CELL AND GENE THERAPY
Orangewood and Barrington James | October 06, 2022
Orangewood Partners a long-term focused private investment firm, announced an investment in Barrington James, a leading global recruitment firm that primarily serves the pharmaceutical, biotechnology and medical device sectors. Terms of the transaction were not disclosed.
In partnering with Orangewood, Barrington James intends to enhance its global recruiting solutions, expand its client-service capabilities and support its ongoing commitment to developing and utilizing cutting-edge technology and software leading to greater access for its clients of exceptional talent on a permanent or temporary basis. Barrington James’ Founder and Chief Executive Officer, Dan Barrington, will continue to lead the business alongside the existing leadership team, who will maintain a significant investment in the company.
Founded in 2002, Barrington James provides life sciences companies with recruitment solutions that combine deep industry expertise with innovative recruitment technology to make talent identification and attraction easier. The company’s specialist areas range from AI, biometrics, and clinical development to finance, medical affairs, commercial, quality assurance and computational sciences, and identifies placement opportunities ranging from contract and interim positions through to board and C-suite-level placements. Headquartered outside of London, Barrington James operates twelve offices in core life sciences clusters globally including in New York, Tokyo, Singapore, Raleigh and Greenville supporting placements across Europe, North and South America and Asia.
Neil Goldfarb, Managing Partner of Orangewood, stated, “All of the whole of the life science and biotech sectors are poised for significant long-term growth, and competition for top talent in virtually every position is continuing to intensify. Barrington James deep focus on life sciences uniquely positions it to provide outstanding and highly bespoke service to its clients and capitalize further on this attractive opportunity. To that end, we are thrilled to bring Orangewood’s deep expertise in partnering with founders and track record of building healthcare-focused businesses to support Dan and his talented team. We look forward to working together as Barrington James continues to innovate and deepen its role as one of the premier life sciences focused recruiting firms.”
“This is an exciting day for Barrington James, our employees and clients. Orangewood is a world-class investment firm with proven capabilities in supporting management teams and driving long-term value from its portfolio companies. We believe this partnership will enable us to continue to assist our top-class clients with their growth by providing exceptional talent to their teams, big or small. Our partnership and growth will allow us to deliver niche recruitment for new biotech’s and volume recruitment for leading pharmaceutical companies with speed and a standard of services that is second to none, on a temporary or permanent basis. I am grateful for the passion and dedication of our talented team around the world who recognize the important role that we play to support our clients whose work has never been more vital.”
Dan Barrington, CEO of Barrington James
K&L Gates LLP served as legal advisor to Orangewood. Fairmount Partners served as exclusive financial advisor to Barrington James and Keystone Law served as its legal advisor. Brightwood Capital Advisors, LLC acted as sole lead arranger and administrative agent for the transaction.
Founded in 2015, Orangewood Partners is a New York-based private investment firm with a long-term approach. Orangewood focuses on growth-oriented private transactions in partnership with founder-led businesses, management teams and entrepreneurs. The firm’s senior investment team and deep bench of active operating advisors has decades of experience across a range of sectors, primarily healthcare, consumer, multi-unit and related industries. Orangewood works to build companies into strategic assets in their industries to create long-term value for investors, companies, and communities.
ABOUT BARRINGTON JAMES
Barrington James is an industry leading, global recruitment business that primarily serves the Pharmaceutical, Biotechnology and Medical Device sectors. With offices all over the world and hundreds of specialists dedicated to sourcing exceptional talent, we have the capacity and capabilities to deliver world-class recruitment solutions to life science companies of all sizes. We combine our reach of more than 6 million industry professionals worldwide and investment in AI platforms with expert consultants specializing in market niches to deliver a personalized approach to global recruitment for life science.
CELL AND GENE THERAPY
Eiger BioPharmaceuticals, Inc. | October 06, 2022
Eiger BioPharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus and other serious diseases, today announced that, following feedback from the U.S. Food and Drug Administration the company will not submit an emergency use authorization application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19.
Following Eiger's press release on September 6, 2022, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic.
FDA suggested that, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, Eiger consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual Biologics License Application. Eiger is evaluating next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections.
"While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections. COVID-19 related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease."
David Cory, President and CEO, Eiger
Eiger is advancing a late-stage pipeline of multiple FDA Breakthrough Therapy designated programs in Phase 3, including lonafarnib and peginterferon lambda for hepatitis delta virus (HDV) infection, and avexitide for congenital hyperinsulinism. The company expects to report topline data from D-LIVR, Eiger's landmark Phase 3 study of lonafarnib-based regimens for HDV, by year end.
About TOGETHER Study
TOGETHER is an independent multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. The study was ongoing at the time the peginterferon lambda arm was added. The evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 therapeutic of > 1,900 patients. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19 and were randomized within seven days of symptom onset. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a reduction in risk of clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo through Day 28. A key secondary endpoint was reduction in risk of hospitalizations or death in patients when dosed within three days of symptom onset. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada.
About Peginterferon Lambda
Peginterferon lambda is an investigational late-stage, first-in-class, type III interferon that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies.
Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials of HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for peginterferon lambda in HDV.
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.
PDS Biotechnology | October 04, 2022
PDS Biotechnology Corporation a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® for the treatment of unresectable, recurrent/metastatic human papilloma virus 16-positive head and neck squamous cell carcinoma.
“We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application for our lead asset PDS0101. The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs.”
Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech
Earlier this year, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA® for the treatment of HPV16-positive HNSCC. The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process.
Dr. Frank Bedu-Addo further commented, “PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease.”
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-associated cancers in partnership with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA®. The combination is being evaluated in CPI-naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.