Summit Biomedical Imaging Signs Agreement with Theragnostics Enabling the Development of Novel Fluorescence-Based Cancer Diagnostics

On September 9, 2020 Summit Biomedical Imaging ("SBI"), a private, clinical-stage company developing products for diagnostic medical imaging and Theragnostics, which is developing molecular radiotherapy for imaging and treating a broad range of cancers, reported their entering into a global license agreement for intellectual property (IP) that will contribute to SBI’s global freedom to operate in the diagnostic field of certain fluorescence-labeled PARP (Poly ADP-Ribose Polymerase) inhibitors (Press release, Theragnostics, SEP 9, 2020, View Source [SID1234564818]).

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SBI’s cancer detection technology uses PARPi-FL, a PARP inhibitor with a fluorescence tag. PARP is a class of enzymes that are involved in normal cellular processes including DNA damage repair. PARP activity and expression are up-regulated in tumor cells. PARP inhibitors block the action of PARP by binding to PARP enzymes.

PARPi-FL combines the ability to bind to PARP with a fluorescence tag to specifically target cancers that over-express PARP. By targeting PARP, PARPi-FL brings the optical imaging agent to the cancer, enabling direct detection of tumors with significantly greater selectivity and sensitivity as compared to other competing technologies.

Andrew Riley, Chief Executive Officer of Summit Biomedical Imaging, said: "This agreement with Theragnostics bolsters Summit Biomedical Imaging’s IP position with regards to PARPi-FL and will allow Summit Biomedical Imaging to focus on developing the oral cancer detection application for this molecule. This will enable Summit Biomedical Imaging to bring new diagnostic solutions to market for detecting cancer earlier and improving patient outcomes."

Dr. Gareth Smith, Chief Operating Officer of Theragnostics, added: "Theragnostics is pleased to work with Summit Biomedical Imaging for the development of PARP inhibitor based diagnostics. Leveraging their expertise in oncological diagnostics applications is an important step forward in implementing our strategy of bringing novel diagnostic agents and new targeted therapies to cancer patients."

SBI’s first target for this technology is the in vivo detection of oral cancer, a large and growing market. Worldwide, over 450,000 cases of oral cancer are diagnosed each year and in many places, including the United States, the incidence rate of oral cancer is increasing. Oral cancer detection is estimated to be a $5 billion market (source, Market Research Future), which is projected to grow over 6.8% annually through 2024. Summit Biomedical Imaging seeks to enable earlier diagnosis using PARPi-FL and fluorescence imaging in the oral cavity. Earlier detection enables earlier intervention, which corresponds to saving lives and lower intervention costs, with the potential to save over $1 billion in patient and insurance costs annually.

TG Therapeutics to Present at Upcoming Investor Conferences

On September 9, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its participation at two upcoming virtual investor conferences. Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, is scheduled to participate in fireside chats during the following conferences (Press release, TG Therapeutics, SEP 9, 2020, View Source [SID1234564817]):

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The H.C. Wainwright 22nd Annual Global Investment Conference – fireside chat scheduled to take place on Monday, September 14, 2020 at 1:30 PM ET
The Cantor Fitzgerald Global Healthcare Conference – fireside chat scheduled to take place on Wednesday, September 16, 2020 at 10:40 AM ET
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

Xenetic Biosciences, Inc. to Present at the H.C. Wainwright 22nd Annual Global Investment Conference

On September 9, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic will present at H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 12:00 PM EDT (Press release, Xenetic Biosciences, SEP 9, 2020, https://ir.xeneticbio.com/news/detail/98/xenetic-biosciences-inc-to-present-at-the-h-c-wainwright-22nd-annual-global-investment-conference [SID1234564809]).

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In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website here.

A live video webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company’s website (xeneticbio.com). The video webcast replay will be made available two hours following the event and will be archived for 90 days.

Cerus Corporation to Participate in Upcoming Virtual Investor Conferences

On September 9, 2020 Cerus Corporation (Nasdaq:CERS) reported that William ‘Obi’ Greenman, Cerus’ president and chief executive officer, and Kevin D. Green, Cerus’ chief financial officer, are scheduled to participate in the following two conferences (Press release, Cerus, SEP 9, 2020, View Source [SID1234564808]):

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The Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 15th at 2:00 P.M. ET.
The H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16th at 12:00 P.M. ET.
A live webcast of the events will be available on the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.

SELLAS Receives IMPD Approval from the French Regulatory Authority for its Pivotal Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia

On September 9, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that it has received approval of its Investigational Medicinal Product Dossier (IMPD) from the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), to advance in France its pivotal Phase 3 REGAL study of galinpepimut-S (GPS) in patients with Acute Myeloid Leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2) (Press release, Sellas Life Sciences, SEP 9, 2020, View Source [SID1234564807]).

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"This clearance marks an important milestone for SELLAS, as the IMPD allows us to expand AML patient enrollment for our pivotal Phase 3 REGAL study of GPS in France," commented Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Obtaining IMPD clearance is a stringent process, and includes submission of information related to the quality, manufacture and controls of GPS as well as data from non-clinical and clinical studies. We look forward to advancing our REGAL study in France and, upon the receipt of requisite approvals, other countries in Europe, particularly given the previously obtained orphan drug designation for GPS in AML by the European Medicines Agency. "

In February 2020, SELLAS announced positive follow-up data from its Phase 2 study of GPS in CR2 AML patients. The final data showed a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well tolerated throughout the study.