On June 5, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer (Press release, MacroGenics, JUN 5, 2020, View Source [SID1234560863]).

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Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with advanced HER2-positive GC or GEJ cancer who have previously been treated with chemotherapy and trastuzumab in the metastatic setting. Data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in September 2019.

"We are pleased that the FDA has granted orphan status to margetuximab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We believe that our immune-enhancing antibody targeting HER2 has the potential to improve upon the clinical activity of existing standard of care for patients with gastric or gastroesophageal cancer."

The FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases of disorders that affect fewer than 200,000 people in the U.S. The designation provides certain incentives, which may include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

About Margetuximab

Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.

On June 5, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11 at 4:40 p.m. ET (Press release, Arvinas, JUN 5, 2020, View Source [SID1234560862]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On June 5, 2020 hugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib), for the treatment of homologous recombination repair mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Chugai, JUN 5, 2020, View Source [SID1234560861]).

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"Currently, various approaches are progressing to investigate new treatments for patients with mCRPC who are resistant to hormonal therapy and genomic medicine could become an important treatment option," said Dr. Osamu Okuda, Chugai’s President and COO. "Since HRR gene alterations are recognized to be identified in multiple genes, we believe FoundationOne CDx Cancer Genomic Profile will be a useful tool that can support physicians to identify patients who may benefit from treatment with Lynparza by comprehensively understanding patients’ genomic profiles."

The filing aims to expand the use as a companion diagnostic to identify patients who could benefit from Lynparza for the treatment of mCRPC with HRR related gene alterations, and have progressed following prior treatment with enzalutamide or abiraterone by detecting HRR related gene alterations. The efficacy and safety of Lynparza in mCRPC patients were investigated in the Phase III PROfound study. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and MSD (MSD: known as Merck & Co. inside the US and Canada).

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

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

On June 4, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that it has entered into a collaboration agreement with the Explorations in Global Health (ExGloH) Division of Leidos to evaluate the potential of using ONCOS oncolytic adenoviruses as a vector to encode Microtide checkpoint inhibitor peptides (Press release, Targovax, JUN 4, 2020, View Source [SID1234564001]).

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Targovax’s clinical program is focused on combining ONCOS viruses with checkpoint inhibitors. This combination is promising since checkpoint inhibition complements oncolytic virotherapy by blocking the tumor’s main defense mechanism against the anti-tumor immune response generated by the oncolytic virus.

ExGloH has developed a unique, proprietary portfolio of microbially-derived peptides, called MicrotideTM, that act as immune checkpoint inhibitors. The simple structure and small size of Microtide peptides make them well-suited for delivery by DNA vectors, and the parties will explore whether this capability can be extended to ONCOS viruses. If successful, this could potentially circumvent the need to combine ONCOS with classical systemically delivered checkpoint inhibitors.

Under the agreement, Leidos and Targovax will investigate the technical feasibility, in vitro and in vivo immune modulatory, and anti-cancer properties of encoding Microtide checkpoint peptides in the ONCOS adenovirus backbone. If successful, the combined ONCOS and Microtide constructs may serve as a platform where additional functionality can be built in to stimulate multiple complementary anti-tumor mechanisms.

Dr. Erik Digman Wiklund, Chief Business Officer of Targovax, said: "We are continuously looking for new strategies to enhance the immune activation potential and explore novel payloads for our ONCOS viruses. In ExGloH we have found a collaborator with a unique class of checkpoint inhibitors that we believe perfectly complements ONCOS. We are very excited to jointly explore whether the ONCOS and Microtide combination can enhance the second generation of ONCOS viruses and serve as a platform for future clinical product candidates to fulfil important medical needs."

On June 4, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported the publication of a prospective study demonstrating that the EndoPredict test predicts which patients with ER+, HER2- early-stage breast cancer will benefit from neoadjuvant therapy (Press release, Myriad Genetics, JUN 4, 2020, View Source [SID1234561737]). The article titled, "The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial," appeared online in the European Journal of Cancer.

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"This study demonstrated that the EndoPredict (EP) test predicted response to neoadjuvant chemotherapy or neoadjuvant endocrine therapy in women with ER+, HER2 negative early-stage breast cancer," said Peter Dubsky, M.D., lead author, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). "Based on these findings and prior studies, we are confident the EndoPredict test can add valuable information to aid in personalized treatment selection in neoadjuvant therapy and provides an important basis for future design of neoadjuvant clinical trials."

The primary objective of this prospective study was to test the predictive value of the EndoPredict test regarding tumor response after neoadjuvant chemotherapy (NaCT) or neoadjuvant endocrine therapy (NET) within the ABCSG-34 trial. The analysis included data from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive NaCT (eight cycles of anthracycline/taxane) according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A-like types of breast cancer and were assigned to receive NET (six months of letrozole). The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.

In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the "luminal A" group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

Table. 1

EndoPredict
Low Score

EndoPredict
High Score Predictive Performance
EndoPredict Score
(p-value)
Response to Neoadjuvant Chemotherapy

0.0

%

26.4

%

p=0.0001
Response to
Endocrine Therapy 27.3 % 7.7 % P=0.015
"In this prospective study, we demonstrated that the EndoPredict test is a useful tool pre-operatively," said Ralf Kronenwett, M.D., director of International Medical Affairs at Myriad. "In two distinct ER-positive, HER2-negative cohorts selected by clinicians to receive neoadjuvant chemotherapy or neoadjuvant endocrine therapy, EndoPredict identified patients with poor neoadjuvant treatment response. Clinicians can use information to determine who might forgo these therapies prior to surgery."

About EndoPredict
EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.