PRESS RELEASE – Ergomed acquires MedSource, a US-based specialist oncology and rare disease CRO

On December 14, 2020 Ergomed plc (LSE: ERGO) ("Ergomed" or the "Company"), a company focused on providing specialised services to the pharmaceutical industry, reported the acquisition of MS Clinical Services, LLC ("MedSource"), a specialised clinical research organisation (CRO) based in Houston, Texas, USA (Press release, Ergomed Group, DEC 14, 2020, View Source [SID1234575064]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: "We are delighted to have delivered on our strategic goals in 2020 with the expansion of our US footprint in both the CRO and PV businesses. The addition of MedSource and its complementary expertise in oncology and rare disease will further establish Ergomed as a specialised services provider in the strategically important US market, building on the successful acquisition and integration of Ashfield Pharmacovigilance (now PrimeVigilance USA) earlier this year. We look forward to developing the potential of this new business to offer truly global clinical research services to our international customer base. We are excited to welcome the MedSource team to Ergomed and are eager to work alongside our new colleagues to leverage our combined expertise in complex therapeutic areas for the benefit of our clients and patients worldwide. Looking ahead to 2021 we expect to see continued momentum across the business as we look to increase our footprint in key geographies, and firmly establish Ergomed as a leading global provider of specialist services to the pharmaceutical industry."

Eric Lund, founder of MedSource who will continue in his current role as President of MedSource after the acquisition, said: "I am delighted to be joining the Ergomed Group and continuing my current role. We are confident that this is an important strategic step and natural fit for MedSource, as Ergomed is an exciting, fast-growing global company with a strong reputation in the CRO industry. Our own extensive experience in oncology and rare disease drug development and across product types, clinical trial phases and study designs will complement the services already offered to Ergomed’s international client base. The combined business will be of great benefit to our US clients and employees, providing a seamless service offering into Europe and globally."

Acquisition benefits
MedSource is a full-service CRO with a focus on complex diseases and study designs. MedSource delivers high-quality clinical trials specialising in oncology and rare disease. With over 20 years’ experience, MedSource has participated in more than 200 oncology and rare disease clinical trials.

The acquisition aligns with Ergomed’s strategy to grow its existing profitable services business both organically and through acquisition and advances a number of important strategic objectives for Ergomed, including:

Complementary specialism in oncology and rare disease. The two businesses have core expertise in complex disease areas. The combined business will enable an even greater degree of specialist expertise in high growth sectors of the overall pharmaceutical services market in which Ergomed specialises.

Expanded US presence. The acquisition will further accelerate Ergomed’s growth in the North American market, with additional offices in Houston, Raleigh and Boston in the USA, and Newcastle upon Tyne in the UK. The increased US presence, with the addition of over 110 US-based employees, is expected to drive substantial new awards in the region and increase Ergomed’s pipeline in both the CRO and PV businesses.

Significantly increases Ergomed’s order book. MedSource joins Ergomed with an existing order book of over $41 million, adding to Ergomed’s £151.4 million order book as reported in September 2020 in its H1 2020 interim results, providing high forward visibility of contracted future revenue.

Acquisition terms and MedSource trading history
Under the terms of the equity purchase agreement (the "EPA"), Ergomed has acquired MedSource for an initial consideration comprising $16.2 million in cash paid at the closing of the transaction, up to $1.8 million in Ergomed shares to be issued at a price based on the average daily closing price for 30 days preceding the acquisition and within 15 months of the closing of the transaction, subject to reduction for breaches of representations and warranties, and up to a further $7.0 million payable 90% in cash and 10% in shares depending on MedSource’s financial results in the year to 31 December 2021. The EPA includes customary provisions relating to normalised working capital and representations, warranties and indemnities.

The acquisition will be funded using the Company’s existing cash resources without significant depletion of cash available to fund future organic and inorganic growth.

In its financial year ended 31 December 2019, MedSource recorded total revenues of $31.3 million, comprising service fee revenue of $19.3 million and pass-through revenue of $12.0 million. In 2019 adjusted EBITDA was $1.3 million and net assets were $2.6 million.

The transaction is expected to be immediately accretive and earnings enhancing, with further growth and strategic benefits expected in future years.

Webcast and conference call for analysts:
A webcast and conference call for analysts will be held at 1pm GMT on Monday 14th December.

Modulus Discovery, Inc. to Present at the 39th Annual J.P. Morgan Healthcare Conference

On December 14, 2020 Modulus Discovery Inc. ("Modulus"), a pre-clinical stage technology-driven drug discovery company reported that it was invited to present at the 39th Annual J.P. Morgan Healthcare Conference in January 2021 (Press release, Modulus Discovery, DEC 14, 2020, View Source [SID1234574447]). The J.P. Morgan Healthcare Conference, which attracts over 500 companies and 12,000 investors, is going virtual for 2021, and the webcast will be made available online following the live event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

S. Roy Kimura, co-founder and CEO, will present on January 12, 2021 at 8:40 AM EST and will give a brief introduction to the company’s cutting edge simulation-based drug discovery platform and its maturing portfolio of small-molecule drug discovery projects in chronic inflammation, oncology, and infectious diseases including COVID and related RNA viruses. Following the event, the company will be available for meetings with interested parties to further describe its unique discovery platform and capabilities and lead programs currently in pre-clinical studies.

Comment from S. Roy Kimura, CEO, Modulus Discovery, Inc.
"We are delighted to be given this opportunity to introduce our company’s technology platform, small-molecule discovery capabilities, and unique portfolio of R&D programs. Our lead programs targeting chronic inflammation / autoimmune diseases and oncology are currently approaching the IND stage, and we would be happy to provide information about them to interested parties for potential clinical partnerships."

Regeneron Provides Update on Odronextamab Clinical Trials in B-cell Non-Hodgkin Lymphomas

On December 14, 2020 Regeneron reported that is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold (Press release, Regeneron, DEC 14, 2020, View Source [SID1234572973]). The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Patient safety is of the utmost concern to Regeneron. The company plans to submit a protocol amendment to the FDA with the goal of resuming patient enrollment early in the first quarter of 2021.

The two trials currently enrolling patients that are impacted are a Phase 1 monotherapy trial in B-NHL and chronic lymphocytic leukemia and a Phase 2 monotherapy trial in several B-NHL subtypes.

Could Amgen’s Xgeva boost immunotherapy in breast cancer?

On December 14, 2020 Amgen reported that osteoporosis drug denosumab is approved as Xgeva for the prevention and treatment of some bone metastases in cancer (Press release, Amgen, DEC 14, 2020, View Source [SID1234572972]). But could the drug’s mechanism of action help breast cancer patients respond to immunotherapy drugs that typically don’t work well in those tumors?

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

That was the premise behind a new study led by the Bellvitge Institute for Biomedical Research (IDIBELL) in Spain and partially funded by Amgen. The researchers studied cells from mouse models and from premenopausal patients with luminal breast cancer to determine whether Xgeva’s inhibition of a signaling pathway called RANK might make the tumor cells more sensitive to immunotherapy.

They discovered that the RANK protein is involved in the communication between cancer cells and immune cells. Inhibiting RANK in the breast tumor cells improved responses to drugs that block the immune checkpoints CTLA-4 and PD-L1, they reported in the journal Nature Communications.

SPONSORED BY MEDIDATA
Your Guide to Maximizing the Benefits of a Unified Clinical Data Capture and Management Platform
Learn how a unified platform can increase visibility across your trial. Adopt technology solutions driving faster, more accurate data interpretation for better decision-making to remain competitive in a new era of drug development.
FIND OUT HOW
RELATED: Manipulating proteins to make ‘cold’ tumors responsive to immunotherapies

The researchers started by showing in mice that inhibiting the RANK protein boosts the recruitment of immune cells to breast tumors. Inhibiting RANK and PD-L1 together cancer reduced tumor growth in half the tumors studied, while blocking PD-L1 alone had no effect. Their research suggested that cancer cells use RANK as "a possible escape route" from immunotherapy, according to a statement.

They went on to study cells from patients that participated in a clinical trial of Xgeva in premenopausal women with early-stage breast cancer. During the trial, patients received two doses of Xgeva before surgery. The study, which enrolled 27 participants, was ended in 2018 because of a recruitment shortfall, but the Spanish researchers were able to analyze tumor samples from 24 of the patients to back up their mouse findings.

They found that while the short course of Xgeva did inhibit the RANK protein, it did not shrink tumors or enhance survival. But, in most of the tumor samples, they found a significant increase in immune cells.

Some immune checkpoint inhibitors, such as Merck’s PD-1 blocker Keytruda, are approved for use in breast cancer, but improving their efficacy in tough-to-treat tumors is a major focus of research. Several academic teams are investigating the roles of different tumor-promoting proteins in suppressing responses to immunotherapy. Earlier this year, for example, a University of Cincinnati team showed it could improve PD-1 and CTLA-4 inhibition by blocking a protein called FIP200.

The IDIBELL-led team noted that during the clinical trial of pre-surgery administration of Xgeva, researchers identified biomarkers that might help clinicians select patients most likely to respond to a combination of RANK inhibition and immunotherapy.

"This strategy could turn immunologically cold breast cancers into [tumors] sensitive to the immune system activity," said co-author Eva Gonzalez-Suarez of the Spanish National Cancer Research Center in the statement.

Junshi’s PD-1 Meets Survival Endpoint as First-Line NSCLC Treatment

On December 14, 2020 Shanghai Junshi Bio reported its lead anti-PD-1 drug met the primary endpoint in an interim analysis as a first-line treatment in patients with non-small cell lung cancer (NSCLC) (Press release, Shanghai Junshi Bioscience, DEC 14, 2020, View Source [SID1234572964]). Toripalimab (JS001), which was administered in combination with chemotherapy in a China trial among patients with advanced disease, showed improvement in progression-free survival, though specific results were not disclosed. In 2018, toripalimab was first approved in China as a second-line treatment for unresectable or metastatic melanoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!