On June 23, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported that the first patient was treated in a First-in-Human Phase 1 clinical trial evaluating BDB018 in advanced solid tumors at Florida Cancer Specialists & Research Institute in Sarasota, FL (Press release, Seven and Eight Biopharmaceuticals, JUN 23, 2021, View Source [SID1234584279]).

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BDB018 is a next-generation intravenously administered Toll-Like Receptor 7 and 8 (TLR 7/8) dual agonist specifically designed to further enhance immune activation against cancer, while maintaining a favorable safety profile similar to its analogue, BDB001. BDB001 has shown to be well tolerated as monotherapy and in combination with an anti-PD-1 mAb, with responses seen in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

BDB018-101 (NCT04840394) is an open-label, dose escalation Phase I clinical trial evaluating the safety and tolerability of BDB018 in patients with advanced solid tumors that have relapsed or are refractory to standard treatments.

"We are excited to bring our next generation program with an intravenously administered TLR 7/8 dual agonist to the clinic, building on our success with BDB001," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma, "The dosing of the first patient with BDB018 will begin to provide us with essential safety information needed to guide the future development of BDB018."

"Initiation of the BDB018-101 Phase I trial is another important milestone for Seven and Eight Biopharma in our mission to develop novel treatments for cancer and expand immuno-oncology treatments beyond targeting PD-1, PD-L1, and CTLA-4." said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

On June 23, 2021 Sosei Group Corporation ("the Company"; TSE: 4565) reported that the first healthy subject has been dosed with HTL0022562 in a Phase 1 clinical study (Press release, Sosei, JUN 23, 2021, View Source [SID1234584295]). HTL0022562 (also known as BHV3100) is a novel, small molecule CGRP* receptor antagonist discovered by Sosei Heptares and the lead compound in a portfolio of CGRP antagonists licensed to Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven",NYSE: BHVN) in December 2020 for development as new therapies for CGRP-mediated disorders .

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The trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of a single ascending dose and multiple ascending doses of subcutaneous HTL0022562 in healthy adult subjects. The trial aims to enroll 88 subjects at a single center in the UK and is expected to complete in 2022.

Sosei Heptares has advanced HTL0022562 successfully though a preclinical development program demonstrating its promising and differentiated properties for further investigation in human trials.

Under the global collaboration and license agreement with Biohaven, Sosei Heptares will conduct the Phase 1 clinical trial itself, receiving a milestone payment for its initiation, and is also eligible for development costs for conducting the trial. Biohaven will lead all future studies and development activities and Sosei Heptares will be eligible for further milestone payments and royalties.

Although the event reported today has no significant impact on the consolidated financial results for the accounting period ending 31 December 2021, the Company considers that an important developmental milestone has been achieved with HTL0022562 becoming the tenth drug candidate overall generated from Sosei Heptares’ SBDD platform to enter clinical development, and therefore makes this announcement.

Tim Tasker, Executive Vice President and Chief Medical Officer of Sosei Heptares, said: "We are pleased to initiate this new clinical trial with HTL0022562 following the successful discovery and preclinical development work conducted by Sosei Heptares. We are also delighted at the speed of progress and the positive collaborative approach that has developed between our team and our partners at Biohaven and the confidence they have shown in our early clinical development capabilities. Together, we are committed to developing this novel differentiated agent to treat CGRP-mediated diseases with unmet need."

*Abbreviations used: CGRP – calcitonin gene-related peptide

About the Agreement with Biohaven
Sosei Heptares and Biohaven entered a global collaboration and license agreement in December 2020 under which Biohaven received exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. Sosei Heptares received an upfront payment of US$10 million on signing in cash and Biohaven common shares and is eligible to receive additional research funding, up to US$370 million in development, regulatory and commercialization milestone payments, plus tiered royalties on net sales of products resulting from the collaboration.

About CGRP
CGRP is an important neuropeptide believed to be involved in multiple neuro-inflammatory and neuro-immune diseases. CGRP receptor antagonism interrupts pathologic signals in CGRP-mediated diseases, such as migraine. Following the success of this approach in migraine, Biohaven is exploring the potential of this approach in other neuro-inflammatory and neuro-immune diseases, including COVID-19.

On June 22, 2021 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) along with one of its wholly owned subsidiaries reported that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US (Press release, Sun Pharma, JUN 22, 2021, View Source [SID1234584223]).

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Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to USFDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. -All brand names and trademarks are the property of respective owners

On June 22, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration with Quest Diagnostics (NYSE: DGX) to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel (Press release, Biocept, JUN 22, 2021, View Source [SID1234584241]). Quest Diagnostics is the leading provider of diagnostic information services, including in advanced diagnostics.

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The Biocept Target Selector NGS-based liquid biopsy assay is a less invasive, lab developed test that can be used for genomic profiling in patients with advanced non-small cell lung cancer (NSCLC) to help qualify them for advanced targeted therapies and monitor the effectiveness of treatment. With a physician order, patients will be able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. The two parties expect the service to be available to Quest Diagnostics’ providers and patients in the fourth quarter of 2021.

"We are pleased to expand Biocept’s relationship with Quest Diagnostics, as we believe its expertise and reach will allow us to serve more patients and potentially grow our customer base," said Michael Nall, President and CEO of Biocept. "Quest shares our focus on improving care for patients with lung cancer, and this agreement provides a strong collaborator to help us provide oncologists with the answers they need to create more personalized, responsive treatment plans for their patients."

"Lung cancer is one of the most prevalent and deadliest cancers," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Better tools to aid in therapy selection and monitoring are urgently needed to improve patient outcomes, which is why we are so excited to work with Biocept on this focused test. Quest has the national scale, oncology expertise and network provider relationships to broaden access to this important innovation in order to potentially improve care for patients in treatment for lung cancer."

Biocept Target Selector NGS-based targeted lung cancer panel includes the most prevalent clinically actionable genes for NSCLC. It combines Biocept’s liquid biopsy biomarker testing expertise with next-generation sequencing and decision support resources. The NGS solution is targeted and actionable—approximately 70% of the biomarkers investigated are based on National Comprehensive Cancer Center guidelines and/or FDA-approved therapies.

On June 22, 2021, United Therapeutics Corporation (the "Company") and Medtronic, Inc. ("Medtronic") reported that agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin ("ISR") (Filing, 8-K, United Therapeutics, JUN 23, 2021, View Source [SID1234584280]). By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension ("PAH") via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the "Commercialization Agreement"). Despite approval by the U.S. Food and Drug Administration ("FDA") of Medtronic’s premarket approval application ("PMA") for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense. Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement.

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