On November 17, 2020 LabCorp reported that Seven leading diagnostics companies and laboratory service providers have formed the Access to Comprehensive Genomic Profiling Coalition (ACGP) (Press release, LabCorp, NOV 17, 2020, View Source [SID1234571227]). The goal of the organization is to collectively advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer. The current members of ACGP are Exact Sciences (NASDAQ: EXAS), Foundation Medicine, Illumina (NASDAQ: ILMN), LabCorp (NYSE: LH), QIAGEN (NYSE: QGEN), Roche Diagnostics (SIX: RO, ROG: OTCQX: RHHBY), and Thermo Fisher Scientific (NYSE: TMO).

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CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes. In advocating for coverage of CGP, ACGP will educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.

CGP tests assess the genomic alterations within a patient’s cancer to help physicians make more informed decisions about personalized treatment approaches. Using next-generation sequencing (NGS) with a tissue biopsy or a blood sample, this testing method can detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA. This helps identify patients who could respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC) as one example.1

"Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade," said Jim Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and the chairman of ACGP. "The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments."

Despite evidence of the benefits of this approach, some health insurers still use an outdated framework to evaluate coverage for CGP, creating a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do. Limited insurance coverage options may prevent some treating physicians from ordering CGP for their patients.

"There is no question that obstacles to coverage have inhibited physicians from ordering comprehensive genomic profiling," said Almas. "Additionally, we believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates."

On November 17, 2020 Cambrex reported that it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet the continually growing demand for small molecule drug substance development and manufacturing (Press release, Cambrex, NOV 17, 2020, View Source [SID1234571206]). It will be the sixth major investment that Cambrex has made at the site in the past eight years to support customers in mid-scale, large-scale and highly potent small molecule API manufacturing.

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The expansion, which will be operational in early 2022, will add 3 large-scale manufacturing work centers and 1 mid-scale work center to the facility in Iowa, increasing the site’s capacity by 30 percent. When completed, the Charles City site will employ more than 400 people.

"Small molecule manufacturing demand has been growing consistently over recent years, and this investment will enable Cambrex to continue to capitalize on this growth, further strengthening our position as a market-leading CDMO," commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, "This expansion in the U.S. for API manufacturing capacity comes at a time when our customers increasingly require high-quality partners to ensure reliable supply chains within the pharmaceutical sector."

Cambrex’s Charles City facility is located on a 45-acre site, and as part of the company’s Drug Substance business unit, manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its integrated service offering across the pharmaceutical value chain.

On November 17, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2020 (Press release, Innate Pharma, NOV 17, 2020, View Source [SID1234571205]).

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"In November, we were very pleased that our lead proprietary asset, lacutamab, was awarded PRIME designation in Sézary Syndrome by the European Medicines Agency, which follows the US Fast Track designation by the FDA last year. Lacutamab is an important part of our strategy to build a focused proprietary pipeline, and these regulatory milestones further validate the unmet need in this patient population," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "In addition, the Phase 3 monalizumab clinical trial recently initiated by AstraZeneca is an important achievement for the Company, as it both validates our scientific approach while fortifying our cash position until the end of 2022. Collectively, these milestones are strong proof points in executing on our strategy and accelerating our efforts to deliver meaningful medicines to patients."

Third quarter 2020 and post-period events:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The Company recently announced that the European Medicines Agency (EMA) has granted PRIME designation to lacutamab for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies.
The TELLOMAK Phase 2 clinical trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced cutaneous T-cell lymphomas, is now fully open to enrollment.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

As recently announced, AstraZeneca has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Dosing of the first patient in this trial, which occurred in October 2020, has triggered a $50 million milestone upcoming payment from AstraZeneca to Innate. Upon this milestone payment, the Company will have received a total of $400 million to date from the AstraZeneca partnership.
Updated data from the IPH2201-203 Phase 2 trial regarding patients previously treated with a platinum-based chemotherapy and a PD(L)1 inhibitor will be presented via an e-poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress in December 2020.
Avdoralimab in Inflammation (IPH5401, anti-C5aR antibody):

The first patient has been dosed in the investigator-sponsored Phase 2 clinical trial in bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be involved in the physiopathology of the disease. The trial is investigating the clinical efficacy of avdoralimab in addition to topical steroids compared to topical steroids alone in BP patients. More information on this study can be found at clinical trials.gov.
Avdoralimab in COVID-19:

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), is ongoing. A third cohort was recently added to the trial, which is addressing COVID-19 related Acute Respiratory Distress Syndrome (ARDS) patients requiring mechanical ventilation. More information on this study can be found at clinical trials.gov.
The investigator-sponsored Phase 2 clinical trial, ImmunoONCOVID-20, has resumed. This study is exploring the potential efficacy of monalizumab and avdoralimab amongst other treatment arms, against COVID-19 in cancer patients with mild symptoms and pneumonia respectively.
Lumoxiti, a first-in-class marketed product for the treatment of relapsed or refractory hairy cell leukemia:

The global COVID-19 pandemic and slower adoption rate continues to impact the sales of Lumoxiti in 2020.
As previously stated, following completion of the transition of US Lumoxiti commercial operations from AstraZeneca, sales will be fully booked by Innate beginning in Q4 2020.
The Lumoxiti EU regulatory decision remains on track for 1H 2021.
Financial results:

Cash, cash equivalents and financial assets of the Company amounted to €163.6 million as of September 30, 2020. As it is a post closing event, the $50 million milestone upcoming payment for the first patient dosed in the Interlink-1 Phase 3 study of monalizumab are not included in those figures. Financial liabilities amounted to €19.8 million.

For the nine-month periods ended September 30, 2019 and 2020, revenue from collaboration and licensing agreements mainly results from the spreading of the initial payments received under our agreements with AstraZeneca. Due to accounting rules and the timing of costs related to development activities under the collaboration with AstraZeneca, the recognition of this revenue can vary on a quarter by quarter each year. As a reminder, this has no impact on cash. Revenues for the first nine-months of 2020 amounted to €33.6 million, compared to €65.4 million for the same period in 2019.

On November 17, 2020 Oxford Drug Design Board of Directors reported the appointment of Dr. Alan D. Roth Chief Executive Officer, effective immediately (Press release, Oxford Drug Design, NOV 17, 2020, View Source [SID1234571204]).

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Alan takes over the position from Dr. Paul W. Finn, who will remain with the company as Chief Scientific Officer.

Alan’s career in health sciences comprises of executive operations, academic research, investment management/capital markets and strategic consultancy. He started his career at Merck & Co. in New Lead Discovery, before moving into consultancy at McKinsey serving leading companies globally. He was Director at Commerzbank Asset Management in charge of global healthcare investments and industrial investment research. He co-founded, took public and was the first CEO and CFO of Chiral Quest, a life sciences company in the area of chiral pharmaceuticals. He is also currently Director at Fitzroy Partners in London developing new life sciences ventures.

Dr. Finn said, "Oxford Drug Design’s unique combination of computational drug design technology and therapeutic pipeline is progressing rapidly. Alan brings key knowledge and expertise that will be instrumental to the company’s growth and development. I am greatly looking forward to working with Alan to take Oxford Drug Design to the next level".

Dr. Roth said "I am delighted to be joining the team at Oxford Drug Design and look forward to building further on the significant achievements made thus far. In our next stage of development ODD can deliver important impact across selected therapeutic and the related computational areas"

Alan earned his BA (Hons) from Cornell University, PhD in organic chemistry from Columbia University and Postdoctoral Fellowship in medicinal chemistry from the University of Oxford. He is Royal Society Entrepreneur in Residence and Visiting Lecturer at Oxford in science entrepreneurship.

On November 17, 2020 xCures Inc. reported that it is launching xACCESS – a new registration module for their AI-assisted clinical study platform (Press release, xCures, NOV 17, 2020, View Source [SID1234571196]). The module is used to enroll cancer patients and empower them, and their physicians, to make informed decisions and learn about access to treatment programs. The xCures platform uses a Master Observational Registry to efficiently run a wide variety of oncology studies and decentralized trials, prospectively generating real-world evidence.

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"xACCESS is xCures’ first patient-centric technology module, onboarding patients directly to our sponsored studies and partner programs," stated Mika Newton, xCures’ CEO. "This is an important milestone on our journey to make the cancer treatment ecosystem work better for patients and facilitating access to the best treatment options."

The xACCESS registration module enables rapid scaling by eliminating bottlenecks in eConsenting and acquiring medical records, providing benefits to patients, physicians, partners, payers, sponsors, and investors. The resulting Real-World Evidence (RWE) supports the assessment of safety, efficacy, and utility of investigational and approved cancer therapies.

The xACCESS module will be used for all clinical studies and programs available on the xCures platform, including the recently announced Compassionate Use program for ulixertinib (BVD-523), currently enrolling patients with MAPK pathway aberrant cancer.