On May 20, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 19, 2021 for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer (mCRPC) with distant metastasis (Press release, Chugai, MAY 20, 2021, View Source [SID1234580339]). With this approval, patients with advanced prostate cancer who may be eligible for the treatment with olaparib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care.

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"We are pleased that the FoundationOne Liquid CDx Cancer Genomic Profiletest was approved as a companion diagnostic for olaparib for advanced metastatic prostate cancer, following the tissue-based FoundationOne CDx Cancer Genomic Profile approval in December last year," said Chugai’s President and CEO, Dr. Osamu Okuda. "Precision cancer medicine is rapidly changing the treatment strategy for mCRPC and it is very important to understand the genomic profile of a patient’s tumor in order to select the optimal treatment. The availability of both liquid and tissue-based companion diagnostics helps to identify patients who may be eligible for olaparib. We are committed to advancing personalized healthcare in cancer treatment."

The approval aims to expand the use of FoundationOne Liquid CDx Cancer Genomic Profile as a companion diagnostic for olaparib in advanced prostate cancer which progressed after treatment with enzalutamide or abiraterone. It identifies patients who my be eligible for the treatment by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25, 2020. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genomic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genomic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.

On May 20, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported that data from its first-in-human Phase 1 trial evaluating RBN-2397, its small molecule inhibitor of PARP7, as a monotherapy in patients with advanced solid tumors was selected for an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ribon Therapeutics, MAY 20, 2021, View Source [SID1234580389]). Presenting the data will be Gerald S. Falchook, M.D., Director, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO and Clinical Investigator in the RBN-2397 Phase 1 trial. The full meeting program is available at: www.asco.org.

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"The data being presented at ASCO (Free ASCO Whitepaper) emphasizes the therapeutic potential of RBN-2397 as a novel inhibitor of PARP7 which aims to restore Type I interferon signaling in tumors and antitumor immunity. Our distinctive approach of targeting stress support pathways is a promising novel strategy for treating multiple types of cancer," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We are encouraged that the data being shared show that RBN-2397 has been well tolerated with evidence of target engagement in the dose escalation portion of our Phase 1 trial and we look forward to providing future updates as the program advances in the clinic."

The data will be presented as follows:

Abstract Title: A first-in-human phase 1 study of a novel PARP7 inhibitor RBN-2397 in patients with advanced solid tumors
Session Date & Time: Friday, June 4, 2021 at 11:00 a.m. ET
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Gerald S. Falchook, M.D., Director, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO and Clinical Investigator in the RBN-2397 Phase 1 trial
Abstract ID: 3000
Summary:

Targeting cytosolic nucleic acid sensing pathways and the Type I interferon (IFN) response is an emerging therapeutic strategy in oncology. PARP7 is a member of the monoPARP class of enzymes and a newly identified negative regulator of nucleic acid sensing in tumor cells. PARP7 expression is increased by cellular stress and aromatic hydrocarbons, and the PARP7 gene is amplified in multiple cancers. RBN-2397 is a potent, selective inhibitor of PARP7. To date, RBN-2397 is well tolerated and demonstrates dose dependent increases in plasma exposures, evidence of target inhibition and preliminary signs of clinical activity.
About RBN-2397
RBN-2397 is an orally available small molecule inhibitor of PARP7 that Ribon Therapeutics is developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors (NCT04053673). PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.

On May 20, 2021 On Target Laboratories, Inc., a privately held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, reported results of the 006 Study, a Phase 3, randomized, multi-center, prospective, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer (Press release, On Target Laboratories, MAY 20, 2021, View Source [SID1234580405]).

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In 33% of patients (36 of 109), near-infrared imaging with pafolacianine sodium injection identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). Among patients who underwent interval debulking surgery, the rate was higher, at 39.7% of patients (23 of 58; 95% CI [0.270, 0.534]).

"We are proud to share the results of the Phase 3 trial for pafolacianine sodium injection in ovarian cancer, which demonstrated identification of additional cancer that was not planned for resection," said Chris Barys, Chief Executive Officer of On Target Laboratories. "These results get us closer to realizing our mission to make cancer visible during surgery so it can be removed more completely."

The data will be presented on June 7 during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract # 5503).

"The surgeon’s ability to achieve a complete resection in ovarian cancer patients impacts their long-term prognosis," said Dr. Janos L. Tanyi, MD, PhD, an Assistant Professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and Principal Investigator of the trial. "The trial results add to the body of evidence supporting the potential of pafolacianine sodium injection as an adjunct to identify malignant lesions that may otherwise be missed."

About the Phase 3 006 Study

In the Phase 3, randomized, multi-center, open-label study, patients with ovarian cancer who were scheduled to undergo cytoreductive surgery were recruited from 11 sites in the US and Netherlands from March 2018 through April 2020. The primary endpoint was the percent of patients in which ≥1 folate receptor positive ovarian cancer lesion was detected by intraoperative fluorescence imaging on tissue not planned for resection and not detected by normal white light or palpation.

This phase 3 trial of pafolacianine sodium injection with near-infrared imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients.

The safety profile observed was consistent with the Phase 2 trial published in 2019.1 The most frequently reported drug-related adverse events (AEs) were nausea (18.0%), vomiting (5.3%), and abdominal pain (4.7%). The majority (97%) of drug-related AEs were mild or moderate in severity and were transient in nature. No drug-related serious AEs or deaths were reported.

On May 20, 2021 Processa Pharmaceuticals, Inc. ("Processa") presented the corporate presentation (Presentation, Processa Pharmaceuticals, MAY 20, 2021, View Source [SID1234580422]).

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On May 20, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported the closing of a $20 million Series A financing of Zentera Therapeutics, a biopharmaceutical company with headquarters in Shanghai, China (Press release, Zentera Therapeutics, MAY 20, 2021, View Source [SID1234585516]). Leading the financing is Tybourne Capital Management, a global investment manager headquartered in Asia, and joining the syndicate is OrbiMed Asia, a leading healthcare fund in Asia. Zentalis, through its wholly owned subsidiaries, remains the majority shareholder of Zentera.

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The proceeds from the Series A financing will be used to develop and commercialize three cancer therapies discovered by Zentalis, in addition to potential future candidates, in China. Anthony Sun, MD, CEO of Zentalis, will serve as CEO of Zentera.

"The launch of Zentera is a key milestone in our global clinical development strategy," commented Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals and Chief Executive Officer at Zentera Therapeutics. "As the second-largest pharmaceutical market in the world, establishing a joint venture in China is the first step toward advancing our product candidates on a global scale. Furthermore, we are building a management team in China of seasoned professionals who are passionate about improving cancer treatment. We would like to thank our partners, Tybourne Capital Management and OrbiMed Asia, for supporting our vision to efficiently advance our best-in-class therapies to markets worldwide."

Bosun Hau, Managing Director and Co-Head of Private Equity at Tybourne Capital Management, commented, "Over the past few years, we have watched Zentalis’ remarkable clinical progress in developing potentially best-in-class candidates for patients with cancer. We are pleased to work with Zentera, as we believe these therapies will greatly benefit patients internationally."

Dr. David Wang, Partner and Senior Managing Director at OrbiMed Asia, added, "At OrbiMed, we are passionate about investing in innovative solutions that improve the lives of patients. The establishment of this joint venture, which helps to bring potentially life-changing treatments to China, aligns with our values and we are delighted to add Zentera to the OrbiMed family."

Zentalis’ pipeline candidates that will be developed in China by Zentera include its oral SERD (ZN-c5), WEE1 inhibitor (ZN-c3), and BCL-2 inhibitor (ZN-d5), which address unmet medical needs in large patient populations in both solid and liquid tumors. Additional Zentalis candidates may also be developed in China by Zentera.