On April 14, 2022 Asieris Pharmaceuticals (688176.SH), a global innovative pharmaceutical company specializing in the treatment of genitourinary cancers and related major diseases, reported its 2021 annual report today (Press release, Asieris Pharmaceuticals, APR 14, 2022, https://www.prnewswire.com/news-releases/asieris-pharmaceuticals-announces-2021-annual-report-steady-progress-in-core-product-pipeline-and-progressive-implementation-of-the-integrated-diagnosis-and-treatment-commercialization-strategy-301525937.html [SID1234612258]). The company is currently making steady progress in multiple global clinical trials for its core investigational drugs and is actively implementing its integrated diagnosis-treatment strategy for commercialization. In addition, the company has sufficient capital reserves for increased R&D investment. It will continue to focus on genitourinary cancers and related major diseases and to explore other highly unmet medical needs. Asieris Pharmaceuticals is becoming a leading global pharmaceutical company in its areas of focus with combined capabilities in R&D, manufacturing, and commercialization, especially by providing the best integrated diagnosis-treatment solutions for patients in China and around the world.

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Indication Expansion and Pipeline Globalization

In the genitourinary (GU) disease area, our core product APL-1202 (trade name: VesiqueTM), independently developed by Asieris, is a first-in-class, orally available and reversible MetAP2 inhibitor for anti-tumor treatment, currently in pivotal/phase III clinical trials. It is also the world’s first oral therapeutics for non-muscle invasive bladder cancer (NMIBC) in the pivotal/phase III clinical phase. Patient recruitment for the combination of APL-1202 and intravesically instilled chemotherapy in relapsed intermediate- and high-risk NMIBC was completed in September 2019, with follow-up currently ongoing. Patient recruitment for APL-1202 monotherapy as a first-line treatment in naive, intermediate-risk NMIBC started in September 2021. In addition, an international multicenter phase I/II clinical trial for its oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) was approved by US FDA and China CDE in June and September 2021, respectively. Recruitment of the first patient has been completed. Previously, results from the phase II clinical trial of APL-1202 for the treatment of chemo-instillation relapsed high-risk NMIBC patients showed significant efficacy compared to chemo-instillation alone as a historical control, making APL-1202 potentially the first choice for second-line therapy in chemo-relapsed intermediate- and high-risk NMIBC patients.

APL-1706 (trade name: Hexvix), another core product in the GU area from Asieris Pharmaceuticals, is the world’s only approved imaging agent indicated for bladder cancer diagnosis or surgery. It has been marketed in more than 30 countries and received approval from China NMPA for a phase III bridging clinical trial in February 2022. APL-1706, combined with blue light cystoscopy, can effectively improve the detection rate of NMIBC (especially for carcinoma in situ), resulting in more complete resection and reduction of tumor recurrence rate.

APL-1501, independently developed by Asieris Pharmaceutical utilizing its proprietary Prodrug Accurate Drug Delivery (PADD) technology platform, is a second generation oral MetAP inhibitor for the treatment of GU tumors and drug-resistant urinary tract infections. A Phase I clinical trial is currently underway in Australia. Based on the results, Asieris Pharmaceuticals will continue the clinical development of APL-1501 for the treatment of GU tumors and drug-resistant urinary tract infections.

In the women’s health area, Asieris’ core product APL-1702 (trade name: Cevira) is a drug-device combination photodynamic therapy product for non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL) caused by any HPV subtypes. It has received regulatory approvals for an international multi-center phase III clinical trial in China, Hungary, Ukraine, Germany, Slovakia, the Czech Republic, the Netherlands, and Poland. Patient recruitment is well under way. At present, non-surgical options do not exist on the market for HSIL patients. APL-1702 could provide patients with a new option that alleviates the pain and risky side effects commonly associated with surgical treatments. APL-1702 will be especially beneficial to women of childbearing age by eliminating the adverse impact of surgical treatment on reproductive functions.

Innovation in Integrated Diagnosis & Treatment Solutions with Accelerated Commercialization

Asieris Pharmaceuticals has strategically developed its business in the genitourinary field, via a highly differentiated product portfolio covering bladder cancer diagnosis, treatment, and follow-up. We effectively address the unmet clinical needs in this field with innovative and integrated diagnosis-treatment solutions for doctors and patients. These include APL-1706, the world’s only approved imaging agent indicated for the diagnosis and surgical treatment of bladder cancer; APL-1202, the only first-in-class orally administered reversible MetAP2 inhibitor for bladder cancers (NMIBC and MIBC); and APLD-2101, a versatile integrated single-use flexible cystoscope for diagnosing bladder diseases.

Asieris Pharmaceuticals is also making solid progress in commercialization by building an end-to-end team: from marketing, sales, commercial operations, market access, integrated operation of diagnosis and treatment, to sales efficiency. We have also launched related products in Hainan Province’s Bo’ao Lecheng National Pilot Zone of International Medical Tourism.

On 20 May 2021, Asieris Pharmaceutical and Sinopharm Group signed a strategic collaboration agreement for launching innovative pharmaceutical and device products in Bo’ao Lecheng. As a result, selected Chinese patients had early access to APL-1706, which also subsequently received approval in March 2022 by the CDE to be included in the real-world clinical data pilot program.

Asieris Pharmaceuticals will continue to develop and implement other comprehensive integrated solutions for diagnosis and treatment to serve patients around the world.

Maintenance of a Healthy Financial Position. Implementation of an ESG Management System

Asieris Pharmaceuticals maintained a healthy financial position while steadily advancing various new drug R&D projects. In 2021, the R&D expenditures amounted to RMB 190.74 million yuan, an increase of 10.88% from the previous year; the monetary funds and trading financial assets at the end of this reporting period amounted to RMB 2.98 billion yuan, with a sufficient capital reserve.

In terms of non-financial indicators, the company has incorporated environmental, social responsibility and governance (ESG) into its corporate development strategy, and continues to build and improve its ESG management system, including paying close attention to environmental protection and the goals of "carbon peaking and carbon neutrality", addressing climate change, optimizing environmental management practices, contributing to green environmental protection, and promoting sustainable development; adhering to the people-oriented principle and incorporating talents development into the company’s strategic goals, protecting employees’ rights, and creating a respectful, equal and collaborative working environment; establishing good corporate governance, strictly abiding by national and local laws and regulations, adhering to the code of integrity and ethics, and creating value for shareholders, customers, employees, partners, and communities.

"In 2021, we have made steady progress across our R&D pipelines and have laid a solid foundation for commercialization and globalization", summarized Dr. Kevin Pan, Founder, Chairman, and CEO of Asieris Pharmaceuticals. "Going forward, we will continue to focus on our clinical specialties by delving deeply into the genitourinary oncology field, filling the gap in the diagnosis and treatment of bladder cancer and cervical precancerous lesions, and bringing more innovative solutions to patients worldwide. The road is long and arduous, and we must press on to achieve our goals. We will continue to adhere to our differentiated development and commercialization strategy and act in alignment with our corporate mission of improving human health and making life more dignified."

On April 14, 2022 Illumina, Inc. (NASDAQ: ILMN) reported that it will issue results for the first quarter 2022 following the close of market on Thursday, May 5, 2022 (Press release, Illumina, APR 14, 2022, View Source [SID1234612257]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, May 5, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing (877) 502-9276 or +1 (313) 209-4906 outside North America, both with Conference ID 7035119. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 14, 2022 XIFIN reported that it has partnered with NCODA, Inc., a globally recognized association that develops unique resources to help medically integrated oncology teams deliver top-tier care (Press release, NCODA, APR 14, 2022, View Source [SID1234612249]). This new strategic partnership "NCODA Informatics Initiative Powered by VisualStrata" provides use of VisualStrata as part of the NCODA membership. As oncology groups work to find and secure clinical trials – thereby expanding patient care options within their practice – purpose-built solutions are needed to enhance the data from their existing electronic health record (EHR) or practice management system (PMS). The partnership will enable NCODA members to integrate and curate siloed patient-centric data from disparate systems into a single unified view for their practice. Enterprise healthcare informatics solutions have previously been financially out of reach for many oncology practices. This initiative provides economies of scale and will help bridge the gap between oncology practices, genomic testing providers, and pharmaceutical stakeholders via a common cause, expanding patient options via clinical trial participation.

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Explicitly designed for oncology, VisualStrata collates structured and unstructured data into a single unified view that includes EHR data, multi-specialty diagnostic results, therapy data, and most importantly, genomic data and social determinants of health (SDOH). The VisualStrata platform gives oncology professionals the power of advanced real world data analytics. Longitudinal patient journeys, treatment paths, and patient and cohort centric insights are crucial to increasing clinical trial participation, reducing administrative burden, and improving the financial health of oncology practices. Oncology groups using VisualStrata decrease their labor costs associated with clinical trial feasibility assessments and significantly reduce the turnaround time for retrospective reviews that help determine practice-level fit and patient volumes. At the same time, practices will be reaping the benefits of a common repository of oncology patient data that can be used to support cancer research initiatives and clinical trial participation.

NCODA’s mission is to empower the medically integrated oncology team to deliver positive, patient-centric outcomes. "Having learned much about VisualStrata from the progress made at one of our member practices, Utah Cancer Specialists, we felt this initiative aligned with our Mission and we decided to introduce the program to our over 800 member practices," said Michael Reff, RPh, MBA, Founder and Executive Director of NCODA. "This unique partnership and program, complimentary to our members, will support researchers’ and clinicians’ efforts, enabling access to the right information, for the right patient, at the right time. This supports our Vision of making sure every cancer patient receives the maximum benefit from their treatment."

The VisualStrata platform also features stringent security measures and controls to keep data safe and accessible to authorized parties. Through continual monitoring, XIFIN will alert, respond, and remediate threats to data security in near-real-time. VisualStrata was launched and adopted by Utah Cancer Specialists, the largest community-based oncology and hematology practice in Utah, in 2019 to help enhance patient care and fill gaps in both outcomes and care across the industry.

"We’re honored to offer all NCODA member practices the ability to use this platform to help solve the pressing challenge of creating a cohesive and full view of the patient that, within oncology, frequently requires the ability to collate and curate dispersed and disconnected data sources from multiple disparate provider types across the patient’s journey," said Harley Ross, Chief Commercial Officer, XIFIN. "VisualStrata can help to accelerate the adoption of precision and personalized medicine by organizing and depicting patient- and population-level data and delivering visualizations and dashboards that ultimately provide insight to oncology professionals so that they can improve the quality of patient care as well as practice operations."

At the 2022 NCODA Spring Forum, Harley Ross, Michael Reff, and Randy Erickson, RN, BSN, MBA, CEO of Utah Cancer Specialists, will discuss the partnership in their session, "NCODA/XIFIN Partnership Provides Members with Powerful Data Platform" on Thursday, April 28 at 11:15 a.m. ET.

Additionally, on Monday, May 16 from 2:00 p.m. to 3:00 p.m. ET, Randy Erickson will participate in, "Harnessing the Power of Oncology Data Through the NCODA Informatics Initiative," a webinar that will provide an overview of the new initiative and demonstrate the uses and benefits of the VisualStrata platform.

To learn more about this NCODA member resource and the value it will bring to an oncology practice, please visit the NCODA Informatics Initiative webpage.

On April 14, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its first quarter 2022 financial results will be released on Thursday, April 28, after the market closes (Press release, Gilead Sciences, APR 14, 2022, View Source [SID1234612245]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s first quarter 2022 financial results and will provide a business update .

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A live webcast will be available on the investor relations page of investors.gilead.com and will be archived there for one year.

On April 14, 2022 Be Biopharma ("Be Bio"), a pioneer in the discovery and development of Engineered B Cell Medicines (BeCM), reported the closing of a $130 million financing, bringing the total investment in the Company to over $180 million (Press release, Be Biopharma, APR 14, 2022, View Source [SID1234612244]). The proceeds will advance Be Bio’s proprietary autologous and allogeneic BeCM platforms across multiple therapeutic areas and progress pipeline candidates toward the clinic. The Series B was led by ARCH Venture Partners and joined by Bristol Myers Squibb and other new investors, alongside existing investors including Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund and Takeda Ventures.

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Steven Gillis, Ph.D., Managing Director at ARCH Venture Partners, joins the Board of Directors. Robert Nelsen, co-founder and Managing Director of ARCH Venture Partners and Robert Plenge, M.D., Ph.D., Senior Vice President, and Head of the Immunology, Cardiovascular and Fibrosis Thematic Research Center at Bristol Myers Squibb, join as observers.

"The human B cell produces thousands of proteins per second. Be Bio is harnessing this remarkable cell to engineer a new class of cellular medicines that produce durable therapeutic proteins in vivo with the potential ability to dose titrate, and re-dose when required, without the need for toxic pre-conditioning," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. "Our pipeline spans multiple therapeutic areas, and we are inspired and humbled by the potential to transform patients’ lives. With the support of highly regarded investors and the addition of Dr. Gillis to our Board of Directors, Be Bio is in a strong position to advance novel programs across our rare disease and oncology portfolios, further develop our platform and manufacturing capabilities and expand our team."

"Be Bio’s leadership has an exemplary record of developing and commercializing products in the cell and gene therapy field and I am encouraged by their progress since launch," said Steven Gillis, Ph.D., Managing Director at ARCH Venture Partners. "I am pleased to join the Board and support the Company in its efforts to develop a transformative B cell platform. The untapped potential of B cell medicines is exciting, as is Be Bio’s highly modular platform that could rapidly unlock a pipeline of product candidates across a variety of serious diseases."

Be Bio has a broad pipeline initially focused on rare disease and cancer. As the Company advances its platform, it plans to expand into additional therapeutic areas including infectious disease, neurological conditions and autoimmune disease.

About ARCH Venture Partners

ARCH Venture Partners invests in life science and advanced technology companies and is one of the world’s leading early-stage venture firms. The firm is a recognized leader in commercializing technologies developed at academic institutions, corporate research groups and national laboratories. ARCH invests primarily in companies it co-founds with leading scientists and entrepreneurs, bringing innovations in life sciences and physical sciences to market. For more information visit www.archventure.com.

About Steven Gillis, Ph.D.

Dr. Gillis joins the Be Bio team with decades of experience advancing life science technologies and growing biotechnology companies. With over 300 peer-reviewed publications in the areas of molecular and tumor immunology he is credited as being a pioneer in the field of cytokines and cytokine receptors. Dr. Gillis has been a Managing Director at ARCH Venture Partners since 2006 where he focuses on the development and growth of ARCH’s biotechnology portfolio companies. Additionally, he serves as a Director of Homology Medicines and Takeda Pharmaceuticals, as well as Director and Chairman of Codiak Biosciences and VBI Vaccines. Dr. Gillis also serves as director or chairman of multiple additional, private ARCH portfolio companies, all involved in bringing forward novel medicines directed at significant unmet medical needs. Dr. Gillis received a B.A. from Williams College and a Ph.D. from Dartmouth College.

About B Cells – A New Class of Cellular Medicines

Imagine what could "Be?" In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines — Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.