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Philochem and Blue Earth Diagnostics Announce First Three Patients Imaged in Phase 1 Clinical Trial of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) for Diagnostic Imaging in Solid Tumors

On December 4, 2023 Philochem AG, a wholly owned subsidiary of Philogen S.p.A., and Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported additional information regarding a March 2022 licensing and collaboration agreement between Philochem and Blue Earth Diagnostics (Press release, Philogen, DEC 4, 2023, View Source [SID1234638131]). The collaboration encompasses the development of OncoFAP, a proprietary, small organic ligand with ultra-high affinity to Fibroblast Activation Protein (FAP), for applications in the diagnostic imaging of solid tumors. Under the agreement, the Philogen Group is conducting a Phase 1 clinical study to evaluate the safety and dosimetry of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) in patients with solid tumors. The agreement provides Blue Earth Diagnostics rights to develop and commercialize 68Ga-OncoFAP worldwide. FAP is a tumor-associated antigen which is expressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as in some soft tissue and bone sarcomas).

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The Philogen Group has a Phase I clinical trial (called FAPrimo) underway in Europe to evaluate the safety and dosimetry of 68Ga-OncoFAP in patients with solid tumors. The study is planned to enroll up to 20 patients who will undergo PET/CT imaging with 68Ga-OncoFAP. The first three enrolled patients in the trial were imaged in November 2023 at the National Cancer Institute of Milan (INT). To date, 68Ga-OncoFAP-DOTAGA has been used for PET imaging applications in approximately 100 patients with various solid tumors through Philochem’s collaboration with the University of Münster, Germany.

Prof. Dr. Dario Neri, Member of the Board of Philochem and CEO of the Philogen Group, commented: "We are excited about the promising tumor-targeting performance of 68Ga-OncoFAP in preclinical models and human patients to date. Philochem discovered and published the first paper on this important tumor targeting ligand in 2021. We believe OncoFAP technology has potential to pave the way for a new approach to tumor diagnosis, and significantly improve diagnosis and informed management for patients who have solid tumor cancers."

"We are delighted to announce this key milestone of the first three patients being dosed in the Phase 1 trial for 68Ga-OncoFAP PET in the detection and localization of advanced solid tumors," commented David Gauden, D. Phil., Chief Executive Officer of Blue Earth Diagnostics. " 68GaOncoFAP is an innovative and promising addition to Blue Earth Diagnostics’ robust portfolio of precision PET radiopharmaceuticals. We are grateful for the support of our parent company, Bracco Imaging, S.p.A., in helping to advance innovation to shape the future of precision medicine and improve patients’ lives worldwide with imaging technology such as OncoFAP. Based on preclinical studies and early clinical experience, 68Ga-OncoFAP has demonstrated favorable radiochemical properties, rapid clearance from organs and soft tissues and avid tumor uptake. We look forward to continuing collaboration with Philochem throughout this Phase 1 trial and applying our deep expertise in radiopharmaceutical development and commercialization as we advance further, with the goal to help patients and address unmet needs in cancer."

About Fibroblast Activation Protein (FAP) and FAP-targeted Technology

Fibroblast Activation Protein, or FAP, is a transmembrane protein that is overexpressed in cancerassociated-fibroblasts (CAFs) in the tumor microenvironment of most tumor types, but expressed at low levels in normal adult tissues. It is involved in a variety of tumor-promoting activities and is considered a promising target with diagnostic and theranostic potential in a variety of diseases. FAP is being investigated for use in diagnostic imaging and therapy in multiple tumor types, such as colon, breast, lung, pancreatic and esophageal cancers, among others. CAFs are also highly expressed in tissue remodeling, and FAP imaging may have applications in benign fibrotic conditions such as wound healing, as well as in chronic inflammation, cirrhosis, and cardiovascular and rheumatoid diseases.

Radiolabeled FAP ligands have demonstrated high binding affinity, rapid binding to FAP-expressing tumors and impressive lesion to background ratios in patients with a broad range of cancer types. They can be labeled with isotopes such as 68Ga or 18F for diagnostic PET imaging, or with therapeutic radioisotopes such as 177Lu or 225Ac for therapy.

Developing Transformational Immunotherapies for Cancer

On December 4, 2023 PDS Biotechnology presented its corporate presentation (Presentation, PDS Biotechnology, DEC 4, 2023, View Source [SID1234638130]).

Nanobiotix Announces Closing of the Remaining $4.8 Million Investment From Johnson & Johnson Innovation – JJDC, Inc.

On December 4, 2023 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – "Nanobiotix" or the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the closing of the previously announced subscription by Johnson & Johnson Innovation – JJDC, Inc. ("JJDC") for 901,256 additional ordinary shares of the Company, in the form of restricted American Depositary Shares ("ADSs"), for an aggregate amount of $4.8 million, equivalent to €4.6 million1 (the "Remaining Placement Amount", and the subscription transaction being the "Remaining Placement"), following the approval by the French Ministry of Economy of JJDC Remaining Placement on November 22, 2023, in accordance with the French foreign investment control rules (Press release, Nanobiotix, DEC 4, 2023, View Source [SID1234638129]).

As previously announced, pursuant to an existing securities purchase agreement, JJDC was obligated to subscribe, subject to any required regulatory approvals, for $25.0 million of the Company’s restricted ADSs (the "Placement Amount"), exempt from the registration requirements of the Securities Act of 1933, as amended. Pursuant to French foreign investment control rules, the Placement Amount as initially agreed was reduced, such that JJDC had initially subscribed for 3,762,923 restricted ADSs (representing, together with JJDC’s existing stake, 9.99% of the then outstanding voting rights of the Company’s capital stock, as of the issuance date thereof) for gross proceeds to the Company of $20.2 million (the "Initial Placement"). The subscription by JJDC of the Remaining Placement Amount was conditioned upon the approval of the French Ministry of Economy.

Form of the Remaining Placement

The Remaining Placement was carried out by way of a share capital increase for an aggregate amount of $4.8 million (issue premium included) decided on November 22, 2023 by the Company’s Executive Board pursuant to the delegation granted to it by the Company’s combined shareholders’ meeting held on June 27, 2023 in its 25th resolution in accordance with Article L. 225-138 of the French Commercial Code (Code de commerce) through the issuance of 901,256 additional ordinary shares, €0.03 nominal value per share of the Company (each an "Ordinary Share"), in the form of restricted ADSs reserved to a specific investor meeting the criteria defined by the shareholders’ meeting in the 25th resolution – i.e., an industrial company, institution or entity operating in the healthcare or biotechnology sector, either directly or through a controlled company or a company by which they are controlled, where applicable when entering into a commercial agreement, financing contract or partnership with the Company.

The subscription price per Ordinary Share and per ADS of the Remaining Placement is equivalent to the subscription price per Ordinary Share and per ADS of the Initial Placement. The subscription price per Ordinary Share is equal to the volume weighted average price of the Ordinary Shares on the regulated market of Euronext in Paris ("Euronext") over the last three trading sessions preceding the pricing of the Remaining Placement (i.e. November 22, 21 and 20, 2023), less a discount of 8,88%, in accordance with the 25th resolutions of the Company’s combined shareholders’ meeting held on June 27, 2023.

The Company intends to use the net proceeds from the Remaining Placement as described in the Company’s press release dated November 6, 2023.

As of November 30th, 2023, the Company had cash and cash equivalents of €77.2 million (unaudited). The Company believes that the net proceeds from the Remaining Placement, together with its cash and cash equivalents, will be sufficient to meet its working capital requirements for operations until the end of the first quarter 2025, and, assuming the receipt from Janssen Pharmaceutica NV (‘‘Janssen’’) of the first milestone payment under the Company’s License Agreement with Janssen dated July 7, 2023, into mid’2025.

The Company’s estimates of the period of time through which its financial resources are expected to be adequate to meet its working capital requirements are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, as described under "Special Note Regarding Forward-Looking Statements" below.

Dilution

The 901,256 Ordinary Shares (in the form of restricted ADSs) that have been subscribed by JJDC in the context of the Remaining Placement represent a dilution of approximately 1,95% of the outstanding share capital of the Company (on a non-diluted basis). On an illustrative basis, a shareholder which held 1% of the Company’s share capital before the Remaining Placement holds a stake of0,98% after closing of the Remaining Placement.

The following table presents, to the Company’s knowledge, the expected allocation of the Company’s share capital following the closing of the Remaining Placement:

Situation before the Remaining Placement Situation after the Remaining Placement
Shareholders

Number of shares % of share capital % of theoretical voting rights(1) Number of shares % of share capital % of theoretical voting rights(1)
Non-diluted Non-diluted Diluted (2) Non-diluted Diluted (2) Non-diluted Non-diluted Diluted (2) Non-diluted Diluted (2)
Invus Public Equities Advisors, LLC (A) 4 375 004 9.5% 7.9% 9.1% 7.6% 4 375 004 9.3% 7.7% 9.0% 7.5%
Baillie Gifford & Co (B) 2 821 261 6.1% 5.1% [·]5.9% [·]4.9% 2 821 261 6.0% 5.0% 5.8% 4.8%
JJDC (C) 4 722 560 [·]10.2% [·]8.5% [·]9.8% 8.2% 5 623 816 11.9% 11.5% 11.5% 11.2%
Qatar Holding LLC (D) 4 298 507 9.3% 7.7% ·]9.0% 7.5% 4 298 507 9.1% 7.6% 8.8% 7.4%
Total (A) + (B) + (C)+(D) 16 217 332 35.1% 29.1% 33.8% 28.2% 17 118 588 36.3% 31.8% 35.0% 30.9%
Laurent Levy 1 139 060 2.5% 5.4% 4.1% 6.6% 1 139 060 2.4% 5.3% 4.0% 6.5%
Bart Van Rhijn – 0.8% - 0.8% - - 0.8% - 0.7%
Anne-Juliette Hermant 140 000 0.3% 0.8% 0.3% 0.7% 140 000 0.3% 0.8% 0.3% 0.7%
Other managers and employees 166 273 0.4% 3.3% 0.5% 3.4% 166 273 0.4% 3.3% 0.5% 3.3%
Total Management and employees 1 445 333 3.1% 10.2% 4.9% 11.5% 1 445 333 3.1% 10.1% 4.8% 11.3%
Other(3) 28 547 289 61.7% 60.6% 61.3% 60.2% 28 547 289 60.6% 58.0% 60.1% 57.8%
Treasury shares 22 118 - - - - 22 118 - - - -
Total 46 232 072 100% 100% 100% 100% 47 133 328 100% 100% 100% 100%
(1) The calculations are based on the assumption of the exercise of all the share warrants (BSA), founders share warrants (BSPCE) and stock options as well as the definitive acquisition of all free shares (AGA).
(2) Double voting rights are granted to all fully paid-up ordinary shares of the Company registered in the name of the same shareholder for at least two years. ADSs do not carry double voting rights.
(3) Including institutional investors holding, prior to the Remaining Placement, 2.7% of the Company’s share capital and 2.6% of its voting rights (2.2% and 2.2% respectively on a fully diluted basis), and after the completion of the Remaining Placement, 2.6% of the Company’s share capital and 2.5% of its voting rights (2.2% and 2.1% respectively on a fully diluted basis).

Risk Factors

[The Company draws attention to the risk factors related to the Company and its activities presented in section 1.5 of the 2022 universal registration document of the Company filed with the French Financial Markets Authority (Autorité des Marchés Financiers – the "AMF") under number D.23-0332 on April 24, 2023, as updated in section 2.4 of the first amendment to the Company’s 2022 universal registration document filed with the AMF under number D.23-0332-A01 on November 1st, 2023 and by a second amendment to the Company’s 2022 universal registration document filed with the AMF under number D.23-0332-A02 on November 3rd, 2023, which are available free of charge on the Company’s website at View Source, as well as on the AMF’s website at www.amf-france.org.]

Settlement and Delivery – Documentation

The Ordinary Shares issued in the Remaining Placement has been admitted to trading on Euronext on December 4, 2023, on the same trading line as the existing ordinary shares of the Company, under the ticker symbol "NANO" and the ISIN code FR0011341205.

The ADSs to be issued in the Remaining Placement are expected to be listed on the Nasdaq Global Select Market under the ticker symbol "NBTX" on December 6, 2023.

The Remaining Placement is not subject to a prospectus requiring an approval from the AMF / French Financial Market Authority (Autorité des Marchés Financiers) (the "AMF").

IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer

On December 4, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead’s sacituzumab-govitecan-hziy ("Trodelvy"), a Trop-2 directed antibody-drug conjugate (ADC), in a Phase 1 clinical trial (Press release, Ideaya Biosciences, DEC 4, 2023, View Source [SID1234638128]).

"We are pleased to collaborate with Gilead to evaluate this potential first-in-class Trop-2 directed ADC and MAT2A clinical combination in MTAP-deletion bladder cancer. MTAP-deletion prevalence in bladder cancer is approximately 26% and this patient population represents a high unmet medical need, as there are no approved therapies for MTAP-deletion bladder cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

"We are delighted to enter into this clinical collaboration with Gilead that advances our multi-pronged strategy designed to deliver maximal benefit to MTAP-deletion solid tumor patients. We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and studied in an earlier-line clinical setting," said Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 19% of squamous NSCLC and 26% of bladder cancer. Sacituzumab govitecan, commercialized under the brand name Trodelvy, is a Trop-2 directed antibody-drug conjugate currently approved in the U.S. for the treatment of HR+/HER2- metastatic breast cancer, metastatic triple-negative breast cancer and metastatic urothelial cancer.

IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion in squamous NSCLC and bladder cancer and collaborating with Amgen in a Phase 1 combination study with AMG 193, Amgen’s MTA-Cooperative PRMT5 inhibitor.

Under the clinical study collaboration and supply agreement, Gilead will provide drug supply to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Gilead each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia

On December 4, 2023 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of GTB-3650, a 2nd generation nanobody TriKE for the treatment of patients with CD33+ leukemia, including relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Press release, GT Biopharma, DEC 4, 2023, View Source [SID1234638127]).

"Today’s announcement is an important milestone for GT Biopharma, and we look forward to advancing GTB-3650 for treatment of CD33+ leukemia. We are excited to expeditiously move this molecule into the clinic as we execute on our clinical objectives in 2024," stated Michael Breen, GT Biopharma’s Executive Chairman, Board of Directors and Interim Chief Executive Officer.