On April 21, 2022 Binhui Biopharm reported that it has closed a $47 million Series B financing to support its R&D of oncolytic virus products (Press release, Binhui Biotechnology, APR 21, 2022, View Source [SID1234612731]). The company’s oncolytic herpes simplex virus (oHSV2) technology platform has produced its first product, BS001 (OH2) injection, which has been approved in China for single and combination drug trials. In August 2021, BS001 was approved to start US trials in various solid tumors. The company also develops viral vector vaccines, recombinant protein drugs and nucleic acid drugs. The B+ round was led by Yangtze River Pharmaceutical Group.

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On April 21, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported preclinical data demonstrating immune responses and protective efficacy of a bivalent second-generation COVID-19 vaccine candidate jointly developed with GSK, combining two mRNAs encoding for the Beta and the Delta variant (Press release, GlaxoSmithKline, APR 21, 2022, View Source [SID1234612733]).

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The preclinical study, conducted in collaboration with the Friedrich-Loeffler-Institut, Germany, assessed the bivalent candidate in comparison to the corresponding monovalent candidates targeting either variant in a mouse model. Despite containing only half the dose per variant-mRNA, the combined Beta/Delta candidate elicited neutralizing antibody titers fully comparable to the monovalent candidates of the respective variant. During exposure of the vaccinated animals to either the Beta or the Delta variant, the bivalent mRNA vaccine significantly reduced the viral load in the animals. High neutralizing antibody titers were accompanied by robust T cell responses. Notably, the bivalent Beta /Delta vaccine candidate induced two-fold higher virus neutralizing antibody titers against the Omicron variant than against the Delta variant in a rat model. This finding provides evidence for a potentially increased breadth of immune responses of the bivalent approach. The full manuscript of the preclinical data is available on the preprint server bioRxiv.

"Since the beginning of the pandemic, new COVID-19 variants have continued to evolve, each characterized by different virulence and transmissibility," said Dr. Igor Splawski, Chief Scientific Officer of CureVac. "New vaccine strategies, such as multivalent approaches, combining several variant-specific mRNAs within one vaccine, can be essential to take control over the COVID-19 virus dynamic and set new standards for broadly effective vaccines against other infectious diseases. Following our recent multivalent approach for influenza, we are now taking advantage of this advanced technology approach in our COVID-19 vaccine program.

Within the study, transgenic mice expressing the human ACE2 receptor were immunized on day 0 and day 28 with a 0.5 µg dose of the monovalent second-generation vaccine candidate against either the ancestral virus (CV2CoV), the Beta (CV2CoV.351) or the Delta (CV2CoV.617.2) variant, or with a 0.5 µg dose of the bivalent vaccine candidate combining the Beta and Delta variant (CV2CoV.351+ CV2CoV.617.2). Vaccinated animals were challenged on day 56 with either the Beta or the Delta virus variant. Vaccine induced T cells, including lung-resident memory CD8+ T cells, were characterized by flow cytometry. Additionally, the neutralizing capacity of the mono- and bivalent candidates was tested against multiple virus variants, including Omicron in serum samples of immunized Wistar rats.

On April 21, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported its participation in the annual meeting of the German Society for Nuclear Medicine from April 27-30, 2022 (Press release, ITM Isotopen Technologien Munchen, APR 21, 2022, View Source;_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc [SID1234612876]). The conference also represents the 60th anniversary congress of the society and will take place as a hybrid event online and in Leipzig. ITM will host a lunchtime symposium on April 28 on Targeted Radionuclide Therapy – Recent Developments and Radiopharmacy Perspective and will also showcase its precision oncology product portfolio at a booth.

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As part of ITM’s symposium, Prof. Wolfgang Wadsak, Head of Medical Radiochemistry and Biomarker Development in the Clinical Department for Nuclear Medicine at the University Hospital Vienna , will talk about the production of radiopharmaceuticals for direct application in the field of cancer medicine in clinics and as an essential component and innovation driver in nuclear medicine to speak. Neil Quigley, Global Product Manager, ITM , will present the latest developments and potential indications in the field of targeted radionuclide therapy using the alpha emitter Actinium-225. This topic is supplemented by a lecture by Dr. Thomas Gottlieb, Vice President Pharmaceuticals – Commercial Operations, ITM, on development opportunities for the innovative radioisotope actinium-225 and on the worldwide supply security of clinics with the established, high-purity medical radioisotope nca lutetium-177 (no-carrier-added). The symposium is part of the official conference program and will take place on April 28, 2022 from 12:30 pm to 1:30 pm in Hall 2 of the congress building.

"We are pleased to complement the scientific conference program with our symposium. The manufacturing of radiopharmaceuticals in clinics is an essential prerequisite to be able to offer cancer patients targeted radionuclide therapies, while the industry develops ready-to-use radiopharmaceuticals," says Steffen Schuster, CEO of ITM . "With our research and development of precision oncological diagnostics and therapeutics for various cancer indications as well as our current product portfolio of medical radioisotopes and radiolabeling equipment, we want to contribute to giving patients worldwide access to targeted cancer therapies that have the potential to improve treatment outcomes and quality of life."

At booth (#A6) in the conference’s industrial exhibition, ITM will present its proprietary portfolio of high-quality medical radioisotopes, as well as all the equipment needed for manufacturing and quality control of radiopharmaceuticals.

– end –

ITM’s research and development activities in the field of precision oncology

In addition to ITM’s central position in the development, production and distribution of medical radioisotopes and radiolabeling equipment, ITM is developing its own broad pipeline of diagnostic and therapeutic radiopharmaceuticals for various cancer indications. ITM’s lead candidate ITM-11 for the treatment of neuroendocrine tumors of gastroentero-pancreatic origin (GEP-NETs) is currently in two phase III studies, COMPETE and COMPOSE. ITM recently announced the successful completion of patient enrollment for the COMPETE trial evaluating ITM-11 for grade 1 and 2 GEP-NETs . In COMPOSE, ITM-11 will be studied for grade 2 and 3 GEP-NETs in order to evaluate ITM-11 for a broader GEP-NET indication.

Targeted radionuclide therapy

Targeted radionuclide therapy is a new form of cancer therapeutics that aim to irradiate the tumor directly while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are made by combining a therapeutic radioisotope with a targeting molecule (eg, peptide, antibody, small molecule) that can accurately recognize tumor cells and bind to tumor-specific features such as receptors on the surface of the tumor cells. The radioisotope accumulates at the tumor and decays, releasing a small amount of ionizing radiation capable of destroying tumor tissue. The high-precision localization enables targeted treatment with potentially minimal effects on the surrounding healthy tissue.

On April 21, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it will publish its financial results for the full year 2021 and provide a corporate update on Thursday, April 28, 2022 (Press release, Vivoryon Therapeutics, APR 21, 2022, View Source [SID1234612664]). The Company will host a conference call and webcast open to the public. The report will be available for download on the Company’s website (View Source).

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On April 21, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the first quarter ended March 31, 2022, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, APR 21, 2022, View Source [SID1234612737]).

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"In the first quarter of 2022, we announced a major corporate milestone, specifically the successful enrollment of the first patient in our ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "This adds a very important new clinical program to our growing drug development pipeline targeting significant unmet medical conditions."

RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

Treated first patient in the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM).
Finalized key 186RNL drug product development and characterization activities for GMP manufacturing to support planned Phase 2 registrational clinical trial and commercialization of 186RNL in recurrent glioblastoma (GBM).
Expanded partnership with Medidata Solutions, Inc., a Dassault Systèmes company, utilizing Medidata’s Synthetic Control Arm (SCA) platform intended to speed enrollment, improve patient access and reduce clinical trial costs in Plus Therapeutics’ planned Phase 2 registrational trial of 186RNL in GBM.
Presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting describing a biology-based, mathematical model to predict response of recurrent GBM to 186RNL treatment (Poster).
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel
radiotherapy in development for solid organ cancers

Announced the in-licensing of a novel targeted radioembolic technology for the treatment of solid organ tumors and biodegradable alginate microspheres (BAM) technology for both diagnostic and/or therapeutic payloads.
The Company began developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer.
FIRST QUARTER 2022 FINANCIAL RESULTS

The Company’s cash balance was $21.2 million at March 31, 2022, compared to $18.4 million at December 31, 2021.
Total operating expenses for the first quarter 2022 were $3.9 million, compared to total operating expenses of $2.5 million for first quarter 2021. Approximately $0.7 million of this increase is due to research and development expenses and $0.7 million to legal, intellectual property and professional fees.
Net loss for the first quarter of 2022 was $4.1 million, or $(0.19) per share, compared to a net loss of $2.7 million, or $(0.33) per share, for the first quarter of 2021.
UPCOMING EVENTS AND MILESTONES

During the remainder of 2022, the Company expects to accomplish the following key business objectives:

Upon U.S. Food and Drug Administration (FDA) approval, initiate a Phase 2/registrational trial in patients with recurrent GBM.
Complete FDA CMC and clinical meetings for 186RNL.
Manufacture GMP 186RNL for Phase 2 registrational trials.
Obtain FDA approval for ReSPECT-GBM multiple dosing clinical trial arm.
Complete initial safety cohort in ReSPECT-LM Phase 1/2a dose escalation trial.
Obtain FDA approval for study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM.
First Quarter 2022 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics First Quarter 2022 Results Conference Call
Date: April 21, 2022
Time: 5:00 p.m. Eastern Time
Live Call: 866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ122
The webcast can be accessed live via the Investor Relations section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.