On May 21, 2024 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM) (Press release, Imvax, MAY 21, 2024, View Source;utm_medium=rss&utm_campaign=imvax-announces-completion-of-enrollment-in-phase-2b-clinical-trial-of-igv-001-and-successful-financing [SID1234643488]). IGV-001 is derived from Imvax’s proprietary Goldspire immuno-oncology platform, which is designed to use a patient’s own tumor cells to induce a broad and durable immune response against tumors. The primary endpoint of the Phase 2b trial is Progression Free Survival (PFS) and top-line data is expected by mid-2025.

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Separately, the Company reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IGV-001 for the treatment of ndGBM based on the Company’s existing Phase 1b data supporting its therapeutic potential in this underserved and life-threatening condition.

Imvax also announced the closing of an approximately $35 million financing round, with half of the capital coming from new investors. Over the past 15 months, the Company has raised $57 million to support the completion of the Phase 2b trial.

"We are very pleased to announce full enrollment of the trial in less than 14 months, which speaks to both the clinical interest in this potential therapy and the efficient execution of our novel approach to treating GBM patients," said John P. Furey, Chief Executive Officer. "We are grateful to the investigators, patients, and their families for their commitment to this study and look forward to seeing top-line data next year. We are also delighted that the FDA has granted Fast Track designation to IGV-001. The last significant advancement in the standard of care for GBM – about an 8-week improvement in PFS – was nearly 20 years ago, highlighting the need for continued innovation and treatment options. We believe IGV-001 may offer meaningful clinical benefit for patients diagnosed with this deadly disease."

Mr. Furey continued, "We are grateful for the support of both existing and multiple new investors in our recent fundraising, which reflects their belief in the promise of IGV-001 and their commitment to patients facing a GBM diagnosis. We now have sufficient resources to support the completion of the trial and carry us beyond the reporting of top-line results in mid-2025."

About the Phase 2b Trial
The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial enrolled approximately 100 participants in a 2:1 randomization across 20 sites in the United States. Approximately 48 hours after surgical resection, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide). The primary endpoint of the trial is progression-free survival (PFS) and key secondary endpoints include overall survival (OS) and safety.

About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.

About Fast Track Designation
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational treatments that have the potential to treat serious conditions and address recognized areas of unmet medical need. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate’s development plan in addition to a rolling submission of the marketing application. Product candidates with Fast Track designation also may be eligible for priority review and accelerated approval.

On May 21, 2024 GT Biopharma, Inc. (NASDAQ: GTBP) (the "Company"), reported that it has entered into a definitive securities purchase agreements for the purchase and sale of 740,000 shares of the Company’s common stock at a purchase price of $4.35 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, GT Biopharma, MAY 21, 2024, View Source [SID1234643487]). In a concurrent private placement, the Company will issue warrants to purchase up to 740,000 shares of common stock. The warrants have an exercise price of $4.35 per share, will be exercisable immediately and will have a term of five years following the date of issuance. The closing of the offering is expected to occur on or about May 23, 2024, subject to the satisfaction of customary closing conditions.

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Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes.

The securities in the offering described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-267870) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on October 20, 2022. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 21, 2024 Genmab A/S (Nasdaq: GMAB) reported that it has completed its acquisition of ProfoundBio, Inc., a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADC)s and ADC technologies for the treatment of cancers in an all-cash transaction of USD 1.8 billion (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses) (Press release, Genmab, MAY 21, 2024, View Source [SID1234643486]).

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With the completion of this strategic transaction, we are excited to welcome our new colleagues and their expertise in developing next-generation antibody-drug conjugates to our exceptionally talented R&D team," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. "We look forward to unlocking new opportunities as we strengthen our oncology portfolio and continue to work towards our goal of transforming the lives of patients with innovative antibody medicines."

The acquisition gives Genmab worldwide rights to ProfoundBio’s portfolio of next-generation ADCs, further broadening and strengthening its clinical pipeline. These programs include Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in part 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors. The addition of Rina-S to Genmab’s portfolio enables Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors. Based on the data from the ongoing Phase 1/2 clinical trial, which also indicates that Rina-S has the potential to address a broader patient population than first-generation FRα-targeted ADCs, Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors. In January 2024, the U.S. Food and Drug Administration (U.S. FDA) granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

In addition, the transaction provides Genmab with access to ProfoundBio’s novel ADC technology platforms, which complement Genmab’s already validated suite of proprietary technology platforms. The combination of the companies’ technology platforms could create new opportunities to generate and develop new medicines with the potential to transform the treatment of cancer and improve patients’ lives.

As previously disclosed in Company Announcement No. 26, following the closing of this acquisition, Genmab’s operating expenses, before expenses incurred by it in connection with the transaction, are anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion. Genmab expects to update its guidance no later than in connection with its second quarter 2024 earnings.

On May 21, 2024 Molecular Targeting Technologies, Inc. (MTTI), reported that it will update findings on both 177Lu-EBTATE clinical and 225Ac-EBTATE preclinical work during the 2024 SNMMI meeting in Toronto June 8-11 (exhibition booth #1819) (Press release, EvaThera Theranostics, MAY 21, 2024, View Source [SID1234643485]).

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177Lu-EBTATE an EvaThera drug, is the first patented long-acting peptide targeted radiotherapeutic drugs. It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide payload. Evans blue in EBTATE binds to serum albumin, extending in vivo circulatory half-life and tumor residence time, enabling effective use of significantly lower radiopharmaceutical activity and fewer dosing cycles vs. the current standard of care (SOC). These benefits are also evident in recent studies of the 225Ac-EBTATE homolog.

Professor Zhaohui Zhu, MD, Peking Union Medical College Hospital, reflected "In our 3-year follow up on 30 patients* with metastatic neuroendocrine tumors (mNETs), 177Lu-EBTATE demonstrated good safety, with no nephro- or hepatoxicity and 86% disease control rate using 60% less radioactivity than 177Lu-DOTATATE. We observed low incidence of grade 3 hematoxicity (3.4% vs 15% of reported SOC) and no long-term nephrotoxicity of any grade."

The study "Long acting 225Ac-EBTATE is highly efficacious against somatostatin receptor-2-positive small-cell lung cancer (SCLC)**" has been accepted for presentation at 2024 SNMMI. Professor Humphrey Fonge of the University of Saskatchewan commented, "225Ac-EBTATE (2x 30 kBq administered 10 days apart) was effective against SCLC with 80% complete remissions and 100% survival. Treatment yielded a 2-fold greater tumor growth inhibition when compared with 225Ac-DOTATATE, at 60% less administered radioactivity. Toxicity, as measured by body weight, blood counts, and chemistry showed that 225Ac-EBTATE was well tolerated at a highly effective dose. 225Ac-EBTATE shows great promise against SCLC." Chris Pak, President & CEO of MTTI commented: "We are pleased to learn that 177Lu-EBTATE exhibited no safety concerns and was effective at a lower dose than SOC in mNET patients. We are also encouraged that 225Ac-EBTATE out-performed 225Ac-DOTATATE, providing a 2-fold greater tumor growth inhibition in preclinical findings using a much lower dose of radioactivity. We look forward to advancing our clinical trials with these radiotherapeutic drugs in small-cell lung and other cancers."

On May 21, 2024 Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, reported that the first two patients with metastatic breast cancer were treated with BTX-A51, a multi-specific kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9), that synergistically targets master regulators of cancer (Press release, Edgewood Oncology, MAY 21, 2024, View Source [SID1234643484]). BTX-A51 is being evaluated in a Phase 2a study for the treatment of estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer with and without GATA binding protein 3 (GATA3) mutations.

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GATA3 is a protein that helps maintain healthy breast cells but mutations in this protein, which are found in approximately 15% of breast cancer cases, are associated with shorter progression free (PFS) and overall survival (OS). Moreover, these mutations are almost always accompanied by a wild type (non-mutated) p53 tumor suppressor protein. Recent studies have shown that targeting MDM2, a molecule that degrades the p53 protein, could be particularly effective in treating cancers with these GATA3 mutations. Due to its ability to reduce MDM2 expression, Edgewood Oncology is testing the hypothesis that BTX-A51 may be beneficial in this breast cancer sub-population.

"This represents an important milestone for both Edgewood Oncology and for patients with ER+/HER2- breast cancer, particularly those with a GATA3 mutation, who need better treatment options targeted to their underlying mutation profile," said Zung L. Thai, M.D., Ph.D., chief medical officer of Edgewood Oncology. "Moreover, while CDK4/6 inhibitors remain a cornerstone of current treatment regimens, resistance to these therapies poses a formidable challenge. By targeting CDK7 and CDK9, key regulators of cell cycle progression, BTX-A51 not only aims to circumvent this resistance but also to transform the treatment landscape."

The ongoing Phase 2a trial of BTX-A51 is a multicenter, open-label, nonrandomized, multiple dose study evaluating the safety, toxicity, pharmacokinetics and preliminary efficacy of BTX-A51 in patients with ER+/HER2- metastatic breast cancer with and without GATA3 mutations. Multiple sites for the clinical study are open for enrollment. For more information, visit clinicaltrials.gov (NCT04872166).