US to buy additional Novavax Covid-19 vaccine doses

I14 February | COVID-19

The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373).

Under the modified deal, Novavax will deliver up to 1.5 million additional doses of its Covid-19 vaccine. The company stated that the deal would maintain the access of the US public to its vaccine.

It will also support smaller dose vials development, selection of strain according to the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market. The modified contract is backed by previously allocated federal funding from Biomedical Advanced Research and Development Authority, HHS, and the Administration for Strategic Preparedness and Response. The protein-based Covid-19 vaccine candidate is engineered from the genetic sequence of the SARS-CoV-2 strain and formulated with the company’s saponin-based Matrix-M adjuvant.

17 February | DEALS

Aqilion and Merck partner to develop TAK1 protein inhibitors

Aqilion and Merck have entered an exclusive licence and strategic research partnership for the discovery, development and commercialisation of the transforming growth factor-β-activated kinase 1 (TAK1) protein-small molecule inhibitors. 

Under the deal, Aqilion will receive $10.6m (€10m) in upfront cash payment from Merck and also eligible for up to $1,015m (€950m) in potential development and commercialisation milestone payments, along with tiered royalties on global net sales. 

The partnership combines the experience of Aqilion in the selective TAK1 inhibitors discovery with the drug discovery and development capabilities of Merck. It will aim to develop advanced TAK1 therapeutics for various inflammatory and autoimmune diseases, including neurological diseases.

15 February | BIOSIMILARS

Similis Bio plans to partner with Novel351k for biosimilars development

JSR Life Sciences’ business unit Similis Bio is planning to collaborate with Novel351k for the development of three biosimilar programmes targeting cancer and autoimmune diseases. Under the terms of the initial deal, Similis Bio will handle the development of cell lines, analytics, process development, and cGMP production. This will lead to pharmacokinetics/pharmacodynamic clinical trials. 

Using its regulatory and clinical strategies knowledge, Novel351k will accelerate the programmes development toward commercialisation. The companies expect the collaboration to help progress the programmes to late-stage development activities and commercial manufacturing. According to JSR Life Sciences, the therapies developed under the collaboration have more than $15bn current annual market value.

15 February | COVID-19

Clover introduces Covid-19 subunit vaccine in China

Clover Biopharmaceuticals has launched its recombinant SARS-CoV-2 subunit vaccine, a protein-based Covid-19 vaccine, in China. The first recombinant SARS-CoV-2 subunit vaccine doses have been delivered and given in Changxing, Zhejiang, as part of the country’s second booster dose (fourth vaccination dose) campaign targeting immuno-compromised people, older adults and those with comorbidities.

In December last year, Clover’s Covid-19 vaccine received emergency use authorisation in the country. Later, a national immunisation plan for a second booster dose campaign was formally announced by the China National Health Commission (NHC). 

The company stated that its vaccine achieved 100% efficacy against severe Covid-19 and hospitalisation caused by all SARS-CoV-2 strains in an international Phase II/III clinical trial.

6 February | R&D

Qurient partners with TB Alliance to develop telacebec

South Korean biotechnology company Qurient has entered a licence agreement with TB Alliance for the development and commercialisation of telacebec (Q203). Under the deal, TB Alliance will have the exclusive global license to develop and market telacebec except in Russia, South Korea, and the Commonwealth of Independent States (CIS) countries.

The first-in-class investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. It will be developed to treat tuberculosis (TB) and other non-tuberculosis mycobacteria (NTM) infections. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB. It was successfully evaluated in Phase IIa early bactericidal activity (EBA) study for the treatment of TB, and the findings were published in the New England Journal of Medicine.

13 February | DEALS

Scilex buys rights to acute migraine treatment Elyxyb in Canada and the US

Sorrento Therapeutics’ majority-owned subsidiary Scilex has acquired rights to Elyxyb (celecoxib) oral solution in Canada and the US. Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

Elyxyb is claimed to be the only FDA-approved first-line treatment, ready-to-use solution of celecoxib developed for the indication. The solution showed a quick onset of action in pivotal studies and also established the efficacy of celecoxib in migraine treatment with fewer adverse events.

In brief

Amylyx and Neopharm sign licence agreement for ALS therapy 


Amylyx Pharmaceuticals and Neopharm have signed a licence and distribution agreement to commercialise AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).

Orphagen’s ACC therapy receives FDA rare pediatric disease status 


Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US FDA to treat paediatric adrenocortical carcinoma (ACC). OR-449 is a first-in-class, selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1).

CARsgen and Huadong Medicine to commercialise CT053 in mainland China 


CARsgen Therapeutics has announced a collaboration with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. Huadong Medicine will hold the exclusive right to commercialise CARsgen’s CT053 in mainland China.

Cidara Therapeutics expands partnership with WuXi XDC 


Cidara Therapeutics has announced the expansion of its existing collaboration with WuXi XDC for advancing the CD73 oncology DFC programme.  WuXi XDC will provide IND-enabling CMC development services for Cidara’s CD73 oncology programme.

17 FEBRUARY | ARTIFICIAL INTELLIGENCE

M2GEN partners with Zephyr AI to identify treatments for cancer patients

Oncology-focused bioinformatics firm M2GEN has entered a multi-year strategic collaboration with Zephyr AI to identify treatments and cures for cancer patients. The collaboration will expedite the discovery of drugs and expand the use of investigations for cancer treatments. 

It will use the machine learning platform from Zephyr AI and a real-world data set (RWD) from M2GEN for creating an oncology discovery product. Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services.

8 FEBRUARY | MANUFACTURING

Genenta Science signs manufacturing service deal with AGC Biologics

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science. Genenta already had an existing MSA with Molecular Medicine’s facility in Milan, which was acquired in 2020 by AGC Biologics. 

Since 2016, the facility has been manufacturing lentiviral vectors (LVV) and drug product for the ongoing programmes of Genenta. Genenta stated that the services offered under the existing deal are in addition to those offered under the agreement signed with AGC Biologics.

In brief

Amylyx and Neopharm sign licence agreement for ALS therapy

Amylyx Pharmaceuticals and Neopharm have signed a licence and distribution agreement to commercialise AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).

Orphagen’s ACC therapy receives FDA rare pediatric disease status


Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US FDA to treat paediatric adrenocortical carcinoma (ACC). OR-449 is a first-in-class, selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1).

CARsgen and Huadong Medicine to commercialise CT053 in mainland China


CARsgen Therapeutics has announced a collaboration with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. Huadong Medicine will hold the exclusive right to commercialise CARsgen’s CT053 in mainland China.

Cidara Therapeutics expands partnership with WuXi XDC

Cidara Therapeutics has announced the expansion of its existing collaboration with WuXi XDC for advancing the CD73 oncology DFC programme. WuXi XDC will provide IND-enabling CMC development services for Cidara’s CD73 oncology programme.