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]).

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!

"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 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has successfully treated its first participant in the diagnostic US-based 64Cu SAR-bisPSMA trial for patients with biochemical recurrence (BCR) of prostate cancer (Press release, Clarity Pharmaceuticals, APR 21, 2022, View Source [SID1234612668]).

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!

COBRA (Copper-64 SAR-bisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with BCR of prostate cancer following definitive therapy (NCT05249127)1. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants. The primary objectives of the trial are to investigate safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to have dosed the first participant in the COBRA trial at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, which continues to actively screen and recruit patients. We are very pleased to see our collaboration with Dr Luke Nordquist at GURN grow and evolve as we fully explore the many clinical and logistical benefits of Targeted Copper Theranostics (TCT)."

Prostate cancer is a key focus of Clarity’s TCT program. Most recently, Clarity announced a collaboration with GURN on a diagnostic 64Cu SAR-bisPSMA investigator-initiated trial (IIT), X-Calibur (NCT05286840)2, sponsored by Dr Luke Nordquist. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)3, has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)4, is well underway, and will soon reach full recruitment in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Luke Nordquist, CEO and Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very excited to have treated the first participant in the COBRA trial and look forward to continuing recruitment at GURN as the more hands-on experience with the TCT platform we gain, the more impressed with these next-generation theranostics we are. Apart from the favourable clinical data acquired in the SECuRE trial at GURN to date, which includes the ability to image tumours between 1 and 72 hours, SAR-bisPSMA enables us to address the significant backlog of patients who cannot access sufficient quantities of PSMA imaging agents based on gallium-68 (Ga-68) or fluorine-18 (F-18) due to the logistical issues of short half-life isotopes. The properties, including the longer half-life of Cu-64, may offer improvements in imaging disease and facilitate central manufacture of the diagnostics, meaning that we can provide critical imaging on-demand and in large scale, delivering the next-generation of technologies to prostate cancer patients and ensuring a timely and accurate diagnosis."

Dr Taylor said, "Treating the first patient in the COBRA trial is an important step in our prostate cancer program and we look forward to receiving preliminary results in participants with suspected recurrence of prostate cancer. We hope that SAR-bisPSMA will enable improved prostate cancer detection, including low volume disease, which is particularly important in this patient population where early and accurate diagnosis has significant implications for the patients’ treatment outcome and prognosis. The preliminary data received from the PROPELLER and SECuRE trials to date is excellent as we have seen high uptake in tumours, and combined with centralised manufacture with on-demand delivery to any zip code in the continental US, this makes SAR-bisPSMA an ideal agent for the pursuit of our ultimate goal of improving treatment outcomes for cancer patients."

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]).

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!

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 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), will be presented at two upcoming conferences: 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy ("ASTCT") and Center for International Blood & Marrow Transplant Research ("CIBMTR"), taking place April 23 – 26, 2022, in Salt Lake City, Utah ("2022 Tandem Meetings") and the 4th International Workshop on CAR-T and Immunotherapies ("iwCAR-T") taking place on April 28 – May 1, 2022, in Tampa, FL (Press release, Mustang Bio, APR 21, 2022, View Source [SID1234612860]).

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!

Both presentations will be given by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center ("Fred Hutch") and University of Washington. MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

"We look forward to Dr. Shadman’s upcoming MB-106 presentations as we continue to progress our CD20-targeted CAR T cell therapy program. MB-106 has been demonstrating compelling clinical activity and a favorable safety profile in the ongoing Phase 1/2 trial at Fred Hutch for patients with relapsed or refractory B-NHL and CLL," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "At the 2022 Tandem Meetings, Dr. Shadman will present updated data that includes patients with diffuse large B cell lymphoma and Waldenstrom macroglobulinemia. Additionally, he will present data focused on CLL at iwCAR-T. Looking ahead, Mustang intends to dose the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND this quarter."

Details of the presentations are as follows:

2022 Tandem Meetings
Title: High Efficacy and Low Toxicity of MB-106, a Third Generation CD20 Targeted CAR-T for Treatment of Relapsed/Refractory B-NHL and CLL
Poster Number: 225
Dates and Time: Sunday, April 24, 8:30 – 9:30 p.m. ET
For more information, please visit the 2022 Tandem Meetings website: View Source

iwCAR-T
Session III: CAR-T in CLL
Title: CD20-targeted CAR T in R/R CLL
Date and Time: Saturday, April 30, 1:10 – 2:10 p.m. ET
For more information, please visit the iwCAR-T website: View Source

Mustang is a sponsor of iwCAR-T, an annual workshop / think tank which provides a forum for the world’s leading clinical researchers in CAR T-cell therapy to share perspectives on the evolving understanding of this cell therapy in a clinical context and provide key learnings to help optimize clinical care.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at using the identifier NCT03277729.

On April 21, 2022 Fusion Antibodies reported that it will attend hubXchange’s East Coast Antibody Therapeutics meeting 2022 (Press release, Fusion Antibodies, APR 21, 2022, View Source [SID1234612740]).

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!

This event takes place in Boston on Monday 16th May.

It brings together executives from pharma and biotech to address and find solutions to the key issues faced in developing antibody therapeutics, through a series of roundtable discussions.