On April 21, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, will report first quarter 2022 financial results on Thursday, May 5, 2022, after the U.S. financial markets close (Press release, Dynavax Technologies, APR 21, 2022, View Source [SID1234612738]).

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Dynavax will host a conference call and live audio webcast on Thursday, May 5, 2022 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4282730. A replay of the webcast will be available for 30 days following the live event.

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.

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 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 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2022 financial results will be released on Thursday, May 5, 2022, after the close of the stock market (Press release, Cerus, APR 21, 2022, View Source [SID1234612727]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8280547. The replay will be available approximately three hours after the call through May 19, 2022.