- AUR200, a potent recombinant fusion protein, has a clinically validated MOA with a high affinity for targeting both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)
- Upon FDA clearance of the IND, AUR 200 will be studied in a Phase 1 first-in-human trial in healthy volunteers, marking a significant advancement for Aurinia’s emerging autoimmune pipeline
ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia plans to initiate a Phase 1 study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of AUR200 in healthy volunteers.
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in connection with our previously published Client Alert, illuminates the details of the Proposed Framework.
Q: If my company takes SBIR/STTR funding from a federal agency, does the Bayh-Dole Act apply?
A: Yes. A company that receives Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding is considered a “contractor” under the Bayh-Dole Act. As such, inventions conceived of or first actually reduced to practice using SBIR or STTR funds will be subject to the Bayh-Dole Act. This applies even if the funds are used only to develop confirmatory data for an invention conceived of without the use of SBIR or STTR funds.
by | Dec 17, 2023
As Smart Incentives marks its 10th year, we have been revealing the top ten ways that incentives have changed since 2013. We are pleased to share the full list of incentive trends here in our last blog article of 2023.
1. Big incentive deals are getting bigger. Top projects receive significantly higher offers than in the past. The most prominent incentive packages are for new electric vehicle and semiconductor facilities. However, looking past these high profile projects, the average incentive offer has been surprisingly stable over the past decade.
2. The rise of remote work. Remote and hybrid work continue to reshuffle our living and working patterns. Incentives to attract remote workers have become part of the landscape. Many traditional business incentive programs are adjusting how they count workers to account for remote or hybrid work.
3. Better project compliance and reporting. State and local governments have improved their ability to track incentivized projects, monitor performance, and share results with internal and external stakeholders.
Navigating the AI Wave: Dr. Juergen Klenk Explores AI’s Reality in the BioHealth Industry on BioTalk
Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.
Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we’ve reached the stage we’re in today.
Listen now via your favorite podcast platform:
- Apple Podcasts: ??️ – https://apple.co/41u5PtL
- Google Podcasts: ?? – https://bit.ly/41z2f1O
- Spotify: ?? – https://spoti.fi/470FMeZ
- Amazon Music: ?? – https://amzn.to/3tpILzZ
- TuneIn: ?? – https://bit.ly/3RvUF3l
Navigating the AI Wave: Dr. Juergen Klenk Explores AI’s Reality in the BioHealth Industry on BioTalk
Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.
Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we’ve reached the stage we’re in today.
Listen now via your favorite podcast platform:
- Apple Podcasts: ??️ – https://apple.co/41u5PtL
- Google Podcasts: ?? – https://bit.ly/41z2f1O
- Spotify: ?? – https://spoti.fi/470FMeZ
- Amazon Music: ?? – https://amzn.to/3tpILzZ
- TuneIn: ?? – https://bit.ly/3RvUF3l
Irazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.
Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.
Novel Approach
Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.
By Dan Brendel – Staff Reporter, Washington Business Journal
United Therapeutics Corp. is teeing up major organ production facility at its Silver Spring biotech campus through a proposed land swap with Montgomery County.
The company (NASDAQ: UTHR), a longtime drugmaker of pulmonary hypertension therapies that in recent years has expanded into bioengineered organs, has agreed to trade several parcels it owns for a county-owned site on 3.8 acres adjacent to its headquarters at 1000 Spring St.
The site, now home to a parking garage and other county operations, could yield up to 831,000 square feet under existing zoning.
December 11, 2023 – What if there was a diagnostic test that could confirm or predict post-traumatic stress disorder?
And what if people from diverse backgrounds participated in clinical trials for its development?
That’s a goal of Polaris Genomics, a Black- and veteran-owned resident company at JLABS @ Washington, DC. Its mission is to develop objective, genomics-based molecular diagnostic tools to accurately identify mental health conditions beyond the symptoms-based classifications laid out in the DSM-5.
Charles Cathlin, CEO of Polaris Genomics and US Air Force veteran, first crossed paths with Tshaka Cunningham, Ph.D., and Chief Science Officer at Polaris Genomics in Washington, DC. Cathlin was Chief of Staff at the Defense and Veterans Brain Injury Center, while Cunningham worked as a Scientific Program Manager at the Veterans Affairs Medical Center.
Cathlin observed the deteriorating mental health conditions of veterans and first responders during his time in the military and at Ground Zero following 9/11. Additionally, the historic mistrust of the healthcare system by Blacks has pushed them to conceive a way to also better support this historically marginalized patient demographic and to help prevent them from suffering in silence.
By Anastassia Gliadkovskaya – Dec 11, 2023 4:00pm –
Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation.
The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization.
“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.
- The collaboration will evaluate the ability of NeoImmuneTech’s immune cell amplifier NT-I7 to increase the number of azer-cel allogeneic CAR T cells per batch during manufacturing.
- The combination potential of azer-cel and NT-I7 to increase the number and cancer-fighting properties of the patients own T cells during their treatment with azer-cel, will be evaluated in preclinical work.
ROCKVILLE, Md., Dec. 11, 2023 /PRNewswire/ — Imugene Ltd (“Imugene”) (ASX: IMU), a clinical stage immuno-oncology company, and NeoImmuneTech, Inc. (“NIT”), (KOSDAQ: 950220) a clinical-stage T-cell-focused biopharmaceutical company, today announced a strategic collaboration to evaluate Imugene’s allogeneic CAR T, azer-cel, in combination with NIT’s proprietary immune T cell amplifier “Fc-fused recombinant human interleukin-7”, NT-I7, for the treatment of cancer.
Azer-cel is an allogeneic CD19 CAR T cell therapy program with extensive clinical data and a potentially fast-to-market development strategy. Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile in blood cancers such as lymphoma and leukemia.