On July 10, 2024 Nusano Inc. (Nusano), a physics company transforming the production of medical radioisotopes, and PharmaLogic Holdings Corp. (PharmaLogic), a leading radiopharmaceutical contract development and manufacturing organization (CDMO), reported a supply agreement to provide a more efficient and reliable supply of critical radioisotopes (Press release, Nusano, JUL 10, 2024, View Source [SID1234644773]). The agreement will increase access to on-demand radioisotope supplies provided by Nusano for use in pharmaceutical products produced in PharmaLogic’s network of facilities.

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Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in a class of new and emerging cancer therapies. Existing supply chains for medical radioisotopes are often strained, posing a challenge to patient care, clinical trials, and ongoing drug development.

"Partnering with innovative companies like Nusano enhances our capabilities to meet the unique needs of our customers," said James Beatty, vice president of development and commercialization for PharmaLogic. "PharmaLogic is excited to collaborate with Nusano in our shared commitment to quality and advancement in radiopharmaceutical diagnostics and therapies."

Under the terms of the agreement, Nusano will collaborate with PharmaLogic in advance of initial orders to determine a radionuclide production schedule that meets the needs of both PharmaLogic and its customers. Radioisotopes of priority interest for both parties include but are not limited to: lutetium-177, actinium-225, copper-67 and astatine-211. The companies intend to revisit and adjust the supply agreement annually to ensure it continues to meet the evolving needs of the radiopharmaceutical industry.

"Nusano is bringing unparalleled production capacity and flexibility to the market," said Chris Lowe, CEO of Nusano. "Our proprietary production platform will be capable of making a full menu of radioisotopes of interest to healthcare and up to 12 different isotopes simultaneously. We look forward to working with PharmaLogic and its collaborators to alleviate supply chain pressures so they can focus on advancing new therapies for cancer patients."

On July 10, 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 the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106) (Press release, Moleculin, JUL 10, 2024, View Source [SID1234644772]). The Company expects to report outcomes from the EOP2 meeting upon receipt of official minutes from FDA which is expected by the end of Q3 2024.

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"The Moleculin team, along with our regulatory advisors and key opinion leaders, discussed with FDA the MB-106 safety and efficacy clinical findings and proposed next steps for our AML clinical development program," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We are grateful to the FDA for what we consider to be a very productive meeting and look forward to reporting its outcome before the end of August."

The EOP2 meeting was supported by second-line treatment results from the Company’s ongoing MB-106 clinical trial. As recently reported on June 14, 2024, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending.

Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 7 months and climbing.

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 acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA). For more information about the ongoing MB-106 Phase 1B/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

On July 10, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics (Press release, Kazia Therapeutics, JUL 10, 2024, View Source [SID1234644771]).

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GBM AGILE STUDY

GBM AGILE is an adaptive phase II/III global trial sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world’s foremost clinical, translational, and basic science researchers, from institutions such as Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute. The trial is designed to efficiently screen for and characterize the response of glioblastoma (GBM) patients to novel investigative agents. Utilizing a complex innovative design, Bayesian principles are applied to the primary endpoint (Overall Survival) comparison of the investigational agents to patients receiving Standard of Care (SOC) enrolled from the study start (also referred to as cumulative control population). In general, secondary analyses and endpoints are assessed based on established statistical models in comparison to the control patients enrolled at the same time as the investigational agent (concurrent control population).

Paxalisib is the third drug candidate to complete its evaluation in the study and was evaluated in newly diagnosed glioblastoma patients with unmethylated MGMT promoter status as well as in patients with recurrent disease.

GBM AGILE Paxalisib Results

Kazia CEO, Dr John Friend stated, "We are excited to have shown a 3.8 month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard of care arm. Having comparable Overall Survival data across two independent studies is a compelling outcome in this difficult to treat glioblastoma population. We look forward to discussing possible approaches for an accelerated approval pathway for paxalisib with the FDA."

A total of 313 newly diagnosed unmethylated (NDU) patients and recurrent patients being treated at top US cancer hospitals were randomized in Stage 1 to either a paxalisib treatment arm (60 mg/day) or the SOC concurrent control arm from January 2021 to May 2022. The cumulative control arm was enrolled from July 2019 (GBM Agile study start date) to May 2022.

For the primary analysis the median Overall Survival (OS) was 14.77 months for paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75).

For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the paxalisib arm (n=54) versus 11.89 months for concurrent SOC (n=46). In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months).

The secondary analysis results are consistent with the previously reported Company-sponsored phase II study, where median OS was 15.7 months (n=27) for paxalisib treated NDU patients compared to 12.7 months historically reported with temozolomide in this patient group (Wen 2022).

Paxalisib was well tolerated in GBM-AGILE, and no new safety signals were identified in this patient population.

An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for paxalisib (n=100). Similar results in this population have been reported in the other two drug candidates that have completed the GBM AGILE trial. Kazia is currently pursuing further analyses of this data to elucidate potential signals for further consideration.

Based on the totality of data available from all completed paxalisib clinical studies in newly diagnosed unmethylated GBM patients, Kazia will request a meeting with the US Food & Drug Administration (FDA) to discuss the results and determine if a potential path to accelerated approval is appropriate for paxalisib.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Full data including secondary endpoints from the paxalisib arm of the GBM AGILE study is expected to be presented at a scientific meeting later this year.

On July 10, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 39,000 shares of its common stock with an exercise price of $0.57, which is equal to the closing price of Gritstone’s common stock on July 3, 2024, the date of the grant (Press release, Gritstone Bio, JUL 10, 2024, View Source [SID1234644770]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On July 10, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that James Dentzer, President and Chief Executive Officer of Curis, will present at the Jones Healthcare Seaside Summit 2024 on July 15, 2024 at 8:00 a.m. PT (11:00 a.m. ET) (Press release, Curis, JUL 10, 2024, View Source [SID1234644768]). A live webcast and archived replay will be available and can be accessed here or on the Events & Presentations section of Curis’s website.

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