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As the market for specialty and generic products continues to become more competitive and pricing pressures increase, the 505(b)(2) pathway may allow companies more options to diversify their portfolios.

505(b)(2): A Pathway to Competitiveness Through Innovation for Specialty and Generic Companies

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

Traci Miller (Director, Sonexus™ Access and Patient Support, Cardinal Health) discusses current digital trends in the patient services industry, as well as how the optimal balance of technology and talent can transform manufacturer-sponsored patient support programs. Cardinal Health combines best-in-class program and pharmacy operations with smart digital tools to ensure product and patient success and reduce operational costs.

Using Technology and Talent to Unlock Value and Cost Savings in Patient Services

Traci Miller, Director, Sonexus™ Access and Patient Support, Cardinal Health, discusses the current digital trends in the patient services industry and how the optimal balance of technology and talent can transform manufacturer-sponsored patient support programs. Hear how Cardinal Health combines best-in-class program and pharmacy operations with smart digital tools to ensure product and patient success and reduce operational costs. 

Unlocking value and cost savings in patient services with technology and talent 

Elyse Blazevich

Colorado has emerged as a thriving hub for life sciences innovation, with over 720 companies spanning sectors like medical devices, diagnostics, biotech, and pharmaceuticals. In this interview with 

, Elyse Blazevich, the CEO and President of the Colorado Bioscience Association, provides a glimpse into the day-to-day operations of the organization, which is dedicated to championing the life sciences industry across the state. Blazevich discusses the association's multifaceted approach, from facilitating access to capital and partnerships to hosting educational and networking events, as well as its work in cultivating a diverse talent pipeline and advocating for the industry at the state and federal levels.

00:23 - Blazevich's background and journey to becoming involved with the Colorado Bioscience Association

02:32 - Day-to-day operations of the Colorado Bioscience Association

03:49 - Overview of the Colorado life sciences market, including key sectors and statistics

05:15 - Talent pipeline and recruitment in Colorado

06:11 - Colorado life sciences incubation program

07:35 - Fundraising trends and advice for Colorado life sciences companies

09:41 - Role of artificial intelligence and machine learning in the life sciences ecosystem

Elyse Blazevich discusses the Colorado Bioscience Association’s efforts to support the state’s life sciences sector by fostering partnerships, advocating for industry growth, and building a diverse talent pipeline.

Elyse Blazevich on Driving Innovation in Colorado's Thriving Life Sciences Ecosystem

Long-term follow-up data from the Phase II PHAROS trial found that Pfizer’s Braftovi (encorafenib) in combination with Mektovi (binimetinib) produced sustained efficacy in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). The findings, which were presented at the ESMO Congress 2024, position the combination as a promising first-line therapy for this type of cancer, according to the trial investigators.

“BRAF V600E-mutant metastatic non-small cell lung cancer tends to be aggressive, and effective targeted first-line treatment options with manageable safety profiles are critical for the thousands of people who are diagnosed globally each year,” said PHAROS investigator Gregory Riely, MD, PhD, vice chair, clinical research, Department of Medicine, Memorial Sloan Kettering Cancer Center, in a press release. “The longer-term follow-up results from the PHAROS trial represent an important step forward in the treatment of BRAF V600E-mutant metastatic NSCLC, especially for treatment-naïve patients. These compelling results support the Braftovi plus Mektovi combination as a standard of care option for these patients.”

The open-label, multicenter, single arm PHAROS study examined Braftovi plus Mektovi combination therapy in treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC. The primary endpoint of the study was a notable objective response rate (ORR), while the secondary endpoint was duration of response (DoR).

Results demonstrated an ORR of 75% in treatment-naïve patients. Additionally, the median DoR was 40 months and median progression-free survival (PFS) reached 30.2 months. In previously treated patients, ORR was 46%, with a DoR of 16.7 months and PFS of 9.3 months.

The safety profile of Braftovi plus Mektovi was consistent with previous findings and no new safety signals were identified. Treatment-related adverse events (TRAEs) resulted in dose reductions for 26% of patients and treatment discontinuation for 16% of patients. Common TRAEs included nausea, diarrhea, and fatigue. Pfizer warns that new primary malignancies, cutaneous and non-cutaneous, can occur during treatment with this combination. Further, uveitis, hemorrhages, hepatotoxicity, cardiomyopathy, and embryo-fetal toxicity have occurred in patients treated with Braftovi plus Mektovi.

Previously, Braftovi plus Mektovi was approved by the FDA in October 2023, and by the European Commission in August 2024, for the treatment of BRAF V600E-mutant metastatic NSCLC. According to Pfizer, it maintains exclusive rights to the treatment in the United States, Canada, and all countries in Latin America, Africa, and the Middle East. Ono Pharmaceutical hold commercialization and for both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre Laboratories has exclusive rights in all other countries, including Europe and the Asia-Pacific region.

“These potentially practice-changing results from the PHAROS trial show that the combination of Braftovi plus Mektovi is providing long-term compelling efficacy for patients, and although no definitive conclusions can be made across trials, the duration of response and progression-free survival in treatment naïve patients appear to be the longest observed for BRAF V600E–mutant metastatic NSCLC compared with historical outcomes,” said Roger Dansey, MD, chief development officer, oncology, Pfizer, in the press release. “These latest data reflect our deep understanding of the science behind biomarker-driven cancers and add to our legacy in developing innovative targeted treatments in NSCLC. We are continuing to build upon this strong foundation with a pipeline of targeted medicines and combinations across our tumor areas of focus, including the ongoing investigation of Braftovi in earlier settings of metastatic colorectal cancer, and the exploration of a next-generation brain-penetrant BRAF inhibitor.”

1. Pfizer’s BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer. 

September 14, 2024. Accessed September 17, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-braftovir-mektovir-shows-long-term-clinically

Results from the Phase II PHAROS trial found that treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer administered Braftovi in combination with Mektovi achieved an objective response rate of 75%. 

Braftovi Plus Mektovi Demonstrates Sustained Efficacy in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer

Octave Bioscience has developed the Multiple Sclerosis Disease Activity Test, a multi-variant blood test that detects for the disease’s activity and, when combined with the company’s AI platform, is able to translate multiple forms of data into actionable insights for doctors. The company’s CEO Doug Biehn is leading the company through its commercialization phase while also implementing plans to scale up and expand its pipeline into Parkinson’s. He spoke with 

 about these plans and the steps being taken to implement them.

Pharmaceutical Executive: How are you utilizing your experience in the industry to lead Octave’s commercialization?


 I'm leveraging my extensive experience in building and scaling growth businesses to help drive Octave’s commercialization. Our focus is on expanding the use and adoption of our breakthrough Multiple Sclerosis Disease Activity (MSDA) test, a first-of-its-kind multianalyte biomarker panel for MS. From sales and marketing to clinical evidence generation and market access, I’m drawing on my expertise to lead a world-class team of deep subject matter experts.

Together, we’re building an innovative commercial engine to accelerate physician and pharma adoption. With over 100 leading MS clinics now using our test, and 90% of our monthly volume from repeat healthcare providers, we’re poised for continued growth. We're also working with health plans to ensure accessibility and affordability for patients nationwide. Octave is building momentum in redefining the standard of care for neuro degenerative diseases.

PE: What is your strategy for developing biomarker tests and how will the tests help inform treatment decision making and drug development for Multiple Sclerosis?


 MS is a complex, heterogeneous disease affecting all patients differently, which makes diagnosis and prognosis difficult. The industry has lacked dynamic, quantitative tools to measure disease activity over time, and currently the approach to care in MS is reactive and subjective. Our strategy is to help physicians move to a proactive and objective approach to optimize treatment for MS patients throughout their lives.

For example, Octave’s MSDA test is the industry’s first and only clinically validated multianalyte biomarker blood test that measures 18 biomarkers to determine 4 biological pathway scores and an overall disease activity score that is specific to MS disease activity. Our MSDA report provides information that is easily interpretable for the physician and patient, and provides actionable insights that inform longitudinal clinical management, including enabling better treatment selection, evaluating treatment response, as well as monitoring for relapses and smoldering disease.

With the MSDA test, physicians and patients can now have a better understanding of the biology of the patient, the level of their disease activity, how patients are responding to treatments, and if changes need to be made to improve outcomes. We have received great feedback from the physician community about how the MSDA test is informing their decision making, and we’re building a body of evidence that supports the clinical utility of our test. In addition, pharma is using our test to support drug development by demonstrating the efficacy of pipeline drugs to reduce MS disease activity and differentiate against competitors for in-market drugs.

PE: When do you plan to expand your products to include tests for Parkinson’s?


 Building on Octave’s progress in Multiple Sclerosis, we are now creating a multi-protein test for Parkinson’s, with funding and support from The Michael J. Fox Foundation. We started this work last year, and we expect to have a fully validated panel for Parkinson’s in 2H2026.

This will be the industry’s first multianalyte biomarker panel for Parkinson’s with the potential for tremendous impact for physicians and patients. We are deploying proven strategies we’ve used to build the MSDA test to create a novel tool for Parkinson’s ranging from market research, literature curation, biological modeling, large scale proteomics, and KOL engagement in support of the discovery, development, and validation of our biomarker panel. These approaches and techniques will help us create a biomarker panel for Parkinson’s that addresses the clear unmet need for deeper, objective, and more precise insights that are based on the individual patient’s biology.

PE: How difficult is it to pivot from focusing on one disease to a broader set of diseases?


 While much of our scientific method can be applied and replicated to new indications, the power of our approach comes from our ability to develop solutions that are highly differentiated and relevant to the specific condition. Each neurological disease is highly heterogeneous, and what works for MS may not work for Parkinson’s disease or Alzheimer's.

We’re recognized as leaders in the space because of our ability to deeply understand the disease, our proven scientific process, and our ability to successfully commercialize and bring these solutions to the clinic. Building off our success with the MSDA test, we’re excited to now expand into Parkinson’s, where there is a huge unmet need for biomarker solutions that can accelerate drug development and guide more effective treatments.

The Octave Bioscience CEO discusses leading the company through commercialization and expansion.

Vinay Torani

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