On May 1, 2023 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAY 1, 2023, View Source [SID1234630779]).

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Deltacel is the Company’s allogeneic, non-engineered, off-the-shelf Gamma Delta T-cell (GDT) therapy. Notably, Deltacel does not require the use of any viral vector as many other cell therapies do, which, among other advantages, allows for reduced manufacturing costs. Kiromic is seeking to address a significant unmet need by applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC. Lung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.

"Receiving the authorization from the FDA to administer Deltacel to patients enables us to advance our GDT therapy candidate into the clinic. As a potentially well tolerated and effective treatment, we look forward to the opportunity for Deltacel to have a meaningful impact on the hundreds of thousands of patients with non-small cell lung cancer and with other solid cancers," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We are in the process of activating clinical trial sites, and we look forward to providing updates on our progress."

On May 1, 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 Aegis Capital Virtual Conference being held on May 2 – 4, 2023 (Press release, Kintara Therapeutics, MAY 1, 2023, View Source [SID1234630778]).

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Presentation Date:

Time:

Webcast Link:

Wednesday, May 3, 2023

1:00 pm ET

View Source

On May 1, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that Chief Executive Officer and Managing Director, Dr James Garner, has resigned from the company (Press release, Kazia Therapeutics, MAY 1, 2023, View Source [SID1234630777]). Dr John Friend, Chief Medical Officer of Kazia, will immediately assume the role of Chief Executive Officer, and will in due course join the Board as Managing Director.

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Non-Executive Chairman of Kazia, Iain Ross, commented:

"Dr James Garner joined Kazia in February 2016 and was responsible for the transformation of the legacy Novogen business into the current organization. He drove the in-licensing of paxalisib and EVT801 and managed the deployment of a broad clinical program for both assets, in collaboration with leading cancer centres in the United States and Europe. He leaves to pursue other opportunities.

On behalf of the Board and on a personal basis, I want to thank James for his enormous contribution to Kazia, and to wish him every success in his future endeavours. As Kazia now moves towards further clinical readouts and potential commercialisation of paxalisib, it is timely to reposition the company’s executive team.

Dr John Friend brings a wealth of drug development and business experience to Kazia and has made an excellent contribution during his time with the Company. The Board is delighted that John has accepted the role of CEO as we believe he will be an excellent steward for the next phase of the Company’s growth."

About Dr John Friend

Dr Friend joined Kazia as Chief Medical Officer in November 2021. Since that time, he has been responsible for managing, and instrumental in expanding Kazia’s portfolio of clinical programs.

He is an accomplished physician executive with a more than 25 year career history and extensive background in establishing and leading critical business units in small to mid-sized biopharmaceutical companies. Prior to joining Kazia, he was Chief Medical Officer at Cellectar Biosciences, Inc (NASDAQ: CLRB), a clinical-stage, oncology-focused biotech company based in Florham Park, NJ. Prior to his time at Cellectar, he held executive roles with responsibility for research & development, regulatory affairs, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Helsinn Therapeutics, Akros Pharma, Actavis, Alpharma, Hospira and Abbott Laboratories.

Dr Friend gained his medical degree at Rutgers University (UMDNJ-Robert Wood Johnson) and also holds a BA in chemistry from Southern Methodist University.

Dr Friend commented:

"I join Iain in adding my thanks to Dr James Garner for the many years of strong leadership he has delivered to Kazia. He leaves the company well positioned with two excellent, unique clinical assets in paxalisib and EVT801, and a broad program of ongoing clinical trials, many of which are expected to produce data during CY2023.

We retain a highly accomplished, professional team which holds a deep understanding of our clinical assets and pipeline. I look forward to working closely with Iain, together with the Board and team to drive the company forward as Kazia’s next CEO."

Dr Friend will continue to be based in the state of New Jersey, USA on terms as outlined in Appendix A and Dr Garner will remain engaged through a transitional period to ensure a smooth handover of operational activities.

On May 1, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 10,600 restricted stock units (RSUs) to four newly-hired employees, with a grant date of April 30, 2023 (Press release, Karyopharm, MAY 1, 2023, View Source [SID1234630776]). Each RSU award will vest over three years, with 33 1/3% 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 200,000 RSUs to Amama Sadiq, M.D., MPH, the Company’s newly hired Senior Vice President, Global Medical and Scientific Affairs, with a grant date of April 30, 2023. This award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of Dr. Sadiq’s employment commencement date.

Each of these RSU 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).

On May 1, 2023 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that in connection with the previously announced appointment of Isabel Kalofonos as ImmunoGen’s Chief Commercial Officer, the compensation committee of the Company’s Board of Directors (the "Compensation Committee") approved, effective as of April 28, 2023, grants of a non-qualified stock option to purchase 284,250 shares of its common stock (the "Kalofonos Options") and restricted stock units ("RSUs") covering 47,375 shares of its common stock under the ImmunoGen, Inc. Inducement Equity Incentive Plan, as amended (the "Inducement Plan") (Press release, ImmunoGen, MAY 1, 2023, View Source [SID1234630775]).

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In addition, ImmunoGen announced that the Compensation Committee approved, effective as of April 28, 2023, grants of non-qualified stock options to purchase an aggregate of 131,600 shares of its common stock (the "Employee Options") and RSUs covering 65,750 shares of its common stock under the Inducement Plan to five other new employees.

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 individuals’ entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The Kalofonos Option and the Employee Options have an exercise price of $5.39 per share, which is equal to the closing price of ImmunoGen’s common stock on the Nasdaq Global Select Market on April 28, 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 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 each employee’s continued employment on each 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.