Strategic Collaborations in the Pharmaceutical Industry: to Advance Biotechnology, Oncology and Rare Diseases

In recent years, with the rapid development of biotechnology and oncology, collaborations between multinational pharmaceutical companies have become increasingly common. Several pharmaceutical companies have announced a number of strategic partnerships in areas such as non-viral gene therapy, gene therapy methods, antibody drugs and Alzheimer's disease.

Modena and Generation Bio collaborate on non-viral gene therapy drugs

Moderna announced on 23 March 2023 that it will partner with Generation Bio, a biotechnology company developing innovative gene therapies for rare and prevalent diseases. The collaboration will combine Moderna's biological and technological expertise with Generation Bio's core non-viral gene therapy technology platform. The goal of the collaboration is to expand the technical applications of both companies by developing novel nucleic acid therapies, including nucleic acid therapies that can reach immune cells, to accelerate their respective non-viral gene therapy pipelines. Moderna will fund all research and development activities in this collaboration.

Under the terms of the agreement, Generation Bio will receive $40 million in upfront research funding and a $36 million equity investment from Moderna, as well as potential additional upfront and milestone payments and royalties on sales. Moderna has also received a licence to use Generation Bio's cell-targeted lipid nanoparticle (ctLNP) and closed-end DNA (ceDNA) technologies for two immune cell projects and two liver projects, with an option for a third immune cell or liver programme.

Sartorius and Teknova collaborate on gene therapy process

Alpha Teknova, a major reagent manufacturer based in the United States, and Sartorius BIA Separations, a subsidiary of Sartorius, announced a collaboration to help gene therapy companies simplify downstream purification processes, particularly in the recovery of adeno-associated virus (AAV) capsids.

Under the agreement, Sartorius BIA Separations will combine its proprietary AAV platform with Teknova's customised high-quality buffer solutions. The AAV platform is designed to optimise the separation of virus particles, while Teknova's buffer solution is designed to maximise capsid enrichment. The two companies have conducted robust experimental designs and successfully developed a screening kit with an optimised buffer solution formulation. When used in conjunction with Sartorius BIA Separations' AAV platform (BIA CIMmultus QA monomer), the optimised buffer formulation can promote consistency and improve purity.

Through this collaboration, AAV-focused gene therapy companies will receive all necessary consumables and a protocol to simplify and accelerate downstream processing workflows. According to the press release, this advantage will enable these gene therapy companies to discover new breakthroughs more quickly. Teknova and Sartorius BIA Separations intend to continue to develop data to demonstrate the improvements in AAV purification brought about by their joint approach.

BioNTech and OncoC4 to co-develop mAb for solid tumour indications

On 20 March, BioNTech and US-based clinical-stage biopharmaceutical company OncoC4 announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialise ONC-392, OncoC4's next-generation monoclonal antibody (mAb) candidate targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), in multiple solid tumour cancers. The two companies aim to jointly develop ONC-392 as a monotherapy or combination therapy in a range of solid tumour indications, including non-small cell lung cancer (NSCLC).

Under the terms of the agreement, OncoC4 will receive an upfront payment of $200 million and is eligible to receive development, regulatory and commercial milestone payments, as well as tiered double-digit royalties. The two companies will jointly develop ONC-392 as a monotherapy and in combination with programmed cell death (PD)-(L)-1 antibodies. The collaboration will target a range of solid tumour indications, including NSCLC. The partnership will continue until the drug candidate is approved. The two companies will share research and development costs equally. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory approvals.

BioNTech will develop all combinations except for PD-1 inhibition indications, in particular all combinations with compounds in BioNTech's pipeline. BioNTech will have exclusive worldwide commercialisation rights to any products developed from these candidates, and OncoC4 will participate in certain markets to be negotiated in the future.

ONC-392 has already received Fast Track designation from the FDA as a monotherapy for the treatment of immune checkpoint inhibitor-resistant NSCLC. Another ongoing phase II trial is evaluating the combination with pembrolizumab in platinum-resistant ovarian cancer.

Roche Collaborates with Lilly to enhance early diagnosis of Alzheimer's disease

On 22 March Roche announced a collaboration with Lilly to support the development of Roche's Elecsys Amyloid Plasma Panel (EAPP), a blood test technology designed to facilitate early diagnosis of Alzheimer's disease.

The EAPP is currently undergoing additional studies to ensure clinical validation. The collaboration aims to help patients by improving the early and accurate diagnosis and treatment of Alzheimer's disease. If approved, the EAPP test will be an additional tool to identify a low likelihood of amyloid pathology in symptomatic patients and to guide further evaluation and testing to confirm the diagnosis.

According to Roche's press release, up to 75% of people with symptoms of Alzheimer's disease remain undiagnosed. The average time from symptom onset to diagnosis is 2.8 years. The EAPP will enable people to have timely access to appropriate new therapies.

Evotec and Bristol Myers Squibb's strategic collaboration makes progress

On 16 March 2023, Evotec announced that its strategic collaboration with Bristol Myers Squibb (BMS) has made progress in building a molecular glue-based pipeline. In total, Evotec will receive $75 million in revenue based on performance and project-related deliverables.

The two companies entered into a strategic protein degradation partnership in 2018, which was expanded in May 2022 with Evotec developing compounds from BMS' CereBLON E3 ligase modulator library. The partnership aims to develop a new pipeline of molecular glue degraders for high-value targets in areas such as oncology. According to the press release, molecular glue degraders are compounds that induce interaction between E3 ubiquitin ligases and molecular targets, leading to protein ubiquitination and subsequent degradation. In this process, the molecular glue itself is not degraded, meaning that it can trigger the degradation process multiple times, resulting in more sustained therapeutic effects.

Invitae and Deerfield Management collaborate to develop new treatments for rare diseases

On 22 March 2023, Invitae, a US medical genetics company, and Deerfield Management, a US healthcare investment company, announced a collaboration to advance the discovery and development of genetics-based drugs for rare diseases. Under the agreement, Invitae will leverage genetic and clinical data from millions of patients and apply this data to Deerfield's drug discovery and development expertise.

The two companies aim to address research gaps in the drug discovery process by gaining insights from Invitae's data platform, which includes a substantial rare disease patient cohort. Through the collaboration, the two companies will analyse data from over 3.6 million genetic tests linked to longitudinal clinical data provided by Invitae, which will strictly adhere to patient preferences for sharing their data. The companies believe that the combination of Invitae's data and Deerfield's analytical expertise will be highly relevant to the discovery and validation of new targets for rare diseases.

Genuv and Celltrion collaborate to develop novel therapeutic antibodies

On 15 March, Genuv, a clinical-stage biotechnology company based in South Korea, announced a collaboration with Celltrion, a biopharmaceutical company also based in South Korea, to jointly discover and develop novel therapeutic antibodies. Under the terms of the agreement, the two companies will use Genuv's patented SHINE MOUSE platform.

Under the terms of the agreement, Genuv will provide antibody discovery services using its mouse platform technology. Following drug discovery, a research collaboration will be established and Celltrion will have the option to join the co-development project. If exercised, this option will trigger agreed milestones, including up to $25 million in development milestones, followed by up to $680 million in total commercial milestones, depending on cumulative sales of each antibody candidate reaching $7.5 billion.

The advantage of the SHINE MOUSE platform is its ability to generate more diverse antibodies than traditional mice, leading to the discovery of the experimental and novel anti-programmed cell death protein 1 monoclonal antibody GNUV201. According to the press release, GNUV201 has unique properties, such as special interspecies cross-reactivity and binding affinity, which make preclinical studies in animal disease models more clinically relevant.

Genuv is also developing GNUV205, an improved interleukin-2-based immune cytokine anticancer drug that is tumor-specific by leveraging the characteristics of GNUV201.

Predictive Oncology and Cancer Research Horizons to collaborate on cancer drugs

On 17 March 2023, Cancer Research Horizons announced a collaboration with Predictive Oncology to advance cancer drug development. The collaboration will use Predictive Oncology's PEDAL artificial intelligence and machine learning platform technology to determine which cancer types and patient populations are most likely to respond to Cancer Research Horizons' preclinical glutaminase drug inhibitors. Predictive Oncology claims that addressing tumour heterogeneity at the preclinical stage increases the likelihood of clinical success.

The agreement brings together non-profit and industry sectors, providing Cancer Research Horizons with the possibility of incorporating PEDAL technology into future drug discovery processes.