On July 23, 2021 ImaginAb Inc, a market leading global biotechnology company, reported that focused on developing next generation immuno oncology imaging agents and therapeutic radiopharmaceuticals (RPT), reported the signing of a new significant multi-year, non-exclusive license agreement with Boehringer Ingelheim (Press release, ImaginAb, JUL 23, 2021, View Source [SID1234585143]).

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The agreement, which builds on the long-term collaboration between the two companies that started in 2017 will see ImaginAb supply clinical doses of its market leading 89Zr CD8 ImmunoPET technology to Boehringer Ingelheim for use in the clinical development of its novel oncology therapeutics throughout North America and Europe.

ImaginAb will receive license fees and payments for providing ongoing technical, clinical, and regulatory support to enable the successful implementation of its CD8 ImmunoPET technology. No other terms were disclosed.

Commenting on the announcement, Ian Wilson, Chief Executive Officer of ImaginAb stated:

"Boehringer Ingelheim were the first to partner with us on our CD8 ImmunoPET agent, and we are delighted we can expand our partnership and enable our technology to be used across multiple clinical programs."

Wilson continued: "ImaginAb has a clear aim to become the lead in diagnostic and treatment choices, transforming patient care and helping patients live better and healthier lives. Our CD8 ImmunoPET technology enables quicker identification of drug efficacy, potentially reduce the length of trials and allowing new therapies to advance to market quicker. It also removes the need for repeat, painful biopsies. All of which will ultimately transform patient care."

"This announcement is just the latest in a number of new non-exclusive license agreements that we have announced this year. It is a clear indication that not only is our technology gaining wider acceptance, but many others also share our vision, and belief in the benefits that our CD8 ImmunoPET technology offers."

On July 23, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported a podium presentation on its DecisionDx-SCC test at the American Head & Neck Society (AHNS) 10th International Conference on Head and Neck Cancer, being held July 22-25, 2021 (Press release, Castle Biosciences, JUL 23, 2021, View Source [SID1234585142]).

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DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Comparison of the 40-Gene Expression Profile Test with Clinicopathologic Risk Factor-Based Assessment to Improve Metastasis Risk Assessment in Cutaneous Squamous Cell Carcinoma of the Head and Neck" will be presented by Jason G. Newman, M.D., University of Pennsylvania Health System, Philadelphia, on July 23 at 3:30 p.m.-4:20 p.m. Central time.

"Study data demonstrate that DecisionDx-SCC is a valuable complement to traditional and trusted risk assessment systems, including the American Joint Committee on Cancer Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH) tumor (T) classification," said Newman. "The data further demonstrate that Castle’s DecisionDx-SCC test can provide clinicians with additional information on a patient’s metastatic risk to help them make more informed choices about their treatment and follow-up care."

Study methods and findings:

Archival, primary tumor specimens and associated data from a cohort of 278 patients from 33 different clinical sites were included in the study; the patients had high-risk SCC located on the head or neck, and 54 patients (19.4%) developed regional and/or distant metastasis.
All SCC tumor specimens were tested with DecisionDx-SCC and analyzed using Kaplan-Meier for metastasis-free survival (MFS) and Cox regression for risk of regional/distant metastasis.
Patients who received a Class 1 (low biological risk), Class 2A (moderate biological risk) or Class 2B (high biological risk) DecisionDx-SCC result had significantly different three-year MFS rates (92.1%, 76.1% or 44.4%, respectively; p<0.0001, log-rank test) compared to the overall cohort MFS rate of 81.3%.
Univariate Cox regression analysis demonstrated that the GEP test has significant, independent prognostic value. Multivariate Cox regression analysis demonstrated that the DecisionDx-SCC results compared to AJCC8 T staging was the most significant predictor of outcomes with a Hazard Ratio of 9.07 compared to AJCC8 at 2.88. Similar results were shown when the GEP test was compared with BWH T stages and individual clinicopathologic risk factors, such as tumor diameter, deep invasion, poor differentiation and perineural invasion.
The specificity and positive predictive value (PPV) of a high-risk Class 2B DecisionDx-SCC result were improved relative to these metrics for high-stage AJCC8 (T3/T4) and BWH (T2b/T3), while maintaining a similar negative predictive value (NPV).
Overall, the study demonstrated that DecisionDx-SCC offers significant, independent prognostic value for determining a patient’s individual risk of SCC metastasis, and that the test could be used to complement AJCC8 and BWH T staging and a patient’s clinicopathologic risk factor-based assessment.
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On July 23, 2021 Incyte Corporation (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy (Press release, Incyte, JUL 23, 2021, View Source [SID1234585141]).

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The complete response letter states that the FDA cannot approve the application in its present form. Consistent with the Oncologic Drugs Advisory Committee recommendation on June 24, 2021, the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the treatment of patients with advanced or metastatic SCAC. Incyte is reviewing the letter and will discuss next steps with the FDA.

"Patients with SCAC who have progressed after first-line chemotherapy currently do not have approved treatment options," said Hervé Hoppenot, Chief Executive Officer, Incyte. "While we are not surprised with the FDA decision given the ODAC recommendation, we are disappointed. We remain committed to advancing science to find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA in order to address feedback and determine next steps for the review of retifanlimab."

The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or were ineligible for or intolerant of, platinum-based chemotherapy.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous PD-1 inhibitor, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

On July 23, 2021 The Board of Directors of PerkinElmer, Inc. (NYSE: PKI), reported a regular quarterly dividend of $0.07 per share of common stock July 23, 2021 (Press release, PerkinElmer, JUL 23, 2021, View Source [SID1234585140]). This dividend is payable on November 12, 2021 to all shareholders of record at the close of business on October 22, 2021.

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On July 23, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and Lee’s Pharmaceutical Holdings Limited (HKEX: 950, "Lee’s Pharm") reported that, on July 15, 2021, China Oncology Focus Limited ("COF"), a subsidiary of Lee’s Pharm, has enrolled the first patient in China in the Phase 3, multicenter, randomized, double blinded, placebo controlled clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) (Press release, Sorrento Therapeutics, JUL 23, 2021, View Source [SID1234585139]). The clinical trial clearance was granted by China’s National Medical Products Administration ("NMPA") in March 2021.

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The initiation of this Phase 3 trial is based on the very encouraging results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer. This clinical trial involves 56 centers and is led by Prof. Shun Lu from Shanghai Chest Hospital.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.