On July 13, 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 that Marc Hedrick, M.D., President and Chief Executive Officer, will give two presentations at the Targeted Radiopharmaceuticals Summit taking place July 25-27, 2023 in Boston, Massachusetts (Press release, PLUS THERAPEUTICS, JUL 13, 2023, View Source [SID1234633230]).

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 presentations will describe data from the ReSPECT-GBM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM), as well as provide an overview of the Company’s scientific approach, current pipeline and a snapshot of where it is headed.

Details of presentations:

Title Re-186 Radiolabelled NanoLiposomes for Rare Brain & Spinal Cord Tumors

Date July 26, 2023, 9:30 a.m. ET

Session Targeted Radiopharmaceuticals in the US: The Past, the Present & the Future



Title Novel Approaches to Central Nervous System Targeted Radiotherapeutics

Date July 26, 2023, 2:30 p.m. ET

Session Addressing TRP Toxicity: Chelators, Clearance & Drug Design

A copy 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

On July 13, 2023 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported that it is discontinuing enrollment in the ongoing phase 1/2 study and terminating development of THE-630 in patients with gastrointestinal stromal tumors (GIST) (Press release, Theseus Pharmaceuticals, JUL 13, 2023, View Source [SID1234633228]).

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!

Theseus previously released initial dose escalation data from the ongoing phase 1/2 trial, which employs a standard 3 + 3 dose escalation design, on May 25, 2023. As of the April 21, 2023 data cutoff date, 23 patients had been dosed through Cohort 6 (18 mg) and 2 patients had been enrolled in Cohort 7 (27 mg). As of May 25, those 2 patients in Cohort 7 had cleared the dose-limiting toxicity (DLT) observation period without experiencing a DLT.

Following the data release on May 25, the third patient enrolled in Cohort 7 experienced grade 3 hand-foot skin reaction (HFSR), which required an expansion of the cohort to 6 patients. Subsequently, one of the patients enrolled in the Cohort 7 expansion group experienced grade 2 HFSR, which required a dose interruption of ≥7 days. Both the grade 3 HFSR and the grade 2 HFSR necessitating ≥7 days dose interruption were determined to be DLTs according to the study protocol. Therefore, with 2 out of 6 patients experiencing a DLT, the 27 mg dose exceeds the maximum tolerated dose (MTD). The Company does not believe that THE-630 has a differentiated profile at doses below 27 mg, which would provide exposure well below the target level of 100 nanomolar average concentration. As a result, the Company has made the decision to terminate the development of THE-630 in GIST. Patients currently enrolled in the trial will continue to receive THE-630 until a treatment discontinuation criterion is met.

As of July 10, 2023, 32 patients have been treated with THE-630 across 7 dose levels (3 mg to 27 mg). Six patients developed grade 1 to 3 HFSR (3 patients in the 27 mg cohort, 2 patients in the 18 mg cohort, and 1 patient originally in the 9 mg cohort after intra-patient dose escalation to 18 mg). Grade 3 HFSR was only observed in a patient who started treatment at 27 mg. HFSR was not observed at doses of 12 mg or lower. No significant skin toxicity was observed in preclinical toxicology studies. The Company is analyzing trial data to inform the feasibility of developing low dose THE-630 for KIT-associated mast cell-driven inflammatory indications, given its potent inhibition of wild-type KIT observed in preclinical assays.

Theseus has continued an extensive medicinal chemistry effort to target KIT, which has led to the discovery of a series of chemically distinct, highly selective, pan-variant KIT inhibitors for the treatment of early-line GIST. Theseus plans to nominate a development candidate from this series in the first half of 2024.

"We are disappointed that we will not be able to achieve the target exposure for pan-variant inhibition with THE-630, as we continue to believe a therapy with potent activity against all major classes of activating and resistance mutations in KIT has the potential to confer significant clinical benefit, given the unmet need in GIST," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "On behalf of the entire Theseus team, I would like to thank the patients, their caregivers, and the investigators and site staff who participated in this study. We remain committed to helping GIST patients with plans to nominate a new, highly selective pan-variant KIT inhibitor candidate for GIST in the first half of 2024. Moving forward, we are excited to have THE-349 as our next near-term clinical program, with its potential best-in-class profile as a fourth generation EGFR inhibitor appropriate for both monotherapy and combination approaches."

Strategic Priorities:

· Advance THE-349 into clinical studies: THE-349 is a potentially best-in-class fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of EGFR mutant non-small cell lung cancer.

o Preclinical data demonstrate THE-349 can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting, possesses kinome and wild-type EGFR selectivity, and has central nervous system (CNS) activity.

o IND-enabling toxicology studies have been completed, and Theseus remains on track to submit an Investigational New Drug Application (IND) for THE-349 in the fourth quarter of 2023, and commence its clinical program as soon as possible thereafter, subject to clearance of the IND by the U.S. Food and Drug Administration.

· Advance BCR-ABL Program: Theseus aims to develop a potent and selective, next-generation, pan-variant BCR-ABL TKI candidate that optimizes the balance of safety and efficacy for patients with relapsed/refractory chronic myelogenous leukemia (CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

o Theseus plans to pursue clinical development in patients with CML who have been previously treated with a second-generation TKI or have the T315I mutation, and in newly diagnosed patients with Ph+ ALL.

o Theseus plans to nominate a development candidate for this program in the first half of 2024.

· Advance KIT program for GIST: KIT mutant GIST remains an area of major unmet medical need, requiring a pan-variant molecule to target all major activating and resistance mutations in KIT, with high selectivity, for use in early-line patients.

o Theseus has continued an extensive medicinal chemistry effort to target KIT which has led to the discovery of a series of chemically distinct, highly selective, pan-variant KIT inhibitors for the treatment of early-line GIST.

o Theseus plans to nominate a development candidate from this series in the first half of 2024.

· As of June 30, 2023, the Company had approximately $234 million in cash, cash equivalents, and marketable securities. Theseus expects its current cash, cash equivalents, and marketable securities to fund operations and capital expenditures into 2026 based on its current operating plan.

On July 13, 2023 Quest Diagnostics (NYSE: DGX), the leading provider of diagnostic information services, reported the launch of a novel prostate cancer biomarker test through its subspecialty pathology business, AmeriPath, in collaboration with Envision Sciences (Press release, Quest Diagnostics, JUL 13, 2023, View Source [SID1234633227]). Envision Sciences Pty Ltd. is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood.

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!

Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

The new, tissue-based test service is intended to address the pressing clinical need for tests to help identify and differentiate potentially aggressive cases of prostate cancer in men. Physicians in the United States, with the exception of New York, may order the test starting today.

Quest developed and validated the laboratory test under an intellectual property license agreement with Envision for use of Envision’s proprietary biomarker and immunohistochemistry technology, which includes Envision’s unique staining technology and novel biomarkers (named EV1, EV2 and EV3).Recently published data in Pathology shows that 22% of tissue specimens examined with a panel based on the three Envision biomarkers and technology were upgraded, and 20% were downgraded, as compared to the conventional assessment of pathologic evaluation based on hematoxylin and eosin-stained tissue alone.1

Prostate cancer is one of the most prevalent and deadly cancers affecting men. According to the American Cancer Society, about 1 out of every 8 men will be diagnosed with prostate cancer during his lifetime.2 A recent Quest Diagnostics Health Trends study showed that, more than two years after the COVID-19 pandemic began, diagnoses of prostate and breast cancer continue to lag behind pre-pandemic levels, suggesting more people are living with undiagnosed cancers now than prior to the pandemic. Although it is one of the most common cancers globally, existing prostate cancer testing methods, particularly for early, lower grade stages, have limited accuracy across pathologists.3

"Our goal for this innovative prostate biomarker test is to improve the accuracy of grading prostate cancer biopsies. We expect this service to help fill a clinical gap affecting millions of men for staging, diagnosis and treatment for prostate cancer," said Kristie Dolan, Vice President and General Manager, Quest Diagnostics Oncology Franchise. "Through our relationship with Envision, we are excited to broaden access to this innovative technology. With Quest’s national scale and industry-leading prostate cancer portfolio, we will be able to reach a larger number of patients and provide them with diagnostic insights to inform their treatment decisions."

"Envision Sciences welcomes this relationship with Quest Diagnostics. We believe this collaboration aligns us with the world leader in prostate cancer testing," said Envision CEO, Peter Pursey. "Our patented technology provides a novel approach to visualizing prostate cancer tissue and improving accuracy in grading the cancer by pathologists. We expect the test to enhance current prostate cancer histology practice and improve the information available to clinicians, enabling them to better align cancer grades with treatment options."

Quest Diagnostics is a world leader in advanced diagnostic services, including in oncology. Its specialty pathology businesses, AmeriPath and Dermpath Diagnostics businesses provide subspecialty expertise based largely from serving community cancer centers, which provide 70% of cancer care nationally. With hundreds of MDs and PhDs, Quest Diagnostics provides highly advanced pathology services for health systems and other providers in the United States and overseas.

About Envision
Envision Sciences is a clinical diagnostics development company with a focus on oncology diagnostics and prognostics in tissue and blood. Our goal is to provide clinicians more detailed information and greater clarity regarding the grading and activity of their patients’ cancer, therefore allowing improved diagnosis and better clinical treatment decisions. Envision licenced the original technology from University of South Australia and continue an active biomarker discovery research and development program with the University. Envision acknowledges funding support from MTP Connect under the BTB program. www.envisionsciences.com

On July 13, 2023 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, reported financial results for the fiscal quarter ended May 31, 2023, and provided a corporate update (Press release, Nurix Therapeutics, JUL 13, 2023, View Source [SID1234633225]).

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 expansion of our NX-2127 clinical trial in non-Hodgkin’s lymphomas provides an opportunity to identify clinical benefit in a significant patient population," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "In the second half of 2023, we expect to generate clinical data that will provide additional insight into the potential specific applications of both the NX-5948 and NX-2127 BTK degrader programs while we continue to advance our internal and partnered programs."

Recent Business Highlights

•Nurix announced the initiation of two additional Phase 1b expansion cohorts in the ongoing Phase 1a/1b trial of NX-2127: In June, Nurix announced the initiation of expansion cohorts in patients with diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The decision to expand was informed by evolving data from the Phase 1a portion of the trial including a rapid and sustained complete response in a patient with DLBCL, as previously reported.

•Nurix enhanced its cash position with the receipt of $20 million from Gilead: In April, Gilead exercised its option to exclusively license Nurix’s oral IRAK4 degrader, which has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. GS-6791/NX-0479 is the first development candidate resulting from the 2019 Nurix-Gilead collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation therapies. In addition to the $20 million license fee, Nurix could potentially receive up to an additional $425 million in clinical, regulatory and commercial milestone payments, as well as up to low double-digit tiered royalties on product net sales.

•Nurix presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting for its Bruton’s tyrosine kinase (BTK) Targeted Protein Degraders, NX-5948 and NX-2127: In April, Nurix presented preclinical data demonstrating the potent tumor cell-killing activity of Nurix’s BTK degraders, NX-5948 and NX-2127, against a broad range of acquired BTK inhibitor resistance mutations and their superiority compared with other reported BTK degraders. For NX-2127, the structure was disclosed to the broader oncology audience following its initial disclosure in an oral presentation at the American Chemical Society Spring 2023 meeting in March.

•Nurix presented additional data for NX-5948 and NX-2127 at the International Conference on Malignant Lymphoma (ICML): In June, Nurix presented early clinical PK/PD data from the Phase 1a trial of NX-5948 demonstrating rapid, robust and sustained BTK degradation and supporting ongoing investigation in B-cell malignancies and continuing dose escalation. Nurix also presented preclinical data demonstrating the potential utility of NX-5948 in addressing the unmet need in patients with central nervous system (CNS) lymphoma. For NX-2127, early clinical data, including a rapid and sustained complete response, informed Nurix’s Phase 1b dose expansion plans in that trial in patients with DLBCL and MCL.

Upcoming Program Highlights*

•NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory activity for the treatment of patients with relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1 clinical trial of NX-2127, which now includes three Phase 1b expansion cohorts in patients with chronic lymphocytic leukemia (CLL), DLBCL and MCL. Nurix anticipates presenting additional clinical results from this ongoing trial in the second half of 2023. Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

•NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable degrader of BTK designed without immunomodulatory activity. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to present initial clinical data from the Phase 1a portion of the study in the second half of 2023. In addition, Nurix expects to define a dose for Phase 1b cohort expansion. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).

•NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1a dose escalation trial in monotherapy and in a combination cohort utilizing Paclitaxel in adults in a range of oncology indications and expects to present clinical data from the Phase 1a portion of the study and to define a dose for Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

•NX-0479/GS-6791: GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s partner, Gilead, is responsible for conducting IND-enabling studies and advancing this program to clinical development.
•Continued advancement of strategic collaborations with Gilead Sciences and Sanofi: Nurix expects to continue to achieve substantial research collaboration milestones throughout 2023 from its collaborations with Gilead Sciences and Sanofi.
*Expected timing of events throughout this press release is based on calendar year quarters.
Fiscal Second Quarter 2023 Financial Results
Revenue for the three months ended May 31, 2023, was $30.7 million compared to $11.4 million for the three months ended May 31, 2022. The increase was primarily due to the receipt of $20 million related to the license option exercise payment from Gilead.

Research and development expenses for the three months ended May 31, 2023, were $45.8 million compared to $47.5 million for the three months ended May 31, 2022. The decrease was primarily related to a decrease in research related costs as we concluded certain studies and sponsored research agreements and a decrease in contract manufacturing as we stabilize the supply needed for our clinical trials, offset by an increase in compensation and related personnel costs and in non-cash stock-based compensation expense. There was also an increase in facility and other costs primarily driven by additional investments in information technology and expenses related to our leases of office and laboratory space.

General and administrative expenses for the three months ended May 31, 2023, were $11.7 million compared to $9.7 million for the three months ended May 31, 2022. The increase was primarily related to an increase in compensation related expenses and non-cash stock-based compensation expense and an increase in outside consulting and professional service costs.

Net loss for the three months ended May 31, 2023, was $24.3 million, or ($0.45) per share, compared to a net loss of $45.4 million for the three months ended May 31, 2022, or ($1.01) per share.
Cash, cash equivalents and marketable securities was $308.6 million as of May 31, 2023, compared to $325.6 million as of February 28, 2023.

On July 13, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the publication of data from its completed MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory AML (Press release, Moleculin, JUL 13, 2023, View Source [SID1234633223]). The manuscript titled, "Results of a Phase 1 Study of Liposomal Annamycin for the Treatment of Relapsed or Refractory AML Patients After Induction Therapy," was published in the peer-reviewed British Journal of Cancer Research.

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 authors of the published manuscript include Dr. Wolfram Dempke (Moleculin’s European Chief Medical Officer), Dr. John Paul Waymack (Moleculin’s Senior Chief Medical Officer) and Dr. Waldemar Priebe (Moleculin’s Chair – Scientific Advisory Board), as well as Polish investigators from the MB-105 trial.

"We are pleased to have the data from our successful MB-105 study published in this prestigious journal," commented Walter Klemp, Chairman and CEO of Moleculin. "This early data provided an important foundation for our AML program and was informative for guiding our clinical development strategy for Annamycin in combination with Cytarabine for the treatment of AML. We continue to be very optimistic about Annamycin’s potential to provide a non-cardiotoxic treatment option for patients."

MB-105 is the Company’s completed multicenter, open-label, dose-escalation study which was conducted to determine the maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Annamycin as a single agent for the treatment of patients with AML after induction therapy. A total of 20 subjects with the age range of 24-76 years with a median age of 64.5 were enrolled across five clinical trial sites in Europe. The median number of prior therapies for all subjects was 4 (range 1-18). Of the 20 subjects enrolled, 17 received the full 3 consecutive days of dosing per protocol.

As previously announced, the final MB-105 results aligned with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally, as detailed in the paper, among the eight subjects treated in the final dosing cohort (240 mg/m2) five were evaluable for efficacy and there were one PRs (Partial Response) and three CRi (complete response with incomplete recovery of peripheral blood count) among these five subjects, representing an 80% overall response rate (ORR) in the last cohort.

For purposes of this clinical trial, a CR means that the subject’s bone marrow blasts reduced to 5% or less (with CRi meaning a CR where there was incomplete recovery of white blood cell and/or platelet counts), and a PR means the subject’s bone marrow blasts reduced by 50% and resulted in a blast count of 25% or less.

Annamycin again demonstrated no evidence of cardiotoxicity based on review of cardiotoxicity biomarkers, LVEF, and ECHO GLS evaluation. These properties differentiate Annamycin from all other anthracyclines that have shown limited or no cardiotoxicity to date and highlight it as a very promising anticancer agent and it retains the ability to poison TOPO-IIα (topoisomerase II) and can also overcome mdr-1-related resistance mechanisms in leukaemic blasts, as shown in its parent compound.

As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial. Based on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, Moleculin commenced its ongoing Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106) clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.