On June 26, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported an update on key corporate and clinical initiatives and release a new investor presentation (Press release, Kazia Therapeutics, JUN 26, 2023, View Source [SID1234632897]).

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Key points
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Dr John Friend completes transition into the CEO role, including a full portfolio review.

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Final data anticipated from GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023.

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Interim data from phase II Pacific Pediatric NeuroOncology Consortium study in diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs) now expected to be available in July or August 2023.

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Phase I expansion cohort is enrolling for brain metastases study sponsored by Memorial Sloan Kettering Cancer Center. Two other preeminent cancer centres have joined the study. Preliminary data from expansion cohort is anticipated by 1Q24.

Following his appointment as CEO on 1 May 2023, Dr John Friend has completed his transition into the role. He commented, "In the weeks since my appointment, I’ve worked with the team to review the full set of assets and clinical trials within the Kazia portfolio and the process has strongly reinforced my conviction in the opportunities ahead of us."

"We believe substantial potential exists across our pipeline and in particular, across three key pillars of development for paxalisib—adult brain cancer, paediatric brain cancer and brain metastases. We are keen to explore paxalisib’s use in patient populations that may have the greatest benefit from a PI3K/AKT/mTOR targeted therapeutic candidate."

"As we move toward the second half of 2023, critical milestones are approaching for both paxalisib and EVT-801. We look forward to keeping investors updated across our progress on these important programs."

Clinical programs update

11 clinical trials are currently in progress or in planning for Kazia’s two assets, paxalisib and EVT-801, and Kazia continues to execute across all programs. Current program highlights are set out in brief below. Refer to the appended corporate presentation for more detail:

Paxalisib

Kazia’s lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in various brain cancers.

GBM AGILE Pivotal study

Final data are expected from the GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023. Depending on the results of the study, Kazia may use such data to support submission of a new drug application for marketing authorisation to the FDA.

PNOC022 phase II study

Paxalisib is being studied as an investigational drug for the treatment of the paediatric brain cancers DIPG and other DMGs in a study sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The study team at PNOC has been diligently collecting and preparing the data for interim analysis. At this point, Kazia expects that the data will be available in July or August 2023.

LUMOS2 phase II study

On 8 June 2023, Kazia announced that it is supporting the University of Sydney on a molecularly-guided phase II clinical study evaluating paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas).

The study, named LUMOS2, will be sponsored by the University of Sydney, and coordinated by NHMRC Clinical Trials Centre, University of Sydney, in collaboration with COGNO (CoOperative Trials Group for Neuro-Oncology). LUMOS2, an umbrella study with multiple arms, is expected to enroll up to 76 patients and will be a multi-centre study at several Australian sites, with the potential to expand internationally. We anticipate enrollment to commence in 4Q23.

MSKCC phase I clinical study

Paxalisib is the subject of an ongoing phase I clinical study in combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY.

Kazia is pleased to confirm that the phase I expansion cohort is enrolling. Two world-renowned cancer centres have joined MSKCC in this study: Miami Cancer Institute and Fred Hutch Cancer Center in Seattle, WA. Preliminary data from the expansion cohort is anticipated by 1Q24.

EVT-801

Phase I study

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data showed EVT801 to be active against a broad range of tumour types and has shown evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.

EVT-801 continues to enroll in the phase I dose finding study. Kazia anticipates stage 1 data in 2H23, which we believe will enable identification of the recommended dose for subsequent phase II trials. Kazia also anticipates reporting preliminary biomarker data focused on high-grade, serous ovarian cancer as part of this data update.

On June 26, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported an oral presentation at the British Society for Gene and Cell Therapy Annual Conference, demonstrating that its proprietary CoStimulatory Antigen Receptor (CoStAR) platform enhances activity of TILs against autologous tumor (Press release, Instil Bio, JUN 26, 2023, View Source [SID1234632896]).

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The presentation highlighted CoStAR’s unique mechanism of action which results in greatly enhanced activity of TILs when activation occurs through both the native TCR and engineered CoStAR receptors. Additionally, novel data demonstrated that Instil’s FRα-CoStAR enhances activity of TILs against autologous tumors with varied expression of FRα including ovarian, renal, and non-small cell lung cancer tumors. The robust activity of NSCLC, ovarian, and renal carcinoma CoStAR-TILs against autologous tumor exceeded that of genetically unmodified melanoma TILs, as measured by secretion of IFNγ.

"The finding that CoStAR can enhance the anti-tumor reactivity of TILs in challenging tumor types such as non-small cell lung cancer even beyond that seen with melanoma TILs is compelling," said Robert Hawkins, MBBS PhD, Head of Research and Development at Instil Bio. "These preclinical data continue to support our excitement around the anticipated resumption of the clinical study of ITIL-306 in patients with advanced cancers which express FRα."

On June 26, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported the first patient was dosed in MATISSE, a Phase 2 multicenter single-arm study (NCT05742607), sponsored by Innate Pharma, evaluating neoadjuvant and adjuvant treatment with IPH5201, an anti-CD39 blocking monoclonal antibody, in combination with durvalumab (anti-PD-L1) and chemotherapy, in treatment-naïve patients with resectable early stage non-small cell lung cancer (NSCLC) (Press release, Innate Pharma, JUN 26, 2023, View Source [SID1234632895]).

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The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety.

Innate is responsible for conducting the study and shares study costs with AstraZeneca (LSE/STO/Nasdaq: AZN). AstraZeneca supplies clinical trial drugs.

Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer at Innate Pharma "We are pleased to announce the dosing of a first patient in this Phase 2 study conducted in collaboration with our partner AstraZeneca. The study aims to assess the potential of combining our IPH5201 drug candidate with durvalumab as neoadjuvant treatment with chemotherapy and adjuvant treatment in patients affected by resectable, early stage non-small cell lung cancer. If this combination shows relevant anti-tumor activity while remaining well tolerated, as observed in the previous Phase 1 study, it will be a major step in the development of IPH5201 in this indication."

Fabrice Barlesi, MD, PhD, Professor of medicine at Paris Saclay University, General Manager of Gustave Roussy and principal investigator of the study added "Despite the introduction of novel treatment strategies, including immunotherapy with immune checkpoint inhibitors, many patients with resectable, early stage non-small cell lung cancer relapse following treatment leaving an important medical need in this setting. IPH5201 is a potential approach to reduce immunosuppression and promote antitumor immune responses in the tumor microenvironment. We look forward to continued enrollment and future results from this trial."

More information about the Phase 2 MATISSE trial can be found on clinicaltrials.gov.

Innate received a $5m milestone payment from AstraZeneca when the decision was made to progress IPH5201 to a Phase 2 clinical trial.

About IPH5201:

IPH5201 is a blocking antibody targeting the CD39 immunosuppressive pathway. CD39 is an extracellular enzyme that is expressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 inhibits the immune system by degrading adenosine triphosphate (ATP) into adenosine monophosphate (AMP), which is then further degraded into adenosine by CD73. By promoting the accumulation of immune-stimulating ATP and preventing the production of immune-suppressive adenosine, the blockade of CD39 may stimulate anti-tumor activity.

On June 26, 2023 Imunon, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Compensation Committee of the Company’s Board of Directors approved the grant of (i) inducement stock options (the "Inducement Option Grants") to purchase a total of 5,000 shares of common stock and (ii) restricted stock grants (the "Inducement Stock Grants") totaling 1,000 shares of common stock as a material inducement to the employment to one individual hired by Imunon during the second quarter of 2023 (Press release, IMUNON, JUN 26, 2023, View Source [SID1234632894]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Inducement Option Grants have an exercise price per share equal to $1.28, which is equal to the closing price of Imunon’s common stock as reported by Nasdaq on June 26, 2023. The Inducement Option Grants vest in quarters over four years with the vesting starting on the one-year anniversary of each employee’s first day of employment with the Company and thereafter vest in three additional installments so all Inducement Option Grants will be fully vested and exercisable as of June 26, 2027, subject to each employee’s continued service relationship with the Company on each such date. Each Inducement Option Grant has a ten-year term.

Each of the Inducement Stock Grants will vest on the one-year anniversary of each employee’s first date of employment with the Company and are subject to each such employee’s continued service relationship with the Company on such vesting date.

On June 26, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. ("Nexcella", "Company", "We" or "Us"), a biopharmaceutical company pioneering cell therapies targeting oncology and other diseases, reported that it has completed a Pre-Investigational New Drug ("Pre-IND") meeting with the FDA (Press release, Immix Biopharma, JUN 26, 2023, View Source [SID1234632893]). The subject of the Pre-IND meeting was planned NXC-201 US manufacturing and US clinical trials in AL amyloidosis and multiple myeloma.

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"Completion of our planned Pre-IND meeting with FDA is an important milestone towards opening U.S. clinical trial sites for NXC-201," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We appreciate the FDA’s guidance and believe that with regulatory clarity in hand, our next step is to proceed with submitting a US IND application to the FDA for NXC-201."

A pre-IND meeting provides an opportunity for communication between a drug development company and the FDA to discuss an investigational new drug (IND) proposed filing and plan to obtain the agency’s guidance for the initial clinical studies of a novel drug candidate. The FDA reviewed the pre-IND package submitted by Nexcella including clinical data, manufacturing plan and the phase 1b/2 study protocol synopsis for NXC-201, provided guidance and recommendations, as well as addressed Nexcella’s questions on the development plan of NXC-201 in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis according to consensus recommendations.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. Nexcella plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. Nexcella plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.