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Top 5 Trends in Immuno-oncology (I-O)

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Postdoctoral Scientist, KU Leuven Abhishek D. Garg Top 5 Trends in Immuno-Oncology (I-O) Immuno-oncology is still in an early stage of development. Research needs to be conducted in determining mechanisms of disease, optimal preclinical models, and targets for therapeutic development. Academia, industry, providers, and patients must work together, educate one another, and find ways to collaborate in ways they have not done in the past. In addition, the concepts of decentralized manufacturing, rational design, and more targeted delivery need to become routine practices. The potential promise of these therapies is great, but the challenge of making them affordable and accessible for both urban and rural patients in developed and emerging markets is crucial. The practice of healthcare and the tools used to administer and monitor these therapies (such as IoMT or the Internet of Medical Things), along with better diagnostic tools and techniques and strategies for handling new adverse reactions, will expand organizational roles and usher in a new era of treatment that will be based on both “universal” and personalized treatment strategies. 10 experts in the field of immuno-oncology came together to delve into the trends that are defining this space. Connect directly to your market. Convetit is the network where teams and experts connect, providing custom research and actionable insights in days instead of months. Learn more at The development of I-O therapies requires "...a more critical examination of rationales and results" (Karel Petrak). The importance of a rational and well-thought-out approach is extremely important at this early stage, since "we need to keep in mind that 70% of patients did not respond to immunotherapy” (Udara Dharmasiri). The ultimate goal is, as Abhishek D. Garg pointed out, that immuno-oncology therapies can only be advanced when preclinical studies and ultimately clinical trials produce long-term survivors. If problematic data is not critically questioned at all developmental stages, then the field of immunotherapy will come to a crashing halt and the potential of these therapies will not be realized. The panel agreed upon and prioritized the Top 5 most-promising therapies as follows: A. B. C. D. E. MAB combos with traditional chemo agents Immune-checkpoint therapies CAR-T cells Dendritic cell vaccines Immunogenic cell-death (ICD) inducers Irrational Exuberance: Therapeutic Development Priorities "I think that antibody/small-molecule agents will probably be developed first, due to the higher complexity of cell engineered methods." FACILITATOR Chief Clinical Officer Darryl Glover Participants: Research Fellow, Harvard Medical School Zoreh Amoozgar R&D Lead & Project Manager, Pall Life Sciences Udara Dharmasiri Consultant, Phila & WW Meg Baker Director Process Development, Promega Denis Boyle, Ph.D. Drug Development Consultant, Galenometrics AB Mattias Andersson Drug Development Consultant, Galenometrics AB Mattias Andersson convetit.com 1 The preclinical testing of current cancer immunotherapies relies heavily on a few mouse models. For instance, most immunotherapies are currently tested in one species (i.e., mouse) and largely in one strain/genetic background (i.e., C57BL/6). This creates considerable bias in preclinical data, in addition to the fact that almost all mouse models suffer from numerous drawbacks. This preclinical reality needs to be confronted, and a higher diversification of preclinical testing is required to ensure that adequate information is gathered before entering human trials. Preclinical Models: Diversity of Approach "The preclinical assessments are essential to match the degree of immune compromise and individual genotype for treatment success.” 3 As personalized medicine takes center stage, one of the major challenges will be moving toward a balance between centralized and decentralized manufacturing. The degree of coordination and number of supporting disciplines will grow exponentially, since regulatory agencies may need to license healthcare organizations as manufacturing sites and QA labs. It will take a private-public partnership to ensure the widespread utilization of the next generation of I-O therapies. Despite these complexities, the panel overwhelmingly believes that the benefits of decentralization far outweigh the cost and implementation challenges. Decentralized Manufacturing: From Bench to Bedside "To deliver affordable treatment, we need to think about the overall cost structure, not only drug prices." Senior Manager Technical Services, Shire Guangquan Wang 2 "These centers of expertise (clinics, training resources, and flexible/diverse manufacturing capabilities) will have to be duplicated at different scales and in many areas. A separate effort to build (and fund) this for larger roll outs will need to be considered." Director Process Development, Promega Denis Boyle, Ph.D. CONVETIT FORESIGHTS TM Allied Medical Staff, Hinsdale Hospital, LaGrange Hospital Kathy Sexton-Radek Business Operations Professional, The Janssen Pharmaceutical Companies of Johnson & Johnson Polina Pomerants Chief Scientific Officer, NangioTx Karel Petrak Senior Manager Technical Services, Shire Guangquan "Guang" Wang Here are 5 trends that our experts have identified as driving I-O development: Allied Medical Staff, Hinsdale Hospital, LaGrange Hospital Kathy Sexton-Radek The costs of I-O therapy and the determination of when it is warranted were a major focus of the experts. These factors become more relevant as we begin looking at personalized medicine, decentralized manufacture, and how these treatments can be brought to rural and remote areas. It may be, as Denis Boyle noted, that first-line treatments will be “universal” and centrally manufactured and that second-line treatments will be personalized and decentralized. This approach would provide a more clear-cut standard of practice to follow until the other trends the experts have noted are realized. Making I-O Affordable for All “Current immunotherapeutics (e.g., cell-based and antibody-based) are all extremely costly. At the moment, these treatment are limited to developed parts of the globe. Efforts need to be put in place to harmonize such therapies for the developing world.” Research Fellow, Harvard Medical School Zohreh Amoozgar 4 Industry, providers, patients, academia, insurers, and regulators must work in concert to ensure that the right treatment is given to the right patient at the right time. This is a paradigm shift from the siloed approach that currently predominates in healthcare. It will require an extension of the traditional patient care team and improved communication among groups that currently have no direct lines of communication. New Communication Channels “Future trends will impact the way clinicians handle patients.” Postdoctoral Scientist, KU Leuven Abhishek D. Garg 5 “It is important to separate the promise of I-O from the reality.” - Meg Baker -
Transcript
Page 1: Top 5 Trends in Immuno-oncology (I-O)

Postdoctoral Scientist, KU LeuvenAbhishek D. Garg

Top 5 Trendsin Immuno-Oncology (I-O)

Immuno-oncology is still in an early stage of development. Research needs to be conducted in determining mechanisms of disease, optimal preclinical models, and targets for therapeutic development. Academia, industry, providers, and patients must work together, educate one another, and find ways to collaborate in ways they have not done in the past. In addition, the concepts of decentralized manufacturing, rational design, and more targeted delivery need to become routine practices. The potential promise of these therapies is great, but the challenge of making them affordable and accessible for both urban and rural patients in developed and emerging markets is crucial. The practice of healthcare and the tools used to administer and monitor these therapies (such as IoMT or the Internet of Medical Things), along with better diagnostic tools and techniques and strategies for handling new adverse reactions, will expand organizational roles and usher in a new era of treatment that will be based on both “universal” and personalized treatment strategies. 10 experts in the field of immuno-oncology came together to delve into the trends that are defining this space.

Connect directly to your market.Convetit is the network where

teams and experts connect, providing custom research and actionable insights

in days instead of months.

Learn more at

The development of I-O therapies requires "...a more critical examination of rationales and results" (Karel Petrak). The importance of a rational and well-thought-out approach is extremely important at this early stage, since "we need to keep in mind that 70% of patients did not respond to immunotherapy” (Udara Dharmasiri). The ultimate goal is, as Abhishek D. Garg pointed out, that immuno-oncology therapies can only be advanced when preclinical studies and ultimately clinical trials produce long-term survivors. If problematic data is not critically questioned at all developmental stages, then the field of immunotherapy will come to a crashing halt and the potential of these therapies will not be realized.

The panel agreed upon and prioritized the Top 5 most-promising therapies as follows:

A.

B.

C.

D.

E.

MAB combos with traditional chemo agents

Immune-checkpoint therapies

CAR-T cells

Dendritic cell vaccines

Immunogenic cell-death (ICD) inducers

Irrational Exuberance: Therapeutic Development Priorities

"I think that antibody/small-molecule agents will probably be developed first, due to the higher complexity of cell engineered methods."

FACILITATORChief Clinical Officer

Darryl Glover

Participants:

Research Fellow, Harvard Medical School

Zoreh Amoozgar

R&D Lead & Project Manager, Pall Life Sciences

Udara Dharmasiri

Consultant, Phila & WWMeg Baker

Director Process Development, Promega

Denis Boyle, Ph.D.Drug Development Consultant,

Galenometrics AB

Mattias Andersson

Drug Development Consultant, Galenometrics AB

Mattias Andersson

convetit.com

1

The preclinical testing of current cancer immunotherapies relies heavily on a few mouse models. For instance, most immunotherapies are currently tested in one species (i.e., mouse) and largely in one strain/genetic background (i.e., C57BL/6). This creates considerable bias in preclinical data, in addition to the fact that almost all mouse models suffer from numerous drawbacks. This preclinical reality needs to be confronted, and a higher diversification of preclinical testing is required to ensure that adequate information is gathered before entering human trials.

Preclinical Models:Diversity of Approach

"The preclinical assessments are essential to match the degree of immune compromise and individual genotype for treatment success.”

3

As personalized medicine takes center stage, one of the major challenges will be moving toward a balance between centralized and decentralized manufacturing. The degree of coordination and number of supporting disciplines will grow exponentially, since regulatory agencies may need to license healthcare organizations as manufacturing sites and QA labs. It will take a private-public partnership to ensure the widespread utilization of the next generation of I-O therapies. Despite these complexities, the panel overwhelmingly believes that the benefits of decentralization far outweigh the cost and implementation challenges.

Decentralized Manufacturing:From Bench to Bedside

"To deliver affordable treatment, we need to think about the overall cost structure, not only drug prices."

“Senior Manager Technical Services, Shire

Guangquan Wang

2

"These centers of expertise (clinics, training resources, and flexible/diverse manufacturing capabilities) will have to be duplicated at different scales and in many areas. A separate effort to build (and fund) this for larger roll outs will need to be considered."

Director Process Development, Promega

Denis Boyle, Ph.D.

C O N V E T I T F O R E S I G H T S T M

Allied Medical Staff, Hinsdale Hospital, LaGrange Hospital

Kathy Sexton-RadekBusiness Operations Professional,

The Janssen Pharmaceutical Companies of Johnson & Johnson

Polina PomerantsChief Scientific Officer,

NangioTx

Karel Petrak

Senior Manager Technical Services, Shire

Guangquan "Guang" Wang

Here are 5 trends that our experts have identified asdriving I-O development:

Allied Medical Staff, Hinsdale Hospital, LaGrange Hospital

Kathy Sexton-Radek

The costs of I-O therapy and the determination of when it is warranted were a major focus of the experts. These factors become more relevant as we begin looking at personalized medicine, decentralized manufacture, and how these treatments can be brought to rural and remote areas. It may be, as Denis Boyle noted, that first-line treatments will be “universal” and centrally manufactured and that second-line treatments will be personalized and decentralized. This approach would provide a more clear-cut standard of practice to follow until the other trends the experts have noted are realized.

Making I-O Affordable for All

“Current immunotherapeutics (e.g., cell-based and antibody-based) are all extremely costly. At the moment, these treatment are limited to developed parts of the globe. Efforts need to be put in place to harmonize such therapies for the developing world.”

Research Fellow, Harvard Medical SchoolZohreh Amoozgar

4

Industry, providers, patients, academia, insurers, and regulators must work in concert to ensure that the right treatment is given to the right patient at the right time. This is a paradigm shift from the siloed approach that currently predominates in healthcare. It will require an extension of the traditional patient care team and improved communication among groups that currently have no direct lines of communication.

New Communication Channels

“Future trends will impact the way clinicians handle patients.”

“Postdoctoral Scientist, KU LeuvenAbhishek D. Garg

5

“It is important to separate the promise of I-O from the reality.”

“- Meg Baker -

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