On July 31, 2023 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and POINT Biopharma Global Inc. (NASDAQ: PNT) ("POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the expansion of their global supply agreements signed in 2020 (Press release, ITM Isotopen Technologien Munchen, JUL 31, 2023, View Source [SID1234633553]). The expanded agreement broadens the supply of ITM’s non-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline. Financial details of the agreement were not disclosed.

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"Since POINT launched in late 2019, ITM has been a key partner to us as we have worked to establish a commercially scalable, reliable and redundant n.c.a. lutetium-177 supply chain," said Joe McCann, Ph.D., CEO of POINT Biopharma. "In building on this established trust and ITM’s position as the world’s leading manufacturer of n.c.a. lutetium-177, we value the ability to utilize ITM’s highly pure radioisotope across our growing pipeline of next-generation radioligands for precision oncology."

Steffen Schuster, CEO of ITM added, "It is our objective to make Targeted Radionuclide Therapy as broadly available as possible, not only by advancing our own pipeline, but also by supporting the whole industry with a stable and scalable isotope supply. We look forward to enriching our long-term collaboration with POINT by supplying our versatile n.c.a. lutetium-177 for the development and commercialization of various novel molecules."

ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta).

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About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.

On July 31, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that data from its TACTI-002 Phase II trial evaluating the chemo-free combination of eftilagimod alpha ("efti") and KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Rahway, NJ, USA) anti-PD-1 therapy, in 1st line non-small cell lung cancer (1L NSCLC) has been accepted for a Mini Oral presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress that will be held in Madrid, Spain from 20-24 October 2023 (Press release, Immutep, JUL 31, 2023, View Source [SID1234633552]). The presentation will include more mature overall survival data, following on from the data announced on 17 May 2023.

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Additionally, data from INSIGHT-003, an investigator-initiated Phase I trial conducted by the Frankfurt Institute of Clinical Cancer Research IKF evaluating efti in conjunction with anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin/pemetrexed) in non-squamous 1L NSCLC, has been accepted for a poster presentation. Also, a Trial in Progress poster for the EFTISARC-NEO investigator-initiated Phase II trial evaluating efti with pembrolizumab and radiotherapy in soft tissue sarcoma will be presented.

Oral Presentation
Title: Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: overall survival data from the 1st line non-small cell lung carcinoma (NSCLC) cohort of TACTI-002 (Phase II)

Presenter: Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO)
Date and Time: Saturday, October 21, 2023; 9:05 AM CEST
Session: Mini Oral session, 1312MO
Abstract ID: (#2174)
Poster Presentations
Title: INSIGHT 003 evaluating feasibility of eftilagimod alpha (soluble LAG-3) combined with 1st line chemo-immunotherapy in metastatic non-small cell lung cancer (NSCLC) adenocarcinomas

Presentation # 1042P

Title: Pembrolizumab in combination with eftilagimod alpha and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas – EFTISARC-NEO trial

Presentation # 1987TiP

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On July 31, 2023 UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") and options ("Options") to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing employment with UroGen (Press release, UroGen Pharma, JUL 31, 2023, View Source [SID1234633550]).

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Up to 30,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 20,000 ordinary shares are issuable upon the vesting and exercise of the Options. The Options have an exercise price of $8.84 per share, which is the closing price of the ordinary shares on the date of grant as reported on The Nasdaq Stock Market. The RSUs and Options will vest over three years, with one third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs and Options are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU and Option grant notice and agreements thereunder. The RSUs and Options were granted as an inducement material to the employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

On July 31, 2023 UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") and options ("Options") to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing employment with UroGen (Press release, UroGen Pharma, JUL 31, 2023, View Source [SID1234633550]).

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Up to 30,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 20,000 ordinary shares are issuable upon the vesting and exercise of the Options. The Options have an exercise price of $8.84 per share, which is the closing price of the ordinary shares on the date of grant as reported on The Nasdaq Stock Market. The RSUs and Options will vest over three years, with one third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs and Options are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU and Option grant notice and agreements thereunder. The RSUs and Options were granted as an inducement material to the employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

On July 31, 2023 Theratechnologies Inc. ("Theratechnologies", the "Company", or "we") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has completed the previously announced consolidation of the issued and outstanding common shares of the Company’s share capital on the basis of one (1) post- consolidation share for each four (4) pre-consolidation shares issued and outstanding (the "Consolidation") (Press release, Theratechnologies, JUL 31, 2023, View Source [SID1234633549]).

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The Consolidation received the applicable regulatory approvals, including from the Toronto Stock Exchange (the "TSX") and the Nasdaq Stock Market ("NASDAQ"). No shareholder approval was required for the Consolidation to come into effect. The Company’s common shares began trading on the TSX and the NASDAQ on a consolidated basis on July 31, 2023.

No fractional common share were issued in connection with the Consolidation and, in the event that a shareholder would otherwise have been entitled to receive a fractional share upon such Consolidation, the number of common shares to be received by such shareholder was rounded up (if the fraction is half a share or more) or down (if the fraction is less than half a share) to the nearest whole common share, provided that no shareholder shall hold less than a single common share as a result of the Consolidation.

Shareholders who hold their common shares electronically either in direct registered book-entry form via a direct registration system advice/statement ("DRS") with Computershare Trust Company of Canada ("Computershare"), the Company’s transfer agent, or in "street name" through an intermediary like a bank, broker or other nominee, will not need to take any action as the Consolidation should automatically be reflected in the transfer agent’s records and on such shareholders’ next account statement. Intermediaries may have specific procedures for processing the Consolidation, including the treatment of fractional shares.

Shareholders holding paper stock certificates were sent by Computershare a letter of transmittal which will enable them to exchange their old share certificates for a DRS representing the number of new post-Consolidation common shares they hold. Until surrendered, each stock certificate representing pre-Consolidation common shares will be deemed for all purposes to represent the number of whole post-Consolidation common shares to which the shareholder is entitled as a result of the Consolidation. A copy of the letter of transmittal is available on the Company’s SEDAR profile at www.sedar.com and on EDGAR at www.sec.gov.