AbbVie and Anima partner for mRNA biology modulators

11 January | R&D

AbbVie has collaborated with Anima Biotech for the discovery and development of mRNA biology modulators against three oncology and immunology targets. The collaboration will use the mRNA Lightning platform from Anima and AbbVie‘s oncology and immunology expertise to discover new mRNA biology modulators against the targets.

AbbVie will get exclusive rights to license and develop and market the programmes. Under the deal, Anima will receive $42m in upfront payment and be eligible for option fees and research and development milestones of up to $540m. The company will also receive further commercial milestones and tiered royalty payments on net sales of the products. It will also have the option to add three more targets under the same terms as the initial partnership, potentially increasing the overall collaboration value.

Anima’s mRNA Lightning platform uses automated high-scale phenotypic screening in live mRNA biology and MOAi technology to identify small molecule mRNA drugs and their mechanisms of action.

11 January  | REGULATORY

US FDA grants Fast Track status for UNION’s oral orismilast to treat HS

The US FDA has granted Fast Track designation for Union therapeutics’ oral orismilast to treat moderate-to-severe hidradenitis suppurativa (HS). Orismilast, a PDE4 inhibitor, targets the PDE4 subtypes which are connected to inflammation. With broad anti-inflammatory properties, the PDE4 inhibitor is also being developed to orally treat psoriasis and atopic dermatitis (AD). It has also received a Fast Track designation for the treatment of moderate to severe AD.

The company intends to discuss with the FDA the most suitable endpoints, and target disease severity, along with further steps in oral orismilast’s clinical development to treat HS.

11 January  | AI

BioNTech to buy UK-based AI company InstaDeep

BioNTech has signed an agreement to buy UK-based artificial intelligence (AI) and machine learning (ML)-based products developer InstaDeep in a deal valued at about $440m (£362m) in cash and shares. InstaDeep shareholders will also receive up to $243.1m (£200m) in additional performance-based future milestone payments.

The latest move follows an initial equity investment made by BioNTech as part of the Series B financing round of InstaDeep in January last year. Under the collaboration, the two companies established a joint AI Innovation Lab to apply for advances in AI and ML technology to develop new therapies for different cancers and infectious diseases.

10 January | DEALS

Asklepios partners with ReCode on gene-editing platform

Asklepios BioPharmaceutical has entered a research partnership and option agreement with Recode Therapeutics for exploring its single-vector gene-editing platform. The multi-year collaboration will focus on discovering precision genetic medicines by developing a new platform for complete gene insertion by delivering a single vector of gene editing and DNA cargo.

Under the partnership deal, ReCode’s selective organ targeting (SORT) lipid nanoparticle (LNP) technology will be combined with AskBio’s synthetic DNA and gene editing nucleases for developing an all-in-one solution. The new solution will enable complete gene insertion by delivering the gene-editing tool and DNA as mixed cargo to desired targets in one LNP.

5 January | DEALS

Belharra and Genentech partner for small molecule medicines development

Belharra Therapeutics and Roche Group member Genentech have announced a partnership for the discovery and development of new small molecule medicines across several therapeutic areas.

Under the multi-year partnership, Belharra and Genentech will employ the former’s platform for developing medicines in therapeutic areas including immuno-oncology, oncology, neurodegenerative and autoimmune diseases.

Genentech will handle late preclinical, clinical activities of such molecules along with their regulatory development and marketing. Belharra will receive $80m in upfront cash payment and is also eligible for development, commercial, and net sales milestone payments over the course of the partnership.

4 January | DEALS

Gilead partners with EVOQ for RA and lupus immunotherapies

Gilead Sciences has entered a collaboration and licensing agreement with EVOQ Therapeutics to advance the latter’s technology and develop immunotherapies to treat rheumatoid arthritis (RA) and lupus. Under the deal terms, the two companies will work together to advance the preclinical development of RA and lupus immunotherapies.

Gilead will be responsible for the clinical development and commercialisation and holds the rights to exclusively license the Nanodisc technology of EVOQ for the product candidates. EVOQ’s technology has been designed for lymph-targeted disease-specific antigen delivery. It uses a NanoDisc that is optimised to provide antigens for restoring immune tolerance.

3 January | M&A

Blacksmith Medicines to merge with Forge Therapeutics

Blacksmith Medicines has signed a definitive merger agreement with Forge Therapeutics to create a combined entity that will discover and develop medicines targeting a large class of proteins called metalloenzymes. The merged entity will focus on developing medicines with an initial focus on oncology and infection.

San Diego, California-based Forge Therapeutics develops novel antibiotics that target bacterial metalloenzymes. Blacksmith Medicines is involved in developing medicines that target metal-dependent enzymes. Currently, Blacksmith has received up to $25.3m in non-dilutive federal funding that will allow it to completely fund its programmes on infectious diseases through Phase I.

In Brief

US FDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV 

Being jointly developed and commercialised by Sanofi and AstraZeneca, nirsevimab is a single-dose, long-acting antibody designed to provide RSV protection for newborns and infants. The submission was made based on the data from the MELODY Phase III, MEDLEY Phase II/III, and Phase IIb trials.

Moderna and UK government sign deal to establish mRNA facility

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country.

Harrow to acquire US rights to Novartis’ ophthalmic products

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the FDA.

Merck and Kelun-Biotech enter ADC development deal

Merck (MSD outside North America) has signed an exclusive licence and partnership agreement with Kelun-Biotech for developing seven investigational preclinical antibody-drug conjugates (ADC) to treat cancer.

22 December | MANUFACTURING

Moderna and UK government sign deal to establish mRNA facility

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

The centre is anticipated to have to capacity to make up to 250 million doses of vaccines per year.

Under the collaboration, the company will also back the mRNA health and science ecosystem of the country. Planned to be operational by 2025, the construction of the facility is anticipated to begin early next year.

14 December | MANUFACTURING

Merck and Synplogen to develop viral vector gene therapies

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan.

Under the deal, Merck will license its VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform. This platform will aid Synplogen in boosting the speed of clinical manufacturing while lowering process development duration and expenses. The method will utilise the Millipore Contract Testing, Development and Manufacturing Organization (CTDMO) Services facility of Merck in Carlsbad, California, US.

In brief

US FDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV

Being jointly developed and commercialised by Sanofi and AstraZeneca, nirsevimab is a single-dose, long-acting antibody designed to provide RSV protection for newborns and infants. The submission was made based on the data from the MELODY Phase III, MEDLEY Phase II/III, and Phase IIb trials.

Moderna and UK government sign deal to establish mRNA facility

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country.

Harrow to acquire US rights to Novartis’ ophthalmic products

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the FDA.

Merck and Kelun-Biotech enter ADC development deal

Merck (MSD outside North America) has signed an exclusive licence and partnership agreement with Kelun-Biotech for developing seven investigational preclinical antibody-drug conjugates (ADC) to treat cancer.