On February 15, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a global, multi-year definitive licensing agreement whereby it granted Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology (Press release, ImmunoGen, FEB 15, 2022, View Source [SID1234608147]). ImmunoGen retains full rights to the camptothecin platform for all targets not covered by the Lilly license.

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As part of the agreement, Lilly will pay ImmunoGen an upfront payment of $13 million, reflecting initial targets selected by Lilly. Lilly may select a pre-specified number of additional targets, with ImmunoGen eligible to receive an additional $32.5 million in exercise fees if Lilly licenses the full number of targets. ImmunoGen is eligible to receive up to $1.7 billion in potential target program exercise fees and milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen is also eligible for tiered royalties as a percentage of worldwide commercial sales by Lilly. Lilly is responsible for all costs associated with research and development.

Camptothecins are an important class of anticancer drugs targeting Type I topoisomerase. ImmunoGen’s proprietary class of camptothecin linker-payloads are designed to optimize existing camptothecin technology to potentially deliver a wider therapeutic window with enhanced safety and efficacy.

"Lilly has a proven track record of bringing transformative oncology medicines to market, and we are pleased that they selected our novel camptothecin technology to integrate with their efforts to develop next-generation ADCs," said Stacy Coen, ImmunoGen’s Senior Vice President and Chief Business Officer. "This licensing agreement demonstrates ImmunoGen’s continued innovation in ADCs, creates value from our intellectual property around a proprietary platform, and further enhances our ability to re-invest in our business as we build out our pipeline and accelerate our transformation into a fully-integrated oncology company."

On February 15, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOneTracker (Press release, Foundation Medicine, FEB 15, 2022, View Source [SID1234608146]). The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma. The Breakthrough Device designation was granted for the assay’s use in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.

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Developed in partnership with Natera, FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in personalized ctDNA monitoring. The companies launched the research use only version of FoundationOne Tracker in June 2021, collaborating to support biopharma and academic partners with clinical trial and companion diagnostic planning.

In addition to the indications granted through the Breakthrough Device designation, FoundationOne Tracker’s personalized technology aims to address ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers, including assessment of a patient’s response to therapy, as well as MRD detection, surveillance, and detection of molecular residual relapse following curative intent therapy.

"Foundation Medicine continues to shape the future of clinical care and research by helping oncologists and our industry partners find the answers they need to bring precision cancer care to patients," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "Personalized molecular disease monitoring enables early detection of ctDNA and can monitor for risk of relapse and track therapy response to help oncologists make personalized treatment plans for their patients. We are enthusiastic about our work to accelerate development of this assay so that it can more quickly impact care decisions in the clinic."

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

On the heels of data presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium last month exploring the feasibility of MRD in metastatic colorectal patients who have undergone curative intent surgical resection, Foundation Medicine will also be presenting additional MRD data at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 18 on the genomics of resected early-stage bladder cancer to validate CGP-informed MRD detection in ctDNA.

On February 15, 2022 Ambrx Biopharma Inc., or Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported it received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) related to an Investigational New Drug (IND) application for ARX305, an antibody drug conjugate (ADC) designed to target CD70 to treat a broad range of solid and hematologic tumors such as renal cell carcinoma (Press release, Ambrx, FEB 15, 2022, View Source [SID1234608145]). ARX305 is the third ADC developed by Ambrx on its proprietary Engineered Precision Biologics platform that has received IND clearance.

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The clinical study cleared by the FDA, ARX305-01, is a first in human, Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of ARX305 in adults with clear cell renal cell carcinoma who are resistant or refractory to prior standard therapies.

ARX305 is an anti-CD70 ADC designed to target cancer cells displaying CD70, a protein expressed on a broad range of tumors including renal cell carcinoma, nasopharyngeal cancers, multiple myeloma, non-Hodgkin’s lymphoma and acute myeloid leukemia. Ambrx previously licensed the rights to develop and commercialize ARX305 in China to NovoCodex Pharmaceuticals Ltd. (NovoCodex).

"I am pleased with the milestones that we have reached on the development of antibody drug conjugates, marked by the filing and clearance of the IND application for ARX305, our third ADC program to reach this stage of development," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "As we continue to explore potential indications for Ambrx’s proprietary ADC technology, the progression of ARX305 towards clinical trials targeting patients with various CD70 expressing tumors reinforces our confidence in the broad application of our platform."

On February 15, 2022 Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported that Kevin P. Foley, Ph.D., Co-founder and Chief Scientific Officer of Ranok, will present at the virtual BMO BioPharma Spotlight Series: Proteins – Degraders and Other Next Gen Technologies on Thursday, February 24th at 10:10 AM ET (Press release, Ranok Therapeutics, FEB 15, 2022, View Source [SID1234608143]).

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Dr. Foley will review the company’s strategic vision and its first clinical program, RNK05047, a first-in-class, small-molecule, BRD4-selective protein degrader which was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP (Chaperone-mediated Protein Degradation). This technology leverages the company’s expertise in protein homeostasis and the cellular chaperone network to degrade disease-associated proteins, and is designed to increase drug safety and efficacy through selective targeting of disease tissues. The U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for RNK05047 and enrollment of the Phase 1/2 study for patients with advanced solid tumors and lymphomas is expected to begin in the first half of 2022.

Following the presentation, a recording will be available for 3 months on Ranok’s website at: View Source

On February 15, 2022 Susan G Komen reported A first-of-its-kind tool may be able to help doctors better diagnose inflammatory breast cancer (IBC) (Press release, Susan G Komen, FEB 15, 2022, View Source [SID1234608142]). The novel tool and the findings of the analysis have been recently published in Breast Cancer Research and Treatment.

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The tool was developed through a collaborative effort between Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and the Milburn Foundation, which brought together a team of leading breast cancer experts including clinicians, researchers and IBC patients.

"IBC has historically been difficult to diagnose and no changes to diagnostic approach have been made since the 1960’s. It is a rare and aggressive type of breast cancer that develops rapidly and can easily be confused with a breast infection and often goes underdiagnosed or misdiagnosed," said Dr. Reshma Jagsi, lead author, Komen Scholar and radiation oncologist.

Before the development of this tool, IBC lacked a formal, objective medical definition and diagnosis was often delayed, misdiagnosed or missed. IBC usually presents as swelling or redness of the breast, and not a lump, so it can be missed on a mammogram.

As the team began their work, it became evident that without a clear definition of IBC that included all the characteristics of this complicated disease, accelerating research would continue to be a significant challenge.

"If you want to study a disease, you have to ask, ‘What causes the disease and is this treatment better than that treatment?’ It’s harder to answer those questions if you haven’t clearly defined the disease," said Dr. Kathy Miller, senior author, Komen Scholar and medical oncologist. "It sounds so simple, but having a diagnosis really is the first step toward tackling the problem."

The group identified "defining characteristics" – including clinical, pathologic and imaging features – of IBC that led them to develop a quantitative scoring system for diagnosis. The system, or tool, is intended to increase diagnostic accuracy, predict outcomes, guide treatment decisions and inclusion criteria for clinical trials.

This tool will also enable researchers to study the biology of IBC and make discoveries to advance progress towards personalized care for all breast cancer patients.

"Komen has been able to see further into the future about how this definition isn’t just about writing something in a dictionary. This is about something that is essential to undergird future research," added Jagsi.

IBC is aggressive and can spread quickly, resulting in approximately 30 percent of patients being diagnosed at stage IV, or with metastatic disease, meaning their breast cancer has already spread to other parts of their body.

Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and Milburn Foundation raised more than $1.4 million in a fundraising campaign last year to support the IBC cohort and the research that was recently published.

"With aggressive breast cancers like IBC, patients need more treatment options, and they need them now. This collaboration is helping us get closer to finding more effective treatments for a type of breast cancer that is difficult to diagnose and treat," said Victoria Wolodzko, Senior Vice President of Mission at Susan G. Komen.

"This partnership illustrates our continued leadership in funding critical IBC research," said Bryon Davis, CEO of the Milburn Foundation. "The impressive results of our campaign have helped us reach this key milestone. Working with Susan G. Komen and the Inflammatory Breast Cancer Research Foundation, we brought together an exceptional team to help define a path forward in the fight against IBC."

"Patient advocacy is about taking an active role in defining the critical conversations that will accelerate research discoveries and drive results for patients," said Ginny Mason, Executive Director of the Inflammatory Breast Cancer Foundation. "In our more than 20 years of work in IBC patient advocacy and research, this partnership with Susan G. Komen and Milburn is critical to push key issues forward."

Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and Milburn Foundation continue to raise funds to support ongoing research studies to validate the new scoring system.

The next step is to perform further studies to validate the scoring system.

Co-authors along with Dr. Jagsi and Dr. Miller include: G. Mason, B.A. Overmoyer, W.A. Woodward, S. Badve, R.J. Schneider, J.E. Lang, M. Alpaugh, K.P. Williams, D. Vaught, A. Smith and K. Smith.