On May 18, 2023 Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) ("Biodexa" or the "Company"), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain is pleased to announce that it has signed non-binding letter of intent to potentially acquire Varian Biopharmaceuticals, Inc. ("VarianBio"), a private US precision oncology company developing novel therapeutics for the treatment of cancer (Press release, Midatech Pharma, MAY 18, 2023, View Source [SID1234631849]).

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Background to the proposed acquisition

In recent communications, the Company has referenced a shift in strategy from a drug delivery company to a therapeutics company. Currently, the Company’s only clinical asset is MTX110 which is being developed for three intractable rare and orphan brain cancers. The Company’s intention is to add to, and diversify, its development pipeline with a continued focus on rare and orphan products and/or oncology therapeutics and VarianBio represents the first of such opportunity.

On May 18, 2023 Micronoma reported that it is serving as the industry partner on a grant the NYU Grossman School of Medicine received from the National Cancer Institute to identify microbial and host genomic signatures that can be used with other methodologies to predict non-small cell lung cancer (NSCLC) in its early stages as well as the chance of post-surgical recurrence (Press release, Micronoma, MAY 18, 2023, https://www.micronoma.com/micronoma-teams-up-with-nyu-school-of-medicine-on-lung-cancer-research-grant-this-latest-collaboration-seeks-synergistic-methodologies-that-will-enable-the-earliest-best-predictions-of-lung-cancer/ [SID1234631848]).

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"Micronoma is thrilled to partner again with NYU researchers to advance the cause of using microbial biomarkers to diagnose cancer as early as possible as well as establish potential recurrence markers," said Micronoma CEO and co-founder Sandrine Miller-Montgomery. "Lung cancer remains the leading cancer killer and the development of non-invasive methods to identify it is key to improving patient outcomes."

"This work will build on our groundbreaking work as the first biotech company offering early cancer detection using OncobiotaLUNG, a microbiome-driven liquid biopsy platform," she added.

Micronoma and NYU Langone Health are currently collaborating to use blood samples to derive multi-omics, including circulating tumor microbial DNA associated with early lung cancer diagnosis, which the company should make commercially available under CLIA regulations later this year.

With this grant, NYU and Micronoma intend to continue identifying the leading microbial and host biomarkers that can be used to predict early-stage lung cancer diagnosis and prognosis and use cutting-edge bioinformatic mechanisms and potentially targeted molecular tools to pursue developing early-stage testing and prognosis.

"We are extremely excited to bring a novel use of microbial genomic signatures as a potential biomarker for early-stage lung cancer to the Early Detection Research Network (EDRN) multicenter consortium," said Leopoldo N. Segal, M.D., Associate Professor of Medicine. "This work has been made possible through the collaborative efforts between NYU Langone Health and Micronoma. This is a promising area of research that we expect to be important in our efforts to diagnose early-stage lung cancer and risk stratify them."

As previously disclosed in the Current Report on Form 8-K filed by Iovance Biotherapeutics, Inc., a Delaware corporation (the "Company") with the Securities and Exchange Commission (the "SEC") on January 23, 2023, the Company and its newly formed, wholly owned subsidiary, Iovance Biotherapeutics UK Ltd ("Purchaser") entered into an Option Agreement (the "Option Agreement") with Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc. (collectively, "Clinigen"), pursuant to which the Purchaser would acquire the worldwide rights in Proleukin (aldesleukin) (the "Product"), as well as the manufacturing, supply, commercialization and the generation of income from such rights and associated operations from Clinigen (the "Acquisition") (Filing, Iovance Biotherapeutics, MAY 18, 2023, View Source [SID1234631847]).

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On May 18, 2023, the Company completed the Acquisition and specifically acquired (i) all issued and outstanding shares of Clinigen SP Limited (the "Target"), (ii) the business of the Target and Clinigen comprising the manufacturing, supply, commercialization and the generation of income from the Product rights and the undertaking of an active role in the development, maintenance and exploitation of those rights, and (iii) certain specified assets identified in the Option Agreement. The closing contemplated by the Option Agreement followed the satisfaction or waiver of the closing conditions under the Option Agreement, including the required submission of the premerger notification and report form filing under the Hart-Scott-Rodino Antitrust Improvement Act of 1976 to the Regulatory Authority (as defined in the Option Agreement).

Pursuant to the Option Agreement, the Company paid to Clinigen (i) an upfront payment of £167.7 million (or approximately $200 million) and (ii) a payment for certain inventory of £2.4 million (or approximately $3.1 million) using existing cash on hand. The Option Agreement also provides for a £41.7 million (or approximately $50 million) milestone payment upon first approval of lifileucel in advanced melanoma, and deferred consideration based on double digit rates on global net sales (as defined therein) payable from the Company to Clinigen following the completion of the Acquisition for the applicable deferred consideration term.

The foregoing description of the Option Agreement does not purport to be complete and is qualified in its entirety by reference to the Option Agreement, a copy of which was filed as Exhibit 10.1 to Amendment No. 1 to the Current Report on Form 8-K filed by the Company with the SEC on January 27, 2023.

On May 18, 2023 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 128,840 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, MAY 18, 2023, View Source [SID1234631846]).

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The stock options were granted on May 17, 2023 at an exercise price of $3.02 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 122,220 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 6,620 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

On May 18, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Galera’s second product candidate, rucosopasem manganese (rucosopasem), for the treatment of pancreatic cancer (Press release, Galera Therapeutics, MAY 18, 2023, View Source [SID1234631845]).

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Rucosopasem is a next-generation selective dismutase mimetic in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer. The Company is currently conducting the GRECO-2 Phase 2b randomized, double-blind, placebo-controlled 220-patient trial of rucosopasem in combination with SBRT in patients with locally advanced pancreatic cancer (LAPC).

"Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S.," said Mel Sorensen, M.D., Galera’s President and CEO. "Following our announcement of encouraging survival results from our pilot proof-of-concept trial in patients with LAPC in 2021, we initiated the GRECO-2 trial, which is currently enrolling. We believe rucosopasem has the potential to improve the efficacy of SBRT for pancreatic cancer, and we anticipate topline data from GRECO-2 by the end of next year."