On March 25, 2024 CureLab Oncologya clinical-stage biotech company, reported that it has been granted a patent in Canada for its novel biological agent, Elenagen, which has been shown to provide clinical benefits for cancer patients (Press release, CureLab Oncology, MAR 25, 2024, View Source [SID1234641406]). Elenagen belongs to a novel class of biological agents that use supercoiled circular DNA (plasmids) to increase anti-tumor immunity and boost the effectiveness of existing therapies.

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Elenagen has demonstrated a desirable safety profile and a statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to a tumor. For example, in a recent study published in Frontiers in Oncology, a research team found that disease progression was significantly delayed in a group of stage III and IV platinum-resistant ovarian cancer patients who received gemcitabine in combination with Elenagen, compared to the group who received gemcitabine alone.

Elenagen addresses an urgent need in Canada

Cancer remains a significant health concern and a substantial economic burden in Canada. Recent studies indicate that in 2021, the total economic cost of cancer in Canada exceeded $26 billion, with a significant portion borne directly by patients and families. These rising costs highlight the urgent need for innovative solutions. The costs of cancer care are highest in the initial treatment period, emphasizing the critical need for advances in prevention and early detection, such as promising vaccine technologies. Elenagen has the potential to alleviate a portion of those costs, while also improving outcomes and quality of life for those affected by cancer.

"For too long, we’ve witnessed the devastating toll cancer takes on Canadian families. Elenagen represents a beacon of hope, moving us closer to a world where a cancer diagnosis doesn’t have to be a devastating sentence," said Alexander Shneider, Ph.D., founder and CEO of CureLab Oncology. "By mitigating the effects of cancer in Canada, we aim to alleviate substantial long-term healthcare costs and improve quality of life for countless patients."

A veterinary version of Elenagen called Elenavet, and the entire IP rights for cancer treatment in dogs, cats and horses has been exclusively licensed by CureLab Oncology to its sister company, CureLab Veterinary Inc. ElenaVet is a gene therapy that enhances the animal’s anticancer immune response. In comparative medicine studies, ElenaVet saved 10 out of 11 dogs with breast cancer and precluded or delayed the metastatic process in dogs with melanoma. Similar results were observed with cats.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor.

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.

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 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 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. ("ABL", KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, reported a collaboration to develop new bispecific antibody-drug conjugates (bsADCs) (Press release, Biocytogen, MAR 25, 2024, View Source [SID1234641396]).

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Biocytogen’s RenLite mice platform can produce fully human antibodies with diverse epitopes and high affinity. This platform is notable for its ability to generate antibodies in a common light chain format, offering a distinctive combination of design flexibility, simplified manufacturing processes, and optimal developability for bsADC development. Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, "We are very pleased to collaborate with ABL, a company that possesses advanced platforms for cancer immunotherapy and treatments against CNS diseases. ABL’s consistent success in advancing its pipeline strongly showcases its expertise and capabilities in regulatory, clinical development, and business development activities. BsADC drugs derived from our RenLite mice platform have shown preferable potency in various tumor models, while also exhibiting good safety profiles. We believe our fully human bsADC platform technology, which features increased tumor selectivity, target synergized internalization, and convenient CMC development, will complement ABL’s capabilities effectively. Together, we aim to expedite the development of innovative bsADC therapies."

Sang Hoon Lee, CEO of ABL, said, "We are excited to establish this partnership with Biocytogen for bsADCs. This collaboration is one of the stepping stones for getting down to developing bsADCs. We look forward to a productive collaboration, and firmly believe that this partnership will contribute towards creating a distinctive pipeline, ultimately leading to novel therapies that improve the quality of life for patients."