On June 8, 2022 Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, reported the successful completion of an oversubscribed EUR 25 million Series A financing round (Press release, Ariceum Therapeutics, JUN 8, 2022, View Source;and-high-grade-neuroendocrine-cancers-301563216.html [SID1234615794]). Ariceum was co-founded by EQT Life Sciences (formerly LSP) and HealthCap who also co-led the financing that was joined by Pureos Bioventures. Ipsen transferred assets, and all corresponding rights into the Company in late 2021.

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The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Satoreotide is a radiopharmaceutical drug and an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in many cancers, including certain hard-to-treat cancers such as small cell lung cancer (SCLC), high-grade neuroendocrine tumours (NETs) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children. Satoreotide will be used as a ‘theranostic’ for both the diagnosis and treatment of tumours expressing the SST2 receptor. Satoreotide is in early clinical development and, as of today, has been administered to more than 100 patients including more than 150 therapeutic administrations.

Ariceum is led by a highly experienced management team with a strong track record and expertise in clinical trials, systemic targeted radiation therapy and radiopharmaceutical development, as well as launching and commercialising diagnostic and therapeutic products in a variety of indications worldwide.

In conjunction with the financing, Karin Kleinhans of EQT Life Sciences, Per Samuelsson of HealthCap and Martin Münchbach of Pureos Bioventures will join Ariceum’s board of directors together with Eduardo Bravo, CEO of EBAC, who has been elected as chairman of the board.

Founded in 2021, Ariceum is headquartered in Berlin, with operations in Germany and activities currently across Europe, North America and Australia.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "We are very pleased to attract this outstanding syndicate of venture capital and corporate investors which validates our approach to developing our lead radiopharmaceutical product, satoreotide. I am excited to lead an exceptional team as we continue to build our platform and advance satoreotide for systemic targeted radiation therapy (STRT) to visualize and treat neuroendocrine tumors and certain other more aggressive cancers."

Karin Kleinhans, PhD, Partner at EQT Life Sciences, stated: "We founded Ariceum with the aim to build a European leader in targeted radiopharmaceuticals. We are delighted to support the Company in the development of its innovative technology to create more effective treatments for patients suffering from hard-to-treat cancers which are currently not adequately addressed by existing therapies, in addition to neuroendocrine cancers expressing the receptor."

Per Samuelsson, Partner at HealthCap, stated: "We are proud to have been involved with the Company since its early days and are very impressed with the progress achieved to date. We believe Ariceum’s innovative theranostic approach to diagnose and treat different types of cancers is world-leading and we look forward to supporting the Company through the next stages of growth."

Martin Münchbach, PhD, Managing Partner at Pureos Bioventures, added: "We are honoured to join this round with HealthCap and EQT Life Sciences and believe it will be a tremendous joint effort to bring Ariceum to the next level. Ariceum understands the power of radiopharmaceuticals which will enable the Company to develop better targeted drugs to eradicate cancer more effectively with less side-effects."

On June 8, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 2022 Jefferies Global Healthcare Conference (Press release, Ideaya Biosciences, JUN 8, 2022, View Source [SID1234615793]).

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2022 Jefferies Global Healthcare Conference
Wednesday, June 8 at 11:00am ET

Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by
Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On June 8, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China (Press release, Harbour BioMed, JUN 8, 2022, View Source [SID1234615792]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022.

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HBM7008 is generated from HBM’s unique and innovative HBICE platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for cancer treatment. As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutics. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide a novel, effective and safe treatment for patients, so that more cancer patients can benefit from the innovative therapeutic." said Dr. Humphrey Gardner, CMO of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor-Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On June 8, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, for the treatment of myelofibrosis (Press release, Sumitomo Pharmaceuticals, JUN 8, 2022, View Source [SID1234615791]).

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"This designation is an important milestone in the development of TP-3654 and highlights the need for potential new treatment options for patients with myelofibrosis," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "This rare hematologic cancer can also progress and worsen. We are excited about collaborating with investigators to advance this clinical-stage asset with the goal of improving patient outcomes."

The FDA’s Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Myelofibrosis is a rare type of bone marrow cancer which disrupts an individual’s normal production of blood cells.1 Myelofibrosis has approximately 1.5 reported cases per 100,000 people each year in the United States.2

"TP-3654 is an investigational oral inhibitor of PIM kinases. PIM kinases have potential antitumor and anti-fibrotic effects through multiple pathways, including induction of apoptosis.3,4 Notably, PIM kinase expression correlates with increased cell survival and reduced apoptosis in tumors, supporting the potential of PIM kinases as novel therapeutic targets,"3 explained Jatin J. Shah, M.D, Chief Medical Officer of Sumitomo Pharma Oncology, Inc. "PIM-1 expression is significantly elevated in myelofibrosis hematopoietic cells and therefore a potential therapeutic target for myelofibrosis."4

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis. It is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment visit clinicaltrials.gov (NCT04176198).

About TP-3654
TP-3654 is an oral investigational inhibitor of PIM kinases, which has potential antitumor and anti-fibrotic effects through multiple pathways, including induction of apoptosis.3,4 TP-3654 inhibited proliferation and increased apoptosis in murine and human hematopoietic cells expressing clinically relevant JAK2V617F mutation.4 TP-3654 alone and in combination with ruxolitinib normalized WBC and neutrophil counts, and reduced spleen size and bone marrow fibrosis in JAK2V617F and MPLW515L murine models of myelofibrosis.4 TP-3654 is currently being evaluated in two clinical trials; A Phase 1 study to treat TP-3654 in patients with advanced solid tumors (NCT03715504); A Phase 1/2 study of oral TP-3654 in patients with intermediate and high-risk myelofibrosis (NCT04176198).

On June 8, 2022 Glympse, a biotechnology company developing revolutionary technology to diagnose and monitor disease, reported that it will have two poster presentations demonstrating that its novel protease biosensor diagnostic platform can detect hepatocellular carcinoma (HCC) at the European Association for the Study of the Liver (EASL) International Liver Congress 2022 (ILC) (Press release, Glympse Bio, JUN 8, 2022, View Source [SID1234615790]). The conference will be held from June 22-26 at ExCeL in London, United Kingdom.

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HCC is the fifth leading cancer globally, and non-invasive diagnostic options are needed to improve early diagnosis for better treatment outcomes. Glympse has developed a novel diagnostic platform technology that utilizes biosensors and machine learning to measure protease activity in plasma samples and will present two analyses demonstrating the platform’s ability to detect HCC. In poster #SAT564, Glympse will present results from a study of two independently tested, diverse cohorts of patients (n = 94) with known HCC vs. healthy controls, which determined Glympse’s platform was effective at detecting HCC (AUC ≥ 0.94). In the second poster (#FRI236), Glympse utilized the platform technology to differentiate between plasma samples with diagnosed HCC and without HCC but with cirrhosis (n = 43 and 26, respectively). Results showed that the protease activity platform was effective at HCC detection (AUC = 0.93) and has potential future utility for early diagnosis, considering 72% of the HCC cases had early-stage tumors.

"Our data demonstrate that the Glympse protease-based diagnostic platform is showing very promising data in the early detection of HCC," said Tram Tran, M.D., Chief Medical Officer of Glympse. "With proper validation, this technology could be used in surveillance strategies for earlier, easier, and more accurate diagnosis of HCC."

"The Glympse diagnostic platform continues to demonstrate highly accurate predictive capabilities for disease detection," said Caroline Loew, Ph.D., Chief Executive Officer of Glympse. "Following our presentation at AASLD, in which we were able to predict NASH vs. healthy patients with 97% accuracy, these data at the EASL conference showcase the platform’s ability to highly accurately detect HCC. We look forward to the continued validation of this platform, and of the measurement of protease activity, to accurately diagnose and monitor disease for patients in need."

Information regarding the two poster presentations can be found below.

Title: Novel and accurate measurement of differential protease activity in diagnosed HCC patients compared to non-HCC cirrhotic patients
Presented By: Amit Singal, M.D.
Poster Session: Non-invasive assessment of liver disease except NAFLD
Time/Date: June 24, 2022, 9:00 a.m. – 6:30 p.m. BST
Abstract #: FRI236

Title: Measurement of protease activity using novel plasma biosensors can accurately detect HCC
Presented By: Tram Tran, M.D.
Poster Session: Liver tumours: Clinical aspects except therapy
Time/Date: June 25, 2022, 9:00 a.m. – 6:30 p.m. BST
Abstract #: SAT564