Bio-Techne and Akoya Biosciences Partner to Deliver Automated Spatial Multiomics Workflow with Industry-Leading Speed and Resolution

On January 5, 2022 Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, and Akoya Biosciences, Inc., (NASDAQ: AKYA), The Spatial Biology Company, reported a partnership to develop the first single-cell, spatial multiomics workflow for comprehensive, unbiased analysis of tissue samples (Press release, Bio-Techne, JAN 5, 2022, View Source [SID1234598298]).

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Through this agreement, the partners will bring to the market an automated, spatial multiomics workflow that can perform rapid, in situ analysis of multiple analytes, at single cell resolution, across whole slides. Akoya’s PhenoCycler-Fusion System, due to launch in early January 2022, will run the company’s well-established protein imaging assays in addition to automating Advanced Cell Diagnostics’, a Bio-Techne brand, proven and highly cited RNAScope HiPlex v2 assay for RNA imaging. The partnership exemplifies the commitment of both companies to offer researchers greater access to innovative and open access solutions for spatial biology applications.

RNA and protein expression offer complementary insights into cell states and phenotypes. Combining the PhenoCycler-Fusion workflow with the RNAScope HiPlex v2 assay has the potential to accelerate scientific understanding of human health and complex diseases like cancer. Spatial multiomics approaches can also unlock new biomarker diagnostic signatures, enabling better stratification of patients and ultimately improving treatment outcomes.

Backed by over 4,500 peer-reviewed publications, RNAScope Assays are an established standard for spatial RNA imaging. Under the terms of the agreement, Bio-Techne and Akoya will develop and co-market protocols to enable automated workflows for running RNAScope assays on Akoya’s spatial phenotyping systems.

This new combined workflow complements Akoya’s spatial transcriptomics capabilities, currently under development, serving as an important validation tool for deep spatial phenotyping applications.

"We are excited to partner with Akoya to accelerate multiomic spatial phenotyping in translational and clinical disease research," said Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "Akoya’s established leadership in spatial phenotyping automation and multiplex protein biomarker imaging is uniquely complementary to Bio-Techne’s proven expertise in specific and sensitive multiplex RNA detection in cells and tissues. Enabling Akoya’s large and rapidly growing installed base with an automated HiPlex RNAScope workflow provides a uniquely powerful solution to advance discovery research and diagnostic assay development across a wide range of diseases."

"The life sciences market has long needed an approach that provides an unbiased, multiomics view of tissue biology and architecture, which is critical for understanding complex mechanisms of disease and response to therapy," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "The partnership with Bio-Techne, which revolutionized RNA in situ hybridization methods, can further empower researchers with the spatial tools and technologies required to ignite innovation, and break barriers to advance discovery of new biomarkers and improve treatment options."

BAUSCH HEALTH TO PARTICIPATE AT THE 40TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 5, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that Joseph C. Papa, chairman and chief executive officer, is scheduled to participate at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 12, 2022 at 9:00 a.m. ET (Press release, Bausch Health, JAN 5, 2022, View Source [SID1234598297]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source

Biohaven and Pfizer Complete Collaboration Transaction for Commercialization of Rimegepant and Zavegepant Outside United States

On January 5, 2022 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), reported that the parties have completed the collaboration transaction between the two companies (Press release, Biohaven Pharmaceutical, JAN 5, 2022, View Source [SID1234598296]). The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of required regulatory approvals and the satisfaction of other customary conditions, and BHVN shares have been issued to Pfizer. Biohaven will continue to lead research and development globally and retain rights to the U.S. market.

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In connection with the closing of the equity purchase and effectiveness of the strategic transaction, Pfizer made an upfront payment to Biohaven of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity. At close, Pfizer will own 3% of Biohaven. Biohaven is also eligible to receive up to $740 million in future milestones. In addition to the tiered double-digit royalties owed to Biohaven on net sales outside of the U.S., Pfizer will compensate Biohaven for a pro-rata share of certain of its sales-based milestone obligations owed to Bristol-Myers Squibb Company ("BMS"), and for the related royalties on net sales outside of the U.S. owed under Biohaven’s license and funding agreements with BMS and Royalty Pharma.

"The successful closing of our collaboration agreements represent an important and exciting step in expanding the impact of rimegepant to people outside the U.S. with migraine," said Nick Lagunowich, Global President, Pfizer Internal Medicine. "We are enthusiastic about working with the Biohaven team to bring this valuable new treatment option to the millions of people across the globe suffering from migraine."

Rimegepant is commercialized as Nurtec ODT in the U.S. and is the only oral CGRP (calcitonin gene-related peptide) receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022. Rimegepant is already approved for the acute treatment of migraine in Kuwait and the United Arab Emirates, and for the acute and preventive treatment of migraine in Israel. Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist delivered in an intranasal spray which recently achieved positive Phase 3 topline data in its second pivotal clinical trial for the acute treatment of migraine in adults. Zavegepant, if approved, would be the first intranasal CGRP receptor antagonist for the acute treatment of migraine in adults. Intranasal treatments like zavegepant offer additional potential benefits including ultra-rapid speed of onset and a non-oral delivery for patients who experience significant nausea or vomiting.

Vlad Coric M.D., Chairman and CEO of Biohaven commented, "Together we hope to establish a world-class migraine business that can deliver on our promise of providing new treatment options for people living with this debilitating disease." Dr. Coric added, "We are excited to collaborate with Pfizer given their global footprint and experience in the treatment of pain and in Women’s Health, which we believe may help establish rimegepant as a leading novel treatment of migraine."

About Migraine
More than one billion people suffer from migraine worldwide, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating headache attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.

About Rimegepant
Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. A single dose of 75 mg Nurtec ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in many patients. Nurtec ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. Nurtec ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

NURTEC ODT U.S. Important Safety Information
Nurtec ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if Nurtec ODT is safe and effective in children.

Do not take Nurtec ODT if you are allergic to Nurtec ODT (rimegepant) or any of its ingredients.

Before you take Nurtec ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

have liver problems,
have kidney problems,
are pregnant or plan to become pregnant,
are breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Nurtec ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take Nurtec ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with Nurtec ODT.

The most common side effects of Nurtec ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of Nurtec ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit View Source or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4Nurtec.

Please click here for full Prescribing Information and Patient Information.

About Zavegepant
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven’s NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety of intranasal zavegepant was shown in two pivotal clinical trials with statistical superiority to placebo on the coprimary endpoints. Previously the efficacy and safety of intranasal zavegepant was shown in a randomized controlled Phase 2/3 dose-ranging trial with more than 1000 patients treated. In December 2021, zavegepant pivotal data showed statistical superiority to placebo on a total of 15 consecutive, prespecified primary and secondary outcome measures in the acute treatment of migraine. Topline results showed ultra-rapid pain relief at the earliest measured time point of 15 minutes, return to function at 30 minutes, 2 hour freedom from pain and freedom from patients’ most bothersome symptom (either nausea, photophobia or phonophobia) and sustained efficacy through 48 hours after a single intranasal dose. Biohaven plans to file a New Drug Application for zavegepant with the U.S. Food and Drug Administration in 1Q2022.

Samus Therapeutics Announces First Patient Dosed in Phase 1b Study of Icapamespib in Recurrent Malignant Glioma

On January 5, 2022 Samus Therapeutics, Inc. ("Samus Therapeutics" or the "Company"), a privately held, Boston-based biopharmaceutical company with a novel approach to protein degradation and restoration of normal cellular functions to treat cancer and central nervous system (CNS) diseases, reported the first patient was dosed in the multicenter Phase 1b study of icapamespib in patients with recurrent malignant glioma (Press release, Samus Therapeutics, JAN 5, 2022, View Source [SID1234598295]).

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Over 24,000 patients are diagnosed with primary brain tumors (non-metastatic) in the U.S. per year and of these approximately half are classified as glioblastomas, a type of fast-growing high grade glioma1. The five-year survival rate for patients >55 years old is particularly poor (6-15%)1.

"Patients with recurrent malignant glioma face a poor prognosis. Currently, standard treatments are sub-optimal and there is an urgent need for the development of new promising therapeutics," said Howard Colman, MD, PhD, Co-Leader of the Center for Neurologic Cancers and Co-Leader of the Experimental Therapeutics Program at the Huntsman Cancer Institute at the University of Utah, and principal investigator of the Phase 1b study. "I look forward to investigating a therapy which may help address this significant unmet patient need."

The Phase 1b trial consists of two stages. The first stage is currently recruiting patients and will evaluate the safety, tolerability and pharmacokinetics of icapamespib. This dose escalation stage is designed to define a recommended Phase 2 dose (RP2D). The second stage, dose expansion, will confirm the safety and tolerability of the RP2D.

Icapamespib (PU-AD, PU-HZ151) is an oral small molecule that crosses the blood brain barrier and is designed to inhibit epichaperomes, protein complexes which support cancer growth. In a recently published article, Bolaender et al2 demonstrated in preclinical studies that glioblastomas express high levels of epichaperomes and that treatment response to icapamespib directly correlates with epichaperome expression levels. In ex-vivo studies using patients’ surgical explants from tumors resistant to temozolomide and bevacizumab, drugs routinely utilized to treat malignant glioma, inhibition of epichaperomes with icapamespib initiated aberrant protein degradation and induced cancer cell death.

"We are excited to test the novel approach of epichaperome inhibition with icapamespib and to evaluate how it can benefit patients with recurrent malignant glioma," said Dick Bagley, Chief Executive Officer of Samus Therapeutics.

References
1 American Cancer Society, View Source
2 Bolaender A. et al. NATURE COMMUNICATIONS 2021;12:4669

Elevation Oncology to Present at the 40th Annual J.P. Morgan Healthcare Conference

On January 5, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that Shawn M. Leland, PharmD, RPh, Elevation Oncology’s Founder and Chief Executive Officer, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 9:45 a.m. ET, in a virtual format (Press release, Elevation Oncology, JAN 5, 2022, View Source [SID1234598294]).

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A live webcast and replay of the event will be available on the Events page of the Company’s Investor Relations website at View Source