Applied BioMath, LLC to Present at World Bispecific Summit

On September 21, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development reported their participation at the World Bispecific Summit occurring virtually September 29 – October 1, 2021 (Press release, Applied BioMath, SEP 21, 2021, View Source [SID1234590099]).

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Alison Betts, PhD, Vice President of Scientific Collaborations and Fellow of Modeling & Simulation at Applied BioMath will present "Mechanistic Strategies for Modeling Avidity: Application in the Design of Tumor Selective Bispecific Antibodies in Oncology" on Thursday, September 30th at 8:50 a.m. ET. In this presentation, Dr. Betts will discuss the importance of avidity in designing tumor selective bispecific antibodies and how modeling can help interpret titration curves and optimize single-site binding affinities. She will also explain a case study about optimizing a 2+1 format T-cell engager for binding selectivity to tumor cells.

"Mechanistic modeling strategies can help understand complexities innate in bispecific design that are not often straightforward or intuitive," said John Burke, PhD, Co-founder, President and CEO of Applied BioMath. "Dr. Betts will explain how an avidity binding systems pharmacology model provided guidance about bispecific molecules and how the model was expanded and translated into a collaboration."

Learn more about Applied BioMath’s work in bispecifics at View Source

LIPAC Oncology to Present at Upcoming Investor Conferences

On September 21, 2021 LIPAC Oncology LLC., a pharmaceutical company utilizing its liposome-bound nano-technology platform to provide precision targeted cancer drugs for the treatment of multiple tumor types, reported that management will participate in the following investor conferences, which will all be held virtually:

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Thursday, September 23, 2021 at 2:55 p.m. E.T.
A.G.P. Biotech & Specialty Pharma Conference on Wednesday, October 13, 2021
BMO Life Sciences Private Company Showcase on Thursday, October 14, 2021 at 9:00 a.m. E.T.
A live webcast of the Oppenheimer and BMO presentations can be accessed by visiting the home page of the Company’s website: View Source

About LiPax

LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). Its liposome-bound nano-technology platform achieves targeted tissue penetration with undetectable systemic exposure, toxicity or chemo-related side-effects. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), thoracic cancers (mesothelioma and malignant pleural effusion) and peritoneal and ovarian cancers. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal followed by intravesical instillation using a typical urinary catheter. LIPAC Oncology completed a Phase 2a clinical trial in August 2020 and intends to initiate a Phase 2b study in the second half of 2021 to further investigate LiPax in the treatment of this condition.

Heron Therapeutics to Present at the 2021 Cantor Virtual Global Healthcare Conference

On September 21, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET (Press release, Heron Therapeutics, SEP 21, 2021, View Source [SID1234590095]).

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

HUYABIO Announces First Patient Treated in a Pivotal Study of HBI-8000 Combined with Opdivo® (nivolumab) in Patients with Advanced Melanoma

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.

Roivant Sciences Reports First Fiscal Quarter 2021 Financial Results and Provides Business Update

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.