On June 8, 2022 PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported a series of data presentations will illustrate outcomes with ropeginterferon alfa-2b (marketed as BESREMi) among adults with polycythemia vera (PV) during the European Hematology Association (EHA) (Free EHA Whitepaper)’s Hybrid Congress (EHA2022), June 9-17 in Vienna, Austria (Press release, PharmaEssentia, JUN 8, 2022, View Source [SID1234615779]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Ongoing evaluations of ropeginterferon alfa-2b expand the depth and duration of data on this innovative therapeutic supporting its ability to control the effects of polycythemia vera (PV)," said Albert Qin, MD, PhD, Chief Medical Officer, PharmaEssentia. "We believe these important new data offer greater clarity and confidence to physicians that this therapeutic tool represents an approach to effectively and durably treat PV."

Ropeginterferon alfa-2b presentations during EHA (Free EHA Whitepaper)2022 will include:

Ropeginterferon Alfa-2b Achieves Patient-Specific Treatment Goals in Polycythemia Vera: Final Results from the PROUD-PV/CONTINUATION-PV Studies (Oral presentation, #S196, presented by Heinz Gisslinger, M.D. of Medical University Vienna)
Phase 2, Open-Label, Multicenter, Single-Arm Study Investigating the Efficacy and Safety of Ropeginterferon Alfa-2b in Japanese Patients with Polycythemia Vera (PV) (Poster presentation, #P1007, authored by Keita Kirito, MD, University of Yamanashi, Japan)
The data presentation regarding the final results of studies leading to marketing authorization of BESREMi in Europe are a result of clinical development work of AOP Health, Vienna. PharmaEssentia has licensed ropeginterferon alfa-2b in Europe to AOP.

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1

About BESREMi (ropeginterferon alfa-2b)

BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients.

BESREMi has orphan drug designation for treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, in the United States in 2021, and has recently received approval in Taiwan and South Korea. The drug candidate was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications.

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

On June 8, 2022 Proscia, a leader in digital and computational pathology solutions, reported that its Concentriq Dx platform has been certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis (Press release, Proscia, JUN 8, 2022, View Source [SID1234615778]). This certification will enable the company’s continued growth in the European diagnostic pathology market, where it is helping leading laboratories to modernize their routine operations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The IVDR certification demonstrates that Concentriq Dx complies with the stronger quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.

"Proscia’s dedication to quality is unwavering," said Kim Rendon, Director of Regulatory Affairs. "The IVDR certification is a testament to our focus on delivering the safe, efficacious solutions that pathologists need to provide faster, more accurate diagnoses and ultimately improve patient outcomes."

A singular, secure platform, Concentriq Dx* helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks. As laboratories increasingly look to unlock new insights with computational solutions, Concentriq Dx is designed to support them in realizing pathology’s AI-enabled future.

Concentriq Dx is the platform of choice for top reference laboratories and health systems in Europe, including LabPON and Uppsala University Hospital. The European geography has seen some of the earliest adopters of digital pathology due to a widespread shortage of pathologists among other systemic challenges in the traditional laboratory model. Rising demand for diagnostic services continues to intensify pressure for digital transformation.

In response, Proscia has established subsidiary entities in Ireland and Spain to further drive its international growth. These entities will enable the company to increasingly scale its operations and continue to support its expanding customer base.

"Since we entered the European market in 2019, we have welcomed leading laboratories onto the Concentriq Dx platform and built a world-class team," said David West, CEO. "We are now better positioned than ever before to accelerate this momentum as we see through our mission of perfecting cancer diagnosis."

Proscia will be exhibiting at next week’s European Congress on Digital Pathology. To learn more about Concentriq Dx and see a demo, visit the company at booth #B09.

*Concentriq Dx is CE-marked under IVDR and is available for primary diagnosis in the US during the COVID-19 public health emergency.

On June 8, 2022 The Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, reported the launch of a five-year strategic alliance to develop next-generation cancer therapies generated from PICI’s network of leading immunotherapy research centers (Press release, Parker Institute for Cancer Immunotherapy, JUN 8, 2022, View Source [SID1234615777]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Together, PICI and Resilience aim to bring novel cell and gene therapies to market through the creation and incubation of new companies with a commitment of up to $50 million in funding. These startups will leverage groundbreaking technologies from across the PICI Network and have direct access to Resilience’s biomanufacturing capacity, capability, and know-how.

"This strategic alliance is representative of the transformative growth underway at PICI as we take our vision to the next level with new company investments and incubation," stated Sean Parker, PICI founder and chairman. "Now, in collaboration with Resilience, we are closing the loop with access to critical biological manufacturing that will further accelerate our mission of delivering breakthrough immune therapies to patients and transforming all cancers into curable diseases."

Under the agreement, Resilience will also collaborate with PICI Network investigators on challenges related to biomanufacturing and novel treatment modalities. As PICI’s first valued manufacturing partner for complex modalities Resilience will be well positioned to work with PICI Affiliated Partners (PICI-invested companies, PICI Network Institutions, and Network Investigators) on developing enabling biomanufacturing technology and to lower the barriers for technology access across the PICI network and more broadly within the therapeutic development community.

"By combining our organizations’ capabilities in drug discovery, development and cutting-edge biomanufacturing technologies, we aim to advance a new wave of treatments to patients in need," said Rahul Singhvi, ScD, Chief Executive Officer of Resilience. "This alliance with PICI will demonstrate the power of new business models in finding and advancing cancer therapies."

Resilience and PICI will establish a Joint Steering Committee to approve investments and new company opportunities, monitor and track the progress of alliance portfolio companies, and identify innovation challenge focus areas, among other duties.

"Through this strategic alliance, we have an opportunity to deliver unparalleled access to innovation in cancer immunotherapy and manufacturing across PICI-invested companies and the PICI Network," stated PICI Chief Scientific Officer, John Connolly, PhD. "The combination of PICI’s bench-to-market-to-patient philosophy and Resilience’s end-to-end biomanufacturing solutions support novel idea generation and development, delivering cutting-edge therapeutics to patients with cancer faster."

"By working closely with PICI Network Investigators, we can develop the advanced manufacturing technologies needed to bring cutting-edge therapies to patients that need them," said Rich Stoner, PhD, Chief Scientific Officer, Resilience. "Our goal is to ensure these therapies can be made at the quality and scale required to bring transformative immune therapies to people with cancer."

On June 8, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Securities Life Sciences Conference (Press release, Syros Pharmaceuticals, JUN 8, 2022, View Source [SID1234615776]). Management will also be available for one-on-one meetings. Details are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

JMP Securities Life Sciences Conference
Date: Wednesday, June 15
Time: 9:30 a.m. ET
Location: The Lotte New York Palace, 455 Madison Avenue, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On June 8, 2022 Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, reported that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will participate in a fireside chat at the JMP Securities Life Sciences Conference being held June 15-16, 2022 at the Lotte New York Palace in New York, NY (Press release, Vedanta Biosciences, JUN 8, 2022, View Source [SID1234615775]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The JMP Securities Life Sciences Conference