On September 28, 2020 Ona Therapeutics, which is focused on the discovery and development of therapeutic biologics to treat metastatic cancer, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Ona Therapeutics, SEP 28, 2020, View Source;utm_medium=rss&utm_campaign=ona-therapeutics-is-named-as-one-of-fierce-biotechs-fierce-15-biotech-companies-of-2020 [SID1234567656]).

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Valerie Vanhooren, CEO and co-founder of Ona Therapeutics, commented: "It is a great honor to be selected from hundreds of companies around the world as a Fierce 15 company. It has been a transformational year for Ona Therapeutics. Following one of the biggest Series A in Europe this year, this award validates our scientific approach and our commitment to developing first-in-class treatments for metastatic cancer patients. I would like to thank our team for their exceptional work, and we look forward to taking Ona Therapeutics to the next stage of development."

Ona Therapeutics was founded in 2019 by research scientists Salvador Aznar-Benitah and Valerie Vanhooren as an IRB Barcelona and ICREA spin-off. Its approach is based on pioneering work from Dr Aznar-Benitah published in Nature in 2017 that validates Metastasis-Initiating Cells as therapeutic targets in metastatic cancer. In June 2020, Ona Therapeutics raised €30 million in Series A financing to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer. The company’s investors include Asabys Partners, Alta Life Sciences, Bpifrance – InnoBio 2, Fund+ and Ysios Capital.

Now in its 18th edition, Fierce 15 celebrates the next generation of healthcare companies championing innovation and creativity in the face of intense competition. Every year Fierce Biotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On September 27, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the results of a Phase 3, open label, randomized study in China (Press release, Innovent Biologics, SEP 27, 2020, View Source [SID1234567638]). The ORIENT-32 trial evaluating TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection, or IBI305) as a first-line treatment in advanced hepatocellular carcinoma (HCC) met the predefined primary endpoints of progression-free survival (PFS) and overall survival (OS) in an interim analysis. This is the first Phase 3 clinical trial using PD-1 inhibitor-based combination therapy that has met the primary endpoint in the first-line treatment of advanced HCC.

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Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) demonstrated a statistically significant improvement in PFS and OS compared with sorafenib. The safety profile of TYVYT (sintilimab injection) and BYVASDA (bevacizumab biosimilar injection) in this trial was consistent with previously reported studies, and no new safety signals were identified. These data will be presented at an upcoming medical conference. Based on the IDMC recommendation, Innovent will review these results with the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.

The principal investigator of the ORIENT-32 study, Professor Fan Jia from Zhongshan Hospital of Fudan University, stated: "In China, HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year. At present, sorafenib, lenvatinib and chemotherapy are the main treatments for HCC in the first-line treatment setting in China, with very limited efficacy. About 85% of HCC patients in China have the history of HBV infection, which is a quite different feature from HCC in the European and American countries. Therefore, continued clinical research in treating HCC is of great importance in China. The ORIENT-32 study confirmed that TYVYT (sintilimab injection), in combination with BYVASDA (bevacizumab biosimilar injection), can prolong PFS and OS in the first-line treatment of HCC. Despite the COVID-19 pandemic, all study investigators worked to overcome many challenges to continue this trial with the goal of bringing new hope to HCC patients."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent stated: "TYVYT is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List in China. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy. BYVASDA (bevacizumab biosimilar injection) was officially approved by the NMPA for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. The results of the ORIENT-32 study demonstrate the potential of TYVYT in combination with BYVASDA to treat patients with advanced HCC in the first-line setting. We hope this clinical trial can potentially provide a more effective treatment option for clinicians and HCC patients. We would like to express our sincere gratitude to all the patients and investigators who participated in the ORIENT-32 study. Outstanding contributions were made through the joint efforts of investigators and the study team, despite the challenges and impact from the COVID-19 pandemic.

About ORIENT-32 Trial

ORIENT-32 is a Phase 3 randomized, open-label, multi-center study to evaluate the efficacy and safety of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT 03794440). The primary endpoints are progression-free survival (PFS) and overall survival (OS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.

Enrolled patients were randomly assigned 2:1 to receive TYVYT (sintilimab injection) combination with BYVASDA (bevacizumab biosimilar injection) or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About Hepatocellular Carcinoma (HCC)

Primary liver cancer (PLC) is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma (ICC) and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection) is an innovative drug with global quality standards jointly developed by Innovent and Lilly in China. TYVYT has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy and was included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the NRDL in November 2019.

In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy in nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with GEMZAR (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications globally, including more than 10 registrational or pivotal clinical trials.

About BYVASDA (Bevacizumab Biosimilar Injection)

BYVASDA (IBI305) is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

On September 27, 2020 InventisBio, a clinical stage biotech company dedicated to the research and development of innovative small molecule drugs, reported the recent completion of a $147 million series D financing which has attracted participation of many top biopharmaceutical and healthcare venture capital funds (Press release, InventisBio, SEP 27, 2020, View Source [SID1234567637]). This round of investment was led by Hillhouse affiliate GL Ventures, followed by Qiming Venture Partners, Janchor, AIHC Capital, Matrix Partner China, Dyee Capital, E Fund Capital and other investors. The existing shareholders including Lilly Asia Venture, OrbiMed Asia, Pudong Innotek, AdvanTech Capital, and CMB International continued their support. China Renaissance was the exclusive financial advisor of this transaction.

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Currently InventisBio has three drug products in the mid- to late-stage clinical development, and one new product just entered global phase I clinical study. Among them, D-0502 is an oral selective estrogen receptor degrader (SERD), which also acts as an estrogen receptor antagonist, with therapeutic potential for the treatment of hormone receptor positive breast cancer. Compared with other oral SERDs under clinical development worldwide, D-0502 has shown promising anti-tumor activity during phase 1 study with excellent bioavailability and tolerable safety profile. In addition, the company has independently developed a third-generation EGFR-T790M tyrosine kinase inhibitor BPI-D0316 and out-licensed China right to Betta Pharma. This product is currently in registration trials of first- and second-line treatment of EGFR-mutated non-small cell lung cancer patients and the trials are progressing smoothly.

Dr. Yaolin Wang, Chairman and CEO of InventisBio, said: "InventisBio is committed to developing first- and best-in-class innovative drugs for cancer and other major diseases. We are grateful and honored to have Hillhouse’s GL Ventures led this series D round and thankful to other top investment funds, as well as the continued support from the existing investors. This investment demonstrated the recognition of our strong pipeline and fully integrated innovative R&D platform by top healthcare investors. It also shows our strategic investors’ confidence in the future success of our company as a key player in the global pharmaceutical market."

Funds raised in this round will be mainly used to support the company’s current products into phase II clinical studies in China and the United States, including D-0502 trials in hormone receptor positive breast cancer and D-0120 trials in gout. This round will also support the company’s global clinical development of other new drugs, enable further expansion of the company’s product pipeline and team.

Michael Yi, co-chief investment officer of Hillhouse Capital and head of biomedicine and medical devices of Hillhouse’s GL Ventures, said: "As a small molecule innovative drug research and development company, InventisBio has an in-depth knowledge of small molecules’ structure activity relationship and integrated understanding and experience in the efficient and successful development of novel molecules. The founding members have more than 20 years of experience in drug discovery and development, thorough understanding of drug’s mechanism of action and selection of lead candidate for development. Since its establishment, InventisBio has balanced innovation and druggability, and has effectively developed multiple assets for diseases with unmet clinical needs. With four drug candidates in various clinical stages and two clinical registration trials ongoing, InventisBio has established its pipeline in two major therapeutic areas of oncology and metabolic diseases. In addition, the company has maintained a leading position in the drug development of similar products in China. We look forward to developing deep collaboration with InventisBio, advancing its drug discovery and clinical development to bring innovative drugs to the market faster to benefit more patients."

On September 27, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS ) and Menarini Group reported an update on Elacestrant Phase 3 EMERALD Study known (Press release, Radius, SEP 27, 2020, View Source [SID1234567636]).

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The target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant. Elacestrant is an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer. The study reached its enrollment goal of 466 patients overall, including 220 (47%) with tumors harboring an ESR1 mutation as detected in circulating tumor DNA by the Guardant Health Guardant360 liquid biopsy test.

Patients will be followed until the required number of events to assess progression-free survival – the primary endpoint of the study – is reached at which time the primary analysis will be performed. It is anticipated that this analysis will take place in the second half of 2021.

An independent data monitoring committee (IDMC) has been continuously monitoring the safety and efficacy of patients enrolled in the EMERALD trial. After enrollment of 70% of planned patients, the committee formally reviewed results of a futility analysis. In completing their review, the IDMC recommended that the trial continues to advance in an unmodified manner.

"We are thrilled about the continued progress for the program. Elacestrant continues to be the most advanced oral SERD in Phase 3 development and given that, we aim on being first to deliver Phase 3 data in the class, and upon clinical success, a regulatory submission," said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.

Commenting further, Barker Ergun added that "the Menarini/Radius partnership has been a tremendous success to date and the completion of patient enrollment in the EMERALD trial brings us one step closer to bringing an oral SERD to women and men with advanced breast cancer."

Dr. Maureen Conlan, Oncology Therapeutic Area Head for Radius, commented "Completing the enrollment of the EMERALD trial, despite the challenges of the COVID-19 pandemic, has been a great achievement. I am grateful to our team as well as the study investigators and patients for their efforts to date in supporting and participating in this trial."

In summarizing on recent progress, Dr. Charles Morris, Chief Medical Officer for Radius added "This is an exciting milestone for Radius and our partner, the Menarini Group, with regard to the elacestrant program. We look forward to seeing additional advancement of the program including activities related to various life cycle management opportunities for the compound."

On September 25, 2020 Nirogy Therapeutics Inc. reported that it was awarded a $2M NIH/NCI SBIR grant to develop dual monocarboxylate transport inhibitors (dMCTi) for Triple Negative Breast Cancer (TNBC) (Press release, Nirogy Therapeutics, SEP 25, 2020, View Source [SID1234576776]).

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"We are delighted to receive this highly competitive award from NIH/NCI under small business innovation research grant program. We are appreciative of the continued support from NCI for our breast cancer program. I believe that this award attests the validity of our science strategy to target the untapped class of solute carrier transporters (SLCT) family of proteins for cancer, and the progress we have made so far in this breast cancer program. This fund allows us to rapidly move through the initial stages of commercialization activities and execute part of the IND enabling studies for the pre-clinical development candidate compound" stated Dr. Vincent Sandanayaka, Founder, President & CEO of Nirogy Therapeutics.

Worldwide, approximately 1 million women are diagnosed with breast cancer each year. TNBC is the deadliest sub-type of breast cancer, accounting for ~15% of the breast cancer diagnoses and ~25% of breast cancer-related deaths. Median survival for 30% of the patients with TNBC is just one year. TNBC has poor clinical outcomes due to its high metastatic rate, resistance to chemotherapy, and lack of effective treatment options. The lactate-rich tumor microenvironment (TME) of TNBC has been shown to be highly immunosuppressive, promoting tumor growth and progression. Lactate metabolite produced from glucose metabolism via glycolysis is increasingly recognized as a strong immune suppressor in many tumors.

Cancer cells transport lactate across the cell membrane to the extracellular matrix via monocarboxylate transporters, MCT1 and MCT4. We have discovered that dMCTi block lactate excretion to the TME, thereby directly killing cancer cells and simultaneously activating local immunity in the TME. In our preliminary studies, we have shown that dMCTi are potent compounds against multiple TNBC cell lines. Also, we have shown that in both mouse xenograft models (MDA-MB-231, TNBC), and syngeneic mouse models (SM1, BRAFV600E, melanoma; and 4T1, TNBC), dMCTi exert significant anti-tumor efficacy. In 4T1 and SM1 syngeneic models, we observed a decrease in expression of multiple immunosuppressive molecules such as B7H family proteins, M2 macrophages, and MDSCs while increase in CD8+ population in treated tumors compared to the control tumors. Furthermore, the profiling of cytokines in these tumors indicated an increase in pro-inflammatory IFNγ, TNFα, IL-1β and decrease in tumor promoting TGFβ, IL-10 compared to the control tumors, confirming that the anti-tumor effect of dMCTi is in part due to the enhanced immune function.