Zydus seeks DCGI approval to undertake clinical trials for monoclonal antibodies cocktail that can neutralise COVID infection
Zydus Cadila, an innovation-driven pharmaceutical company today announced that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild COVID 19. SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody based treatments have received emergency use authorization in mild COVID 19 in the US, Europe and in India because they significantly reduced viral load in mild patients and their rate of hospitalization. Two of these products are cocktail based products comprising of two mAbs binding to two different epitopes on the spike protein of SARS-CoV-2 virus. Cocktail of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants. Zydus is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID 19.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID. It is important to look at different stages of the disease progression and look at options that can reduce patient’s suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment.”
Recently, the US FDA withdrew the emergency use authorization of a mAb product after new variants emerged in the country that were not being neutralized by the product. ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes on the spike protein of SARSCoV-2. The monoclonal antibodies of ZRC-3308 have been specifically designed to provide protection for a much longer period of time than the currently approved products. The enhanced design would also help in preventing any further tissue damage and thereby reducing the risk of severe disease. ZRC-3308 has demonstrated the ability to neutralize SARS-CoV-2 both in vitro and in animal studies. In animal studies ZRC-3308 reduced damage to the lungs in both prophylactic and therapeutic settings. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies. Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.
Hester
MOU signed between Bharat Biotech and Gujarat Covid Vaccine Consortium (GCVC) Hester is a part of GCVC
An MOU has been signed between Bharat Biotech International Limited and GCVC towards contract manufacturing for the Drug Substance for COVAXIN
GCVC comprises of:
1. Gujarat Biotechnology Research Centre (GBRC), a Government of Gujarat undertaking
2. Hester Biosciences Limited
3. Omnibrx Biotechnologies Private Limited
Highlights of the MOU:
1. Bharat Biotech shall provide the technology for the production of the Drug Substance for
COVAXIN.
2. GBRC will act as an advisor and mentor and will facilitate the technology transfer from Bharat
Biotech
3. Hester shall provide the complete infrastructure at its Gujarat plant for the manufacturing of the
Drug Substance
4. Omnibrx shall act as a technology support partner
This entire process is facilitated by Department of Biotechnology, Government of India.
If everything goes as per the schedule, the Drug Substance would be available from August 2021 which will be supplied back to Bharat Biotech for producing COVAXIN
Hester has estimated an outlay of INR 40 crores for this project.
This proposed manufacturing activity at Hester would not disturb any manufacturing or marketing forecasts of Hester’s on-going business, for the financial year 2021-2022.
Lupin Announces Achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound
-> Lupin’s proprietary MEK inhibitor compound is planned for clinical development in combination with Boehringer Ingelheim’s KRAS inhibitor pipeline to address KRAS-driven cancers
-> Lupin has received USD 50 million as part of successful achievement of key milestones
Global pharma major Lupin Limited (Lupin) today announced the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers.
As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones.
Lupin and Boehringer Ingelheim inked a licensing, development and commercialization agreement in 2019 for Lupin’s novel oncology compound to treat KRAS-driven cancers. Lupin’s MEK inhibitor developed as part of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in combination.
Lupin’s New Chemical Entity Research team is focused on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the oncology space. Lupin’s NCE activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally
Onward Technologies Limited to raise INR 70 crores from funds advised by Convergent Finance LLP
Onward Technologies Ltd in its board meeting held on 27 th May 2021 has considered and approved the raising of funds of INR 70.2 crores from funds advised by Convergent Finance LLP
Structured as a subscription to equity shares and warrants priced in accordance with applicable SEBI regulations, the investment will aggregate up to INR 70.2 crores will result in an approximately 24.78% ownership stake on a fully diluted basis. Customary closing conditions, including shareholder approval, will apply.
Commenting on this development, Jigar Mehta, Managing Director of Onward Tech, welcomed the investment by saying, “This investment is a vote of confidence for the Onward Tech team, reinforcing the tremendous growth underway within our organization. Harsha and his team have an excellent track record of value creation, and we look forward to working closely with the Convergent team.
Onward Tech is already a cash positive company & the objective of raising additional cash is to strengthen our presence in India, USA and Europe. Our new international subsidiaries in Netherlands and Canada will also become fully functional next quarter. On the home front, after a successful launch in Bangalore in Jan 2021, we plan to expand our portfolio of services into new territories Hyderabad and Noida in 2021, where we see a major opportunity of growth.
Devanand Ramandasani, CFO of Onward Tech “We have gone through a roller-coaster last few quarters with the pandemic. In-spite of Covid-19 and challenges from WFH, the company has shown strong resilience and hired 500 engineers across the digital & engineering services verticals to support our fast growing multinational OEM customers. This new investment will help us accelerate both organic & inorganic growth opportunities in the digital ER&D industry. “
Harsha Raghavan, Managing Partner at Convergent, commented, “Onward Tech is one of the oldest and most well-established IT service companies, founded by the visionary Harish Mehta, a pillar of the Indian IT services industry since the ‘70s. As we move forward into the digital era, we are extremely excited to partner with Onward Tech team, now led by his son Jigar Mehta. At Convergent, our motto has always been to help great companies become global leaders, and Onward Tech exemplifies this approach. We will look to use our global networks, strategic insights and operational expertise to help transform Onward Tech into a global leader in engineering R&D and digital transformation.”
Centrum Capital Ltd. is acting as the sole financial advisor and DSK Legal is acting as legal advisor to Onward Technologies for this assignment.
TCS Recognized as a Leader in AWS Servicesin the US by ISG
Tata Consultancy Services (TCS) (BSE: 532540, NSE: TCS), a leading global IT services, consulting and business solutions organization, has been recognized as a Leader in the ISG Provider Lens™ AWS Ecosystem Partners Report for the U.S., across all quadrants – SAP Workloads, Internet of Things, Managed Services and Consulting Services.
According to the report, TCS’ depth and breadth of global resources, strong relationship with AWS, and global market presence make it a Leader and a potential candidate for all client AWS-related service needs.
“TCS' AWS Business Unit partners with customers in modernizing their entire technology stack and offers industry-specific transformative products and services, leveraging the native capabilities of AWS to help them innovate, transform and drive superior business outcomes for every stakeholder,” said Krishna Mohan, Global Head, AWS Business Unit, TCS. “This Leadership position is a reflection of our vision, comprehensive portfolio of services and solutions and the resultant market success.”
The TCS AWS BU is a full-stack, multidisciplinary business unit that offers global enterprise customers customized end-to-end services and solutions around cloud migration, application and data modernization, managed services, and industry-specific innovation leveraging the AWS cloud. TCS seeks to expand enterprise capabilities through research and co-innovation with other ecosystem players, enabling clients to harness the power of the AWS cloud stack in their growth and transformation initiatives.
TCS’ large pool of AWS-cloud-ready professionals leverage their domain knowledge and AWS technology building blocks to create transformational solutions that address non-CIO value imperatives.
Furthermore, TCS’ rich portfolio of leading-edge, industry-centric products like the TCS BaNCS™ suite in financial services, TCS Optumera™ in retail, TCS HOBS™ in telecom, TCS ADD™ in life sciences, TCS Aviana™ in airlines and Water Cloud in utilities are available on AWS, driving synergies across the enterprise value chain and impacting every stakeholder.
“A strong portfolio and market presence, breadth and depth of experience and expertise, and continued investment in training, certification, and its growing AWS relationship, all position TCS as a Leader in Consulting Services, IoT, Managed Services, and SAP Migration and Support in ISG’s 2020 U.S. AWS Partner Ecosystem Provider Lens study,” said Bruce Guptill, Author, Global Lead Analyst & Distinguished Analyst, ISG Research.