support from Roche Diagnostics Ltd for a new liquid biopsy prospective pilot study for liver cancer surveillance through MedCity’s Collaborate to Innovate: London Diagnostics programme (Press release, Mursla, MAR 29, 2022, View Source [SID1234611153]). Liver cancer is the third most common cause of premature cancer death worldwide and its incidence has increased significantly over other forms of cancer in the last three decades.

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Mursla’s aim is to develop a blood test that can detect early-stage hepatocellular carcinoma (HCC) more effectively than the current standard of care. To this end, the primary objective of the prospective pilot study is to select and confirm the relevance of novel HCC biomarkers for a larger longitudinal study demonstrating high clinical performance in a more tailored cohort. A secondary objective is the assessment of Mursla’s tissue-specific and multi-omics exosome approach as proof of concept for the development of other related cancer liquid biopsy tests.

To enable the pilot study, Mursla will leverage its proprietary multi-omics exosome characterisation platform technology for the discovery and profiling of exosome phenotypes, ExoPheno. It consists of proprietary and patented technologies, which integrate wet lab (validated exosome tissue-of-origin markers, pre-analytical multi-omics sequencing workflow and ultrasensitive exosome marker detection systems) and dry lab analysis via machine learning.

Hundreds of blood samples will be prospectively collected by Tissue Access for Patient Benefit (TAPB), a University of College London (UCL) and NHS initiative based at the Royal Free Hospital in London, UK, and by Biobanco-IMM Lisbon Academic Medical Center Portugal in collaboration with Gastroenterology Service at Hospital de Santa Maria in Lisbon, Portugal. The samples will then be characterised by ExoPheno to establish differences in the multi-omics cargo of specific exosome sub-populations between patients with various chronic liver diseases and cancer at various stages. In addition, Roche Diagnostics Ltd will support Mursla in bringing its solution to the clinic by sharing its expertise and best practice in evidence generation, scaling up and market access.

First generation liquid biopsy tests measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns) with low positive predictive value (PPV) for early-stage cancer detection, potentially leading to millions of distressing false positives. Mursla intends to improve PPV with its novel ExoPheno platform which:

Uses tissue-of-origin markers to capture tissue-specific exosomes in blood.
Detects specific multi-omics disease markers (including DNA, RNA, proteins, lipids and metabolites) contained in exosomes, mirroring the parental cell with disease.
Focuses on dynamic information released by living cells in exosomes, not by dying cells in the case of ctDNA.
Gerard Harkin, Head of Innovation UK & Ireland, Roche Diagnostics Ltd commented: "We are delighted to support the MedCity programme that encourages innovations in diagnostics and to provide in-kind mentorship to Mursla. In the field of cancer, we see the potential for new technologies to significantly improve the existing standard of care."

Pierre Arsène, Founder and CEO, Mursla added: "We are very pleased to receive the support of Roche’s UK team for the application of our novel exosome characterisation platform in early-stage liver cancer detection and beyond. We believe that the specific multi-omics information carried by blood exosomes from the tumor and its microenvironment will enable the next generation of liquid biopsy tests."

The collaboration has been enabled via Collaborate to Innovate: London Diagnostics, a MedCity programme, which is part grant-funded by the London Economic Action Partnership (LEAP). Collaborate to Innovate is an initiative that streamlines the process for building effective collaborations between SMEs and academia, commercial and non-profit partners, by helping SMEs to refine and validate their promising early-stage innovative scientific developments in their journey to provide established commercial solutions.

Mursla is one of nine successful SMEs to be selected to proceed with its study having been chosen by a panel comprising leading experts from Cancer Research UK, NHS England, BIVDA, LifeArc and world leading London academic institutions. Mursla will retain full intellectual and economic rights.

On March 29, 2022 XNK Therapeutics AB ("XNK") reported it has secured a private placement of SEK 132 million, to existing and new investors, led by Flerie Invest AB (Press release, XNK Therapeutics, MAR 29, 2022, View Source [SID1234611152]). The purpose of the issue is primarily to finance the company’s clinical development in multiple myeloma and other indications.

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XNK is at the global forefront of the development of autologous NK cell-based products using its proprietary technology platform. The company’s lead investigational candidate drug is currently being evaluated in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) in a Phase II clinical study in multiple myeloma.

Flerie Invest led the SEK 132 million financing by placing SEK 100 million and thus gains approximately 22 percent of the total number of shares and votes in the company becoming XNK’s largest owner. Ted Fjällman, partner at Flerie Invest, will as a result of the investment join the board of directors.

"This substantial fundraising is an important milestone for XNK. It allows us to accelerate our global growth initiatives and invest in the further development of our product portfolio in multiple myeloma and other cancer indications, such as our ongoing proof of concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center. We are thankful for the continued support of our current shareholders and excited to further strengthen our specialist investor base with Flerie Invest and welcome them as a new shareholder." said Johan Liwing, CEO of XNK Therapeutics.

"XNK Therapeutics and the innovation ecosystem around Karolinska University Hospital in Stockholm have long been at the forefront of clinical cell therapy development" said Ted Fjällman. "We’re excited to lead this round and use our network to further commercialise the company and in so doing bring cell therapies to more patients."

XNK has engaged ABG Sundal Collier AB as financial adviser. The private placement is subject to approval by an extraordinary general meeting, which is scheduled to be held on April 5, 2022.

On March 29, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported a charitable commitment totaling $7.5 million to The Leukemia & Lymphoma Society (LLS), a global leader in the fight against blood cancer (Press release, Royalty Pharma , MAR 29, 2022, View Source;lymphoma-society-lls-to-advance-initiatives-that-address-healthcare-disparities-in-blood-cancer-care-and-treatment-301512545.html [SID1234611151]). Through this five-year alliance, Royalty Pharma will support initiatives focused on reducing healthcare disparities in blood cancer care and treatment. Royalty Pharma is a founding donor of the LLS IMPACT grant program (Influential Medicine Providing Access to Clinical Trials) which awards funding to major cancer research and treatment centers to expand access to clinical trials for underserved and minority populations. Royalty Pharma plc will not receive any economic benefit in exchange for any aspect of these donations.

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Royalty Pharma is supporting initiatives focused on reducing healthcare disparities in blood cancer care and treatment.

"Despite many advances in blood cancer care and treatment, barriers exist in many communities to prevent patients from accessing new, more effective therapies and protocols that can lead to better outcomes," said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. "The gift awarded through Royalty Pharma’s alliance with The Leukemia & Lymphoma Society is intended to propel the work LLS is doing in underserved communities through three key initiatives that will help break down these barriers and ensure that everyone has access to the care they need to treat their blood cancer."

Blood cancer does not discriminate, affecting people of every age, gender, race and ethnicity. But not all people have equal access to care and treatments. LLS exists to ensure that all patients get the care they need. Royal Pharma’s annual contribution of $1.5 million over five years will be equally distributed to the following LLS initiatives that address disparities:

Equity in Access Research Program is a grantmaking program designed to generate evidence that will guide changes in healthcare policy and practice to ensure that all blood cancer patients and survivors achieve access to the cancer care and services they need throughout their lives. This new and novel program is based on the concept of health equity as the principle underlying a commitment to reduce—and ultimately, eliminate—disparities in health.
LLS IMPACT* Research Grants initiative has been established to improve access to clinical trials for underrepresented patients, including Black, Indigenous and People of Color (BIPOC) patients and people from rural communities. Through this initiative, LLS has awarded funding to three major cancer centers located in New York, Tennessee, and Minnesota to partner with community-based hospitals and clinics on creating networks of clinical trial sites in their regions. Additional sites will be selected in the coming months. More information, including participating sites, the communities they serve and the need to address disparities in these areas can be found here.
Myeloma Link is carried out by LLS staff and volunteers in 13 Black communities across the country. It is an education and outreach initiative that raises community awareness about myeloma and connects Black patients and caregivers to trusted, free myeloma information and support and enhances access to care and the latest treatments. Black Americans have at least double the incidence of myeloma as any other racial or ethnic group, and recent studies show they experience less optimal care. To learn more, including the cities where Myeloma Link is active, please visit this site.
"The Leukemia & Lymphoma Society has a long-standing commitment to serving all blood cancer patients and reaching underserved communities where there are barriers to access and equitable care," said Louis J. DeGennaro, Ph.D., President and Chief Executive Officer of The Leukemia & Lymphoma Society. "Royalty Pharma’s generous contribution to these three important initiatives will bring us closer to achieving our goal to ensure a future of expanded access and better outcomes for all blood cancer patients and their families."

On March 29, 2022 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage pharmaceutical company focused on research and development for novel cancer therapeutics, reported that the first patient has been dosed in the Phase 1/2 study of DSP-5336, an inhibitor of menin binding to mixed-lineage leukemia (MLL) protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) (Press release, Sumitomo Dainippon Pharma, MAR 29, 2022, View Source [SID1234611150]).

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"Patients with refractory or relapsed AML or ALL have an unfavorable prognosis and respond poorly to available treatments.1 Dosing the first patient in our Phase 1/2 study is an important milestone as we evaluate DSP-5336 and its safety and potential benefits for this patient population," said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, Inc (SDP Oncology). "It is our hope that the data generated by this study furthers our goal of advancing meaningful treatments for patients with blood cancer."

The Phase 1/2 open-label study consists of two parts, dose escalation and dose expansion. The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D). Secondary objectives include assessment of preliminary clinical activity of DSP-5336 in adult patients with relapsed or refractory AML or ALL.

Following the completion of the Phase 1 dose escalation portion of the study, the study will move into the Phase 2 dose expansion. The primary objective of the Phase 2 dose expansion portion of the study is to further evaluate the safety and clinical activity of DSP-5336 in adult patients with relapsed or refractory AML who have MLL rearrangement or nucleophosmin 1 (NPM1) mutation.

Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04988555).

About DSP-5336

DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2, 3 Binding of menin to MLL fusion and wildtype proteins leads to the upregulation of HOXA family and MEIS1 genes that function to stall myeloid cellular differentiation and induce leukemogenic transformation.2,4,5 Preclinical evidence shows that the disruption of fusion and wild-type menin-MLL interactions inhibits leukemic cell proliferation and restores terminal differentiation of MLL-rearranged and nucleophosmin 1 (NPM1)–mutated leukemic cells.1,6 (NCT04988555).

On March 29, 2022 Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, reported that the first patient has been dosed in its Phase 3 registration study AB-205-301 (E-CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT) (Press release, Angiocrine Bioscience, MAR 29, 2022, View Source [SID1234611148]). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.

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E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ vascular stem cell niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. The US Food and Drug Administration has conferred special regulatory status to AB-205 via the Regenerative Medicine Advanced Therapy and Orphan Drug designations for this indication.

More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.

"We expect 2022 to be a transformational year at Angiocrine, and we are excited to initiate this pivotal Phase 3 study," said Paul Finnegan, MD, Angiocrine’s CEO. "We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program."

Series B Financing
Angiocrine Bioscience recently completed a Series B equity financing led by Cobro Ventures along with participation from Angiocrine’s existing stockholders. The newly raised capital will be used to accelerate Angiocrine’s clinical assets and expand its research pipeline. "We are enormously excited about the potential of Angiocrine’s E-CEL platform," said Dennis Klinman, MD, PhD, Chief Scientific Officer at Cobro Ventures. "Angiocrine’s approach is truly innovative and has great potential to regenerate tissues that have been injured or damaged by diseases including degenerative, auto-immune, and ischemic diseases, in addition to high-intensity cancer treatments."

About AB-205
AB-205 is an experimental, genetically engineered cell therapy consisting of allogeneic engineered human endothelial cells (E-CEL cells). AB-205 is being developed for multiple indications and is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the vascular stem cell niches of multiple organs sustained during high-dose chemotherapy.

About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is considered a standard-of-care consolidative treatment to cure patients with aggressive systemic lymphoma who have failed 1st-line chemotherapy and respond to chemotherapy induction. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue, which can lead to severe toxicities and serious, costly complications. Complication rates and severity increase with age and, thus, many older patients are turned away from this potentially curative therapy due to concerns over complication risks.