On March 25, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM") reported the publication of new data analysis from a long-term Early Access Program ("EAP") studying the company’s drug Ampligen (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma ("PDAC") (Press release, AIM ImmunoTech, MAR 25, 2024, View Source [SID1234641401]). The manuscript titled "Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses," appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.

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Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center ("Erasmus MC") found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

AIM Chief Executive Officer Thomas K. Equels stated: "We have already seen that Ampligen as a single-agent therapy was associated with improved progression-free survival and overall survival in these Early Access Program pancreatic cancer patients. This new data analysis provides us further insight into exactly why that’s the case, which could give us the ability to identify cancer patients who might benefit more from Ampligen treatment than they would from other known cancer treatments. Additionally, the changes in the tumor microenvironment we see in pancreatic cancer are similar to those we have seen in triple-negative breast cancer, ovarian cancer and colorectal cancer metastatic to the liver. We have hypothesized that Ampligen has the potential to be efficacious in almost every solid tumor type based on its direct effect on malignant tumor cells and its effect on the tumor micro-environment. All these data combined lend further credence to the broad applicability of Ampligen in solid tumors."

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published paper, stated, "Based on these results, we believe Ampligen may break immunological tolerance by enhancing anti-tumor immunity through DC-mediated T-cell responses. The data suggests that Ampligen infusions modulate PD-L1 and PD-L2 expression in the tumor microenvironment, while at the same time they upregulate Ki67+CD4+ and Ki67+CD8+ T-cells. We therefore believe that combining Ampligen with an immune checkpoint inhibitor – such as durvalumab – could synergistically circumvent immune blockade and potentially mitigate the T-cell exhaustion known to occur with immune checkpoint therapies. We look forward to further evaluating Ampligen toward potentially meeting the critical need for more effective therapies to treat pancreatic cancer, including with the ongoing DURIPANC trial, which looks at the combination effect of Ampligen and AstraZeneca’s durvalumab."

AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).

On March 25, 2024 GC Genome Corporation, a leading diagnostics company, reported that the company will present two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California, from April 5–10, 2024 (Press release, GC Genome, MAR 25, 2024, View Source [SID1234641419]). During the event, GC Genome will showcase the innovative performance of its liquid biopsy technology for early cancer detection using cfDNA, highlighting its effectiveness across diverse ethnic groups.

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Poster Presentation Details:

Title: A deep learning-based multimodal ensemble algorithm for lung cancer early detection with cross-ethnic generalizability

Date and Time: Monday, April 8, 2024 9:00 AM – 12:30 PM PT
Location: Poster Section 40
Poster Board Number: 7
Abstract Number: 2411
Title: Analysis of analytical variables in the cancer detection assay utilizing cfDNA fragmentomics

Date and Time: Tuesday, April 9, 2024 9:00 AM – 12:30 PM PT
Location: Poster Section 40
Poster Board Number: 19
Abstract Number: 5032

On March 25, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the H.C. Wainwright 2nd Annual Autoimmune & Inflammatory Disease Virtual Conference on Thursday, March 28, 2024, at 2:30 p.m. ET and the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, at 10:15 a.m. ET (Press release, BioCryst Pharmaceuticals, MAR 25, 2024, View Source [SID1234641403]).

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Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On March 25, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα) (Press release, BioThera Solutions, MAR 25, 2024, View Source;302098092.html [SID1234641420]). The phase II study will investigate the use of BAT8006 for the treatment of subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

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FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal tissues. This differential expression makes FRα an attractive target for cancer drug development. BAT8006 is developed using Bio-Thera’s proprietary anti-FRα antibody and proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. Preclinical studies have shown that BAT8006 demonstrates good stability and safety along with strong anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, which enables the payload to kill nearby cancer cells after the cancer cells initially targeted by the ADC are killed. This bystander effect gives BAT8006 the potential to effectively overcome the heterogeneity of the tumor. Currently, a phase I study of BAT8006 is ongoing in China. In that trial, the dose escalation study has completed and the dose expansion and dose optimization study in a series of tumors are ongoing. The preliminary data indicated that BAT8006 could potentially be a best-in-class drug. Updated clinical data will be presented at future academic conference.

On March 25, 2024, BioXcel Therapeutics, Inc. (the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (collectively, the "Purchasers") (, BioXcel Therapeutics, MAR 25, 2024, View Source [SID1234641404]). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchasers in a registered direct offering (the "Offering") an aggregate of 3,054,609 shares (the "Shares") of common stock, par value $0.001 per share ("Common Stock"), and accompanying warrants (the "Accompanying Warrants") to purchase up to 3,054,609 shares of Common Stock at a combined offering price of $2.901 per Share and Accompanying Warrant and pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 5,565,027 shares of Common Stock and Accompanying Warrants to purchase up to 5,565,027 shares of Common Stock, at a combined offering price of $2.900 per share underlying each Pre-Funded Warrant and Accompanying Warrant, which equals the offering price per Share and Accompanying Warrant less the $0.001 exercise price per share of the Pre-Funded Warrants, under an effective shelf registration statement on Form S-3 (File No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission ("SEC") on March 25, 2024 (the "Prospectus Supplement"). The closing of the Offering is expected to occur on or about March 27, 2024, subject to the satisfaction of customary closing conditions. The Pre-Funded Warrants and Accompanying Warrants are not listed on the Nasdaq Capital Market or any other securities exchange or trading system and the Company does not intend to list them.

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The Company expects to receive net proceeds from the Offering of approximately $24.9 million, after deducting estimated offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Accompanying Warrants sold in the Offering. The Company intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to fund planned clinical trials of BXCL501, commercialization activities for IGALMI and for working capital and other general corporate purposes.

The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The Pre-Funded Warrants have an exercise price per share of Common Stock equal to $0.001 per share. The exercise price and the number of shares of Common Stock issuable upon exercise of the Pre-Funded Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. The Pre-Funded Warrants will be exercisable at any time after the date of issuance.

The Accompanying Warrants have an exercise price per share of Common Stock equal to $3.20 per share. The exercise price and the number of shares of Common Stock issuable upon exercise of the Accompanying Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. The Accompanying Warrants will be exercisable at any time after the date of issuance and will expire on the fifth anniversary of the date of issuance.

Under the terms of the Pre-Funded Warrants and the Accompanying Warrants, a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates) would exceed 9.99% or 4.99%, respectively, of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of such warrant, which percentage may be increased at the holder’s election upon 61 days’ notice to the Company subject to the terms of such warrants, provided that such percentage may not exceed 19.99%.

The foregoing descriptions of the Purchase Agreement, Pre-Funded Warrants and Accompanying Warrants are not complete and are qualified in their entirety by reference to the Purchase Agreement and forms of Pre-Funded Warrants and Accompanying Warrants, which are filed as Exhibits 10.1, 4.1 and 4.2, respectively, to this Current Report on Form 8-K (the "Form 8-K") and are incorporated by reference herein.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated March 25, 2024, regarding the validity of the Shares, the Pre-Funded Warrants and the Accompanying Warrants to be issued and sold in the Offering and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the Accompanying Warrants, in each case in accordance with their respective terms. A copy of the opinion is filed as Exhibit 5.1 to this Form 8-K.

This Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.