On September 22, 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 that it has finalized and signed a grant contract with the Cancer Prevention & Research Institute of Texas (CPRIT) for its previously announced $17.6 million Product Development Research funding award (Press release, Cytori Therapeutics, SEP 22, 2022, View Source [SID1234621347]). The award will cover the majority of the development costs of the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with leptomeningeal metastases (LM) over a three-year period, beginning in the fourth quarter of 2022.

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 award from CPRIT significantly strengthens the company’s balance sheet," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "This non-dilutive funding coupled with existing cash, extends our expected cash runway through 2025. Currently, our two lead CNS cancer programs are externally funded through Phase 2 and multiple clinical milestones."

The agreement provides for $17.6 million in funding from CPRIT over the three-year grant period starting on August 31, 2022 and follows the expected increase of development costs as the ReSPECT-LM clinical trial progresses to later stages:

Year 1: September 1, 2022 to August 31, 2023: $3.7 million

Year 2: September 1, 2023 to August 31, 2024: $6.7 million

Year 3: September 1, 2024 to August 31, 2025: $7.2 million

The Company reported $18.1 million in cash as of June 30, 2022. In conjunction with the National Institutes of Health (NIH) and CPRIT grants, together with cash on hand, the Company believes it has capital to fund both its currently planned overhead and development expenses through 2025.

In the second quarter of 2022, the Company completed enrollment of Cohort 1 in the ReSPECT-LM Phase 1/2a dose escalation trial (NCT05034497). Blinded interim data for Cohort 1 was reviewed and assessed by the independent Data and Safety Monitoring Board (DSMB) which determined it was appropriate to begin enrolling patients in Cohort 2. The U.S. Food and Drug Administration has granted Fast Track designation to 186RNL for the treatment of LM. Safety and feasibility data from the ReSPECT-LM clinical trial was recently presented at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases.

On September 22, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported it has been awarded $1.98 million in additional grant funding to expand its ongoing Phase 1 study of iopofosine I 131 (iopofosine) in children and adolescents with inoperable relapsed or refractory high grade gliomas (HGGs) (Press release, Cellectar Biosciences, SEP 22, 2022, View Source [SID1234621345]).

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 grant was awarded by the National Institute of Health’s National Cancer Institute (NCI) based upon the initial signals of efficacy in the Phase 1 study, which is an international, open-label, dose escalation, safety study. The funding allows for an expansion from the Part 1a into the Part 1b portion of the company’s ongoing Phase 1 pediatric study. To accelerate development, the study is designed as a two-part approach. The currently ongoing Phase 1a is designed to determine the safety, tolerability, and initial efficacy of iopofosine in pediatric brain tumors whereas the Phase 1b is designed to identify the dose and dosing regimen that results in optimal efficacy. Previously announced preliminary data demonstrated therapeutic responses to iopofosine as evidenced by changes in multiple tumor parameters and patients experiencing extended progression free survival.

"The approximately $2 million non-dilutive grant funding from the NCI’s peer reviewed process is additional validation that iopofosine has shown encouraging potential in this very difficult to treat patient population. Unfortunately, patients with HGGs often have very poor prognoses, with limited treatment options," said James Caruso, president and CEO of Cellectar. "We continue to be encouraged by the ability of iopofosine to cross the blood brain barrier, deliver sufficient radiation to the tumor and demonstrate early efficacy signals. We remain steadfastly committed to the thoughtful development of iopofosine in this devastating indication."

Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes including diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas and ependymomas. Children with these tumors have very poor prognoses, with typical progression-free survival of only a few months and a 5-year survival of less than 30%.

About iopofosine I-131

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

On September 22, 2022 Caladrius Biosciences Presented the Corporate Presentation (Press release, Caladrius Biosciences, SEP 22, 2022, https://www.sec.gov/Archives/edgar/data/320017/000032001722000085/a991lisatacorporateprese.htm [SID1234621344]).

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!

On September 22, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will give a corporate presentation and participate in a fireside chat at the Ladenburg Thalmann 2022 Healthcare Conference on Thursday, September 29, 2022, at 3:30 p.m. ET in New York, New York (Press release, Aileron Therapeutics, SEP 22, 2022, View Source [SID1234621343]).

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!

A webcast of the presentation and fireside chat will be available under the Investors & Media section of the company’s website at aileronrx.com. A replay of the webcast will be archived on the Aileron website for approximately 30 days following the presentation.

On September 22, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that Vish Seshadri, Chief Executive Officer of Abeona, will participate in a fireside chat at the Jefferies Cell and Genetic Medicine Summit on Friday, September 30, 2022 at 8:30 a.m. ET (Press release, Abeona Therapeutics, SEP 22, 2022, View Source [SID1234621342]). The Company will also participate in one-on-one investor meetings at the conference.

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!

A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at View Source The webcast will be archived for 30 days. Those interested in attending the fireside chat or requesting a one-on-one meeting with Abeona are encouraged to contact their Jefferies representative.