On April 18, 2024 Panbela Therapeutics, Inc. (OTCQB: PBLA)("Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place April 10, 2024 (Press release, Panbela Therapeutics, APR 18, 2024, View Source;utm_medium=rss&utm_campaign=panbela-announces-poster-presentation-at-american-association-for-cancer-research-2 [SID1234642155]). The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine.

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"Ivospemin, reduces the viability of human ovarian adenocarcinoma cell lines regardless of their platinum sensitivity and we found that the combination treatment with doxorubicin increases median survival, delays tumor onset, and decreases overall tumor burden compared to either clinical or subclinical doxorubicin dosing schemes." said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The continued work by collaborators at Johns Hopkins University School of Medicine is providing the foundation for the initiation of our ovarian cancer program in this year."

"The results suggest that SBP-101 in combination with doxorubicin may have a role in the clinical management of ovarian cancer, in particular the difficult to treat platinum-resistant population where few options exist," said Dr. Simpson. "These studies continue to support the basis for moving into a clinical trial program in ovarian cancer with a goal of developing effective novel therapeutics in combination with standard of care for patients with unmet medical needs."

The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro.

Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.

Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators.

Details of the presentation are as follows:

Poster Presentation

Title: Ivospemin/doxorubicin combination modulates polyamine metabolism to improve survival in murine ovarian cancer models Session Category: Experimental and Molecular Therapeutics Session Title: Novel Antitumor Agents 6 Session Date and Time: Wednesday, April 10, 9:00-12:30 Abstract #: 7154

Additional meeting information can be found on the AACR (Free AACR Whitepaper) website: View Source

The abstract and poster will also be available on the Company’s website at View Source

On April 18, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI) (Press release, Oncternal Therapeutics, APR 18, 2024, View Source [SID1234642154]). Patients in the fourth dosing cohort will receive ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 300 mg taken orally each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the patients treated to date, including the third dose level of 160 mg ONCT-534 daily.

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"Reaching the 300 mg dose level represents a significant milestone for our ONCT-534 program. The drug has been well tolerated so far, and based on preclinical analyses, we are optimistic that study participants are receiving doses of ONCT-534 that may be within the active dose range for antitumor activity," said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. "We continue to see strong demand from investigators and patients to participate in the study and expect to continue enrolling at a brisk pace. We look forward to announcing initial efficacy and safety data from the study, which we expect will be at the end of this quarter."

About Study ONCT-534-101
Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and preliminary antitumor activity of ONCT-534 to support selecting an optimal dose.

On April 18, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that its abstract on the preclinical data for its radiopharmaceutical program MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) submitted to the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting has been selected for a presentation (Press release, Monopar Therapeutics, APR 18, 2024, View Source [SID1234642153]). SNMMI 2024, held in Toronto, Canada, is recognized as the premier educational, scientific, and research event in the radiopharma space.

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Meeting Details:

Event: Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting

Date: June 8 – June 11, 2024

Location: Metro Toronto Convention Centre, Toronto, ON, Canada

On April 18, 2024 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 that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML (Press release, Moleculin, APR 18, 2024, View Source [SID1234642152]).

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Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has shown to be non-cardiotoxic in the 82 subjects treated in multiple studies in the U.S. and in Europe. Furthermore, Annamycin has recently shown in Moleculin’s European clinical study for the treatment of AML using Annamycin in combination with Cytarabine (MB-106) a preliminary 60% composite complete response (CRc) rate in 2nd line subjects (N=10) and an overall interim CRc of 39% in all subjects (N=18), regardless of the prior number of therapies, in the European trial. Durability of the CRc’s is developing. One subject has surpassed the one-year mark with a durable complete response. Recruitment in MB-106 has ended for 2nd line subjects while recruitment for 1st line and 3rd line subjects continue. Annamycin is currently in development for the treatment for AML and STS lung mets, and the Company believes the drug may have the potential to treat additional indications.

"We are pleased to receive Orphan Drug Designation from the EMA for Annamycin, which further supports our ongoing efforts to advance this compelling next-generation anthracycline for the treatment of hard-to-treat cancers," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Combined with the Orphan Drug Designation we already have in the US and with the new composition of matter patent just awarded by the US Patent and Trademark Office with coverage through 2040, we believe the commercial exclusivity of Annamycin is now very well protected. We continue to be encouraged by the growing body of promising interim clinical data demonstrated by Annamycin. We remain focused on advancing our clinical and regulatory strategies toward our next phase of development, including the planned commencement of a pivotal registration study as a 2nd line therapy in AML before year end."

The EMA grants orphan drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare, life-threatening or chronically debilitating diseases or conditions that affect fewer than five in 10,000 people in the European Union. Orphan designation allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants and up to 10 years of potential market exclusivity in the European Union if approved.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets.

On April 18, 2024 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, reported that Immix Biopharma is on track to dose NXC-201 patients in the U.S. with no change in patient enrollment timing (Press release, Immix Biopharma, APR 18, 2024, View Source [SID1234642151]).

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"We are on track to dose relapsed/refractory AL Amyloidosis NXC-201 patients at our New York City lead site and other leading U.S. sites in mid-2024. U.S. site clinical trial agreements have been signed, and site initiation visits are being scheduled," said Ilya Rachman, MD PhD CEO of Immix Biopharma. "Building on our existing NXC-201 clinical dataset, our U.S. relapsed/refractory AL Amyloidosis clinical trial design is focused on patients with adequate cardiac function who are most likely to experience the greatest clinical benefit from NXC-201. We are committed to providing additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, where there are no FDA approved drugs today."

About NEXICART-2

NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site Phase 1b dose expansion clinical trial in relapsed/refractory AL Amyloidosis for CAR-T NXC-201 in the United States. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function over a period of approximately 18 months from first patient dosing. The objectives are the safety and efficacy of NXC-201. The expected primary endpoints are complete response rate and overall response rate according to consensus recommendations (Palladini et al. 2012).

About NXC-201

We believe NXC-201 (formerly HBI0101) is the only "Single-Day CRS" BCMA-targeted CAR-T cell therapy that is uniquely suited to target AL Amyloidosis and other autoimmune diseases. It is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, and expanding into other autoimmune indications. These trials build on a robust NXC-201 clinical dataset initiated in February 2021. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and awarded EU ODD by the EMA in AL Amyloidosis.