On June 9, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that its Chief Executive Officer, Masoud Toloue, will join the Goldman Sachs 43rd Annual Global Healthcare Conference for a fireside chat on June 16, 2022 at 8:40 a.m., EST (Press release, Quanterix, JUN 9, 2022, View Source [SID1234615841]).

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To register for the live webcast, please visit: View Source

Toloue will also host one-on-one meetings with institutional investors on Thursday, June 16. A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On June 9, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported data from a preclinical combination study of SON-1010 with a commercially available anti-PD1 compound (Press release, Sonnet BioTherapeutics, JUN 9, 2022, View Source [SID1234615826]). These results suggest that dosing of SON-1010 (IL12- FHAB) in combination with anti-PD1 demonstrated strong efficacy in the B16F10 mouse melanoma model, historically known as an immunologically insensitive model to anti-PD1.

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Checkpoint inhibitors provide viable treatment alternatives to chemotherapy and/or radiation for patients with solid tumors, but there remains a robust need for more effective combination treatment regimens. With the objective of improving the checkpoint inhibitor response rate, Sonnet BioTherapeutics is developing a targeted approach using the company’s Fully Human Albumin binding (FHAB) platform. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only Interleukin 12 (IL-12), but a variety of synergistic and potent immunomodulators. SON-1010 is currently undergoing Phase 1 clinical study in cancer patients and this preclinical study was designed to explore the combination potential with a checkpoint inhibitor (anti-PD1).

"We are excited to see that the combination of SON-1010 with an anti-PD1 antibody yielded compelling data in this preclinical model" said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer, and further added that, "These data support our strategy of pairing SON-1010 with a checkpoint inhibitor, with the goal of developing an improved treatment option for cancer patients."

Experimental Study Design: Three randomized cohorts of nine mice (n = 27), each with 150 mm3 B16F10 melanoma tumors, were dosed with 3µg IL12-FHAB and/or 10µg anti-PD1 antibody on days 0, 4 and 8 while the placebo cohort was not treated. Mean tumor volumes were measured every two or three days through an 18-day period.

Table 1: Mean Comparisons of Tumor Volume Growth Inhibition

Test Article

Mean Tumor
Volume (mm3) – Day 14

Tumor Growth Inhibition Ratios
( % Inhibition )

Placebo (n = 9)

2260

–

Anti-PD1 antibody (n = 9)

2016

10.7%

Anti-PD1 + IL12-FHAB (n = 9)

472

79.1%

Compared to the tumor-bearing placebo group at day 14, the treatment groups administered three doses of anti-PD1 antibody or three doses of the IL12-FHAB + anti-PD1 antibody combination resulted in 10.7% and 79.1% tumor growth inhibition, respectively.

Survival data for study mice at 18 days further supports the efficacy synergy of IL12-FHAB co-injected with anti-PD1 by improving the survival rate: (i) for anti-PD1 administration, only one mouse survived out of a total of nine, and (ii) for anti-PD1 + IL12-FHAB administration, seven mice survived out of a total of nine. Additionally, the mice cohorts used in the preclinical efficacy study did not show any weight loss during the study in either the single agent or combination dosing arms.

"We are excited to have demonstrated these important data in an immunologically distinct animal model when IL12-FHAB was dosed in combination with an anti-PD1 antibody," said John Cini, Ph.D., Sonnet’s Chief Scientific Officer. "Further, this study evaluated the sequence of test article administration, whereby co-injection of IL12-FHAB and anti-PD1 antibody was optimal when compared to administration of either anti-PD1 or IL12-FHAB first. Targeting the tumor by linking IL-12 to an albumin-binding domain extends the cytokine half-life in the body, and we believe that is the key to inducing a successful local immune response in the tumor microenvironment."

On June 9, 2022 NEXT Bio Research Services LLC (www.nextmolecular.com), dba NEXT Molecular Analytics reported that the New York State Department of Health (NYSDOH) has accredited the Company’s L-Asparaginase enzyme activity assay platform (Press release, NEXT Molecular Analytics, JUN 9, 2022, View Source [SID1234615842]). This means that NEXT is now able to receive clinical test samples from New York State institutions without waiver and also means that NEXT is now accredited in all 50 states to process asparaginase test samples.

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Dr. Robert B Harris, the original developer of the Laboratory Derived Test for asparaginase, the holder of the Certificate of Quality from the NYSDOH, stated, "Reaching this milestone is a tremendous accomplishment for our Company and is testament to the diligent and precise work of our dedicated employees." He added, "The NYSDOH standards are among the most rigorous in the country for testing labs to meet, and we take great pride in the fact that NEXT has met these standards."

L-asparaginase chemotherapy is integral in the treatment of pediatric patients with acute lymphoblastic leukemia (ALL). Its incorporation as part of a multi-agent chemotherapy regimen has resulted in improved, event free survival in childhood ALL. NEXT’s test measures asparaginase levels in patients being treated with any of the current therapeutic biologics used in ALL patients including Oncaspar, Asparlas, Erwinaze, and Rylaze. NEXT has assayed more than 16000 patient samples from well over 250 institutions worldwide, including hospitals and clinics in Canada, Switzerland, Hong Kong, Singapore, and the United Arab Emirates. Assay results are returned by the close of business the same day that the sample is received, thereby providing the clinician real-time therapeutic monitoring of his patient with respect to asparaginase activity levels. In addition to providing results to ordering physicians, NEXT is also partnering with the different drug manufacturers of asparaginase to help propagate the usefulness of real time therapeutic monitoring of asparaginase levels, NEXT is actively using its assay to support several human pre-clinical and clinical trials.

On June 8, 2022 Proscia, a leader in digital and computational pathology solutions, reported that its Concentriq Dx platform has been certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis (Press release, Proscia, JUN 8, 2022, View Source [SID1234615778]). This certification will enable the company’s continued growth in the European diagnostic pathology market, where it is helping leading laboratories to modernize their routine operations.

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The IVDR certification demonstrates that Concentriq Dx complies with the stronger quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.

"Proscia’s dedication to quality is unwavering," said Kim Rendon, Director of Regulatory Affairs. "The IVDR certification is a testament to our focus on delivering the safe, efficacious solutions that pathologists need to provide faster, more accurate diagnoses and ultimately improve patient outcomes."

A singular, secure platform, Concentriq Dx* helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks. As laboratories increasingly look to unlock new insights with computational solutions, Concentriq Dx is designed to support them in realizing pathology’s AI-enabled future.

Concentriq Dx is the platform of choice for top reference laboratories and health systems in Europe, including LabPON and Uppsala University Hospital. The European geography has seen some of the earliest adopters of digital pathology due to a widespread shortage of pathologists among other systemic challenges in the traditional laboratory model. Rising demand for diagnostic services continues to intensify pressure for digital transformation.

In response, Proscia has established subsidiary entities in Ireland and Spain to further drive its international growth. These entities will enable the company to increasingly scale its operations and continue to support its expanding customer base.

"Since we entered the European market in 2019, we have welcomed leading laboratories onto the Concentriq Dx platform and built a world-class team," said David West, CEO. "We are now better positioned than ever before to accelerate this momentum as we see through our mission of perfecting cancer diagnosis."

Proscia will be exhibiting at next week’s European Congress on Digital Pathology. To learn more about Concentriq Dx and see a demo, visit the company at booth #B09.

*Concentriq Dx is CE-marked under IVDR and is available for primary diagnosis in the US during the COVID-19 public health emergency.

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."