On July 20, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union (Press release, Agilent, JUL 20, 2021, View Source [SID1234584988]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

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"This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Lung cancer is the leading cause of cancer death overall and the 2nd most commonly diagnosed cancer in Europe.1 NSCLC makes up approximately 85% of all lung cancer cases.2 In Europe, the average five-year survival rate for lung cancer is less than 20%.3

"This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.4 Sanofi and Regeneron developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 (Study 1624) clinical trial.4

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.4

On July 20, 2021 Immunicom, Inc., a clinical stage biotech, reported that shared preliminary data from its metastatic triple-negative breast cancer (mTNBC) clinical trial with its novel breakthrough Immunopheresis therapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 (Press release, Immunicom, JUL 20, 2021, View Source [SID1234584987]). Immunicom’s subtractive immunotherapies are designed to remove immune inhibitors and enhance patients natural immune response without compromising quality-of-life as is typically seen after treatment with chemo-/immuno-oncology agents. ASCO (Free ASCO Whitepaper)’s Annual Meeting is one of the world’s premier scientific gatherings of cancer specialists and researchers.

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Immunicom is investigating its FDA-designated breakthrough Immunopheresis therapy, which is a filtration-based subtractive treatment designed to capture sTNF-R proteins that are shed by cancer cells and inhibit a patient’s natural anti-tumor immune activity. Immunicom presented data for the second cohort of mTNBC patients treated with Immunopheresis in combination with weekly chemotherapy procedures (paclitaxel [60 mg/m2] plus carboplatin [AUC2] combination), which were found to be generally safe and provided early, promising signs of antitumor activity.

Immunicom previously presented data for the initial cohort of patients treated with Immunopheresis alone at AACR (Free AACR Whitepaper)’s Annual Meeting 2021, revealing an 80% decrease of the inhibitory sTNF-R proteins and observation of sustained quality-of-life while on therapy with minimal side effects (details here).

"The ASCO (Free ASCO Whitepaper) data expand on our breakthrough Immunopheresis therapy, specifically in combination with low-dose chemotherapy to demonstrate potential for synergistic and enhanced activity of sTNFR pulldown in late-stage patients who have failed multiple prior lines of therapy," said Dr. Robert Segal, Immunicom Chief Medical Officer. "The goal of halting disease progression and the potential of going into disease remission with this approach, where side-effects are minimal, has significant implications for the health and well-being of these patients with terminal disease. To be able to continue with normal daily activities, is in stark contrast to what these patients might normally experience if they choose to undergo a last-ditch treatment effort with yet another round of standard chemotherapy."

Immunicom’s abstract, "Extracorporeal pulldown of soluble TNFRs to unleash the activity of endogenous TNFα in chemorefractory triple-negative breast cancer patients – first-in-human experience" was published in ASCO (Free ASCO Whitepaper)’s June 2021 Journal of Clinical Oncology. The study’s principal investigator and lead author is Piotr Wysocki, MD, PhD, Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow, and President of the Polish Society of Clinical Oncology.

On July 20, 2021 Fight Colorectal Cancer (Fight CRC), the nation’s leading colorectal cancer (CRC) patient advocacy organization, and Guardant Health, Inc. (Nasdaq: GH), a leader in precision oncology, reported that it will be recognizing clinical researchers and advocates who have demonstrated exceptional leadership during the pandemic in getting people back to routine colorectal cancer screening (Press release, Fight CRC, JUL 20, 2021, View Source [SID1234584986]).

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The award, called "Back to Screening Award for Research Advocacy Excellence," will honor key contributions made by Fight CRC research advocates, as well as Principal Investigators participating in Guardant Health’s ECLIPSE trial, a clinical study evaluating the use of a blood test to screen for colorectal cancer. Selected recipients of the award will be honored at Fight CRC’s "Path to a Cure" event in December 2021. Notably, this year’s event will convene a group of research and advocacy experts who will be tasked with mapping out a path leading to a cure for colorectal cancer. The framework will be shared with the National Cancer Institute (NCI) and National Institutes of Health (NIH) to request action to help achieve this goal.

"The COVID-19 pandemic forced colorectal cancer screening to a standstill in some communities. The data shows drastic declines in 2020, compared to the same timepoints in prior pre-pandemic years," said Anjee Davis, President of Fight CRC. "Despite these challenges, herculean efforts were made by Fight CRC research advocates and Principal Investigators participating in the ECLIPSE trial to continue to move the needle forward to improve colorectal cancer screening rates and, ultimately, save lives. Fight CRC and Guardant Health have been focused on our shared goal of getting people back to routine cancer screening after the pandemic."

The ECLIPSE trial, a 10,000-plus patient study, is currently underway to evaluate the performance of Guardant Health’s blood test to detect colorectal cancer in an average-risk adult population.1 If successful, Guardant Health expects data from the trial will support a premarket approval (PMA) submission to the FDA. Despite the incredible pressure that the pandemic put on enrolling patients into the study, which requires patients to consent to undergo an invasive, inpatient colonoscopy procedure, the trial is expected to complete enrollment by the end of 2021. The test is intended to offer a non-invasive, patient-friendly blood testing option that could bridge the gap to the Centers of Disease Control’s (CDC) target compliance goal of 80 percent.2,3

Today, it is estimated that only 66% of adults 50 years and older3 are screened despite compelling evidence that routine cancer screening can reduce colorectal cancer mortality, the second leading cause of cancer death.3 The problem is expected to get worse. The Journal of the American Medical Association recently predicted that COVID-19–related reductions in care utilization may result in an estimated 1.2 to 2 million fewer colorectal cancer screenings between 2020 and 2023.4

Colorectal cancer is on the rise for younger adults too. The U.S. Preventative Services Task Force (USPSTF) recently lowered the recommended age to start screening from 50 to 45.5 This increases the pool of people who need to be screened by an additional 21 million Americans aged 45 to 49.6 By 2030, it is expected that colorectal cancer will be the leading cause of cancer related death for those aged 20 to 49, making colorectal cancer screening increasingly a priority for all Americans.7

"Given what we have learned during the pandemic about its detrimental impact on cancer screening and healthcare disparities among underserved communities, it has become abundantly clear that a non-invasive, patient-friendly blood test to routinely screen for colorectal cancer is desperately needed," said Helmy Eltoukhy, Guardant Health CEO. "We look forward to recognizing the exceptional performance of the institutions participating in our ECLIPSE trial who have worked tirelessly to conclude this trial so that one day soon we can offer patients a more accessible solution for routine colorectal cancer screening. We are proud to stand together with Fight CRC to not only honor these investigators, but to also recognize the incredible dedication of the Fight CRC advocates for their unwavering commitment to CRC screening during these difficult times."

On July 20, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL) (Press release, Aldeyra Therapeutics, JUL 20, 2021, View Source [SID1234584985]). There are no approved treatments for PVRL, a rare, aggressive, high-grade cancer that affects approximately 2,800 people in the United States, with approximately 600 new cases diagnosed annually.

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"PVRL is an often fatal cancer that creates unique challenges for diagnosis and treatment," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The FDA’s orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191, which represents the first methotrexate preparation specifically formulated for intraocular injection. The designation is another important step forward for our retinal disease program, complementing our ongoing clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy, the leading cause of failure of retinal reattachment surgery."

The FDA’s orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.

About ADX-2191

ADX-2191 (methotrexate for intravitreal injection) inhibits dihydrofolate reductase, an enzyme involved in cellular replication and activation. Methotrexate is the most commonly used intravitreal medication for the treatment of PVRL. ADX-2191 was previously granted orphan drug status and fast track designation by the FDA for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.

On July 20, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and its partner in Greater China, Qilu Pharmaceutical, reported that the first patient has been enrolled in China in the clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, JUL 20, 2021, View Source [SID1234584983]). The milestone comes only four months after the Investigational New Drug (IND) application for Vicineum was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which triggered a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments to Sesen Bio.

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"The enrollment of the first patient in the clinical trial in China is a significant milestone in realizing our mission to save and improve the lives of patients globally," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu Pharmaceutical has strong clinical and regulatory experience, and we are encouraged by the speed in which Qilu Pharmaceutical is moving forward with its clinical and regulatory efforts. We look forward to working closely with Qilu Pharmaceutical in the coming months as we continue to make progress in bringing Vicineum to market in China."

"We continue to believe in the differentiated clinical profile of Vicineum and its potential to address a significant unmet need in the treatment of BCG-unresponsive NMIBC in the Greater China region," said Oliver Kong, M.D., chief medical officer and corporate vice president of Qilu Pharmaceutical. "We look forward to completing enrollment of the trial, and to working with the NMPA to potentially bring Vicineum to market to make a meaningful impact on the lives of patients."

The open-label, single-arm, multi-center bridging trial will evaluate the efficacy and safety of Vicineum in approximately 53 patients with carcinoma in situ (CIS) with or without papillary disease, high-grade Ta papillary disease or T1 papillary disease of any grade. Patients will be required to have failed previous treatment with BCG for inclusion in the trial. The primary endpoints are the complete response rate (for CIS patients) and the recurrence-free rate (for papillary patients) at six months, with the complete response rate and the recurrence-free rate at three months, safety and tolerability as the secondary endpoints. Based on the partnership agreement between Sesen Bio and Qilu Pharmaceutical, the trial is being run at the sole cost of Qilu Pharmaceutical.

Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in China in 2022, with potential approval expected in 2023. Sesen Bio believes China represents a large potential market for Vicineum, with unadjusted peak year sales estimated at $155M-$418M.

In the US, the Company believes it remains on track for an FDA decision on its Biologics License Application for Vicineum by the target PDUFA date of August 18, 2021.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.