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Pulmonomy and Cellix Bio Announce

Frost & Sullivan is pleased to announce that Cellix Bio has been selected as the recipient of the 2020 Indian Drug Discovery Platform Technology Innovation Award

JUNE 2020

Frost & Sullivan Best Practices Awards are independent, research -backed accolades that identify the market’s true leaders and innovators. The methodology for determining award recipients is unique, wherein a deep dive research and analysis is conducted by Frost & Sullivan industry experts. Award recipients are identified using a structured metrics -based evaluation process.

For the Drug Discovery Platform Technology, Frost & Sullivan analysts independently evaluated the following,

Key Benchmarking Criteria:

  • 1. Commitment to Innovation and Commitment to Creativity
  • 2. Application Diversity
  • 3. Operational Efficiency and Growth Potential
  • 4. Human Capital

Cellix Bio reflected strong overall performance across all of the above parameters and has been chosen for 2020 Indian Drug Discovery Platform Technology Innovation Award. This is a great achievement and is a result of many stakeholders (employees, customers, and investors) believing in the organisation and contributing to its future in a meaningful way.

For more visit: https://ww2.frost.com/about/best-practices-recognition/best-practices-promotional-videos/
Pulmonomy and Cellix Bio Announce

Pulmonomy and Cellix Bio Announce Exclusive Development Agreement for Anti-fungal Inhalation Therapeutics

Lexington, Mass.–Mar. 6, 2020 – Pulmonomy, an inhalation therapeutics-focused subsidiary of TotalClarity, Inc., today announced a collaboration agreement with Cellix Bio for exclusive global rights to develop CLX-159 for the treatment of Invasive Pulmonary Aspergillosis (IPA) and Allergic Bronchopulmonary Aspergillosis (ABPA).

Under the terms of the agreement, Pulmonomy will pay Cellix Bio an upfront research and development funding fee, and potential payments tied to development milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty on global sales of CLX-159.

Pulmonomy plans to submit an IND application for CLX-159 as a first line treatment for Invasive Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis to the US FDA in the first quarter of 2021. Under the terms of the agreement, Pulmonomy will undertake and fund future regulatory and commercial activities to bring CLX-159 to market and commercialize the product within the agreement’s territories.

“CLX-159 has the potential to become an important new first line treatment for Invasive Pulmonary Aspergillosis (IPA), and we look forward to submitting an IND early next year,” said Shekhar Shastri, Chief Executive Officer of TotalClarity, Inc. “As a recently established specialty pharma company, Pulmonomy has ambitious growth plans, and CLX-159 is a strong strategic fit with our pipeline of high-impact drug candidates, especially in the inhalation therapeutics as we expand our focus and capability in pulmonary and infectious disease areas.”

“Patients at risk for infection are rising rapidly due to a number of risk factors, predisposing them to Invasive Fungal Infections (IFI). The development program between Cellix Bio and Pulmonomy is aimed at addressing this epidemiological trend,” said Dr. Regis DeSilva, Chief Medical Officer of TotalClarity, Inc., the parent company of Pulmonomy.

“Our agreement with Pulmonomy marks a critical step in the execution of our company strategy. We have a solid foundation to potentially generate near-term capital and long-term value for this important asset CLX-159 globally,” said Mahesh Kandula, Chief Executive Officer of Cellix Bio. “This CLX-159 partnership would amount to potential payments over the next 18 months in addition to potential payments from our other licensed pipeline assets, which could provide substantial additional funding to support our CLX-159 development strategy for North America. We look forward to working with the experienced commercial and regulatory team at Pulmonomy as they seek to successfully commercialize CLX-159 in North America and Europe.”

About Pulmonomy

Pulmonomy, Inc. is a specialty pharmaceutical company and is a wholly-owned subsidiary of TotalClarity, Inc. The company has commercial operations in the US and India. Currently, Pulmonomy has a portfolio of eight pre-clinical drug candidates in its pipeline, and the company has ambitious plans to expand this through acquisition and in-licensing. For more information please visit www.Pulmonomy.com.

About Cellix Bio

Cellix Bio, Pvt. Ltd. is a biopharmaceutical company committed to developing targeted therapies through novel drug-design insights to provide improvements in patient outcomes where significant unmet medical needs exist. Cellix Bio’s unique insights into drug-design chemistry and related disease biology are what Pulmonomy is seeking to leverage in the clinical development strategy of its therapeutics candidates. For more information, please visit www.cellixbio.com.

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PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE)

Cellix Bio Pharma Initiates Acquisition of Avaca Pharma: Formulation Development CRO

Hyderabad, 06-March-2020- Cellix Bio Pharma initiates the acquisition of Avaca Pharma, a formulation development CRO. Avaca Pharma services include discovery, formulation development, pre-formulation, regulatory support, and product development activities.

The acquisition of Avaca Pharma provides Cellix Bio Pharma with world-class expertise in NME/NCE discovery R&D services and a unique and extensive set of high-content formulation. Combined with Cellix Bio’s established small molecule discovery and development capabilities, this expansion uniquely position Cellix Bio Pharma as a leading provider of integrated R&D services across both large and small molecule platforms and provides a base for further expansion.

With a shared vision of an innovative approach to execution, exceptional customer service, and focus on providing value, Cellix Bio Pharma is delighted to offer expanded leading-edge service solutions to our clients.

About Cellix Bio Pharma

Cellix Bio Pharma is leading Discovery Research and Development organization. Cellix Bio Pharma provides a broad spectrum of integrated services, across the R&D and manufacturing value chain with a focus on speed and quality. Cellix Bio Pharma capabilities include Discovery Research, Discovery Services, Contract Manufacturing, Formulations and Informatics. For more information log on to www.cellixbiopharma.com

About Avaca Pharma

Avaca Pharma is a new-gen pharmaceutical development and commercialization organization with a vision to innovate for better health. Rooted in integrity, technical acumen, customer service and reliability, our organizational goal is to thrive for the best patient outcome. Avaca Pharma is vested in bringing quality pharmaceutical products with a patient centric approach. More information on Avaca Pharma can be found at www.avacapharma.com

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PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE)

New Therapy Targets Painful Side Effect of Cancer Treatment

March 26, 2019 - Jessica McBride - Office of the Vice President for Research
“We knew that there was a huge unmet need, that the market was wide open, and that significant data indicated this molecule was an excellent candidate,” says Mahesh Kandula, CEO and managing director of Cellix Bio. “We are thrilled to be collaborating with such qualified researchers like Drs. Burgess and Lalla from UConn. We are confident this partnership will lead not only to successful commercialization, but also to a better prognosis for thousands of patients undergoing treatment for cancer.”

Funding for this technology has been provided by Cellix Bio, the UConn SPARK Technology Commercialization Fund, the UConn Research Excellence Program, and an Innovation in Oral Care Award from the International Association for Dental Research (IADR).

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PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE)

Logic Biosciences Announces International Award for LBS-101 Program

July 29, 2018 08:00 AM Eastern Daylight Time
NEWARK, N.J.--(BUSINESS WIRE)--Logic Biosciences, Inc., a development-stage pharmaceutical company, today announced that its lead product candidate, LBS-101, has been recognized with an Innovation in Oral Care Award from the International Association for Dental Research (IADR). LBS-101 is a long-acting topical formulation of a novel salt of bupivacaine, being developed for oral pain from mouth ulcers (oral mucositis) secondary to chemotherapy or radiation therapy for cancer. The award also includes research funding to the University of Connecticut (UConn), to advance the drug development program. This funding is supported by GlaxoSmithKline, through an unrestricted grant to the IADR. Awardees are selected by a scientific review panel of the IADR. The award was given at the IADR conference held in London, England from July 25-28, 2018.

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PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE)

Cellix Biosciences Announces Regulatory Pathway Confirmation for CLX-106 in the U.S.

July 11, 2018 02:09 PM Eastern Daylight Time
NEWARK, N.J.--(BUSINESS WIRE)--Cellix Biosciences Inc. (“Cellix Bio”), a development-stage pharmaceutical company, today announced confirmation from the U.S. Food and Drug Administration (FDA) that the 505(b)(2) regulatory pathway is appropriate for development of CLX-106 for treatment of relapsing-remitting multiple sclerosis (RRMS). CLX-106 is a novel molecular conjugate designed to deliver an optimal therapeutic profile of monomethyl fumarate (MMF) for RRMS. MMF is the active moiety of dimethyl fumarate (DMF), an approved RRMS therapy that achieved global sales of over $4 billion in 2016.

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PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE)

V ClinBio Acquires 49.98% Stake in Cellix to Advance Synergix, a Transformative Pro-drug Technology Platform

PRINCETON, N.J., Feb. 06, 2018 (GLOBE NEWSWIRE) -- V ClinBio Inc., an innovative biopharmaceutical company focused on transforming existing compounds into differentiated new therapeutics, today announced that it has acquired a 49.98% equity stake in Cellix Bio, an innovative drug design and development company.

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Research in International Immunopharmacology

Research in International Immunopharmacology

Cellix Bio Publishes CLX-103 Research in International Immunopharmacology: Discovery and preclinical development of a novel prodrug conjugate of mesalamine with eicosapentaenoic acid and caprylic acid for the treatment of Inflammatory Bowel Diseases.

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Research in International Immunopharmacology

Logic Biosciences, Inc.

Cellix Bio and Logic Biosciences, Inc., Joint Venture is focused to develop and commercialize novel therapies and targeted delivery formulations for the management of Pain in various therapeutic indications such as Oral Mucositis and Post-Operative Pain.

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Research in International Immunopharmacology

SPARK Technology

Cellix Bio’s CLX-117 pipeline lead candidate qualifies for UConn SPARK Technology Commercialization Fund Program 2016 with the investigative supervision of Dr. Rajesh V Lalla. The award aims to help investigators from UConn-Storrs and UConn Health (UCH) move ideas into the earliest stages of commercialization and development.

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Research in International Immunopharmacology

VClinBio, Inc.

Cellix Bio and VClinBio, Inc., Collaboration is focused to develop and commercialize novel therapies for the treatment of Multiple Sclerosis and Psoriasis. CLX-106 pipeline lead candidates comprises of Novel MonoMethylFumarate Glyceryl Ester molecular entities.

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Research in International Immunopharmacology

New Jersey Medical School, Rutgers

Cellix Bio and New Jersey Medical School, Rutgers; collaboration is focused to screen novel anti-fungal compounds developed and patented by Cellix Bio. These novel therapies are focused to address the drug resistance in pathogenic fungal infections.

Research in International Immunopharmacology

Excellence Award

Cellix Bio bags 2017 Fastest Growing Indian Company Excellence Award. The award will be presented during the National Seminar & Awards Ceremony on “Individual Achievements & National Development” at New Delhi.

Research in International Immunopharmacology

Texas A&M University

Cellix Bio and Texas A&M University collaboration is focused to screen Gastro-Intestinal Tolerable NSAIDs with improved efficacy and safety profile. Cellix Bio’s Patented Platform Technology driven Diclofenac Novel Long Chain Fatty acid conjugate had low GI ulceration with improved safety and tolerability profile. The collaboration is also extended to investigate the Novel Sulindac and Eflornithine novel molecular conjugates for the effective treatment of GI Polyps.

Strong scientific platform ! Synergix