Dr. Reddy’s signs license deal for anti-BCMA CAR-T PRG1801 in India

Dr. Reddy’s Laboratories has signed an agreement with Shenzhen Pregene Biopharma to acquire an exclusive license in India for PRG1801, Pregene’s single domain antibody-based anti-BCMA chimeric antigen receptor T (CAR-T) cell therapy injection.

Besides acquiring the exclusive rights to commercialise PRG1801 in India, Dr. Reddy’s will be responsible for future development including clinical trials, in the country.

Pregene will be the sole supplier of the core material – lentiviral vectors for manufacturing PRG1801.

As per the terms of the license agreement, Pregene will get an upfront payment and future milestone payments of $5m for first indication and up to $7.5m of milestone payments for subsequent indications.

Pregene is eligible to secure a double-digit royalty, up to $150m on future sales of PRG1801 in the licensed territory.

PRG1801 is an autologous anti-BCMA CAR-T therapy in development intended to treat relapsed/refractory multiple myeloma.

It has demonstrated signs of efficacy and a safety profile in 34 patients in an investigator-initiated trial in China.

Last year, PRG1801 had secured NMPA IND clearance, and a Phase I clinical trial of the product candidate is ongoing in China.

This license agreement offers Pregene with an experienced partner in India, and bolsters Dr. Reddy’s capacity in immune cell therapy for cancers.

CD&R agrees to acquire UDG Healthcare for $3.7bn

Clayton, Dubilier & Rice (CD&R), a private investment firm, has signed an agreement to acquire London-listed UDG Healthcare for £2.6bn ($3.7bn).

Under the terms of the deal, CD&R will pay £10.23 in cash per share in UDG.

Headquartered in Dublin, UDG Healthcare provide healthcare advisory, communications, commercial, clinical and packaging services.

UDG Healthcare chairman Shane Cooke said: “We believe that this is an attractive offer for UDG shareholders, which secures the delivery of future value for shareholders in cash today.

“The offer reflects the quality, strength and long term performance of UDG’s businesses and its future growth potential.

“We believe that our people, our clients and our businesses will continue to prosper under the stewardship of CD&R.”

Employing about 9,000 people in almost 30 countries, the firm has two divisions – Ashfield and Sharp.

CD&R partner Eric Rouzier said: “UDG has long established itself as a leading provider of high-value services to pharma and biotech companies globally, supported by a highly skilled workforce.”

Following shareholder and regulatory approvals, the deal is expected to be declared effective during Q3 2021.

During the half-year results to the end of March 2021, UDG posted adjusted pretax profit increase of 10% at $82.4m on revenue drop of 5% at $661.4m.

Ashfield posted an increase in adjusted operating profit by 7% compared with the same period of last year, while Sharp’s adjusted operating profit grew by 19%.

UDG said its board is not proposing an interim dividend for 2021.

The firm divested its supply chain business in 2015.

Lilly, MiNA Therapeutics partner to develop new drug candidates

Eli Lilly and Company and MiNA Therapeutics are set to develop new drug candidates as part of a global research collaboration.

The companies will leverage MiNA Therapeutics’ small activating RNA (saRNA) technology platform to develop the drug candidates.

Using its saRNA platform, MiNA Therapeutics will research up to five targets selected by Lilly that aim to address diseases across the latter’s key therapeutic focus areas.

Eli Lilly and Company new therapeutic modalities vice-president Andrew Adams said: “Small activating RNAs are a promising new technology, which will expand the breadth of Lilly’s RNA therapeutics platform and the targets we can pursue.

“We are excited about the potential of combining MiNA’s leading saRNA platform and our expertise in new modalities to accelerate development of RNA-based medicines in areas of high unmet medical need.”

Activities related to preclinical and clinical development of candidates will be handled by Lilly, which will also retain exclusive commercialisation rights for any products that will be developed as part of the collaboration.

Lilly will make a $25m upfront payment to MiNA Therapeutics.

Additionally, MiNA Therapeutics will be eligible for $245m potential development and commercialisation milestones per target, and tiered royalties from the low-single to low-double digits on product sales that result from the collaboration.

MiNA Therapeutics CEO Robert Habib said: “This collaboration with Lilly is an important validation of our saRNA platform. Lilly’s expertise in the field of RNA therapeutics and clinical development will greatly enhance our efforts to realise the technology’s full potential.

“Together, we aim to unlock new targets in multiple therapeutic areas and to ultimately move them towards clinical development and commercialisation.”

The company is also advancing a pipeline of new medicines with an initial focus on cancer and genetic diseases.

US FDA approves emergency use of Pfizer-BioNTech Covid-19 vaccine in adolescents

The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 vaccine to include adolescents aged 12 to 15 years.

The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 vaccine to include adolescents aged 12 to 15 years.

With FDA authorisation, the vaccine is claimed to be the first product authorised for this age group in the country.

The authorisation is based on data from the Phase III clinical trial from a total of 2,260 subjects aged 12 to 15 years in the US.

All participants will be followed-up for long-term protection and safety for two years after receiving their second dose.

This trial showed 100% efficacy in subjects with or without prior SARS-CoV-2 infection and robust antibody responses.

Upon receipt of the second dose of the vaccine, the trial subjects will be observed for long-term protection and safety for two years.

Pfizer chairman and CEO Albert Bourla said: “Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year.

“We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”

Additionally, a paediatric trial evaluating the efficacy and safety of the Covid-19 vaccine in children aged six months to 11 years is underway.

Based on BioNTech proprietary mRNA technology, the Covid-19 vaccine is developed by both BioNTech and Pfizer.

BioNTech holds the marketing authorisation in the European Union as well as emergency use authorisations (EUA) or similar approvals in the US, along with Pfizer, the UK, Canada and various other countries.

India’s DCGI allows use of oxygen dependence-lowering Covid-19 drug

The Drugs Controller General of India (DCGI) has granted emergency use authorisation for a new drug, 2-deoxy-D-glucose (2-DG), as adjunct therapy that can help lower supplemental oxygen dependence in moderate to severe Covid-19 patients.

India’s Defence Research and Development Organisation (DRDO) lab Institute of Nuclear Medicine and Allied Sciences (INMAS) developed the drug in alliance with Dr Reddy’s Laboratories (DRL).

The drug is available in powder form and can be dissolved in water for oral administration.

According to clinical trial data, the therapeutic led to faster recovery of hospitalised patients and lowered need for supplemental oxygen. Majority of Covid-19 patients on the drug had RT-PCR negative conversion.

In April last year, researchers at INMAS-DRDO studied 2-DG in laboratory, in collaboration with Centre for Cellular and Molecular Biology (CCMB), Hyderabad. These experiments showed that the molecule works effectively against the Covid-19 virus and supresses its growth.

Based on these data, DCGI’s Central Drugs Standard Control Organization (CDSCO) allowed Phase II Covid-19 trial of the drug in May last year.

The Phase II trial, in a total of 110 Covid-19 patients, assessed the safety and efficacy of the drug, which was found to be safe and led to significant improvement in their recovery.

Phase IIa was carried out in six hospitals while Phase IIb dose ranging study was performed at 11 hospitals across India.

Efficacy data revealed quicker symptomatic cure with 2-DG versus standard of care (SoC) on different endpoints. Also, the drug had favourable trend on the median time to normalisation of certain vital signs parameters compared to SoC.

The Phase III trials of the drug were started in November last year and involved 220 patients at 27 Covid-19 hospitals in India.

Results demonstrated symptomatic improvement and freedom from supplemental oxygen dependence by day 3 in higher proportion of patients on 2-DG, versus SoC, representing an early relief from oxygen therapy.

The data was similar in patients aged more than 65 years.

In a separate development, Pfizer and BioNTech have initiated a Biologics License Application (BLA) seeking complete approval from the US Food and Drug Administration (FDA) for their mRNA Covid-19 vaccine in people aged 16 years and above.

Meanwhile, the European Medicines Agency (EMA) has begun a rolling review of data on GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab to treat Covid-19 patients aged 12 years and over who do not need oxygen supplementation but may progress to severe disease.

Russia approves single dose Covid-19 vaccine Sputnik Light

The Russian Direct Investment Fund (RDIF) has announced that a single dose Covid-19 vaccine called Sputnik Light, obtained authorisation for use in the country.

The Russian Direct Investment Fund (RDIF) has announced that a single dose Covid-19 vaccine called Sputnik Light, obtained authorisation for use in the country.

With recombinant human adenovirus serotype number 26 (rAd26), Sputnik Light is the first component of Sputnik V Covid-19 vaccine, which is claimed to be the world’s first registered vaccine for the disease.

As per the analysis of data gathered from 28 days after the injection, Sputnik Light showed 79.4% efficacy.

The results of Phase I/II Safety and Immunogenicity Study of the single dose vaccine showed that it can trigger antigen specific IgG antibodies in 96.9% of participants on day 28 after injection.

Meanwhile, virus-neutralising antibodies were observed in 91.67% of the participants.

The study also demonstrated the development of cellular immune response against the S Protein of SARS-CoV-2 in all volunteers. Sputnik Light did not cause any serious adverse events, RDIF said.

RDIF added that a Phase III clinical study in 7,000 volunteers is underway in the UAE, Russia, Ghana and other countries, with the interim results of the study expected this month.

RDIF CEO Kirill Dmitriev said: “The Sputnik Light vaccine significantly reduces the possibility of severe cases leading to hospitalisation, with only one injection needed.

“The single dose regimen solves the challenge of immunising large groups in a shorter time, which is especially important during the acute phase of the spread of coronavirus, achieving herd immunity faster.

“The characteristics of the vaccine provide for simple storage and logistics, while Sputnik Light has an affordable price of less than $10.”

Dmitriev noted that the two dose Sputnik V vaccine will continue to be the main vaccination source in Russia. The plan is to export Sputnik Light to RDIF’s international partners to help fight the pandemic.

Pfizer-BioNTech Covid-19 vaccine gets Canada approval for adolescents

Pfizer Canada and BioNTech have received Interim Order authorisation from Health Canada for the use of their Covid-19 vaccine in adolescents aged 12 to 15 years.

Pfizer Canada and BioNTech have received Interim Order authorisation from Health Canada for the use of their Covid-19 vaccine in adolescents aged 12 to 15 years.

This Covid-19 vaccine is the first product authorised for this population in Canada, Pfizer noted. It is allowed for active immunisation to prevent the disease and must be given intramuscularly.

Health Canada authorisation is based on the Phase III clinical trial results from 2,260 subjects aged 12 to 15 years in the US. All participants will be followed-up for long-term protection and safety for two years after receiving their second dose.

Furthermore, a paediatric trial to assess the safety and efficacy of the vaccine in children aged six months to 11 years is underway.

BioNTech co-founder and chief medical officer Özlem Türeci said: “Since securing the Interim Authorization in December for individuals 16 years and older, we have been working tirelessly to get our Covid-19 vaccine authorised around the world in order to provide access to as many countries as possible.

“Our work is not yet complete, as we continue our research into the use of our vaccine in paediatric populations.”

Pfizer Canada vaccines lead Fabien Paquette added that the latest authorisation will enable the Canadian government to expand its vaccination programme against Covid-19.

Developed by BioNTech and Pfizer, the Covid-19 vaccine is based on BioNTech’s mRNA technology. The vaccine generated $3.5bn in global revenues during the first quarter of this year, reported Pfizer.

Anticipating further increase in the Covid-19 vaccine sales, Pfizer increased its revenue guidance for the product from $15bn to $26bn.

BioNTech holds marketing authorisation for the vaccine in the European Union. It also secured the emergency use authorisations or equivalent in the US, along with Pfizer, as well as the UK and Canada, among other countries.

ViiV begins rolling submission for cabotegravir to prevent HIV in US

ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for long-acting cabotegravir to prevent human immunodeficiency virus (HIV).

ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for long-acting cabotegravir to prevent human immunodeficiency virus (HIV).

This submission allows the company to provide completed sections of its regulatory application to the FDA instead of waiting for every portion to be completed before the application can be reviewed.

ViiV Healthcare stated that the complete submission will depend on results from HIV Prevention Trials Network (HPTN) 083 and 084 studies.

HPTN 083 is a Phase IIb/III double blind study to assess the safety and efficacy of long-acting injectable cabotegravir for prevention of HIV.

The study was conducted in nearly 4,566 men who have sex with men and transgender women at research centres located in Argentina, Brazil, Peru, US, South Africa, Thailand and Vietnam.

Also a Phase IIb/III study, HPTN 084 assessed the safety and efficacy of cabotegravir to prevent HIV in 3,223 women who are at increased risk of acquiring HIV.

The blinded, randomised portion of both studies were stopped by the Data Safety Monitoring Board as the drug showed superior protection when given every eight weeks compared with daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

ViiV Healthcare Research and Development head Kimberly Smith said: “With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill.

“If approved, cabotegravir would play a role in expanding the PrEP landscape in the US, particularly for those who are most vulnerable to acquiring HIV.”

The company is planning to submit regulatory files by the end of this year to global regulatory authorities, with initial focus on countries in which the HPTN 083 and 084 studies were performed.

Revive Therapeutics, UCSF partner to study Bucillamine for severe Covid-19

Specialty life sciences company Revive Therapeutics has signed a research agreement with University of California, San Francisco (UCSF) to study Bucillamine as a potential treatment for severe Covid-19.

Specialty life sciences company Revive Therapeutics has signed a research agreement with University of California, San Francisco (UCSF) to study Bucillamine as a potential treatment for severe Covid-19.

The deal will support research at UCSF Pulmonary and Critical Care Medicine Division professor Dr John Fahy’s laboratory to evaluate the drug’s efficacy in pre-clinical Covid-19 models.

It will also support the design of protocols to examine Bucillamine in human trials.

Revive Therapeutics CEO Michael Frank said: “Revive is focused on proving Bucillamine’s clinical utility for all forms of Covid-19.

“Evaluating Bucillamine for severe Covid-19 along with our dedication in completing our ongoing Phase III clinical study for mild-to-moderate Covid-19, which has grown from 14 clinical sites to now 26 participating sites in 10 US states, will position Bucillamine as a potential oral treatment option for mild-moderate to severe Covid-19.”

A recent by Dr Fahyfound that thiol-based drugs such as Bucillamine mitigate the binding of SARS-CoV-2 spike protein to its receptor.

It also found that these drugs reduce the entry efficiency of SARS-CoV-2 spike pseudotyped virus and prevent SARS-CoV-2 live virus infection.

These findings have shown vulnerability of the Covid-19 virus to thiol-based drugs and allow testing of thiol-based drugs, including Bucillamine, as potential Covid-19 treatments.

The company previously initiated a Phase III study to assess the safety and efficacy of Bucillamine in patients suffering from mild to moderate Covid-19. Enrolment for this US Food & Drug Administration (FDA) trial is expected to close in the second half of this year.

As of March this year, the study did not reveal any serious adverse events or safety concerns with the drug.

WHO grants emergency use listing for Moderna’s Covid-19 vaccine

World Health Organization (WHO) has granted emergency use listing (EUL) for Moderna’s Covid-19 vaccine to prevent the infection in people aged 18 years and above.

World Health Organization (WHO) has granted emergency use listing (EUL) for Moderna’s Covid-19 vaccine to prevent the infection in people aged 18 years and above.

The Covid-19 Vaccine Moderna is an mRNA vaccine against Covid-19 designed to encode a prefusion stabilised form of the Spike (S) protein that was co-developed by the company and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.

Moderna noted that the listing procedure assesses the safety, efficacy and quality of Covid-19 vaccines as well as novel health products during public health emergencies to make medicines, vaccines and/or diagnostics available.

The listing is a prerequisite to supply vaccines to the COVAX Facility, a global mechanism to procure and distribute Covid-19 vaccines in participating countries, including lower-income countries.

Moderna CEO Stéphane Bancel said: “We thank the WHO for their data review and for their issuance of an Emergency Use Listing for our Covid-19 vaccine. We are actively participating in discussions with multilateral organizations, such as COVAX, to help protect populations around the world.

“This EUL is an incredible step forward as we continue our quest to ensure that people on every continent have access to our mRNA vaccine so that we can defeat the devastating Covid-19 pandemic.”

The company noted that the WHO’s decision is based on the whole scientific evidence shared including the pivotal Phase III clinical study’s data analysis on 30 November last year.

Furthermore, Moderna’s Covid-19 vaccine has already been authorised in the US, Canada, Switzerland, Singapore, Qatar, Taiwan and in the UK.

Through the EUL, many countries across the globe will be able to expedite their own regulatory approval processes to import and administer a vaccine.