On June 15, 2022 Imagia Canexia Health, a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions, reported the CE-IVD marking for its Imagia Canexia Health Insights Platform (ICHIP) to operate across Europe (Press release, Canexia Health, JUN 15, 2022, View Source [SID1234616015]). ICHIP provides intricate molecular and computational genome analysis, from targeted next-generation sequencing (NGS) data, for individual cancer patients. The company offers a unique clinical solution for European oncologists to quickly generate reports—including therapeutic and clinical trial recommendations. This new approval furthers Imagia Canexia Health’s mission to combine advanced genomics, oncology, artificial intelligence, and informatics to enable health systems to provide cost-effective testing in-house—thus delivering precision cancer treatments to patients no matter where they live.

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Clinicians receive next-generation sequencing (NGS) data sourced from human tissue or blood samples. These insights are collected, as well as processed, on Illumina’s NextSeq and MiSeq devices. Then, ICHIP uses AI to detect and analyze genomic variants, match interpretations, identify potential clinical trials, as well as generate a cancer-treatment results report. This creates a new ability to integrate clinical and genomic patient data, augmenting treatment decisions by oncologists. With this crucial information, health professionals can rapidly access data about a cancer patient’s genetics, as well as describe the potential associations between detected variants and specific therapeutics, all while making the most informed care-management decisions.

"Achieving the CE-IVD mark, a highly regarded standard around the globe, represents an important milestone that reflects the technological quality and rigor upon which we built the Imagia Canexia Health Insights Platform (ICHIP)," said Imagia Canexia Health CEO Geralyn Ochab. "Our company takes pride in the platform’s ability to quickly provide specialists with vital information to fight cancer, now supporting European oncologists with life-saving information for their patients."

On June 15, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, reported that it will report financial results for the fourth quarter and fiscal year 2022 before the market open on Tuesday, July 12, 2022 (Press release, AngioDynamics, JUN 15, 2022, View Source [SID1234616014]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13730672.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 12, 2022, until 11:59 p.m. ET on Tuesday, July 19, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13730672.

On June 15, 2022 Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide reported that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market LLC ("Nasdaq") on Thursday, June 16, under the new ticker symbols "ALVO" and "ALVOW", respectively (Press release, Alvotech, JUN 15, 2022, View Source [SID1234616013]). This follows the successful completion of the company’s business combination with Oaktree Acquisition Corp. II ("OACB"), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"). The merger, which was approved on June 7 by OACB shareholders, creates a publicly traded, pureplay company focused on the growing global biosimilar market.

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The public listing is expected to be the largest debut on a U.S. exchange by an Icelandic company. Ordinary shares of the company are also expected to trade on the Nasdaq First North Growth Market in Iceland commencing on June 23, 2022. Alvotech is expected to be the first dual-listed Icelandic company on both a U.S. and Icelandic stock exchange.

"Becoming a public company is a historic milestone on Alvotech’s growth journey," said Robert Wessman, founder and Executive Chairman of Alvotech. "We expect that becoming a listed company will allow us to continue strengthening our position in the biosimilar space while delivering value to our partners and patients across the globe."

"Oaktree is proud to be associated with Alvotech, a world-class biosimilar platform with a mission-critical focus on providing important drugs at a reduced cost," said Howard Marks, Co-Founder and Co-Chairman of Oaktree. "We look forward to the continuation of our relationship as the company enters its next phase of growth."

Since its inception a decade ago, Alvotech has built a vertically integrated, state-of-the-art platform for developing and manufacturing biosimilars at scale. Biosimilars are therapeutic equivalents to biologics, a rapidly growing category of highly efficacious medicines, that provide lower-cost alternatives to higher-priced originator medicines. Biologics represent over 40% of all pharmaceutical spending in the U.S. and over 30% of spending on medicines in Europe at list prices1. Alvotech’s current portfolio of eight products and product candidates targets multiple therapeutic areas and represents an estimated total addressable market of over $85 billion based on estimated peak sales of the reference products2.

Alvotech’s lead product, AVT02 (adalimumab), a biosimilar to Humira, has launched in Canada and Europe and is expected to launch in the U.S. on July 1, 20233. For the U.S. market, Alvotech is pursuing an interchangeability designation for AVT02 (adalimumab) and has previously announced FDA acceptance of Alvotech’s BLA supporting interchangeability for the company’s high-concentration, citrate-free biosimilar candidate. More recently, the company has announced positive topline results for AVT04 (ustekinumab), Alvotech’s proposed biosimilar to Stelara, for both the confirmatory clinical, safety and efficacy study and a pharmacokinetic (PK) study.

In order to give its products global reach with local expertise, Alvotech has formed strategic commercialization partnerships with leading pharmaceutical companies spanning global markets. These include partnerships with Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) for the US market; STADA Arzneimittel AG for EU and select other territories; and Fuji Pharma Co., Ltd (TSE: 4554) for Japan, among others.

The transaction is supported by a PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. The PIPE was backed by top-tier investors such as Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

To celebrate the public listing, Mr. Wessman will ring the opening bell at NASDAQ with live ceremonies beginning at 9:15 ET on June 16 at the Nasdaq Market Site in New York City. The event will be livestreamed and can be viewed at View Source

On June 15, 2022 Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum physics reported that it has entered a new research collaboration with Sanofi (Press release, Aqemia, JUN 15, 2022, View Source [SID1234616012]).

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This new agreement is a follow-up to a Research Collaboration initiated at the end 2020 by Sanofi to bring the unique technologies of Aqemia to the design and discovery of novel molecules in several projects in oncology, a priority therapeutic area for Sanofi.

This initial collaboration resulted in promising molecules for an oncology program, for which Sanofi and Aqemia decided to pursue joint efforts.

Aqemia will take responsibility for the AI-based design of optimized molecules that fulfill several small molecule design goals among which potency and selectivity in a priority project in oncology. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the drug discovery project by generating its own data with quantum and statistical physics-based calculations.

This collaboration includes an undisclosed upfront payment from Sanofi.

Maximilien Levesque, CEO and co-founder of Aqemia, commented, "We are really proud of the results obtained in the first Sanofi-Aqemia oncology collaboration and are very excited to continue working together to accelerate important projects in oncology." He added, "This follow-up of our first collaboration project with Sanofi, a global leader in the Pharmaceutical industry, demonstrates our ability to quickly generate novel potent and selective compounds for a given target, and we can’t wait to scale it up to dozens of drug discovery projects."

"We are also extremely excited by the promising results obtained by Aqemia using their proprietary and disruptive technology to design potent inhibitors on given targets. We are eager to prolong our collaboration to speed up our candidate finding process for the sake of patients suffering from cancer," said Laurent Schio, head of Integrated Drug Discovery of Sanofi France,

On June 15, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported inter- and intra-reader reproducibility results from its Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer (Press release, Blue Earth Diagnostics, JUN 15, 2022, View Source [SID1234616011]). Results for the inter-reader agreement showed that agreement was high across all readers. The inter-reader agreement for 18F-rhPSMA-7.3 PET/CT was more than 75% overall and greatest for the pelvic lymph node region, with more than 87% concordance. Intra-reader agreement was more than 85% overall. 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in an oral presentation at the 2022 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.

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"Biochemically recurrent prostate cancer can be locally recurrent disease, metastatic disease, or both. Therefore, optimal assessment of the extent and location of recurrent prostate cancer is critical for clinical decision-making by physicians and patients," said Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Needham, Mass., on behalf of the SPOTLIGHT study group. "Unfortunately, recurrence of prostate cancer is common. Conventional imaging, such as CT and bone scintigraphy, is often negative particularly when PSA is still low, so the demonstrated performance of PSMA-PET imaging fits an important unmet need. But no matter how good the radiotracer or scanner, reliable and consistent interpretation of PET imaging is foundational and has the potential to substantially impact patient care. These findings from the SPOTLIGHT study showed high inter-reader and intra-reader agreement for interpretation of 18F-rhPSMA-7.3 PET/CT scans in the setting of biochemical recurrence. Such high reproducibility, particularly for extra-prostatic regions, is clinically valuable, due to the potential of these findings to influence patient management."

"We are pleased to present these reader interpretation results from the Phase 3 SPOTLIGHT trial at SNMMI’s 2022 Annual Meeting, as they will be a critical element of a New Drug Application with the U.S. Food and Drug Administration (FDA) for 18F-rhPSMA-7.3 PET imaging," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In designing the image interpretation training to be used for the 18F-rhPSMA-7.3 Phase 3 program, we drew upon Blue Earth Diagnostics’ expertise and experience in designing PET image interpretation programs and training for commercialized Axumin (fluciclovine F 18). We selected 18F as the isotope of choice for PET imaging with rhPSMA in consideration of its spatial resolution and resulting high quality of PET images, and its physical half-life which greatly facilitates ease of large-scale manufacturing and distribution for broad-based patient access. 18F-rhPSMA-7.3 represents a new class of high affinity PSMA-targeted PET radiopharmaceuticals. Early studies of 18F‐rhPSMA‐7.3 showed a binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity."

The findings presented at SNMMI discussed inter- and intra-reader agreement for the interpretation of 18F-rhPSMA-7.3 scans. Overall agreement between all three blinded readers who received identical training was assessed and repeated for the regions of the prostate/prostate bed, pelvic lymph nodes, and other (extra-pelvic) sites (lymph nodes outside pelvis, soft tissue/parenchyma, and bones). Results showed that agreement was high across all readers. The inter-reader agreement for 18F-rhPSMA-7.3 PET/CT was more than 75% overall and greatest for the pelvic lymph node region, with more than 87% concordance. Intra-reader agreement was more than 85% overall. Reproducibility was lower for the prostate/prostate bed than other regions; however, the high reproducibility for extra-prostatic regions is clinically valuable due to the potential of these findings to influence patient management.

The SPOTLIGHT trial (NCT04186845) is a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO (Free ASCO Whitepaper) GU in February 2022,1 with additional results announced at AUA in April 20222.

The findings were discussed in an oral presentation at SNMMI 2022 on June 14, 2022, "Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET image interpretation in patients with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT)," by Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Boston, Mass., on behalf of the SPOTLIGHT study group. Full session details and the abstract are available in the SNMMI online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.