On September 21, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the first patient treated in a pivotal trial designed to measure the safety and efficacy of HBI-8000 combined with Bristol Myers Squibb’s anti-PD-1, antibody Opdivo (nivolumab), in patients with unresectable or metastatic melanoma (Press release, HUYA Bioscience, SEP 21, 2021, View Source [SID1234590092]). The multicenter, randomized, double blinded, placebo-controlled Phase 3 trial entitled, "Study Comparing the Investigational Drug HBI-8000 Combined with Opdivo vs. Opdivo in Patients with Advanced Melanoma," will have a primary outcome of objective response rate and progression-free survival. Secondary outcomes include safety and overall survival. Opdivo is a trademark of Bristol-Myers Squibb Company.

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "The initiation of the Phase 3 trial represents another significant milestone for HBI-8000 following the recent approval for the drug as monotherapy for the treatment of ATLL in Japan. The Company has taken another important step in expanding the clinical indications for our lead oncology asset in solid tumors. The results from our Phase 2 trial of HBI-8000 combined with Opdivo in solid tumors pointed to the important immunomodulatory activity for our drug. We are pleased to begin this global study in collaboration with Bristol Myers Squibb."

The pivotal multi-national trial will enroll 480 patients from the United States, Europe, Australia, New Zealand and Japan. In the US Phase 2 trial, the combination of HBI-8000 with Opdivo was well tolerated with a favorable safety profile in checkpoint naïve melanoma patients who achieved a promising clinical response.

"Australia has one of the highest rates of melanoma in the world, especially relevant to the Sunshine Coast and Queensland", said Principal Investigator Dr. Hong Shue, who treated the first patient and is from Sunshine Coast Haematology and Oncology Clinic and University of the Sunshine Coast Clinical Trials Unit. "We are really excited to participate in this HUYABIO International sponsored Phase 3 registrational clinical trial. This trial potentially offers a practice-changing, effective combination treatment of HBI-8000 with Opdivo to our patients on the Sunshine Coast. This study, if positive, may provide an additional treatment option and significant change in the metastatic melanoma treatment paradigm."

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models. The Company recently reported results from its ongoing Phase 2 study for the Opdivo combination demonstrating an overall objective response rate of approximately 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.

On September 21, 2021 Roivant Sciences Ltd. ("Roivant" or the "Company"), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the fiscal quarter ended June 30, 2021 and provided an update on the Company’s operations (Press release, Roivant Sciences, SEP 21, 2021, View Source [SID1234590091]).

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"Over the past quarter we have made significant progress as a business, both at Roivant centrally and across our family of companies," said Matthew Gline, Chief Executive Officer of Roivant. "I look forward to providing an update on these developments and an overview of key milestones to come at our R&D Day next week."

On September 28, Roivant will host its annual R&D Day, at which the Company will provide updates on clinical development at the Vants and Roivant’s new small molecule discovery engine. The webcast for this virtual event will begin at 1 p.m. ET and can be accessed at View Source

Recent Developments

Datavant: In June 2021, Datavant and Ciox Health entered into a definitive agreement to merge the two companies. The combined entity, named Datavant, is the nation’s largest health data ecosystem, enabling patients, providers, payers, health data analytics companies, patient-facing applications, government agencies and life science companies to securely exchange their patient-level data. The merger closed on July 27, 2021. At closing, Roivant received approximately $320 million in cash and a minority equity stake in the combined company.
Aruvant: In June 2021, Aruvant announced data published on ARU-2801, an investigational gene therapy, that showed improved survival out to 18 months in hypophosphatasia mice.
Immunovant: In August 2021, Roivant made a $200 million investment in Immunovant. Following this transaction, Roivant owns 73,398,664 shares of Immunovant common stock, representing approximately a 63.8% ownership interest.
Dermavant: In August 2021, the FDA accepted for filing Dermavant’s NDA for tapinarof for the treatment of plaque psoriasis in adult patients. The FDA has assigned a PDUFA target action date in the second calendar quarter of 2022. In September 2021, Dermavant dosed the first patient in a Phase 3 trial of tapinarof for the treatment of atopic dermatitis.
Genevant: In August 2021, Genevant entered into a global collaboration and license agreement with Takeda for the development and commercialization of novel nonviral gene therapies for up to two rare liver diseases. Genevant will be eligible for up to $303 million in upfront and potential milestone payments, plus royalties on product sales. This is the second collaboration between Genevant and Takeda.
Major Upcoming Milestones

Roivant: We expect to close our business combination with MAAC, along with a concurrent PIPE financing, and commence trading on Nasdaq on October 1 under the symbol "ROIV." Assuming no redemptions by MAAC shareholders, the business combination and concurrent PIPE financing are expected to deliver approximately $575 million in net proceeds to Roivant.
Dermavant: We expect a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second calendar quarter of 2022. We also expect to report topline data from Dermavant’s Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
Immunovant: Contingent upon FDA feedback, Immunovant plans to initiate a pivotal trial evaluating IMVT-1401 for the treatment of myasthenia gravis in the early part of calendar year 2022. Immunovant also plans to announce at least two new indications and submit INDs with their trial designs to the FDA over the next 12 months.
Aruvant: We expect Aruvant to report additional clinical data from the ongoing Phase 1/2 trial of ARU-1801 in sickle cell disease patients in the second half of calendar year 2021.
First Fiscal Quarter 2021 Financial Summary

Research and Development Expenses

Research and development expenses increased by $19.9 million to $78.6 million for the three months ended June 30, 2021 compared to $58.7 million for the three months ended June 30, 2020. The increase is primarily due to an increase in personnel-related expenses, which is partially driven by additional headcount to support drug discovery efforts using our computational discovery technology and targeted protein degradation platform, following the acquisition of Silicon Therapeutics in March 2021 and Oncopia Therapeutics, Inc. in November 2020.

General and Administrative Expenses

General and administrative expenses increased by $25.6 million to $82.8 million for the three months ended June 30, 2021 compared to $57.1 million for the three months ended June 30, 2020. The increase was primarily due to increases in professional and transaction fees, personnel-related expenses and share-based compensation expense.

Capital Resources

As of June 30, 2021, we had cash and cash equivalents of approximately $2.0 billion.

On September 21, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 8:00 a.m. EDT on Tuesday, September 28, at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Puma Biotechnology, SEP 21, 2021, View Source [SID1234590089]).

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A webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On September 21, 2021 Persephone Biosciences Inc., ("Persephone") a privately held, data-driven microbiome-focused biotechnology company, reported that it has entered into a collaboration agreement with Janssen Biotech, Inc. (‘’Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Janssen Biotech, SEP 21, 2021, View Source [SID1234590087]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the collaboration, Persephone will analyze stool samples collected as part of a Janssen oncology clinical trial using Persephone’s proprietary stool collection kit, and the company will have exclusive licensing rights to any biomarkers discovered.

"We are excited for this collaboration as it will provide us with an opportunity not only to further our understanding of the microbiome’s role in disease, but also to build upon the growing body of evidence highlighting the microbiome’s role in influencing patient treatment outcomes," said Stephanie Culler, CEO and Co-founder of Persephone Biosciences.

Persephone’s laboratories are currently located at the Johnson & Johnson Innovation – JLABS incubator in San Diego, CA and the company is also part of BLUE KNIGHTTM, a joint initiative between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA) dedicated to anticipating potential health security threats, activating the global innovation community, and amplifying scientific and technological advancements with the aim to prepare for and respond to our rapidly evolving global health environment.

On September 21, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a collaboration with the Center for Immunotherapy and Precision Immuno-Oncology (CITI) and the Cleveland Clinic Lerner Research Institute, Cleveland, Ohio (Press release, Personal Genome Diagnostics, SEP 21, 2021, View Source [SID1234590084]).

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Both parties will collaborate to enhance capabilities within elioTM plasma complete reporting, as well as collaborate on the development of proprietary methods for complex biomarker detection and assay iterations to meet emerging liquid biopsy applications in solid tumors. This strategic collaboration combines Cleveland Clinic’s world-class research and commitment to innovation with the comprehensive PGDx portfolio and actionable genomic information. Both organizations are driven to elevate the standard of care for patients and increase utilization of precision diagnostics within the cancer care continuum.

"We are thrilled to collaborate with Cleveland Clinic, whose dedication to empowering the best care and research possible for patients with cancer, along with an immense track record of superior outcomes, makes them an ideal partner in this venture," said PGDx CEO Megan Bailey. "We look forward to expanding upon the capabilities of elioTM plasma complete and paving the way for a Center of Excellence enabling enhanced testing of ctDNA in cancer."

The CITI ctDNA team will work closely with the Cleveland Clinic Taussig Cancer Institute and the Pathology and Laboratory Medicine Institute to accelerate progress in ctDNA work in cancer patients. This effort is a partnership with Jame Abraham, M.D., Interim Chair, Cleveland Clinic Taussig Cancer Institute and Brian Rubin, M.D., Chairman of the Pathology and Laboratory Medicine Institute at Cleveland Clinic.

Timothy Chan, M.D., Ph.D., Chair of Cleveland Clinic’s Center for Immunotherapy & Precision Immuno-Oncology, said "This collaboration allows us to continue exploring new options to improve treatment strategies and patient outcomes in cancer. By investing in comprehensive testing solutions that utilize non-invasive sampling techniques, we intend to explore the clinical utility of high impact biomarkers such as blood TMB, clonal hematopoiesis, and others, with the aim to improve therapeutic modalities for human cancers."