Kineta to Present at 22nd Annual Needham Healthcare Conference

On April 3, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that Shawn Iadonato, Ph.D., CEO will present at the 22nd Annual Needham Healthcare Conference, being held virtually from April 17-20, 2023 (Press release, Kineta, APR 3, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-present-at-22nd-annual-needham-healthcare-conference [SID1234629750]). Company management will also be available for virtual one-on-one meetings.

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Event: 22nd Annual Needham Virtual Healthcare Conference
Date: Tuesday April 18, 2023
Time: 12:45 – 1:25 P.M. Eastern Time

The webcast presentation replay will be available for viewing on the Events & Presentations section of the Company’s website.

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On April 3, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 221,900 restricted stock units (RSUs) to thirteen newly-hired employees (Press release, Karyopharm, APR 3, 2023, View Source [SID1234629749]). These RSU awards were granted as of March 31, 2023. Each RSU award will vest over three years, with 33 1/3% percent of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the applicable employee’s employment commencement date.

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In addition, the Company granted an award of 60,000 RSUs to Tahira Payne, the Company’s newly hired Senior Vice President, Development Operations, with a grant date of March 31, 2023. The RSU award will vest as to 25% of the shares underlying the award, on each of four consecutive anniversaries of Ms. Payne’s employment commencement date.

Each of these equity awards were granted pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4). The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each RSU award will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee’s employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable RSU agreement).

INOVIO Reports Inducement Grant Under Inducement Plan

On April 3, 2023 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, reported that it has made an equity grant to its newly hired Senior Vice President, Regulatory Affairs under its 2022 Inducement Plan (the "Inducement Plan") (Press release, Inovio, APR 3, 2023, View Source [SID1234629748]).

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The Compensation Committee of INOVIO’s Board of Directors has approved the award of restricted stock units ("RSUs") covering an aggregate of 45,000 shares of common stock and options to purchase an aggregate of 70,000 shares of common stock, with a grant date of March 31, 2023 (the "Grant Date"), to the newly hired employee in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over a three-year period, with one-third of the shares vesting on each of the first, second and third anniversaries of the Grant Date. The stock option has an exercise price of ­­­$0.82, the closing price of INOVIO’s common stock on the Grant Date. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option vested on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of the RSUs and stock options will be subject to the employee’s continued employment with INOVIO on the applicable vesting dates. Each of these awards is subject to the terms and conditions of a stock option agreement and RSU award agreement, as applicable, under the Inducement Plan.

INmune Bio, Inc. Announces Submission of Investigational New Drug (IND) Application for INKmune™ to the U.S. Food and Drug Administration for Treatment of Metastatic Castration-Resistant Prostate Cancer

On April 3, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of INKmune to treat metastatic castration-resistant prostate cancer (mCRPC) (Press release, INmune Bio, APR 3, 2023, View Source [SID1234629747]).

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"We believe this IND highlights the potential for INKmune, our natural killer cell targeting immunotherapy, to treat solid tumors," said RJ Tesi M.D., CEO of INmune Bio. "We believe INKmune provides a new treatment option that may allow men with mCRPC to safely avoid cytotoxic chemotherapy and potentially live longer."

The trial is expected to take place in four or more medical centers in the U.S and will enroll approximately 30 patients in a flexible Bayesian design. 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, will be Principal Investigator of the INKmune mCRPC trial. The goal of the trial is to define the safety of INKmune and demonstrate the ability of INKmune-primed NK cells to attack prostate cancer. The results should allow us to choose the best dose of INKmune to move into a blinded randomized trial. Given the novel nature of the treatment, the Company expects a period of consultation with the FDA prior to initiating the planned trial.

"NK cells are often seen in prostate tumor biopsies, but in many cases the cancer cells appear to be resistant to NK killing," said Mark Lowdell Ph.D., CSO of INmune Bio and inventor of the INKmune technology. "The Company believes that INKmune can convert the patient’s own NK cells into cancer killing memory-like NK (mlNK) cells that can survive in the hostile immunosuppressive and hypoxic tumor microenvironment (TME) that as we have shown in vitro, can kill NK-resistant prostate cancer cells."

The 6-month trial will test three doses of INKmune. The therapeutic potential of INKmune in mCRPC will be tested in two ways. First, the immunologic effects of INKmune therapy will be measured by the ability of INKmune to convert the patient’s resting NK cells into cancer killing memory-like NK cells, the ability of those cells to kill a tumor target (RAJI cell line) in vitro and the persistence of that response after treatment. Second, the tumor response to INKmune therapy will be measured using traditional biomarkers of prostate cancer response – progression free survival, changes in blood PSA level and imaging studies (bone and CT scan). Novel biomarkers of tumor response, change in PMSA PET scan and circulating tumor DNA, will also be studied.

Currently, in INmune’s ongoing Laurel INKmune trial, the Company’s MDS/AML INKmune Phase 1 program, the latest patient treated at the Royal Hallamshire Hospital at Sheffield University Medical School finished INKmune treatment without side effects. Initial biomarker data from this patient show, as in previous patients, that she has developed tumor killing memory-like NK cells in her peripheral blood one week after the first dose. Analysis of her later blood samples is underway. The clinical sites continue to review patients for treatment in the Laurel trial. An additional patient will be eligible for treatment in three weeks.

About INKmune

INKmune is an NK cell targeted therapy that is not an NK cell per se but a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells in the patient and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination; it is a pseudokine. These INKmune-generated 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.

ImmunoGen Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On April 3, 2023 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that on March 31, 2023, the Compensation Committee of the Company’s Board of Directors approved, in aggregate, grants of non-qualified stock option awards to purchase 106,600 shares of its common stock and restricted stock units ("RSUs") covering 7,800 shares of its common stock to three new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan, as amended (the "Inducement Plan") (Press release, ImmunoGen, APR 3, 2023, View Source [SID1234629746]).

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The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $3.84 per share, which is equal to the closing price of ImmunoGen’s common stock on the Nasdaq Global Select Market on March 31, 2023. Each option will vest as to 25% of the shares underlying such option on the first anniversary of the grant date and as to an additional 6.25% of the shares underlying the option quarterly thereafter, subject to each such employee’s continued employment on each vesting date. Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to such employee’s continued employment on each such vesting date. Each option and RSU is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement and an RSU agreement covering the respective grants.