Under the terms of the deal, Lonza will help ALSA’s portfolio of pre-clinical and early clinical biotechs develop and manufacture biologics and small molecule drug candidates.
Lonza is focused on early de-risking, development and manufacturing, and optimization services for large molecule biologics, bioconjugates and complex proteins, as well as small molecules.
The CDMO said the biopharmaceutical industry is experiencing a global shift towards new molecular formats and more complex molecules, including bi- and multispecific antibodies, fusion proteins, and various types of bioconjugates. In addition, small molecules continue to play a vital role in innovative treatments.
As these therapies gain complexity in their applications and properties, unique challenges related to their bioavailability and handling arise, said Lonza.
Developing and manufacturing such increasingly complex modalities requires sophisticated facility design and expertise, which is often challenging to establish in-house, it added.
This is where Lonza steps in. We ran a Q&A with Pnina Weitz, VP, global head of venture capital business development and relationship management at the Swiss company, to dig a little deeper on the deal.
BioPharma-Reporter: Can you outline how Lonza will go about supporting ALSA Ventures’ portfolio companies? Will they get accelerated access to Lonza’s services?
Pnina Weitz: There are always high risks and attrition rates related to a candidate molecule. Even if a molecule gets marketing authorization, it does not guarantee commercial success. Lonza will help the portfolio companies to identify potential risks as early as possible and seek to address them. This can be done by leveraging Lonza’s extensive experience and know-how in candidate selection, optimization and development of a robust manufacturing process.
BPR: How can Lonza support early de-risking for emerging biotechs in their development of next-generation modalities?
PW: For many small biotech companies, it is essential to add value to a product with each stage of development. This is particularly important for companies that own only one asset in late discovery or early development and are seeking to attract funding from investors needed to advance to trials. We at Lonza work with biotech partners from the earliest stages to help de-risk products and add value ahead of trials and through to commercialization.
At Lonza, we have the capabilities to de-risk clients’ lead candidates by assessing and improving both safety and manufacturability. Immunogenicity testing can be done with as little as an amino acid sequence. From these tests, we can begin to determine whether a customer’s candidate vaccine, biologic or gene therapy, will be viable for human tests. This helps to reduce the chances of adverse effects for patients in trials. By assessing developability in-silico and in-vitro, Lonza can also determine risks when entering CMC development.
For biotech firms, especially those operating on accelerated timelines, quickly advancing to development is essential. For discovery and early development customers, our Ibex Design offering for monoclonal antibodies is one of the fastest DNA-to-IND services on the market. Subject to the terms of the agreement, we offer GMP drug product for clinical phase 1 trials within 11 months from DNA transfection.
BPR: Why has the biologics pipeline been evolving towards more complex protein formats for the past few years?
PW: Monoclonal antibodies have historically been a popular therapeutic choice across many disease areas. However, the entry of multichain molecules – a diverse group of proteins including bi- and multispecific non-standard antibodies – is slowly changing that.
Due to their complex structures, multichain molecules – bi- or multispecific antibodies – have multiple sites with which to interact and bind with targets, achieving more precise binding with higher efficacy and potency than conventional antibodies.
This increase in specificity and efficacy is especially useful in progressive cancers with high mortality rates, where multispecific molecules have enabled access to new, previously inaccessible targets.
As a result, significant interest has been generated in these molecules, which are being referred to as the next generation of protein therapeutics. This is reflected in the 32% growth rate seen in bi-specific molecules that entered clinics from 2015 to 2020, with 161 new bi-specific clinical trials initiated in 2020 alone [as per Beacon Bispecific Database April 2021 & Bispecifics Landscape Review Jan 2021].
For bispecific antibodies on accelerated timelines, we offer a DNA-to-IND service in only 13 months and 7 months to tox drug substance so that toxicological studies can be performed before entering GMP manufacturing. Currently, Lonza is collaborating with several companies to develop and manufacture complex bsAbs and multispecific biotherapeutics that can also target indications such as neurological disorders, targeted drug delivery or infectious diseases.