FDA clears Truebinding IND application for TB006 in treatment of  COVID19 patients!

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GENERATION  BIOTHERAPEUTICS 

 

FDA clears IND application for TB006 for COV19 patients

TrueBinding, Inc. announced on March 9th, 2021 that the U.S. Food and Drug Administration (FDA) has granted clearance of the Investigational New Drug (IND) application to proceed with the clinical development of its lead product candidate, TB006, for reducing the severity of underlying diseases in COVID-19. The TB006 treatment aims to decrease the potential acute severe deterioration in ambulatory COVID-19 patients with underlying diseases, such as diabetes, cardiovascular disease (hypertension), and cancer. TrueBinding, Inc. will expect to initiate the Phase I Trial for TB006 in patients with mild to moderate COVID-19 disease in the Spring of 2021 (NCT04801056).

 

Dr. Dongxu Sun, CEO of TrueBinding stated, “we are proud to achieve this important milestone despite the ongoing COVID-19 pandemic. TB006 has shown promising potential to mitigate severity of COVID-19 and underlying diseases in nonclinical studies, and we hope that TB006 can help provide better treatment options to patients with COVID-19.”

 

Dr. Qinhua Cindy Ru, managing director of CRC Oncology stated, “the IND clearance of TB006 marks our first regulatory milestone of our collaboration with TrueBinding, and we look forward to expanding the development of TB006.”

About TB006

TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that was developed by TrueBinding, Inc. In pre-clinical evaluations, TB006 showed promising capabilities in modulating the host immune response, reducing the post-infectious incidence of pulmonary fibrosis, which could mitigate the risk of adverse in COVID-19 patients with underlying comorbidities, including diabetes and cardiovascular diseases such as hypertension.

 

About COVID-19

 

COVID-19 is a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a strain of virus belonging to the coronavirus family. COVID-19 can range from mild to severe disease, the latter including pneumonia, severe acute respiratory syndrome, multi-organ failure, and death. [1] In a clinical study conducted in 44,000 COVID-19 patients, 81% experienced mild to moderate symptoms, 14% experienced severe symptoms, and 5% experienced critical symptoms.[2]

 

About TrueBinding, Inc.

 

TrueBinding Inc. is an early stage biotherapeutics development company focused on creating molecules for applications in immuno-oncology and other disease areas with unmet medical needs, such as neurological disorders and neurodegenerative diseases. TrueBinding has discovered novel, uncharacterized ligands to receptors of known checkpoint inhibitor pathways for potential therapeutic development

For more information, please visit https://www.truebinding.com/.

 

About CRC Oncology

 

CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit www.crconc.com.

 

References

 

1. U.S. Food and Drug Administration. COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. 2021, May. Retrieved from https://www.fda.gov/media/137926/download

2. Centers for Disease Control and Prevention. Clinical Care Guidancehttps://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-managementpatients.html

AT A GLANCE

TrueBinding Inc. is a clinical stage biotherapeutic company focusing on creating new and exciting molecules for applications in immuno-oncology and other disease areas with great unmet medical need including neurological disorders and neurodegenerative diseases.

Based on the application of the TruebindingTM platform, TrueBinding has to date discovered over 6 novel ligands, previously uncharacterized, to receptors of known checkpoint inhibitor pathways.

 

PLATFORM

Our proprietary TrueBindingTM technology is proven to be a powerful tool to discover new targets and their binding partners. Our technology is superior to other traditional approaches. The novel interactions identified by TrueBindingTM technology are confirmed in various in vitro and in vivo assays. TrueBinding, Inc has over sixteen patent applications in its portfolio protecting discoveries and their utility.

 

PIPELINE

TrueBinding, Inc has a number of programs in its portfolio at different stages of development. Our lead program focused on characterization of a new ligand for Tim-3 already completed in vitro validation, antibody development and pre-clinical in vivo efficacy stages, and is currently in the late stage of pre-clinical development. A number of additional programs are in the early discovery stages ranging from target validation to lead antibody development.

 

WE ARE

Dr. Dongxu Sun
Co-founder &  CEO

Lead discovery efforts at ImmuNext

Successfully identified new protein binding interactions in cytokine signaling pathways

Project Scientist at Cleveland Clinic

Postdoctoral training at Cornell Medical College

Dr. Fan Chen
SVP of Biologics and CMC

20+ years of experience in Bioprocess Development

VP of Process Development at LakePharma

Senior Leader of Process Development at Dendreon and MedImmune

 
 

CONTACT

For any inquiries, questions or commendations, please fill out the following form

MD.  Mitchel Berger
Advisor

Chair of neurological surgery department at UCSF

Director of the Brain Tumor Research Center

President, American Association of Neurological Surgeons

President, American Academy of Neurological Surgery

Professor Debbie Thurmond

Key opinion leader in the field of Diabetes and Metabolism. 

Founding Chair of the Department of Molecular & Cellular Endocrinology at the City of Hope Beckman Research Institute

Deputy Director of the Diabetes & Metabolism Research Institute

 

head of regulatory affairs

Position Summary

The Head of Regulatory Affairs, Global Regulatory Affairs Development Strategy (GRA-DS), will be responsible for developing and implementing regulatory strategies in US and China for all assigned products with the intention of achieving successful registration and life-cycle management of unique products serving patients with unmet medical needs diseases.

This individual will, with a high sense of urgency, build and lead a team of regulatory professionals to provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also develop an alliance strategy with business partners and ensure effective communication and constructive working relationships with representatives of regulatory authorities.


 

 

General Position/Summary

  • Built a team at various levels and functions within the organization from junior level Specialists to more senior level managers/Global Regulatory Leads (GRLs), coordinating resourcing and balancing project support across portfolio products. Ensure the ability to execute critical regulatory activities, including but not limited to Regulatory strategy meetings, IND and NDA filings, labeling, preclinical and CMC regulatory strategy, writing and publishing, and pharmacovigilance[a1] . Supervise regulatory staff to provide inspirational leadership and career development input as well as coaching/mentoring support.

  • Provide strategic oversight for all projects, aligned to overall R&D objectives from early development, through initial registration and subsequent global expansion, and including implementation of new indications and formulations.

  • Actively collaborate with management and cross functional colleagues (including commercial, research, clinical development, business development) within TrueBinding, Inc to provide portfolio level regulatory insight and broader drug development expertise.

  • May represent TrueBinding, Inc as point contact with regional health authority and lead the TrueBinding, Inc delegation to regulatory meetings.

  • Monitor the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs. Provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment

 

Qualifications:

  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.

  • Established track record of leading and developing regulatory professionals within an organization

  • Experience providing strategic regulatory advice for the global development of products through all stages of development

  • Ability to manage complex issues and coordinate multiple projects simultaneously

  • Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.

  • Strong interpersonal, and written/verbal communication skills.

  • Proven track record practicing sound judgment as it relates to risk assessment

  • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.

Education

  • Bachelor’s Degree in a related discipline

  • Preferred Education: Relevant advanced degree is preferred

  • 10+ years in pharmaceutical industry regulatory affairs

  • Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products. Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies

 

Senior scientist/principle scientist Antibody Engineering

Job Summary:

We are seeking an experienced Senior Scientist / Principal Scientist Antibody Engineering with a strong background in antibody research.

 

Responsibilities:

  • Work in a fast-paced team environment to collaborate in the company’s antibody research programs.

  • Manage antibody production timelines and deliverables.

  • Manage antibody sequencing, molecular cloning, protein engineering and small-scale protein production.

  • Ensure inter-department collaboration.

  • Analyze data, track project progress and present recommend improvements to project teams. 

  • Ability to prioritize work and the work of others on multiple projects to successfully reach company goals. 

  • Plan experiments and train and supervise others to successful completion of research projects.

  • Responsible for lab safety, supplies and equipment.

 

 

Qualification and Experience:

  • PhD and 5 plus years of antibody engineering and/or relevant industry experience.

  • Experience in setting and reaching department goals and objectives.

  • Demonstrated ability to collaborate with cross-functional teams in a positive manner.

  • Strong organizational skills and record keeping for data and sample collection, storage and recovery.

  • Demonstrated ability to present ideas concisely, both verbally and in writing, to diverse audiences including scientific colleagues and senior leadership.

Director of biology group

Job Summary:

We are seeking an experienced Director/Sr. Director to lead our growing Biology department.  This individual should have extensive experience with everything biology and enjoy the challenge of discovery, strategy and building and leading teams.

 

Responsibilities:

  • Work in a fast-paced team environment to direct the company’s biology research and drug discovery.    

  • Understand and direct the long- and short-term planning and supervision of projects.

  • Manage department timelines and deliverables.

  • Manage/supervise new research, screenings.

  • Lead and organize all in-vitro and in-vivo studies.

  • Lead all company ongoing research and explore and develop new potential target therapies.

  • Strong decision making skills with the ability to analyze data, track project progress and present recommend improvements to project teams. 

  • Ability to prioritize work and the work of others on multiple projects to successfully reach company goals. 

  • Plan experiments and train and supervise others to successful completion of tasks.

  • Directs the departmental patent applications and other publications. 

  • Responsible for lab safety, supplies and equipment.

 

 

Qualification and Experience:

  • PhD and 10 plus years of increasing responsibility and seniority in biology research and development, and/or industry experience.

  • Experience in data analysis and software such as GraphPad prism, ImageJ, Flowjo, MS excel, MS word.

  • Experience setting and reaching department goals and objectives.

  • Demonstrated ability to lead and collaborate with teams in a positive manner.

  • Strong organizational and record keeping skills for data and sample collection, storage and recovery.

  • Demonstrated ability to present ideas concisely, both verbally and in writing, to diverse audiences including scientific colleagues and senior leadership.

 
 
 

300 Lincoln Center Drive, 

Foster City, CA, 94404

info@truebinding.com

Tel: 650-847-1117

© 2018 by TrueBinding Inc.