On December 9, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, and WuXi Biologics (2269.HK), a global company with leading open-access biologics technology platforms, reported an expansion of their existing strategic relationship under which the parties will discover anti-CD39 antibodies using WuXi Bio’s proprietary technology (Press release, Arcus Biosciences, DEC 9, 2020, View Source [SID1234572544]). This CD39 collaboration represents the fourth antibody development program on which the two companies have joined forces. Arcus was granted exclusive worldwide rights to anti-CD39 antibodies discovered under the collaboration and will be responsible for all further development and commercialization activities of such anti-CD39 antibodies.

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The ATP-adenosine axis is believed to play a critical role in maintaining an immunosuppressed tumor microenvironment. Inhibition of one or more of the key nodes (CD39, CD73, or adenosine A2a and A2b receptors) along this axis aims to reduce the formation or activity of the highly immunosuppressive adenosine. A potential additional benefit of CD39 inhibition, aside from blocking an important source of adenosine, is the increase in intra-tumoral ATP, an important molecule for the recruitment and activation of dendritic cells. Preclinical experiments indicate that the combination of CD39 inhibition with either CD73 or adenosine receptor inhibition provides robust inhibition of this axis and increased anti-tumor immunity.

"WuXi Biologics is a global leader in the development and manufacture of therapeutic antibodies. Our relationship with WuXi Biologics started in 2017 with a clinic-ready anti-PD1 antibody, zimberelimab, which possesses molecular properties similar to those of marketed anti-PD1 therapies and has shown impressive clinical anti-tumor activity," said Juan Jaen, Ph.D., president and head of research at Arcus Biosciences. "Furthermore, WuXi Biologics has been an excellent manufacturing partner for our anti-TIGIT antibodies, domvanalimab (AB154) and AB308. We are excited to now extend our existing relationship with WuXi Biologics by combining core competencies to discover anti-CD39 antibodies that have the potential to synergize with adenosine-targeted molecules in our existing portfolio of clinical agents. This will allow us to continue to maintain our position as one of the industry’s leading companies in the targeting of the ATP-adenosine axis for the treatment of cancer."

"We’re thrilled to expand our strategic partnership with Arcus Biosciences to further enable this innovative company to bring new biologics solutions using WuXi Biologics’ proprietary integrated platforms. This partnership is a strong testament to our industry-leading capabilities and expertise," said Dr. Chris Chen, CEO of WuXi Biologics. "We’re committed to offering global open-access technology platforms with premier quality standards to support our global partners as they build their innovative ideas into transformative new treatments for patients worldwide."

Financial terms of the agreement were not disclosed, and the development of any anti-CD39 antibodies from the collaboration is not expected to materially impact Arcus’s financial position over the current cash runway.

On December 9, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that updated results from the ongoing Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place (Press release, Puma Biotechnology, DEC 9, 2020, View Source [SID1234572543]). The presentation entitled, "Latest findings from the breast cancer cohort in SUMMIT – a phase 2 ‘basket’ trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer," is being presented at a Spotlight Poster Discussion Session by Komal Jhaveri, M.D., FACP, Memorial Sloan Kettering Cancer Center, an investigator of the trial. A copy of this poster presentation is available on the Puma website.

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The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 (ERBB2) or lung cancers with EGFR exon 18 mutations (NCT01953926). In the HER2-mutant, hormone receptor (HR)-positive breast cancer cohort, 51 patients received 240 mg of neratinib daily in combination with trastuzumab and fulvestrant. In this cohort, patients had received a median of 4 prior lines of therapy in the metastatic setting (range 1-10 prior regimens) before entering the trial. 36 patients (70.6%) had received prior fulvestrant, 35 patients (68.6%) had received prior aromatase inhibitor and 4 patients (7.8%) had received prior tamoxifen. Further, 30 patients (58.8%) received prior cyclin-dependent kinase 4/6-inhibitor (CDK4/6i) therapy. Thirty-five patients (68.6%) had received prior chemotherapy.

The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 37 RECIST efficacy evaluable patients, 17 patients (45.9%) experienced a confirmed objective response, including one complete response (2.7%) and 16 (43.2%) partial responses, and 20 patients (54.1%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response was 10.9 months and the median progression-free survival was 8.3 months.

The safety profile observed in patients treated with the combination of neratinib plus trastuzumab plus fulvestrant in the SUMMIT study was consistent with that observed previously in metastatic patients with HER2 amplified tumors. All patients received anti-diarrheal prophylaxis with loperamide alone. The interim safety results of the study showed that the most frequently observed adverse event was diarrhea. For the 51 safety evaluable patients enrolled in this cohort, 20 patients (39.2%) reported grade 3 diarrhea. The median duration of grade 3 diarrhea for those patients was 6 days. No patient permanently discontinued neratinib due to diarrhea.

Komal Jhaveri, M.D., FACP, Memorial Sloan Kettering Cancer Center, Clinical Director of the Early Drug Development Service and Assistant Professor of Medicine, Weill Cornell Medical College, said, "HER2 mutations appear to be oncogenic drivers in a subset of metastatic breast cancers and are clinically actionable. The combination of neratinib + trastuzumab + fulvestrant therapy demonstrates encouraging clinical activity with durable responses in this molecular-defined patient population with clinical benefit observed in patients who have previously been treated after standard of care CDK4/6i and endocrine therapies."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are pleased to see that the combination of neratinib + fulvestrant + trastuzumab continues to demonstrate encouraging clinical activity in this heavily pre-treated cohort. We are continuing to enroll the randomized cohorts in the SUMMIT trial of neratinib in hormone receptor positive breast cancer patients with HER2 mutations and we anticipate the completion of this enrollment in the first half of 2021."

On December 9, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies targeting specific pathogenic bacteria, reported the results of an analysis of presence of target bacteria, Fusobacterium nucleatum, in tumor samples obtained from patients with colorectal cancer and reported on progress in engineering of genetic payloads for therapeutic applications (Press release, BiomX, DEC 9, 2020, View Source [SID1234572542]). The analysis confirmed the presence of Fusobacterium nucleatum in over 80 percent of tumor samples obtained from patients with colorectal cancer and identified Fusobacterium nucleatum animalis as the most prevalent subspecie.

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In addition, the Company reported successful engineering of a functional fluorescence gene payload into Fusobacterium nucleatum phage and disclosed three candidate payloads which are being evaluated for delivery to the tumor microenvironment via phage. Candidate payloads include gene-encoding immune-stimulating proteins GM-CSF and IL-15 as well as the pro-drug converting enzyme cytosine deaminase. The BiomX colorectal cancer program utilizes phage therapy in combination with checkpoint inhibitors in order to target bacteria that are naturally present within tumors, with the aim of converting ‘cold’ tumors to ‘hot’ by delivering a payload to the tumor.

The results are featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020 and will be available at the Company’s website at View Source Presentation details are as follows:

Title: Novel Analysis of Fusobacterium Nucleatum Subspecies in Human Colorectal Cancer and Engineering of Therapeutic Bacteriophage
Lead Author: Lihi Ninio-Many, Ph.D., Project Leader, BiomX

On December 9, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the second quarter of fiscal year 2021 before the market open on Thursday, January 7, 2021 (Press release, AngioDynamics, DEC 9, 2020, View Source [SID1234572541]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13714154.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 7, 2021, until 11:59 p.m. ET on Thursday, January 14, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13714154.

On December 9, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for PyLTM (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer (Press release, Lantheus Medical Imaging, DEC 9, 2020, View Source [SID1234572540]).

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The FDA granted Priority Review for the PyL NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021. The FDA has also indicated in the NDA filing acceptance notification that it is not currently planning to hold an advisory committee meeting to discuss the application.

"We are pleased that the FDA has accepted our PyL NDA for review and granted our application Priority Review, which is a significant milestone for Lantheus. We believe that there is a significant unmet need for reliable, targeted imaging in prostate cancer, particularly in the high risk and biochemically recurrent populations," said Istvan Molnar, MD, Chief Medical Officer of Lantheus. "We look forward to working with the FDA during the NDA review process with the goal of bringing PyL to patients and physicians who need it."

The PyL NDA is supported by data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of PyL imaging across the prostate cancer disease continuum. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer. OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent, hormone sensitive, non-metastatic castrate resistant, and metastatic castrate resistant. OSPREY Cohort B demonstrated the sensitivity of PyL PET imaging in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings, demonstrated PyL’s high correct localization rate and detection rate, including in patients with low PSA values. In the CONDOR study, 63.9% of patients had a change in intended disease management plans due to the PyL PET imaging results. We believe the results from these two studies, taken as a whole, demonstrate the ability of PyL to reliably detect and localize disease and could enable more appropriate patient management.

PyL has been administered in approximately 3,500 subjects globally, including the two Company-sponsored pivotal studies, multiple investigator sponsored studies, as well as clinical use reported in the literature. Across these studies, PyL has shown an attractive safety profile.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About OSPREY

The Phase 2/3 OSPREY trial assessed the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high risk, locally advanced prostate cancer (Cohort A) and distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% although the trial did not meet one of its the primary endpoints. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

About CONDOR

The Phase 3 CONDOR trial evaluated the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy. 63.9% of subjects in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the United States currently count themselves among prostate cancer survivors.1