On May 8, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that, on April 27, 2023, the Compensation Committee of Precision’s Board of Directors approved the grant of inducement awards to new employees under the Precision BioSciences, Inc. 2021 Employment Inducement Incentive Award Plan ("Inducement Award Plan") (Press release, Precision Biosciences, MAY 8, 2023, View Source [SID1234631172]). The inducement awards consist of options to purchase ("stock options") an aggregate of 259,641 shares of Precision’s common stock, par value $0.000005 (the "Common Stock"), which stock options were granted among five employees in connection with their commencement of employment. Each of the stock options were granted under Nasdaq Listing Rule 5635(c)(4) as an inducement for the employees to commence service with Precision.

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The stock options have a per share exercise price equal to the fair market value of Precision’s Common Stock on the grant date, which was equal to $0.82. Each of the stock options has a 10-year term and vests (subject to continued service to Precision through the applicable vesting dates) as to 25% of the award on the first anniversary of the date of the commencement of their employment and, as to the remaining 75%, in substantially equal quarterly installments over the three years thereafter.

On May 8, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported its financial results and operational updates for the quarter ended March 31, 2023 (Press release, ORIC Pharmaceuticals, MAY 8, 2023, View Source [SID1234631171]).

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"We continue to execute and make strong progress in advancing our novel oncology pipeline," said Jacob M. Chacko, MD, chief executive officer. "At the 2023 AACR (Free AACR Whitepaper) meeting, we presented promising preclinical data highlighting our comprehensive biomarker strategy for ORIC-944, our allosteric PRC2 inhibitor, and preclinical data for our PLK4 program, demonstrating the potential of highly selective PLK4 inhibition as a synthetic lethal approach for TRIM37 amplified cancers. Our three clinical programs are enrolling steadily and we look forward to reporting initial clinical data from our ongoing studies in the second half of 2023."

First Quarter 2023 and Other Recent Highlights

ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Enrolling a Phase 1b trial of ORIC-533 as a single-agent, in patients with relapsed/refractory multiple myeloma.
Expect to report initial Phase 1b data for ORIC-533 in the second half of 2023.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Enrolling a Phase 1b trial of ORIC-114 as a single-agent, in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications, including patients with CNS metastases that are either treated or untreated but asymptomatic.
Expect to report initial Phase 1b data for ORIC-114 in the second half of 2023.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Enrolling a Phase 1b trial of ORIC-944 as a single-agent, in patients with advanced prostate cancer.
Presented preclinical data highlighting a comprehensive biomarker strategy for the ongoing Phase 1b trial in metastatic prostate cancer at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Expect to report initial Phase 1b data for ORIC-944 in the second half of 2023.
Discovery Pipeline:

Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibition as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
First Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $208.9 million as of March 31, 2023, which the company expects will be sufficient to fund its operating plan into the first half of 2025.

R&D Expenses: Research and development (R&D) expenses were $19.5 million for the three months ended March 31, 2023, compared to $16.8 million for the three months ended March 31, 2022, an increase of $2.7 million. The increase was due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs.

G&A Expenses: General and administrative (G&A) expenses were $6.2 million for the three months ended March 31, 2023, compared to $6.4 million for the three months ended March 31, 2022, a decrease of $0.3 million.

On May 8, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its President and CEO, Robert E. Hoffman, will present a corporate overview at the Sidoti Micro-Cap Virtual Conference being held on May 10 – 11, 2023 (Press release, Kintara Therapeutics, MAY 8, 2023, View Source [SID1234631169]).

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Presentation Date:

Wednesday, May 10, 2023

Time:

4:00 pm ET

Webcast Link:

Kintara Presentation Registration

On May 8, 2023 INmune Bio, Inc. (NASDAQ: INMB) reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for INKmune, a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, INmune Bio, MAY 8, 2023, View Source [SID1234631168]). The Company believes this is the first NK immunotherapy trial in men with mCRPC, which affects more than 80,000 men in the U.S. The trial is expected to enroll the first of 30 patients in the second half of 2023. It will be opened at 4 more clinical study sites, with a goal to determine short and long-term safety of INKmune, demonstrate the ability of INKmune to control prostate cancer tumor burden, and identify a dose of INKmune to be used in a future blinded randomized pivotal trial.

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The principal investigator of the clinical trial is Prof. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer. Prof. Rettig is a consultant to INmune Bio. According to RJ Tesi, MD, CEO of INmune Bio, "Prostate cancer is one of the few solid tumors that has no immunotherapy options and chemotherapy, the standard-of-care, has suboptimal efficacy with measurable toxicities. INKmune has the potential to provide a safe and effective therapeutic option for men with this difficult disease."

This will be the second clinical trial using INKmune to treat cancer. The first trial, called Laurel, is an on-going Phase I trial in patients with high risk MDS or AML. Mark Lowdell PhD, CSO of INmune Bio and inventor of the INKmune technology said, "There are compelling clinical evidence demonstrating that men with prostate cancer have lots of NK cells in the blood and their tumor, but often these NK cells are resting or immature NK cells that do not kill cancer. INKmune therapy can convert these inert NK into therapeutically relevant and effective NK cells."

Patients will receive one of three doses of INKmune as an out-patient treatment during the six-month trial. Two markers of INKmune efficacy will be measured – immunologic and therapeutic efficacy. Immunologic efficacy will measure the increase in memory-like NK cells in the blood and how long those cells are present in the patient’s blood. Therapeutic efficacy will measure tumor response to INKmune therapy, using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden measured by bone and CT scan). Novel biomarkers of tumor response, PMSA PET scan and circulating tumor DNA, will also be studied.

The Company will host a Webinar entitled: INKmune Primed NK cell Therapy for mCRPC on Friday, 12 May at 11 AM EDT on to discuss why INKmune is well suited for the treatment of men with mCRPC and provide details of the clinical trial design. RJ. Tesi, MD will moderate a discussion between Prof. Matt Rettig, MD and Prof. Mark Lowdell, PhD.

To register for the webinar, please sign-up by clicking here or the link below:

View Source

About INKmune

INKmune is a product designed to improve the function of the patient’s own NK cells. INKmune is a clinical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication or cytokine support.

On May 8, 2023 Inhibrx, Inc. (Nasdaq: INBX), or Inhibrx, or the Company, a biopharmaceutical company with four clinical programs in development and a strong emerging pipeline, reported its financial results for the first quarter of 2023 and provided an update on recent corporate highlights (Press release, Inhibrx, MAY 8, 2023, View Source [SID1234631167]).

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Recent Corporate Highlights

•On April 26, 2023, Inhibrx announced the initiation of a registration-enabling trial for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treatment of patients with emphysema due to alpha-1 antitrypsin deficiency. The initial read-out from this trial is expected to occur in late 2024.

•On April 26, 2023, Inhibrx announced the U.S. Food and Drug Administration has lifted the partial clinical hold on studies evaluating its death-receptor 5 agonist, INBRX-109. Patient enrollment has resumed.

Financial Results

•Cash and Cash Equivalents. As of March 31, 2023, Inhibrx had cash and cash equivalents of $234.3 million, compared to $273.9 million as of December 31, 2022. The increase in cash outflow during the first quarter of 2023 was a result of the timing of payments made to the Company’s contract development and manufacturing organizations, or CDMO, related to batch production for its clinical and preclinical candidates. Additionally, there was an increase in cash outflow during the period in advance of the initiation of the INBRX-101 registration-enabling trial to the Company’s contract research organizations, or CRO, partners, as well as the timing of payments associated with the INBRX-109 Phase 1 combination cohorts and expanded patient enrollment targets for the Phase 1/2 trials for both INBRX-105 and INBRX-106.

•R&D Expense. Research and development expenses were $37.4 million during the first quarter of 2023, compared to $24.9 million during the first quarter of 2022. During the first quarter of 2023, Inhibrx’s clinical trial expenses increased, both for its Phase 1/2 trials as they continue to progress, as well as its continued expenses related to the ongoing INBRX-109 registration-enabling trial and the initiation of the INBRX-101 registration-enabling trial. The Company also incurred increased CMC expenses at our CDMO and CRO partners supporting our clinical and preclinical therapeutic candidates, including early and late stage drug substance clinical manufacturing, drug product manufacturing, and selected BLA-enabling activities. Personnel-related costs also increased during both periods, partially attributable to an increase in headcount as the Company continues to expand its research and development and clinical operations teams as well as increased salaries and the expansion of our bonus eligibility pool in the current year.

•G&A Expense. General and administrative expenses were $6.4 million during the first quarter of 2023, compared to $5.1 million during the first quarter of 2022. This overall increase was primarily driven by an increase in additional personnel-related costs in part due to the expansion of the Company’s commercial strategy team as well as an increase in salaries and the expansion of our bonus eligibility pool in the current year. In addition, market research and other scientific publication expenses were incurred related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109.

•Net Loss.

Net loss was $48.9 million during the first quarter of 2023, or $1.12 per share, compared to $31.3 million during the first quarter of 2022, or $0.80 per share.