Labcorp Strengthens Oncology Leadership Position With the Addition of Personal Genome Diagnostics, a Provider of Comprehensive Liquid Biopsy and Tissue-Based Genomic Products and Services

On December 23, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has entered into a definitive agreement to acquire Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products (Press release, LabCorp, DEC 23, 2021, View Source [SID1234597658]).

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The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology. PGDx enhances Labcorp’s ability to increase access to oncology care in the global community through kitted solutions that allow hospital systems and laboratories to run these tests internally, bringing precision diagnostics closer to the patient and helping close a common gap in the delivery of cancer care. Labcorp’s global reach also provides the opportunity to bring this technology to pharmaceutical companies for clinical trial research to advance cancer treatments, potentially impacting clinical outcomes in millions of people with cancer.

"Labcorp’s leadership and scale in diagnostic testing and drug development, coupled with PGDx’s innovative technology and suite of capabilities, will accelerate access to personalized treatments for cancer patients globally," said Adam Schechter, chairman and CEO of Labcorp. "PGDx’s comprehensive portfolio of next-generation sequencing products will meaningfully add to our breadth of capabilities, in line with our strategic priority to lead in oncology. PGDx’s technology is well positioned in an important segment with strong growth prospects. We look forward to welcoming PGDx’s talented team and working together to bring world-class diagnostics, technology and treatments within reach for all."

Under the terms of the agreement, Labcorp will pay $450 million in cash at closing and up to an additional $125 million on achieving future performance milestones.

PGDx’s centralized and decentralized offerings will enhance the scalability of the technology and support long-term growth across Labcorp’s oncology portfolio, while also enabling Labcorp to seamlessly offer oncology testing at every stage of care. PGDx offers the only diagnostic kit cleared by the U.S. Food and Drug Administration for pan-solid cancer comprehensive tumor profiling using a 500+ gene panel.

Next-generation sequencing, including liquid biopsy, represents the future of treatment and response monitoring in people with cancer. Liquid biopsy testing can also eliminate the need for an invasive biopsy procedure, reducing costs and improving patient outcomes. When combined with cutting-edge data analysis capabilities, NGS is the most advanced technology in the field today for identifying the best therapy available for each patient. As more cancer patients gain access to NGS testing, Labcorp will be able to offer enriched, actionable and data-driven insights. These insights can be used by pharmaceutical companies and cancer care teams to accelerate patient recruitment for clinical trials and identify patients eligible for approved treatments.

Overall demand for noninvasive tumor profiling and therapeutic response monitoring is expected to grow significantly—largely attributable to technological advances in the identification of biomarkers utilizing NGS, applicability to companion diagnostics and immuno-oncology solutions, and widespread government support.

"We share Labcorp’s vision of improving health care decisions and outcomes through science, data and a continued commitment to innovation," said Megan Bailey, CEO of PGDx. "For over a decade, PGDx has made great progress toward that goal. As a part of the Labcorp family, we have an incredible opportunity to broaden and accelerate our impact on cancer care through Labcorp’s global reach."

The acquisition of PGDx is the latest development in Labcorp’s long-standing commitment to integrate precision medicine into its comprehensive offering of oncology solutions. Labcorp currently offers OmniSeq INSIGHTSM, a NGS-based, precision medicine test for solid tumors, IntelliGEN Myeloid, a NGS-based precision medicine test for myeloid malignancies, and hereditary cancer genetic testing through VistaSeqSM. Labcorp also offers clonoSEQ, the first and only FDA-cleared assay for measurable, residual disease detection, and Resolution ctDx Lung, a non-invasive test for patients with non-small-cell lung cancer.

PGDx 2021 revenues are expected to be approximately $22 million and projected revenues for 2022 are expected to grow to nearly $40 million. The acquisition is expected to be slightly dilutive to Labcorp’s adjusted earnings per share over the next couple of years and provide returns in excess of its cost of capital by year five.

The transaction is subject to customary closing conditions and regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The transaction is expected to close in the first half of 2022. Hogan Lovells and Kilpatrick Townsend acted as legal advisors to Labcorp. Cooley LLP acted as legal advisor and Cowen acted as financial advisor to PGDx.

AMGEN TO PRESENT AT THE GOLDMAN SACHS 14TH ANNUAL HEALTHCARE CEOS UNSCRIPTED CONFERENCE

On December 23, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 14th Annual Healthcare CEOs Unscripted Conference at 1:00 p.m. ET on Thursday, Jan. 6, 2022 (Press release, Amgen, DEC 23, 2021, View Source [SID1234597657]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Aarvik Therapeutics and ArriVent Biopharma Announce Research Collaboration to Advance Novel Oncology Drug Candidate Using Aarvik’s Proprietary Modular Antibody Platform

On December 23, 2021 Aarvik Therapeutics and ArriVent Biopharma Inc. reported a strategic research collaboration to develop and commercialize an undisclosed oncology-focused drug (Press release, ArriVent Biopharma, DEC 23, 2021, https://arrivent.com/aarvik-therapeutics-and-arrivent-biopharma-announce-research-collaboration-to-advance-novel-oncology-drug-candidate-using-aarviks-proprietary-modular-antibody-platform/ [SID1234597656]).

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As part of the collaboration, Aarvik is responsible for the discovery and preclinical development of the novel molecule that is based on its unique modular platform that combines multiple target mechanisms. ArriVent will be responsible for clinical development and commercialization of the collaboration drug candidate that successfully achieves target criteria. For this program, Aarvik will receive an upfront payment and research funding, along with the opportunity for option fees, as well as development and commercial milestones for a potential total value of approximately $100 million, plus royalties.

"Aarvik’s innovative platform enables us to rapidly create a pipeline of differentiated programs across a range of therapeutic targets," said Jagath Reddy Junutula, Ph.D., Co-founder, President and CEO of Aarvik Therapeutics. "This collaboration with ArriVent leverages their strong global development expertise, enabling us to expeditiously advance a novel cancer therapeutic into the clinic. We are excited to partner with ArriVent’s team, which brings a proven clinical track record in this space. Collaborations such as this one will help Aarvik execute its mission to deliver transformative therapeutics to patients in an accelerated timeframe."

"Our main business focus at ArriVent is to identify and secure strategic partnerships with companies such as Aarvik who share a similar vision of advancing highly innovative molecules for difficult to treat diseases such as cancer," said Bing Yao, Ph.D., Chairman, Co-founder and CEO of ArriVent Biopharma. "Developed with their proprietary modular antibody technology, we believe the molecule resulting from this research collaboration will demonstrate enhanced efficacy and safety over available therapies. Coupled with ArriVent’s expertise in global drug development, we aim to rapidly advance this highly novel therapy for patients to benefit globally."

Genor Biopharma announces submission of clinical trial application for EGFR/cMET/cMET trispecific antibody (GB263T) in Australia

On December 22, 2021 Genor Biopharma (Stock code: 6998.HK) reported that the company has submitted a clinical trial application to the Bellberry HREC Ethics Committee in Australia on December 20 for the first-in-human (FIH) clinical trial of GB263T, a novel EGFR/cMET/cMET trispecific therapeutic antibody, in patients with advanced malignant tumors (Press release, Genor Biopharma, DEC 22, 2021, View Source [SID1234656305]).

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GB263T is the world’s first EGFR/cMET/cMET trispecific antibody, which has been designed as a trispecific antibody targeting EGFR and two different cMet epitopes. The trispecific antibody has two Fabs to bind EGFR. Its Fc fragment has been mutated to enhance Fc functions. Thus, GB263T with a highly differentiated design exhibits multiple action mechanisms to inhibit primary and secondary EGFR mutations and cMet signaling pathway simultaneously. The significant anti-tumor activities have been demonstrated by in vitro studies and in vivo animal models.

Preclinical studies showed GB263T potently blocked ligand-induced phosphorylation of EGFR and c-Met, and demonstrated better dual inhibition of EGFR and cMet signaling pathways compared to theJNJ analogue. GB263T effectively induced internalization of EGFR and cMet, and downregulated the expression levels of both EGFR and cMet proteins. The in vivo anti-cancer efficacy of GB263T was demonstrated in five different tumor models, including Ba/F3 containing EGFR exon20_D770_N771insSVD mutation model, Ba/F3 with EGFR exon20_D770DEL_ins_GY mutation model, Ba/F3 containing EGFR exon19 del/T790M/C797S mutation model, HCC827/ER1 and LU2503 NSCLC patient-derived xenograft (PDX) model with Met exon14 skipping mutation. In all the models studied, GB263T demonstrated significant tumor inhibition dose-dependently. In addition, GB263T did not show any major toxicities in monkeys, even at a high dose given for four weeks in a GLP tox study.

Genor Biopharma is simultaneously preparing the clinical trial applications for this innovative drug in the United States and China.

Juniper Biologics In-Licenses Helsinn’s Oncology Portfolio For Aloxi®, Onicit®, Paloxi®, Akynzeo® and anamorelin (INN)

On December 22, 2021 Helsinn Healthcare SA ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and Juniper Biologics Pte Ltd ("Juniper"), a science-led healthcare company focused on researching, developing and commercializing novel therapies, reported the signing of exclusive distribution, license and supply agreements for Aloxi, Onicit, Paloxi, Akynzeo (IV and oral formulations) and anamorelin (INN) (Press release, Juniper Biologics, DEC 22, 2021, View Source [SID1234615017]).

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Under the terms of the agreements, Helsinn has granted Juniper exclusive licenses to register, import, distribute, promote, market and sell these products in Australia, New Zealand, Southeast Asia, and certain markets in Middle East and Africa.

Approved products:

Aloxi, Onicit and Paloxi (Palonosetron hydrochloride, IV, 25 mg as Palonosetron) for the prevention of chemotherapy induced nausea and vomiting (CINV)
Aloxi and Onicit (Palonosetron hydrochloride, IV, 075 mg as Palonosetron) for the prevention of post-operative nausea and vomiting (PONV)
Aloxi (Palonosetron hydrochloride, oral, 5 mg as Palonosetron) for the prevention of CINV
Akynzeo (Netupitant and Palonosetron hydrochloride, oral and Fosnetupitant and Palonosetron hydrochloride, IV) for the prevention of CINV
Product[s] under development:

Anamorelin (INN), an investigational, is a selective, novel, orally active ghrelin receptor agonist being developed for the treatment of malignancy-associated weight loss and anorexia in non-small cell lung cancer patients. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented:

"This agreement with Juniper Biologics further secures access to Helsinn’s supportive care products for those patients in real need in these important markets. We are pleased to be partnering with Juniper Biologics and are happy to share the future growth based on their top management vast knowledge in commercialization of novel therapies in these markets. We would like to always make a difference in the lives of many patients living with cancer."

Raman Singh, CEO of Juniper Biologics, commented: "Juniper Biologics was founded on a vision to provide the next generation of life-changing therapies to address unmet patient needs. Our partnership with the Helsinn Group with their excellence in innovation and cancer supportive care, helps us further this goal and is an important extension of our commitment to increase access to break-through medicines and to offer relief to patients suffering with cancer."

About Aloxi, Onicit and Paloxi

The exact therapeutic indication may be different in each country. Please consult the official approved product information in your country.

About Akynzeo

The exact therapeutic indication may be different in each country. Please consult the official approved product information in your country.