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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

On March 22, 2024 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; "Ono") reported that it has entered into a comprehensive drug discovery collaboration agreement with the University of Oxford (Oxfordshire, UK; "Oxford") to verify drug discovery seeds and obtain screening compounds for the creation of innovative medicines (Press release, Ono, MAR 22, 2024, View Source [SID1234646257]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In this comprehensive collaboration, Ono will select drug discovery seeds from the portfolio of Oxford that align with our research priority themes, and Oxford will conduct validation tests and compound screening for the drug discovery seeds at Oxford. First, Ono has selected the research theme relating to neuroscience, which is one of our four priority research areas and is also an expertise area at Oxford.

 More specifically, Oxford will conduct target validation experiments and compound screening, and Ono will generate drug candidates based on the compounds obtained from Oxford including their hit compounds, towards the development and commercialization of new drug candidates. Ono will obtain an option right to exclusively develop and commercialize these drug candidates worldwide.

 The University of Oxford, located in Oxfordshire, UK, is a collegiate university and one of the top universities in the world. It has the Centre for Medicines Discovery, which is focusing on drug discovery, and based on basic research by experts and researchers with deep insights into drug discovery seeds. It possesses the research infrastructure and drug discovery capabilities that enables to obtain highly unique drug discovery seeds and hit compounds for difficult-to-modulate target groups.

 Ono has generated a number of innovative medicines, by proactively promoting "open innovation", in the fields of cancer, immunology, neurology, and specialty area as priority areas for drug discovery. Ono keeps on committing to creating innovative medicines, aiming to become a global specialty pharma through our unique drug discovery approach based on the open innovation.

 "We are pleased to have the opportunity to collaborate with the University of Oxford, which possesses world-leading research capabilities." said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono. "We expect the potential for the development of new treatment through this partnership."

 "We are delighted to be starting this strategic collaboration with Ono Pharmaceuticals, to validate new therapeutic approaches across a range of different unmet medical needs. " said John Davis, Professor of Pharmaceutical Discovery, Centre for Medicines Discovery, the University of Oxford. "Combining innovative academic research together with the development insights and capability of pharmaceutical industry partners is key to unlocking the potential of new research findings"

On March 22, 2024 Acerand Therapeutics (Acerand) reported the successful completion of the first patient enrollment in the Phase 1/2 clinical trial (ACE-106-001) of their groundbreaking selective PARP1 inhibitor (ACE-86225106 tablets) (Press release, Acerand Therapeutics, MAR 22, 2024, View Source [SID1234641764]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ACE-106-001 is a first-in-human trial of Acerand’s self-developed selective PARP1 inhibitor ACE-86225106. This trial consists of two phases: dose escalation and backfill module in phase 1, followed by the dose expansion module in phase 2. The primary objective is to evaluate the safety, tolerability, PK/PD profile, and pre-liminary efficacy of ACE-86225106 as a monotherapy. The coordinating investigators leading this study are Professor Dingwei Ye and Jian Zhang from Fudan University Cancer Hospital. The study is being conducted simultaneously across multiple clinical institutions nationwide.

Remarks by Dr. Genshi Zhao, Acerand Co-Founder, President and CSO:

"This study is the first clinical trial of Acerand and represents a crucial milestone in our journey towards developing innovative small-molecule anti-tumor drug independently. While first-generation pan-PARP inhibitors have been approved for several indications (i.e., advanced ovarian, breast, prostate, and pancreatic cancers), their clinical optimal dose has been limited by adverse effects, limiting the therapeutic window. Highly selective PARP1 inhibitors hold promise in mitigating hematologic toxicity associated with PARP2 inhibition, potentially broaden the therapeutic window, enhancing patient compliance, and demonstrating improved efficacy."

About ACE-86225106：

ACE-86225106 is a novel, oral, and highly selective inhibitor of poly (ADP-ribose) polymerase 1 (PARP1) developed independently by Acerand Therapeutics. It showed significant inhibitory effect on PARP1 in vitro, which was comparable with the positive controls (Olaparib, the first-generation pan-PARPi, and AZD5305, the second-generation PARP1 selective inhibitor under development), and showed no significant inhibitory effect on PARP2/3/5A/5B/6/7/12/14/15. In a DNA-PARP trapping assay, ACE-86225106 showed significant induction of DNA-PARP1 complex trapping, with no significant induction of DNA-PARP2 complex trapping, reaffirming its high PARP1 selectivity. Collectively, these findings suggest that compared to first-generation PARP inhibitors, ACE-86225106 is expected to uphold its anti-tumor efficacy with potentially reduced hematological toxicity risks (i.e. anemia) and extended therapeutic window, thereby improving the prognosis for patients with advanced solid tumor.

On March 22, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), one of the leading Canadian biotechnology companies working in the field of immune-oncology, reported the closing of the 2nd tranche of its previously announced non-brokered private placement (the "Offering") of units of the Company (the "Units") at a price of $1.50 per Unit for aggregate gross proceeds of $600,000.00 (the "Closing") (Press release, Defence Therapeutics, MAR 22, 2024, View Source;utm_medium=rss&utm_campaign=defence-completes-2nd-tranche-of-financing [SID1234641441]). Each Unit consists of one common share in the capital of the Company (each, a "Share") and one common share purchase warrant (each, a "Warrant").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Each Warrant is exercisable to acquire one Share at an exercise price of $2.00 per Share on or before March 22nd, 2026 (the "Warrant Expiry Date").

In connection with the Closing, the Company paid a cash finder’s fee of $48,000.00 and issued 32,000 finder’s warrants (the "Finder’s Warrants") to a certain qualified arm’s length finder. Each Finder’s Warrant is exercisable into one Share at an exercise price of $2.00 per Share on or before the Warrant Expiry Date.

The Company intends to use the net proceeds of the Offering to advance its preclinical and clinical programs and for general working capital.

All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day from their date of issue in accordance with applicable securities legislation.

The securities being referred to in this news release have not been, nor will they be, registered under the United States (U.S.) Securities Act of 1933, as amended, and may not be offered or sold in the U.S. or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This news release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.