Cell Signaling in Cancer

December 17, 2018 | 20 views

Cancer is a complex disease caused by genetic and/or epigenetic changes in one cell or a group of cells. These alterations disrupt ‘normal’ cell function and cause cancerous cells to over proliferate and avoid mechanisms that would typically control their growth, division, and migration.1,2 Many of these ‘disruptions’ map to specific cell signaling pathways. This article discusses the relationship between cell signaling and cancer, highlights key signaling pathways involved in cancer, and explores how critical mediators of aberrant signaling can be turned into therapeutic targets for cancer.

Spotlight

Shields Health Solutions

One of the fastest growing companies in America, Shields Health Solutions partners with hospital leaders on every aspect of specialty pharmacy creation and growth. The company provides the fastest, lowest risk model for Hospital leaders to create and grow a hospital-owned specialty pharmacy business, whether starting from scratch or adding specialty capabilities to a hospital’s existing pharmacy programs.

OTHER ARTICLES
MEDTECH

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 13, 2022

Gene therapy has historically been used to treat disorders with in-depth knowledge caused by a single genetic mutation. Thanks to the introduction of new generation technologies, the potential of gene therapy is expanding tAo treat diseases that were previously untreatable. Evolution of Gene Therapy One of the major success stories of the twenty-first century has been gene therapy. However, it has not been the same in the past. The field's journey to this point has been long and mostly difficult, with both tragedy and triumph along the way. Initially, genetic disorders were thought to be untreatable and permanently carved into the genomes of individuals unfortunate enough to be born with them. But due to the constant technological advancement and research activities, gene therapy now has the potential to treat various genetic mutation-causing diseases with its ability to insert a new copy and replace faulty genes. Gene Therapy is Finding New Roads in the Medical Sector Gene therapy can help researchers treat a variety of conditions that fall under the general heading of epilepsy, instead of only focusing on a particular kind of disorder brought on by a genetic mutation. Following are some of the domains transformed by gene therapy. Neurology – Gene therapy can be used for the treatment of seizures by directly injecting it into the area causing an uncontrolled electrical disturbance in the brain. Furthermore, by using DNA sequences known as promoters, gene therapy can be restricted to specific neurons within that area. Ophthalmology – Genetic conditions such as blindness can be caused due to the mutation of any gene out of over 200 and resulting in progressive vision loss in children. With advanced gene therapies such as optogenetics, lost photoreceptor function can be transferred to the retinal cells, which are responsible for relaying visual information to the brain. This might give patients the ability to navigate in an unknown environment with a certain level of autonomy. The Future of Gene Therapy The news surrounding gene therapy has been largely favorable over the past few years, with treatment after treatment obtaining regulatory approvals, successful clinical trials, and garnering significant funds to begin development. With more than 1,000 clinical trials presently underway, the long-awaited gene therapy revolution might finally be here.

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MEDTECH

Expansion of BioPharma: Opportunities and Investments

Article | September 22, 2022

Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine. In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development. Biopharma: Leading the Way in the Pharma Sector In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth. Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth. According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector. Massive Investments Directed Towards Biopharma Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure. For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

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MEDICAL

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | August 16, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MEDTECH

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Spotlight

Shields Health Solutions

One of the fastest growing companies in America, Shields Health Solutions partners with hospital leaders on every aspect of specialty pharmacy creation and growth. The company provides the fastest, lowest risk model for Hospital leaders to create and grow a hospital-owned specialty pharmacy business, whether starting from scratch or adding specialty capabilities to a hospital’s existing pharmacy programs.

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CELL AND GENE THERAPY

Orangewood Partners Makes Strategic Investment in Barrington James

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. ABOUT ORANGEWOOD 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.

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CELL AND GENE THERAPY

Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback

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. About Eiger 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.

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INDUSTRIAL IMPACT

PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial

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 About PDS0101 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. About VERSATILE-002 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.

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CELL AND GENE THERAPY

Orangewood Partners Makes Strategic Investment in Barrington James

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. ABOUT ORANGEWOOD 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.

Read More

CELL AND GENE THERAPY

Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback

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. About Eiger 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.

Read More

INDUSTRIAL IMPACT

PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial

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 About PDS0101 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. About VERSATILE-002 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.

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