As Xencor ramps up, Chief Medical Officer Paul Foster exits

fiercebiotech | June 27, 2019

After nearly 10 years leading Xencors clinical development, Chief Medical Officer, Paul Foster, M.D., is calling it quits. The biopharma veteran is set to retire in October, capping a 35-year career in academia, medical practice and industry.  The announcement comes as the antibody specialist moves two more programs into the clinic and works to resume a phase 1 study of its Novartis-partnered blood cancer drug.  Xencor didn’t have the best start to 2019, with Novartis handing back the rights to a bispecific antibody it licensed in a 2016 deal worth $150 million up front. One month later, a second asset from the deal—which came with a promise of up to $2.41 billion in milestones—ran into a clinical holdfrom the FDA due to a pair of patient deaths that were “at least possibly” treatment-related. That program, XmAb14045, was in a phase 1 study in patients with relapsed or refractory acute myeloid leukemia and other blood cancers expressing CD123. The bispecific targets CD3 and CD123. The FDA placed the hold after Xencor submitted safety reports about two patient deaths—one patient had cytokine release syndrome (CRS) after the first dose of XmAb14045, while the other developed acute pulmonary edema after several doses.

Spotlight

The life sciences industry has fared well in past economic recessions but how is it performing in today’s volatile marketplace, one characterized by economic uncertainty, reform-driven pricing pressures, increased demand for innovation and value, more focus on the consumer and consumer engagement, and an ever-changing regulatory and risk environment?

Spotlight

The life sciences industry has fared well in past economic recessions but how is it performing in today’s volatile marketplace, one characterized by economic uncertainty, reform-driven pricing pressures, increased demand for innovation and value, more focus on the consumer and consumer engagement, and an ever-changing regulatory and risk environment?

Related News

MEDTECH

Ginkgo Bioworks Announces Strategic Purchase of Epidemiological Data Infrastructure Assets

Ginkgo Bioworks | August 20, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, announced the purchase of certain epidemiological data infrastructure assets from Baktus, Inc., a Delaware-based public benefit corporation. Under the terms of the deal, Ginkgo will assume ownership of proprietary datasets, modeling and analytic tools, and a software platform with the capabilities to track, model, and forecast epidemics and associated risks and impacts. Ginkgo also expects to integrate several ongoing epidemiological analysis projects and a team of epidemiological data experts into its biosecurity and public health initiative, Concentric by Ginkgo. Baktus, through its subsidiary, Metabiota, Inc., has built an extensive database of infectious disease outbreaks. In addition to epidemiological tracking and forecasting, the company created specialized data infrastructure to help governments and other partners understand and model the risks and disruptive impacts of pathogens in order to promote resilience to pandemics and epidemics. Baktus and Metabiota are expected to continue their independent operations after transferring the assets and epidemiological data personnel included in this transaction. "We believe robust public health data is the bedrock of biosecurity—it's what enables public health leaders to direct resources where they're needed the most and researchers to develop targeted vaccines, diagnostics, and therapeutics. Integrating state-of-the-art epidemiological modeling and predictive capabilities with our end-to-end biosecurity offerings will help us continue making the data we gather on pathogen spread and evolution that much more meaningful and actionable for public health leaders and communities." Matt McKnight, General Manager for Biosecurity at Ginkgo "Our team has spent nearly a decade building epidemiological data and risk modeling tools for the public and private sector to more effectively quantify, mitigate and manage epidemic risk. This transaction demonstrates the importance of these efforts and capabilities," said Nita Madhav, outgoing CEO of Metabiota, who will be joining Ginkgo as part of the transaction. "Ginkgo's biosecurity initiative is an ideal home for our data, analytics, and expertise, and we are very excited to join the Ginkgo team." Concentric has built a large-scale biosecurity platform, bolstered by a nationwide laboratory and operational network, to deliver comprehensive COVID-19 monitoring programs and services across thousands of sites in the U.S., including schools, airports, and other congregate settings. Concentric is building upon this foundation to create a sustainable global biosecurity infrastructure to help detect, mitigate and respond to a wide variety of biological threats, and we expect this transaction to be a key milestone towards developing that infrastructure. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization, and therapeutics discovery.

Read More

CELL AND GENE THERAPY

Merck and Orna Therapeutics Collaborate to Advance Orna’s Next Generation of RNA Technology

Merck and Orna Therapeutics | August 17, 2022

Merck known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. Under the terms of the agreement, Merck will make an upfront payment to Orna of $150 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results. In addition, Orna will be eligible to receive up to $3.5 billion in development, regulatory, and sales milestones associated with the progress of the multiple vaccine and therapeutic programs, as well as royalties on any approved products derived from the collaboration. Orna will retain rights to its oRNA-LNP technology platform and will continue to advance other wholly owned programs in areas such as oncology and genetic disease. Merck will also invest $100 million of equity in Orna’s recently completed Series B financing round. Orna’s proprietary oRNA technology creates circular RNAs from linear RNAs by self-circularization. oRNA molecules have been shown to have greater stability in vivo than linear mRNA and have the potential to produce larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules are more compactly packaged into custom lipid nanoparticles which Orna has engineered to target key tissues in the body. Preclinical data, including presentations at the 2022 American Society of Gene & Cell Therapy Annual Meeting, have demonstrated the potential of oRNA expression and delivery as an approach for further development in multiple areas, including vaccines and oncology therapeutics. “This broad strategic collaboration brings together Merck’s significant expertise in nucleic acid biology, clinical development, and manufacturing with Orna’s compelling circular RNA technology to explore the opportunity to develop a new generation of potential vaccines and therapeutics. We look forward to working with the talented scientific and technical teams at Orna." Fiona Marshall, senior vice president and head of discovery, preclinical and translational medicine at Merck Research Laboratories “We are thrilled to collaborate with Merck, a company committed to breakthrough science, which has recognized the potential our platform can bring to patients. Our oRNA technology plus novel delivery solutions are designed to unlock the full potential of RNA in therapeutics and vaccines,” said Tom Barnes, Chief Executive Officer of Orna. “The combined expertise of Orna and Merck aims to accelerate the development of RNA therapeutics for patients in need of better treatment options.” About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. About Orna Therapeutics Orna Therapeutics was founded on groundbreaking research by Alex Wesselhoeft, Ph.D., and Daniel G. Anderson, Ph.D. from MIT and built by MPM Capital and BioImpact Capital, an investment management affiliate of MPM. Orna’s proprietary circular RNA (oRNA) is engineered as linear RNA that self-circularizes. By taking a line and turning it into a circle, oRNA exhibits numerous advantages over traditional linear mRNA therapies such as simplified production, increased protein expression, and a superior immunogenicity profile. With proprietary lipid nanoparticles including those from Orna’s joint venture with ReNAgade Therapeutics, an RNA delivery company, our technologies expand the possibilities of what RNA therapeutics can achieve.

Read More

CELL AND GENE THERAPY

Intravacc announces additional favorable preclinical and toxicology data for Avacc 10®, an intranasal SARS-CoV-2 candidate vaccine

Intravacc | September 12, 2022

Intravacc, a world leader in translational research and development of preventive and therapeutic vaccines, today announced additional favorable preclinical and toxicology data for Avacc 10®, the company's SARS-CoV-2 intranasal candidate vaccine. These results demonstrate a reduction in upper respiratory tract viral load, broad cross protection against circulating variants of concern. and a good safety profile, allowing progression towards a phase I clinical study. "Based on our additional pre-clinical data, Avacc 10® has the potential to reduce the spreading of the virus as well as providing broad protection against circulation variants. Combined with the favorable toxicological safety data, this puts us a good position for our Phase I clinical trial, which will commence in Q4 2022." Dr. Jan Groen, Intravacc's Chairman & CEO The first set of pre-clinical studies of Avacc 10®, published in Frontiers of Immunology in December 2021, demonstrated high levels of spike-binding immunoglobulin G (IgG) and A (IgA) antibodies in serum, and the nose and lungs after two intranasal vaccinations 3 weeks apart. Avacc 10® vaccinated hamsters challenged with SARS-CoV-2 were protected from weight loss and viral replication in the lungs and histopathology showed no lesions in lungs 7 days after challenge. The objectives of the additional pre-clinical and toxicology study of Avacc 10® were to study the dosing, cross neutralization and safety of the intranasal vaccine. For the dosing study, mice were vaccinated intranasally with two doses of various concentrations of OMV and Spike protein. Three weeks after the last vaccination neutralizing antibodies against the SARS-CoV-2 Wuhan strain and variants of concern Delta, Gamma and Omicron were determined in the sera. High virus neutralizing antibody titers were detected against all the variant viruses. Syrian hamsters were used to study viral replication after challenge with SARS-CoV-2. A reduced viral load in throat and lungs and highly reduced lung lesions were observed in Avacc 10® vaccinated animals exposed to placebo vaccinated, challenged animals. Furthermore, delayed transmission of Avacc 10® vaccinated, challenged animals to placebo vaccinated animals was observed. The purpose of the repeated dose toxicity study was to assess the safety and tolerability of Avacc 10® when administered through the intranasal route in New Zealand White Rabbits. Animals were vaccinated 3 times with Avacc 10® , and control animals with OMV only, or saline buffer. Toxicity was monitored until 2 weeks after the final vaccination. No clinical signs of toxicity nor morbidity/mortality were found in any of the groups, and no gross pathological changes were observed, demonstrating the safety of OMV based vaccine. All Avacc 10® vaccinated animals showed high IgG antibodies levels against Spike as well as virus neutralizing antibodies. Based on the outcome of the Phase I trial, Intravacc will seek manufacturing and commercialization license partners. About Intravacc's OMV platform technology For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) - spherical particles with intrinsic adjuvant properties. The OMVs can be rigged with immunogenic peptides and/or proteins that stimulate effective adaptive immunity. The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens. Intravacc has also developed genetic tools to increase the yield of OMVs, reduce the toxicity and achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs. About Intravacc Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. As an established independent CDMO with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology world-wide for many vaccines including polio-, measles-, DPT-, Hib- and influenza. Around 40% of childhood disease vaccines are based on Intravacc's know-how and proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, public health organizations biotech and pharmaceutical companies.

Read More