InflaRx flatlines after skin disease drug flops in midstage trial

pharmaphorum | June 06, 2019

The phase 2b SHINE study of the anti-human complement factor C5a antibody was conducted in hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. Unfortunately for InflaRx, the 179-patient study appears to be a near-total bust, with IFX-1 showing no improvement over placebo on symptoms after 16 weeks’ treatment. Most worryingly, there was no evidence of any dose response with the four IFX-1 dose levels tested, which was the trial’s primary endpoint, and the responses were significantly lower than had been previously reported in phase 2a. But for that earlier result it would be tempting to suggest that the primary problem is that C5a’s role in HS had been dramatically overstated. The only crumb of comfort for the Nasdaq-listed biotech came from a secondary endpoint – the dermatology life quality index (DLQI) – which just scraped a statistically significant improvement over placebo for the four IFX-1 groups as a whole.

Spotlight

When you’re testing hundreds of different cancer drugs in the lab, knowing the backstory of the cells you’re testing them on is important. But cellular history might not always be quite what scientists expect – especially when working with cancer cells that have been growing for decades, not in a patient, but in a flat 2D layer in a plastic dish.


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GNS Healthcare and Arvinas Enter into Neuroscience Drug Discovery Collaboration

GNS Healthcare | May 10, 2022

GNS Healthcare, the leader in the use of "Virtual Patients", Causal AI and simulation technology for biopharmaceutical companies, today announced a collaboration with Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, to generate insights to help accelerate drug development for neurodegenerative diseases. Every year more than six million patients in the United States alone are diagnosed with Alzheimer's, Parkinson's, and Huntington's diseases. These diseases are chronic, debilitating and there is substantial heterogeneity in the presentation of the symptoms and the rates of their progression among patients. The GNS Gemini Virtual Patient models help discover and unravel the complex biological circuitry of the diseases and predict patient response, which can help biopharmaceutical companies accelerate the discovery and development of new therapeutic options for patients. Under the terms of the agreement, Arvinas will leverage GNS' Gemini Virtual Patient models to better understand the biology of the underlying disease, how it progresses, and how potential drugs might perform at the individual patient level. This will help Arvinas researchers discover and prioritize novel drug targets and drug candidates, simulate clinical trials to better understand drivers of diseases for various clinical outcomes, better select patients for clinical trials, and help determine which treatments are most effective for given patient types. "We believe this collaboration will provide novel insights and will help us understand the underlying mechanisms of complex neurodegenerative diseases to inform our discovery and development efforts with the aim of improving patient outcomes." Angela Cacace, Ph.D., Senior Vice President of Neuroscience & Platform Biology at Arvinas "We are committed to supporting the critical work Arvinas is doing to discover and develop breakthrough therapies that help patients who suffer from these conditions," said Joseph F. Donahue, Chief Business Officer at GNS Healthcare. "These diseases impact so many families and we are proud to be able to help contribute to potential treatments that lead to better outcomes for them." About Arvinas Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: bavdegalutamide and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. About GNS Healthcare GNS Healthcare is the leader in the application of Causal AI and simulation technology to help pharmaceutical and biotech companies discover and develop new medicines faster. GNS' patented AI uncovers new insights from multi-omic and real-world data leading to the discovery and prioritization of novel biological targets, more efficient clinical trials, and patients who are likely to respond to therapies. The Gemini Virtual Patient models across oncology, auto-immune diseases, and neurology allow researchers and data scientists to simulate clinical trials, disease progression and drug response at the individual patient level in diverse patient cohorts. GNS' partners include seven out of the top ten pharmaceutical companies, leading research centers, medical societies, and patient advocacy groups globally, and our advisory board consists of a renowned group of scientific and medical experts.

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BUSINESS INSIGHTS

Elligo Health Research® Partners With Peoples Rx

Elligo Health Research | April 21, 2022

Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain. “We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.” Stephen Erickson, Peoples Rx president One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said. Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records. “Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.” About Elligo Health Research® Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. About Peoples Rx Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.

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PHARMACY MARKET

Farmacon Global Partners With Validcare for Performance-Based Clinical Research Solutions

Validcare | February 17, 2022

“Validcare’s partnership with Farmacon Global will literally redefine clinical trial success from patient-centric design through database lock,” said Patrick McCarthy CEO Validcare. The Validcare platform accommodates site-based, hybrid and decentralized clinical trials and establishes key performance indicators to ensure study success. “Partnering with Validcare allows our sponsors to quickly identify and implement ROI generating activities like increased patient enrollment and site set up, while facilitating easier communication with principal investigators and on-going participation. This is especially critical for clinical trials in Latin America where Farmacon Global is uniquely positioned for delivering on-time and on-budget studies. Our focus has always been on the voice of the patients enrolled in a study. Today through our Validcare partnership we can offer the empirical results of better access and data integrity with our trial participants through e-CRF, e-diaries and more efficient RWE data being applied at a whole new level,” Tylosky concluded. Sara Tylosky CEO Farmacon Global Validcare will provide critical infrastructure to power Farmacon Global along with relevant metrics and KPIs. “Together, we provide proven processes, tools and technology to overcome the obstacles that typically cause clinical trial delays and failures,” said McCarthy. “We are excited to reset sponsor expectations and execute clinical trials on time and on budget.” About Validcare Founded by experts with more than 20 years of industry experience, Validcare offers the leading solution for best practices in streamlining research for regulatory compliant, life-improving products. Validcare brings a decade of experience powering clinical trials and value-based care models spanning pharma, med device and supplement market segments. About Farmacon Global Farmacon Global is a strategic CRO of medical consultants, providing solutions to accelerate clinical trials in emerging markets – with a specialty in Latin America and emerging markets with in-place medical associates and KOL alliances. Specialties include rare disease, cancer, immunology and infectious disease

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BUSINESS INSIGHTS

Avidien Technologies Receives $4M Investment from BroadOak Capital Partners

Avidien Technologies | February 02, 2022

Avidien announced a new financing round of $4M from BroadOak Capital Partners. The investment will help Avidien expand its product roadmap, scale commercial production, and better serve research and pharmaceutical clients. "The partnership with BroadOak is exciting and ushers in the next phase for Avidien by creating the opportunity to quickly scale up the business with investments in new products, sales, marketing, and manufacturing." Avidien CEO and Founder Rich Cote Avidien's flagship product, the microPro 300, provides precision semi-automated 96 and 384 channel pipetting to hundreds of biotech, medical testing, and research laboratories worldwide. The compact and portable liquid handling platform has built a loyal customer base thanks to its innovative design, intuitive interface, and industry-leading capabilities. The microPro 300 fills gaps in automation workflows by streamlining repetitive pipetting tasks and ensuring accurate, repeatable liquid transfers. BroadOak Capital Partners is a life sciences focused financial institution with a track record of supporting companies at the forefront of major industry trends. "Aviden's affordable pipette automation platform sets a new standard for common research methods and is at the cutting edge of laboratory automation technology. We're proud to partner with the Avidien team to help them achieve even greater growth," said Bryan Poltilove, Operating Partner at BroadOak Capital Partners. Mr. Poltilove is also joining Avidien's Board of Directors to guide the company's next phase of business expansion. About Avidien Technologies Avidien Technologies is a Massachusetts based company that manufactures innovative and precision liquid handling solutions that are deployed in life science labs around the world. About BroadOak Capital Partners BroadOak Capital Partners, with headquarters in Washington, DC and San Francisco, is a life sciences focused financial institution that provides direct investment and investment banking services to companies in the research tools and consumables, diagnostics, biopharma services, and adjacent markets. BroadOak has led or participated in investments in more than 50 companies across multiple funds and investment vehicles.

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Spotlight

When you’re testing hundreds of different cancer drugs in the lab, knowing the backstory of the cells you’re testing them on is important. But cellular history might not always be quite what scientists expect – especially when working with cancer cells that have been growing for decades, not in a patient, but in a flat 2D layer in a plastic dish.

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