GOODWIN BIOTECHNOLOGY: MASTERING NOVEL CONJUGATION APPROACHES … · 2020. 12. 21. · With two approved antibody-drug conjugates currently available and more than 50 in clinical

2/16/16, 10:05 PMGoodwin Biotechnology: Mastering Novel Conjugation Approaches – ADC Review ADC Review

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GOODWIN BIOTECHNOLOGY: MASTERING NOVELCONJUGATION APPROACHESPublished on 01st February

Often described as target-seeking molecular missiles with a lethal warhead, antibody-drugconjugates have, over the last 15 years, shown to have staying power. With two approved antibody-drug conjugates currently available and more than 50 in clinical trial programs, some expertsbelieve that a number of ADCs may hit blockbuster status in the next 5 – 10 years.

The regulatory approval of antibody-drug conjugates as well as successes in clinical dervelopmentof ADCs, have clearly confirmed that developing and manufacturing novel, targeted, therapeutics istechnically feasible and that regulatory approval is possible. However, while the idea behind ADCsseem relatively straightforward, developing and manufacturing these drugs requires understanding– and overcoming – technically challenging problems involving biology and chemistry.

In December 2015 we asked Ekaterina (Kate) Dadachova, PhD, Professor of Radiology,Microbiology and Immunology Sylvia and Robert S. Olnick Faculty Scholar in Cancer Research,Albert Einstein College of Medicine, Muctarr Sesay, PhD, Chief Scientific Officer and VicePresident of Bioconjugation at Goodwin Biotechnology, Inc. and Dave Cunningham, Director,Corporate Development at Goodwin Biotechnology, Inc., a number of questions about theirexpectations of the industry and the future of antibody-drug conjugates.

With more than a decade of experience and multiple patents pending in protein modificationsthrough chemical bioconjugation of novel cancer drugs, protein toxins, bifunctional ligands andmetal chelates (for radio-isotope labeling), antibodies and other biological molecules ontomonoclonal antibodies and recombinant proteins, the company has a unique and unrivaledexpertise in the research, development, validation and multi-gram manufacture of Antibody-drugConjugates, radioimmunoconjugates, and other protein bioconjugates.

Successful development of novel Antibody-drug Conjugates is not only exciting for scientists andresearchers in the field. It offers especially good news for patients and their physicians who aretrying to help find solutions for, so far, unmet medical needs.

Question: The ADC market is a growing market. What is your expectation for the ADC market in thenext 5-10 years? In particular, with 2 currently approved drugs, and more than 50 ADCs in clinicaltrials (a number that is growing every month), what do projections look like?

Answer: We’ve seen data from a couple of sources that suggest the current ADC market wasvalued to have been in excess of $500 million in 2014 and will grow to $10 to $12 billion by 2024. In2014, there were around 238 Phase I to Phase IV clinical trials underway involving 45 ADCs in thepipeline and the majority of these trials were Phase I and Phase II studies. The results of anindustry survey suggest that there will be 11+ ADCs on the market by 2024.

Many of these projections are based on a strict definition of antibody: drug conjugates, which tendto focus on antibodies linked to cytotoxic drugs. When adding other types of conjugations such as

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Photo 1.0: Ekaterina (Kate) Dadachova, PhD,Professor of Radiology, Microbiology andImmunology Sylvia and Robert S. Olnick FacultyScholar in Cancer Research, Albert EinsteinCollege of Medicine.

linking radioisotopes, nanoparticles or photo-sensitive dyes to antibodies, the marketprojections could increase significantly.

These projections and data support ourcontention that bioconjugation is still in itsinfancy with tremendous upside potential,and Goodwin Biotechnology is uniquelyqualified and well suited to partner withclients to help them capitalize on theopportunities with their product candidates.

Question: How is the development of ADCs,and other targeted therapies, such as CAR-T,PD-L1s andnanodrugs, changing medicine?What does this means for the industry? Howdoes this impact the need for specializedcompanies like Goodwin?

Answer: Monoclonal antibodies (mAbs)conjugated with a payload have shown somepromise based on the antibody’s ability totarget diseased cells. However, one

significant finding is impacting the growth of the ADC market. Some researchers have reported thatupwards of 95% of ADCs don’t affect the target cell. These researchers explain that this problem isbased on the complexity of the antibody:linker:payload conjugate, premature cleavage of thepayload from the conjugate, binding to non‐target sites, and/or getting eliminated from the bodyprematurely.

Further, internalization adds another level of complexity to the biology of ADCs with someresearchers suggesting that greater than 95% of the administered dose never reaches theintracellular target. This is primarily because the majority of antibodies selected are based on theirability to target receptors on the cell surface. Therefore, all too often neither the conjugate norpayload are internalized into the cell where they can do their work.

Therefore, in an attempt to counter these challenges, many are looking at other means to makeADCs more effective. For example, payloads with greater cytotoxicity are being studied. However,this strategy requires higher drug doses, which increase the cost of therapy and the potentialadverse effect profile of the treatment.

Goodwin Biotechnology has conducted development and manufacturing of novel therapeutictargeting technologies. For example, we have had a significant amount of success conjugatingradioisotopes and photosensitive dyes to antibodies for different modes of action. We have alsoreceived interest in miniaturized biologic drug conjugates (mBDCs) comprised of nanoparticles andsmall molecule drug conjugates (SMDCs). Both are designed to enable the penetration of theconjugates deep into the tumor tissue where they selectively bind to tumor cells, becomeinternalized, and release their potent cell killing payload.

It is also important to note that we are exploring a novel approach and the preliminary findings areencouraging. Goodwin Biotechnology and Transporin, a Silicon Valley R&D company with a broadarray of life science proprietary technologies, are collaborating on exploring and functionalizingTransporin’s proprietary metal-binding domain transporter technology in the development ofantibody and peptide-based biopharmaceutical drugs.

Goodwin Biotechnology will utilize the proprietary metal-binding domain of human insulin‐likegrowth factor binding protein‐3 conjugated to monoclonal antibodies or antibody fusion proteins,and perform process development and manufacturing services using such conjugates for research,evaluation, and clinical trial purposes.

We are currently investigating the metal-binding domain or MBD-peptide sequence when covalentlyor genetically linked to the antibody can enhance the ability of the antibody to target diseased cellsand improve targeting specificity an estimated 3x to 10x fold by binding to the cell surfacetransferrin receptor and integrin beta‐3. Hence, it can help reduce the off-target effects of theconjugate and increase the speed of the agent to the target.

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Photo 2.0: Muctarr Sesay, PhD, Chief ScientificOfficer and Vice President of Bioconjugation atGoodwin Biotechnology, Inc.

What’s more important is that the MBDpeptide carrier may also provide activetransport into the target cell to help ensurethat the payload does its job. MBD uptakecorrelates with the expression of genesassociated with cellular stress‐copingmechanisms commonly up‐regulated incancer (nuclear factor‐kappaB and HSP‐70B), for example. Once inside the cell, thepayload can then modify the diseaseprocess.

As a contract manufacturer, we welcome theopportunity to partner with our clients onthese and other methodologies designed toenhance the ability of conjugates toeffectively target and deliver payloads directlyto tumor cells.

Question: Based on the previous question. Intherapeutic areas like oncology andhematology, there is a drive towardspersonalization/individualization of therapies.How does this change medicine? What role,if any, does Goodwin play – and, how may

this change the role of CDMOs in general. What can Goodwin offer to help their (pharmaceutical)clients to be successful in this unique market?

Much optimism and promise supports the focus on precision medicine as an approach forunderstanding diseases and developing targeted therapies. Advances in genomic sequences andthe development of tools to analyze genetic variations to model disease physiology and the efficacyof treatments are moving the world of precision and personalized medicine forward at a rapid pace.The possibility of improving the selectivity of therapy for a number of diseases may be enhanced bythe use of targeting strategies. Some are exploring CAR-T, PD-L1s, nanodrugs, prodrugs,nanoparticle delivery, etc.

The trend towards personalized and individualized medicine focuses on segmenting the patientpopulation for a certain disease to better customize a specific treatment for a subset of patients withthat ailment, and has had and will continue to have a significant impact on the therapeutic approachto certain diseases. As a result, the large blockbuster drugs developed to treat the full universe ofpatients with a specific disease are becoming a thing of the past.

Goodwin Biotechnology, has been one of the pioneers in bioconjugation and has nearly 15 years ofexperience in this field. Over that time, we have developed the “know how” that help us design andsuccessful produce robust conjugates for our clients.

This has helped us partner with our clients to fulfill the promise of bioconjugation in advancing anumber of bioconjugation strategies, including antibody:drug, antibody:dye, antibody:peptide, andantibody:radioisotope conjugates for diagnostic, therapeutic, and theranostic (treatment andmonitoring) applications.

As the cost of ADCs is much higher than that of the small molecule drugs, it seems very importantto be able to image the binding of the ADC to its respective target by attaching a PET or SPECTradioisotope to the ADC before making individualized treatment decisions.

Towards that end and as noted previously, we can also offer our clients the value associated withMBD:Peptide technologies, as well as miniaturized biologic drug conjugates (mBDCs) and smallmolecule drug conjugates (SMDCs) that are designed to enhance the ability of ADCs to target anddeliver payloads into diseased cells!

Question: Ongoing research points to new developments in ADCs (different linkers, payloads andmonoclonal antibodies– a good example is the work of Aspyrian). How does Goodwin expect this toimpact the market? And, how does Goodwin’s experience benefit industry How is this differentfrom other industry players?

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Answer: Over the last 15 years, we have adopted a solutions-oriented approach to help our clientsovercome significant challenges, including aggregation, especially that associated with IgMantibodies and conjugates, multiparameter optimization, optimizing drug-to-antibody ratios (DAR),working with antibody fragments, purification challenges, etc. We have developed proprietaryprocesses to help address many of those challenges. We have also overcome the challengesassociated with random conjugations with site-directed conjugation of radionuclide chelators andother payloads to antibodies which results in narrower DAR (drug-to-antibody mole ratios) andimproved conjugate binding and, hopefully, an enhanced therapeutic index. For example, we areworking on developing linkers that will have higher solubilizing properties for the cytotoxic drugsmost of which are highly insoluble in an aqueous environment, thereby, minimizing the use of highquantities of organic solvents as well as minimizing the potential for aggregation and otherdeleterious effects on the antibody.

In addition to our bioconjugation experience, Goodwin Biotechnology has over 23 years ofexperience in manufacturing mAbs through mammalian cell culture expression systems. So, notonly can Goodwin do the bioconjugation work, we can also manufacture the “naked” antibodies ourclients need.

As a testament to our commitment and dedication, Goodwin Biotechnology recently receive Frost &Sullivan’s 2014 Global Customer Value Leadership Award for demonstrating Best Practices inBiologics Contract Manufacturing. In addition, we were recently notified that GoodwinBiotechnology has received the 2015 Best in Sector: Biopharmaceutical Contract Development &Manufacturing award from Acquisition International.

Question: How does Goodwin see the future or these novel drugs and what is the role doesGoodwin plays in shaping the future of ADC and other targeted therapies?

Answer: We feel that the future of the ADC market will be focused on finding the best combinationof antibody, linker, and payload to effectively treat a specific disease and minimize the off-targeteffects of the conjugate.

Goodwin Biotechnology is uniquely qualified to develop the next generation of ADCs andantibody:cytotoxic drug conjugates, as well as antibody:dye, antibody:peptide, andantibody:radioisotope conjugates, as well as miniaturized biologic drug conjugates (mBDCs) andsmall molecule drug conjugates (SMDCs).

In short, we offer a Single Source Solution™ to take a client’s product candidate from cell linedevelopment and/or proof-of-concept process development and optimization through to the deliveryof early- and late-stage clinical trial material of not only the “naked” antibody but also thebioconjugated ADC.

We’re a relatively small CDMO and we pride ourselves in being flexible and agile. What’s more, wefocus on a solutions-oriented approach to every project. Over the last 23 years, we have worked onnearly 400 projects for over 100 clients, and that experience has enabled us to be able to identifyand overcome many challenges in developing and manufacturing biologics, in general, and,specifically, ADCs

Question: How do those changes impact health policy in the US and abroad? How does thisimpact treatment and treatment “value” and, finally, how does this impact medical technology?

Ekaterina (Kate) Dadachova, PhD, Professor of Radiology, Microbiology and Immunology Sylviaand Robert S. Olnick Faculty Scholar in Cancer Research, Albert Einstein College of MedicineMuctarr Sesay, PhD, Chief Scientific Officer and Vice President of Bioconjugation at GoodwinBiotechnology, Inc.Dave Cunningham, Director, Corporate Development at Goodwin Biotechnology, Inc.

Answer: Enhancing target cell specificity and enabling the payload to affect the target cell willimprove therapy, minimize side effects, and lower the cost of therapy. Further, many of theapplications associated with bioconjugation can help in the diagnosis and monitoring of diseases inorder to improve treatment plans.

All aspects of bioconjugation promise to have a positive impact on patient care as well as healthcare systems in general. Converting the promise into reality has been the challenge. That’s wherethe experience and expertise of a company like Goodwin Biotechnology can make the differencebetween success and failure.



Photo 3.0: Dave Cunningham, Director, CorporateDevelopment at Goodwin Biotechnology, Inc.

Question: There are only a fewfacilities/companies around the world capableof offering a“one-stop shop” for thedevelopment of ADCs (from monoclonalantibody development/production to linkertechnology, cytotoxins, fill/finish,regulatory services, etc.). How does Goodwinsupport their clients in this importanttherapeutic area and how does the companyhelp customers seamlessly scale ADCproduction from preclinical to commercialphases?

Answer: It’s important to note that wemanage all aspects of biopharmaceuticalmanufacturing whether it’s developing theprotein from the DNA sequence and/or fullyoptimizing a bioconjugation project. While allaspects of a project may not be done underone roof at Goodwin Biotechnology, we offerone point of contact throughout the length ofthe project in that we have collaborations inplace to perform the requisite activities todeliver the highest quality product candidates

rapidly and cost effectively

What’s more, we have a strong Quality Assurance program in place that not only assurescompliance to the most rigorous regulatory standards, but our staff has the regulatory experiencethat has helped many of our clients successfully submit INDs.

Question: Given the announcements and media attention SAFC (a business unit of Sigma Aldrich)received last year when it announced the expansion of their production facility, offering a fullycommercial development and commercial production in the US, how important is geography? Howis a US based competitor facility expected to impact Goodwin? What is Goodwin doing tocounter/address this?

Answer: Over the last 23 plus years as an independent CDMO, we’ve had clients from Eastern andWestern Europe, Asia, as well as North America, so geography is not of critical importance. Whatremains important is the quality of work and the level of service our clients receive. Our clientscome to us based on our unique level of experience and expertise as a biopharmaceutical CDMOand in bioconjugation, and they stay with us because we partner with them by nurturing anenvironment of total transparency that our clients find refreshing.

For every project, Goodwin Biotechnology assembles a Project Team with a single Project Manager(PM) as the point-of-contact. The PMs are experienced veterans in biological manufacturing andare the advocates for our clients within Goodwin Biotechnology. They will ensure that projecttimelines are met and that information is communicated in a timely manner. Beginning with the TechTransfer meetings, we listen to our clients to understand the challenges they face and theirobjectives, then we develop solutions jointly to meet their technical as well as budgetary goals.Throughout all phases of the project, the PM coordinates weekly or biweekly meetings with theclients and the Goodwin Biotechnology Project Team as appropriate in order to communicate theprogress of the project and discuss the path forward. To ensure adherence to set schedules andtimelines (e.g., Gantt charts) for completion of the project, the PM uses systems for internal projectmonitoring such as project status meetings and project checklist, among other tools.

Question: Can you describe some of the developments and additional services/updates created byGoodwin, and how does this set the companyapart? What is new, unique? What has worked andwhat did not?

First of all, Goodwin Biotechnology has 23 years of experience and expertise in the contractbioprocess development and cGMP manufacturing of cell culture-derived Monoclonal Antibodies,Recombinant Proteins, and Vaccines. Therefore, we can develop the “naked” antibody andoptimize it through our Process Development department for efficient scale up and cGMPmanufacturing. Our solutions-oriented approach to all projects has paid handsome dividends, even

http://adcreview.com/wp-content/uploads/2016/02/Goodwin_cunningham.jpg



with the most challenging projects.

Goodwin Biotechnology is one of the pioneers in providing development and GMP manufacturing ofADCs, Radioimmunoconjugates, Peptide:Immunoconjugates, and other Bioconjugates for over 15years.

Our Bioconjugation services include:

Exploratory Proof-of-Concept Studies

Process Development and Scale Up of Bioconjugation Processes

Scale Up Manufacturing Process and Production of Tox Material

cGMP Manufacturing of Clinical Trial Supplies

GMP Aseptic Fill & Finish of Bioconjugates and cytotoxic drugs

Method Development and Qualification / Validation

QC Release and Stability Testing

QA and CMC Support

Our Bioconjugation technologies include:

SteadFastTM Non-Cleavable Linker (Thioether based)

Site-directed conjugation of radionuclide chelators to antibodies to improve conjugate binding

In development:

Metal Binding Domain-peptide technology to enhance the ability of ADCs to target anddeliver payloads into diseased cells.

FlexReleaseTM Cleavable Linker (Disulfide based)

In summary, we are a fully-integrated, customer-focused, and highly-flexible contract developmentand manufacturing organization that delivers high-quality, timely, and cost-effective services to ourclients. In recognition of this, we recently received Frost & Sullivan’s 2014 Global Customer ValueLeadership Award for demonstrating Best Practices in Biologics Contract Manufacturing. Also asnoted, Goodwin Biotechnology has received the 2015 Best in Sector: Biopharmaceutical ContractDevelopment & Manufacturing award from Acquisition International.

Question: In a conversation late last year with representatives from Merck KgaA, it was made clearthat Merck is expanding its offerings in targeted therapies. In 2014 Merck took over Sigma Aldrich(now Millipore Sigma). How important is this development? How does Goodwin view this? Isthere a benefit to be part of large pharmaceutical company (such as in the case of Merck or Pfizer)or are there more benefits to operate independently (like Goodwin is doing today)? How doesGoodwin feel, will this ‘merger’ change the (CDMO) industry?

Answer: There are benefits and drawbacks when dealing with a contract manufacturer who is partof a large pharmaceutical firm. Certainly, the deep pockets of a large, multinational pharmaceuticalfirm help enhance the investment in the facility and retain skilled personnel even during the downtimes.

However, a significant drawback to those seeking a contract development and manufacturingorganization (CDMO) is that large pharmas tend to be less flexible and responsive. They prioritizetheir facility’s production capacity for their own products leaving excess capacity, if any, to thedecision making is slow due to the many layers of bureaucracy.

As an independent CDMO, our clients don’t have those problems. Our clients know well in advance when they are scheduled for bioreactor production, for example, and we don’t deviate from that schedule.

There’s no question that mergers are affecting the CDMO industry. There are fewer and fewer independent biological CDMOs every day, but it’s important to recognize that mergers can change the culture of an organization. Management changes, deletion of redundancies, shifting and / or evolving focus, etc. can cause a lot of distractions and have a negative impact on the quality of work that they can provide.

Goodwin Biotechnology has been a relatively small, independent CDMO for 23 years. Throughout

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this period of time, we have been consistent with a laser focus on our clients and their products.

Question: What are some other changes (industry and market developments) that will impact theindustry and market in the (near) future – 2015– 2020 – 2025?

Answer: We anticipate that there will be increased competition from developing countries likeChina, India, South Korea, and other Asian countries, but a number of questions remain. They mayhave impressive facilities, but there are distance and language barriers for effective communicationand timely decision making, and it can be a challenge for them to recruit the highly skilled technicalexpertise required to successfully perform complex biological processes. Further, many clientsprefer the quality that is required for contract manufacturers who operate under strict FDAcompliance guidelines.

Another trend, as we have discussed, is overcoming the challenges noted earlier to improve celltargeting and killing strategies, as well as reducing off-target effects of ADCs. This includes:

Optimizing each part of the ADC to specifically target and impact the diseased cell

Finding and validating new targets

Overcoming drug/mAb resistance

Controlling development costs by overcoming the lack of preclinical predictability based onmultivariable aspects of the target cell and heterogeneity of the tumor, aspects of the tumormicroenvironment, etc., especially in rodent models

Exploring alternative delivery routes as well as multiple or different payloads

Addressing unwanted toxicity which is linked to the antibody half-life and renal toxicity of smallconjugates

Developing ADCs with cytotoxic, diagnostic, and theranostic (treatment and diseasemonitoring) capabilities

Adding imaging capabilities to ADCs

We’ve also seen concerns about which medical discipline will drive the usage of conjugates withradioisotopes. The challenge for each institution is to determine if the treatment is under theauspices of medical oncology or does it fall under the radiology department. As the value ofradioisotope conjugates is demonstrated, cooperation between these two groups will be enhancedand the treatment pathways will be more clearly defined.

In short, changes in the ADC industry have been constant, and the challenges create manyopportunities for innovation and product differentiation. Given the growth potential, the winners inthe CDMO business will be companies like Goodwin Biotechnology who can remain flexible andleverage their experience and technical expertise to capitalize on opportunities. These types ofcompanies will be on the forefront of new developments in the bioconjugation business.

This article is based on interviews with:

Ekaterina (Kate) Dadachova, PhD, Professor of Radiology, Microbiology and ImmunologySylvia and Robert S. Olnick Faculty Scholar in Cancer Research, Albert Einstein College ofMedicine (Photo 1)

Muctarr Sesay, PhD, Chief Scientific Officer and Vice President of Bioconjugation at GoodwinBiotechnology, Inc. (Photo 2)

Dave Cunningham, Director, Corporate Development at Goodwin Biotechnology, Inc. (Photo3)

Featured image: Bone scintigram of the body showing vertebral bone cancer metastases fromprostate cancer, labelled with technetium 99m (Tc 99m), frontal (left) and rear (right) views. Scansare scintigrams showing bone metastases from primary tumors. Photo and Featured ImageCourtesy: © Goodwin Biotechnology. Used with permission.

Last Editorial Review: January 29, 2015

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GOODWIN BIOTECHNOLOGY: MASTERING NOVEL CONJUGATION APPROACHES … · 2020. 12. 21. · With two approved antibody-drug conjugates currently available and more than 50 in clinical