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Bill Barr is a partner at Acuitas Analytics.

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

Jennifer Hawks Bland, CEO of NewYorkBIO, shares her journey from litigation to biotech leadership, discusses fostering innovation in New York's thriving bioscience ecosystem, and outlines her vision for the state as a global biotech hub.

Biotech in the Empire State: Building a World-Class Bioscience Ecosystem in New York

Jennifer Hawks Bland, CEO of NewYorkBIO, shares her inspiring journey from a legal career to leading New York’s burgeoning bioscience ecosystem. Throughout her interview with 

, Jennifer discusses the unique strengths of New York as a biotech hub, including its world-renowned academic institutions, diverse population for clinical research, and robust financial infrastructure. She highlights NewYorkBIO’s role in fostering innovation, supporting early-stage companies, and connecting industry leaders. With her vision to position New York as a global leader in bioscience, Jennifer offers insights into the collaborative efforts shaping the future of biotechnology in the Empire State.

00:00 – Jennifer’s background in litigation and advocacy
2:57 – Jennifer’s approach to leadership at NewYorkBIO
4:11 – Advantages of forming a large bioscience ecosystem across New York State
6:29 – Leveraging partnerships between academia and research to fuel innovation
9:00 – Current advocacy priorities at NewYorkBIO
11:09 – NewYorkBIO’s approach to addressing current macroeconomic conditions in New York and beyond
14:19 – Significance of forging connections between Big Pharma and emerging biotech firms
15:36 – NewYorkBIO success stories demonstrating impact across the Empire State

IPF Progress

PE: Are there any ongoing collaborations with patient advocacy groups or organizations to raise awareness of IPF or facilitate patient participation in the clinical trial?

We’re working with a number of different pulmonary fibrosis advocacy groups right now, both in the United States and internationally. These include PF Warriors, the Pulmonary Fibrosis Foundation United States, Foundation Australia, EUPFF, and the Action for Pulmonary Fibrosis in the UK. We really need to do this, because even while IPF is a rare disease with around 150,000 patients in the United States, it’s not common. You don't have a patient on every corner. It's kind of weird, because if you talk to people, it doesn't seem like anyone's more than one to two degrees of separation away from an IPF patient. You really need to use the patient advocacy groups to let them know about the trial and bring the patients in and give them an opportunity to be on this drug. Our hope is that because the efficacy data is superior to current standard of care and standard of care is generally not very well tolerated, and this drug seems to be better tolerated, even more patients will come out, get on the study, and benefit from the drug. Advocacy groups can help with that. 

The initiation of the WHISTLE PF trial for ENV-101 aligns with the company’s broader strategic goals by advancing its priority of addressing idiopathic pulmonary fibrosis (IPF) with transformative therapies. ENV-101 targets the Hedgehog signaling pathway, directly addressing the disease’s underlying pathology by reducing fibrosis and potentially reversing lung damage, distinguishing it from current IPF treatments that only slow disease progression.

Phase IIa trials have demonstrated both clinical and statistical significance in improving lung function, structure, and reducing fibrosis. With a favorable safety profile observed across 230 patients, including oncology studies, the WHISTLE PF trial will further validate these findings in a larger, more diverse population. The Phase IIb trial will explore additional lower doses to optimize efficacy and tolerability while permitting standard-of-care therapies, ensuring comprehensive data collection. Safety monitoring will include an independent review board to oversee adverse events.

The company is also collaborating with patient advocacy organizations like the Pulmonary Fibrosis Foundation (USA), PF Warriors, and international groups in Australia, Europe, and the UK. Given IPF’s life-threatening nature and the drug’s promise to outperform standard care in both efficacy and tolerability, these partnerships are important for patient education and awareness.

While regulatory timelines remain uncertain, the company is committed to expediting the process, acknowledging the severe prognosis of IPF. The potential for accelerated approval, typically rare in pulmonary conditions, underscores the drug’s unique position as a game-changer for this devastating disease.

John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials for idiopathic pulmonary fibrosis. 

Partnering for Progress: Leveraging Advocacy Groups to Drive Awareness and Participation in IPF Trials

In the wake of the murder of UnitedHealth Group CEO Brian Thompson outside of a New York City investor meeting in early December, authorities are taking steps to increase security measures at the upcoming J.P. Morgan Healthcare Conference, 

 reports that the San Francisco Police Department has canceled all time off requests for its officers during the conference, which is considered to be the largest annual gathering of healthcare executives and investors globally. According to the report, authorities in San Francisco are implementing extensive safety measures in an effort to halt any potential copycat attacks, however, no credible threats have been identified.

“The San Francisco Police Department is working closely with the event organizer, and we are committed to ensuring the safety and security of all attendees,” the department said in the 

 report. “The SFPD will be fully staffed, and all time off has been canceled to ensure that sufficient officers are on hand throughout the conference.”

The conference, as well as the killing, come during a time in which attention has increased regarding public resentment over rising healthcare costs and stagnant life expectancy in the United States and the role of health insurers in these trends.

, the event, often a focal point for industry protests, could see heightened demonstrations this year. Companies such as Gilead have previously been targeted by activists over drug pricing, while ongoing Bay Area hotel worker strikes could possibly draw attention to labor issues, according to the report. A union group representing the workers stated that the conference should be canceled in light of the strike.

“With 20% of the hotel rooms in San Francisco on strike, J.P. Morgan cannot host a successful conference in San Francisco this year without its attendees crossing union picket lines,” the union group wrote in a statement.

Many pharma giants, including Pfizer, Bristol Myers Squibb, and Johnson & Johnson, are set to present at the conference.1 However, the conference agenda can only be viewed by those invited to attend the event.

1. San Francisco Police Cancel Time Off as Healthcare Execs Descend. 

January 9, 2025. Accessed January 10, 2025. https://www.msn.com/en-us/news/us/san-francisco-police-cancel-time-off-as-healthcare-execs-descend/ar-BB1r7mZB?apiversion=v2&noservercache=1&domshim=1&renderwebcomponents=1&wcseo=1&batchservertelemetry=1&noservertelemetry=1

2. Insurance executive killing puts spotlight on security measures at JP Morgan meeting. 

December 6, 2024. Accessed January 10, 2025. https://endpts.com/insurance-executive-killing-puts-spotlight-on-security-measures-at-jp-morgan-meeting/

3. 43rd Annual J.P. Morgan Healthcare Conference. 

Accessed January 10, 2025. https://www.jpmorgan.com/about-us/events-conferences/health-care-conference

San Francisco Police cancel time off requests to increase security at the J.P. Morgan Healthcare Conference after the recent murder of UnitedHealth Group CEO Brian Thompson. 

Latest Conference Coverage

Additional Security Measures Taken for J.P. Morgan Healthcare Conference 

WHISTLE-PF IPF Safety

PE: Given the progressive and life threatening-nature of IPF, how soon do you anticipate ENV-101 might be available to patients if the Phase IIb trial meets its objectives?

That’s going to be up to the data from the IIb trial. If it replicates what we saw in the IIa trial, that would be amazing. At that point, it’s up to the regulatory authorities, which makes it a really tough question. Obviously, as the sponsor of the trial, we're going to do everything possible to get the drug to patients as soon as possible. Since IPF is actually more deadly than most cancers, I would hope that the regulatory authorities are also keen to help us get it to patients as soon as possible.

PE: The Phase IIa trial highlighted a favorable safety profile for ENV-101. What steps are being taken in WHISTLE-PF to monitor and further validate its safety across a larger and more diverse population?

The drug was very well tolerated in the IIa trial, and also, in the additional 200 subjects that have previously been treated with the drug in oncology. So, we have a pretty robust database of 230 patients, and it's been very well tolerated in the studies. In the IPF, there were no serious adverse events, no grade three or higher events, and most of the tolerability signals were considered mild. When we go into the IIb study, we'll explore an additional two doses going even lower, which could actually be efficacious, based on what we know about those doses, and we'll have regular monitoring of all side effects, including an independent review board that looks at it as well at the end of the day.

The other difference with IIb is that we're going to allow standard of care this time, which wasn’t in the IIa trial, it was just monotherapy. At the end of the day, we'll increase the number of patients on drug. We'll have patients at lower doses, and to the patient's benefit, most of the patients will actually be on active drug in the trial.

y: The initiation of the WHISTLE PF trial for ENV-101 aligns with the company’s broader strategic goals by advancing its priority of addressing idiopathic pulmonary fibrosis (IPF) with transformative therapies. ENV-101 targets the Hedgehog signaling pathway, directly addressing the disease’s underlying pathology by reducing fibrosis and potentially reversing lung damage, distinguishing it from current IPF treatments that only slow disease progression.

John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment's safety profile. 

Monitoring the Safety of WHISTLE-PF in IPF Across Diverse Populations

Introduction of Panelists

e Roundtable video series, Robert Alaburda, Associate Editorial Director, talks with several experts about the building blocks for success in CAR T-cell clinical trials. The panelists introduce their expertise and background in clinical trials.

Panelists set up for addressing the clinical trial landscape, key challenges, regulations, and the future of cell and gene therapy.

Bill Barr

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