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.

On May 8, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company’s participation in the following upcoming industry and investor conferences to be held in May 2023.

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Event: Sidoti Micro Cap Conference

Conference Dates: May 10 – 11, 2023

Virtual Presentation: Thursday, May 11 at 12:15 p.m. ET in Track 3

Virtual Presentation Link: https://bit.ly/3APq2xY

Presenter: Ryan Confer, Chief Financial Officer

Mr. Confer will deliver an overview of the Company’s pioneering gene therapies for cancer and diabetes and will be available for virtual one-on-one meetings with investors through the Sidoti conference platform.

A recording of this presentation will be available for replay on Genprex’s website for a period of time.

Event: American Society of Gene & Cell Therapy Annual Meeting

Conference Dates: May 16 – 20, 2023

Genprex’s Chief Technology and Manufacturing Officer, Hemant Kumar, PhD, and Senior Vice Preisdent of Intellectual Property and Licensing, Thomas Gallagher, will participate in the ASGCT (Free ASGCT Whitepaper) annual meeting. Both Dr. Kumar and Mr. Gallagher will be available for in-person meetings with conference attendees.

Event: A.G.P.’s Virtual Healthcare Conference

Conference Date: May 23 – 24, 2023

Several members of the Genprex management team will participate in the A.G.P. Virtual Healthcare Conference.

For those interested in meeting Genprex management during these conferences, please request a meeting through the conference portals or reach out to Investor Relations at [email protected].

On May 8, 2023 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2023 (Press release, Foghorn Therapeutics, MAY 8, 2023, View Source [SID1234631165]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"In the coming months, we anticipate the initial Phase 1 results for FHD-286 in metastatic uveal melanoma and we continue to advance our exciting early-stage oncology programs—including our BRM selective inhibitor, CBP, EP300 and ARID1B—toward the clinic while showcasing our ability to repeatedly generate selective chemical matter against important targets in oncology," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "These programs have the potential to deliver novel therapies that hold tremendous value for large patient populations in a broad range of different cancers."

Key Recent Updates and Upcoming Milestones

•FHD-286. FHD-286 is a potent, selective inhibitor of the BRG1 and BRM subunits of the BAF chromatin remodeling complex where dependency on BRG1/BRM is well-established pre-clinically with multiple tumor types, including uveal melanoma, acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), non-small cell lung cancer (NSCLC) and prostate cancer.
•mUM Update. Phase 1 dose escalation of FHD-286 in metastatic uveal melanoma (mUM) continues to enroll patients per protocol. Top-line Phase 1 safety and efficacy data is expected in the second quarter of 2023.
•AML/MDS Update. In August 2022, the U.S. Food and Drug Administration (FDA) placed a full clinical hold on the Phase 1 dose escalation study of FHD-286 in relapsed and/or refractory AML and MDS. The Company anticipates providing a regulatory update for FHD-286 in AML/MDS in the second quarter of 2023.

•FHD-609 Update. On April 24, 2023, Foghorn provided an update on the FHD-609 Phase 1 program in synovial sarcoma and SMARCB1-deleted tumors. (Link to press release here).

•Differentiated Pipeline Advancement. Foghorn continues to expand its platform and pipeline. The Company anticipates the potential for six new molecular investigational new drug (IND) applications in the next four years. The Company continues to progress programs for multiple targets which include chromatin remodeling complexes, transcription factors, helicases and other chromatin related factors. These targets include Selective BRM* and wholly owned programs including CBP, EP300 and ARID1B, as well as other undisclosed targets, which combined could address more than 20 tumor types impacting more than 500,000 new patients annually.

•Medical Conference Participation. In April 2023, Foghorn participated at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 18th Annual Drug Discovery Chemistry Meeting, highlighting preclinical data from its selective CBP and EP300 protein degrader programs, preclinical data for FHD-286 and its transcription factor and protein degradation capabilities. To access the presentations, please visit the "Our Data" section of the Foghorn website.

•Strategic Collaborations. During the first quarter of 2023, Foghorn continued to progress the Company’s strategic collaborations with two world-leading pharmaceutical companies, which validate the rigor of our science, highlight the importance of the targets we are tackling and confirm the relevance of the biology on which we are focused.
•In December 2021, Foghorn entered into a strategic collaboration with Loxo@Lilly. In 2023, Foghorn anticipates continued progress across the collaboration including a co-development and co-commercialization agreement on the Selective BRM program*, an additional undisclosed oncology target and three additional discovery programs. The Selective BRM program is on track to transition to Loxo@Lilly in the second half of 2023.
•In July 2020, Foghorn entered into a strategic collaboration with Merck Sharp & Dohme. In 2023, Foghorn will continue to utilize its Gene Traffic Control platform to discover and develop novel therapeutics under the collaboration based on disruptors of a specified transcription factor target.

*In December 2021, Foghorn announced a strategic collaboration with Loxo@Lilly to create novel oncology medicines. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s Selective BRM oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three discovery programs using Foghorn’s proprietary Gene Traffic Control platform.

First Quarter 2023 Financial Highlights

•Strong Balance Sheet and Cash Runway. As of March 31, 2023, the Company had $316.0 million in cash, cash equivalents and marketable securities, which provides a cash runway into the second half of 2025.

•Collaboration Revenues. Collaboration revenue was $5.3 million for the three months ended March 31, 2023, compared to $3.9 million for the three months ended March 31, 2022. The increase year-over-year was primarily driven by revenue recognized under the Lilly collaboration agreement.

•Research and Development Expenses. Research and development expenses were $30.0 million for the three months ended March 31, 2023, compared to $24.5 million for the three months ended March 31, 2022. This increase was primarily due to costs associated with continued investment in R&D personnel and platform and early-stage research investments.

•General and Administrative Expenses. General and administrative expenses were $8.6 million for the three months ended March 31, 2023, compared to $7.2 million for the three months ended March 31, 2022. This increase was primarily due to an increase in investments to support the growing business which included increases in personnel-related costs and stock-based compensation expense.

•Net Loss. Net loss was $30.5 million for the three months ended March 31, 2023, compared to a net loss of $26.9 million for the three months ended March 31, 2022.

About FHD-286
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. To learn more about these studies, please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

About Uveal Melanoma
Uveal (intraocular) melanoma (UM) is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

On May 8, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported its financial results for the first quarter 2023, recent business highlights and key upcoming catalysts (Press release, Atara Biotherapeutics, MAY 8, 2023, View Source [SID1234631164]).

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"We are entering an important period of potential value-generating milestones for our prioritized pipeline assets and continue to have productive dialogue and senior level engagement with FDA regarding tab-cel," said Pascal Touchon, President and Chief Executive Officer of Atara. "In parallel, we continue to identify operational efficiencies and reduce cash burn with the goal of further extending our cash runway to best position Atara for future success."

Tabelecleucel (tab-cel or EBVALLOTM) for Post-Transplant Lymphoproliferative Disease (PTLD)

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Following a recent meeting with FDA on chemistry, manufacturing, and controls (CMC) matters, Atara and the FDA agreed to hold a subsequent meeting, anticipated in Q2, to discuss additional details requested by the FDA on CMC aspects related to a potential biologics license application (BLA) submission for tab-cel. We expect to provide an update on our plans for a BLA submission for tab-cel at our next earnings release
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Following the successful transfer of the European Commission (EC) Marketing Authorization of EBVALLO to Pierre Fabre, the first patients have received treatment. Pierre Fabre is progressively launching EBVALLO on a country-by-country basis
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Atara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023
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Atara is engaged in discussions with potential U.S. commercialization partners

ATA188 for Progressive Multiple Sclerosis (MS)

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The primary analysis data read out for the Phase 2 EMBOLD study is on track for October 2023

ATA3219: CD19 Program for B-Cell Malignancies

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Atara is advancing an Investigational New Drug Application (IND) for ATA3219, an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy that incorporates multiple clinically validated technologies designed for T-cell memory, robust expansion, and potent anti-tumor efficacy, that is anticipated for filing in Q2 2023

Leadership Changes

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Jakob Dupont M.D., who has served as the Company’s Head of Global Research & Development since 2020, will depart Atara to pursue an opportunity in venture capital effective May 12, 2023. Following this date, Dr. Dupont will consult for Atara until the end of the year in support of progressing a potential BLA for tab-cel, the Phase 2 EMBOLD primary analysis data readout for ATA188, and advancing an IND for ATA3219. AJ Joshi, M.D., Chief Medical Officer, Jill Henrich, Head of Global Regulatory Affairs, and Cokey Nguyen, Ph.D., Chief Scientific Officer, will assume Dr. Dupont’s responsibilities
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Separately, Charlene Banard, who has served as Atara’s Chief Technical Officer since 2022, will be departing the Company effective June 9, 2023. Dr. Cokey Nguyen and Ms. Jill Henrich will assume Ms. Banard’s responsibilities

First Quarter 2023 Financial Results

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Cash, cash equivalents and short-term investments as of March 31, 2023, totaled $205.4 million, as compared to $242.8 million as of December 31, 2022
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Atara believes that its cash and investments as of March 31, 2023, will be sufficient to fund the Company’s planned operations into Q2 2024
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Atara reported net losses of $74.8 million, or $0.72 per share for the first quarter 2023, as compared to $88.1 million, or $0.87 per share for the same period in 2022
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Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $13.0 million for the first quarter 2023, as compared to $15.9 million for the same period in 2022
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Research and development expenses were $62.2 million for the first quarter 2023, as compared to $75.0 million for the same period in 2022
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Research and development expenses include $6.8 million of non-cash stock-based compensation expenses for the first quarter 2023 as compared to $8.5 million for the same period in 2022
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General and administrative expenses were $13.9 million for the first quarter 2023, as compared to $20.6 million for the same period in 2022
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General and administrative expenses include $5.0 million of non-cash stock-based compensation expenses for the first quarter 2023, as compared to $5.8 million for the same period in 2022