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."

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.

Clinical Trials Update – December 2021

On December 22, 2021 The Life Raft Group reported that highlighted recent clinical trials that are still recruiting in the U.S. which investigate potential treatments for GIST patients (Press release, The Life Raft Group, DEC 22, 2021, View Source [SID1234597850]).

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Our database, gisttrials.org, lists over 70 trials that are GIST-related which are ongoing around the world. Currently there are 11 GIST-related trials recruiting in the United States. (Of these 11, two are no Phase (0), three are Phase 1, five are Phase 2, one is Phase 1/2.) This article gives a sampling of four trials currently recruiting for KIT/PDGFRa mutant GIST, SDH-deficient GIST (2), and a no Phase Surgery trial for all GIST Types. For further information about GIST trials including international trials, visit: The Life Raft Group Clinical Trials Website.

About Phase 1 trials
It is important to recognize that Phase I studies are held to find the highest dose of the new treatment that can be given safely without causing severe side effects.

• The first few people in the study get a very low dose of the treatment and are watched very closely. If there are only minor side effects, the next few participants get a higher dose. This process continues until doctors find a dose that’s most likely to be and effective treatment while having an acceptable level of side effects.

• Safety is the main concern. The research team monitors participants and watches for severe side effects. Due to the small numbers of people in Phase I studies, rare side effects may not be seen until later phases of the trial when more people are receiving the treatment.

• While some people may benefit from being on one, disease response is not the main purpose of a Phase I trial. Phase I trials carry the most potential risk, but these studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose
to join Phase I trials when all other treatment options have already been tried.

Phase I trials carry the most potential risk, but these studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose
to join Phase I trials when all other treatment options have already been tried.

For patients with advanced KIT/PDGFRa mutant GIST:

NB003 Phase 1 – "A Study of NB003 in Patients With Advanced Malignancies"
Site is Memorial Sloan Kettering Cancer Center NY, NY.
Principal Investigator: Dr. Ping Chi. The trial started 8/6/2021. Dose escalation phase will be followed by
an expansion phase. Plans are to recruit 36 over a period of 20 months. NB003 oral tablets are administered twice daily for repeated 28-day cycles.

Primary objectives are incidence of dose limiting toxicity and incidence of adverse events. Tumor sample collection is required. Includes GIST and other solid tumors with either KIT or PDGFRa mutations. Includes patients with advanced GIST who have progressed on or had an intolerability to imatinib and other standard of care (SoCs) or refused other SoCs.

Sponsor is Ningbo Newbay Technology Development Co., Ltd in China. Obtained development rights from AstraZeneca in 2020. NB003 was previously called AZD3229. AstraZeneca employee authors described AZD3229 translational relevance in a 2019 paper: "AZD3229 has potential as a best-in-class treatment for patients with GIST with mutations in KIT and PDGFRα, and this compound may overcome the limitations experienced with existing treatment options in the clinic which are limited by off-target effects leading to drug holidays and dose reductions leading to lack of optimum efficacy." Contact at MSKCC, 646-888-3915
or email [email protected] NCT04936178

For patients with SDH-deficient GIST

Temozolomide Phase 2 – "Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH) Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)".

Trial sites include University of California San Diego, University of Miami, Oregon Health Science University, Portland, Fox Chase Cancer Center, Philadelphia. Principal Investigators include Adam Burgoyne, Jon Trent, Mike Heinrich, Margaret von Mehren. Started 9/12/2018.

Recruiting 23 participants over 48 months. Temozolomide (Temodar) tablets taken orally once a day for 21 days followed by seven days off drug for each 28-day drug cycle.

Primary objective is overall response rate. Patients will continue treatment until disease progression or unacceptable toxicity. Includes patients who have pathologically confirmed SDH-mutant/deficient GIST and tumors measurable on CT scans.

Information concerning the rationale for use of Temozolomide in SDH-deficient GIST can be found in the following reports:

• 1/7/2019 – "Preferential MGMT methylation could predispose a subset of KIT/PDGFRA-WT GISTs, including SDH-deficient ones, to respond to alkylating agents"

• 10/12/2020 – "Abnormal MGMT Promoter Methylation in Gastrointestinal Stromal Tumors: Genetic Susceptibility and Association with Clinical Outcome"

Information concerning side effects of TMZ in GIST patients can be found in the following report:

• 12/4/2003 – "A two-arm phase II study of temozolomide in patients with advanced gastrointestinal stromal tumors and other soft tissue sarcomas".

Sponsor is Dr. Adam Burgoyne. Contact at UCSD at 858-822-3092 or email [email protected] NCT03556384

Rogaratinib Phase 2 – "Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)"

Trial sites include: Dana-Farber Boston, Boston, The National Cancer Institute Bethesda, City of Hope Duarte, CA, Memorial Sloan Kettering New York, NY, Washington University School of Medicine St. Louis, University of Pittsburgh Cancer Institute.

Principal Investigators include: Suzanne George, A. P. Chen, Mark Agulnik, Katherine Thornton, Brian Van Tine, Melissa Burgess. Started 2/1/2021.

Recruiting 48 participants over 24 months. Patients take Rogaratinib pills twice daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary objective is to estimate the objective radiographic response rate. Serial biopsies may be required. Confirmed SDH-deficient patients must have measurable disease on scans. The sponsor is the National Cancer Institute.

The rationale for targeting FGFR in SDH-deficient GIST is provided in the following paper:

• 10/16/2019 – "Altered chromosomal topology drives oncogenic programs in SDH-deficient GISTs"
Information about the safety and side effects of Rogaratenib is provided in the following paper reporting results of a Phase 1 dose escalation study:

• 8/9/2019 – "Rogaratinib in patients with advanced cancers selected by FGFR mRNA expression: a phase 1 dose-escalation and
dose-expansion study."

Contact information is available for each site at clinicaltrials.gov NCT04595747

For all GIST patients:

Surgery, No Phase – "Surgery in Gastrointestinal Stromal Tumors (GISTs)
for Treatment, Tumor Modeling, and Genomic Analysis"

National Institute of Health Clinical Center in Bethesda, MD.

Principal Investigator is Dr. Andrew M Blakely. Started 12/18/2020. Recruiting 400 participants over 20 years. Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to five years after surgery.

If a participant has surgery, tumor tissue samples will be taken. If a participant does not need surgery, their participation will end after 10 years. If they have surgery, the five-year monitoring period will restart after each surgery.

The overall objective is to follow people with GISTs and collect tumor tissue so that it can be studied in the lab. The Primary objective is to evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare disease Time Frame: on-going. People aged six and older who have GIST are eligible.

Inclusion criteria include: Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.