On June 29, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois (Press release, PLUS THERAPEUTICS, JUN 29, 2023, View Source [SID1234632981]).

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An oral presentation titled, Safety and Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988], brief highlights include:

Data from 21 patients in the Phase 1 trial used to support the recommended Phase 2 trial dose for patients with tumor volumes ≤20 mL was presented.
A single dose of rhenium (186Re) obisbemeda was generally safe and well-tolerated, with no dose-limiting toxicities and minimal systemic radiation exposure.
The data demonstrates efficacy signals in a prognostically unfavorable patient population.
The median overall survival (OS) in all 21 patients (including those receiving small radiation doses in early cohorts and five patients previously treated with Bevucizamab) was 11 months or a 38% increase in OS versus a median OS of approximately 8 months for standard of care in rGBM.
Median OS in patients receiving >100 Gy of absorbed radiation dose was 76 weeks (17 months) versus 22 weeks (6 months) for those receiving <100 Gy (p=0.0002).
Increased absorbed radiation dose and percent tumor volume treated correlates with improvement in overall survival, specifically:
For each 100 Gy increase of Total Dose in Distribution Volume, the risk of death decreases by 45.6% (p=0.003).
For each 10% increase in the Ratio of Treated to Total Tumor Volume, the risk of death decreases by 66.9% (p=0.002).
A poster presentation titled, Preliminary Clinical Data in The Phase 1/2a Dose Escalation Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial [P978], includes data that showed:

Interim results from 10 patients in the Phase 1 trial show a single treatment with rhenium (186Re) obisbemeda decreased cerebrospinal fluid (CSF) tumor cell count and was well-tolerated in patients with LM.
Rhenium (186Re) obisbemeda doses administered through an intraventricular catheter (Ommaya reservoir) showed prompt, complete and durable distribution throughout the CSF through Day 7.
A single rhenium (186Re) obisbemeda administered dose between 6.6 mCi and 26.4 mCi achieved absorbed doses of up to 88.98 Gy to the ventricles and cranial subarachnoid space.
No dose limiting toxicities were observed and safety observations were generally minor and resolved.
Phase 1/Part B, for continued dose escalation (Cohorts 4-7), will open following review by the U.S. Food and Drug Administration, and repeated dosing will be explored. An expansion in Cohort 3 is currently enrolling eligible patients.
A full update will be provided at the SNO/ASCO CNS Cancer Conference in August 10-12, 2023.
"Our Phase 1 ReSPECT-GBM trial has shown feasibility, safety and a strong correlation between both absorbed tumor radiation dose and tumor coverage," said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. "As Phase 1 trials are designed for safety, statistically significant correlations between dose and overall survival are unusual. We are currently on track to complete the Phase 2 trial in late 2024 while we continue to extend the open Phase 1 dose escalation trial, which is now enrolling patients at approximately twice the radiation dose of the current Phase 2, without dose limiting toxicities observed thus far."

Copies of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at View Source

About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

On June 29, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported it will present financial results and provide a business update for its second quarter ended May 31, 2023, on Wednesday, July 12 at 8:30 a.m. EDT (Press release, Theratechnologies, JUN 29, 2023, View Source [SID1234632979]).

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The call will be hosted by Mr. Paul Lévesque, President and Chief Executive Officer. Mr. Lévesque will joined be other members of the management team, including Chief Financial Officer, Mr. Philippe Dubuc, Chief Medical Officer, Dr. Christian Marsolais and Global Commercial Officer, Mr. John Leasure, who will be available to answer questions from participants following prepared remarks.

Participants are encouraged to join the call at least ten minutes in advance to secure access.

Conference call dial-in and replay information is below:

CONFERENCE CALL INFORMATION
Conference Call Date July 12, 2023
Conference Call Time 8:30 a.m. EDT
Webcast link View Source
Dial in 1-888-317-6003 (toll free) or 1-412-317-6061 (international)
Access Code 0616524
An archived webcast will also be available on the Company’s Investor Relations website under ‘Past Events’.

On June 29, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported new positive data on progression-free survival (PFS) from the pivotal Phase III open label TIGeR-PaC study of RenovoGem (intra-arterial administration of gemcitabine) in locally advanced pancreatic cancer (LAPC) (Press release, Renovorx, JUN 29, 2023, View Source [SID1234632978]). The interim data was featured as a late-breaking oral presentation at the 2023 ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer, and presented by Michael J. Pishvaian, M.D., Ph.D., Johns Hopkins Medicine and Principal Investigator (PI) of the TIGeR-PaC study.

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The interim analysis demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care. PFS is the measure of the length of time from study randomization to either death or progression of disease.

"Clinical practice has been waiting decades for a meaningful advancement in the standard of care for pancreatic cancer treatment, with less toxicity and better outcomes. The new data from the TIGeR-PaC interim results support that RenovoGem has the potential to more than double progression-free survival compared to systemic chemotherapy alone in this difficult-to-treat cancer, which demonstrates support for a new treatment standard," said Michael J. Pishvaian, M.D., Ph.D., PI of the TIGeR-PaC study. "This data has the potential to be a paradigm-shifting treatment for patients at risk of cancer progression, including those who have limited well-tolerated options."

The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and stereotactic body radiation therapy (SBRT). The TIGeR-PaC Data Monitoring Committee met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the date of the analysis, 45 patients from U.S. sites had been randomized in this trial and the survival status of all subjects was used for the analysis.

23 patients were randomized to intra-arterial (IA) gemcitabine (RenovoGem investigational treatment) arm and 22 patients to continuation of intravenous (IV) gemcitabine and nab-paclitaxel (standard-of-care) control arm.
The median PFS data in the IV gemcitabine and nab-paclitaxel control arm was 7 versus 15 months in the IA RenovoGem arm.
Patients had a greater than 65% reduction in adverse events compared to the control arm.
The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the IA RenovoGem arm, from time of randomization. (NOTE: Both arms’ median overall survival calculations do not include approximately 5.5 months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial.)
The TAMP (Trans-arterial Micro-perfusion) therapy platform delivers gemcitabine directly to the tumor site, potentially enhancing the therapeutic effectiveness while potentially minimizing the systemic side effects, commonly associated with traditional chemotherapy (IV) administration, and improving patient outcomes.

"The TIGeR-PaC study results reinforce the intended clinical advantage that TAMP brings to pancreatic cancer treatment, versus the non-targeted approach of the current standard of care (IV) therapy," said Ramtin Agah, M.D., Chief Medical Officer, RenovoRx. "The first look at interim analysis data of our pivotal trial supports this important advantage in overcoming the barrier of solid tumors in resisting drug uptake."

"Placing patients at the center of everything we do is a critical focus. We are thrilled to announce these pivotal TIGeR-PaC study results supporting RenovoGem’s meaningful clinical benefit and impressive safety profile for patients with LAPC," said Shaun Bagai, CEO, RenovoRx. "We are committed to advancing this therapy as rapidly as possible, with the goal of delivering a treatment that is capable of improving survival outcomes while preserving patient quality of life in pancreatic cancer."

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the U.S. To learn more about the study and the participating clinical trial sites, visit View Source RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.

About Locally Advanced Pancreatic Cancer (LAPC)

According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond the pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in Stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.

On June 29, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2023 financial and operating results on Thursday, August 3, 2023, before the U.S. financial markets open (Press release, Regeneron, JUN 29, 2023, View Source [SID1234632977]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On June 29, 2023 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the second quarter of 2023 before the market opens on Thursday, July 27, 2023 (Press release, LabCorp, JUN 29, 2023, View Source [SID1234632976]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings press release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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The call will be webcast live on the Labcorp Investor Relations website. Participants may also register for the call by clicking on this link, to receive the dial-in numbers and unique PIN to access the call. The webcast and dial-in are listen-only. It is recommended that participants join 10 minutes prior to the start, although participants may register and join at any time during the call.

A replay of the webcast will be available approximately two hours after the conclusion of the live event, and will be available until July 13, 2024. To access the webcast recording, visit the Labcorp Investor Relations website.