On March 28, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that study data evaluating the direct effects of Ampligen (rintatolimod) on human pancreatic ductal adenocarcinoma (PDAC) cells was accepted for presentation at the 15th Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress being held March 30 – April 2, 2022 in New York, NY (Press release, AIM ImmunoTech, MAR 28, 2022, View Source [SID1234611059]).

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Details of the presentation are as follows:

Title: Rintatolimod: a potential therapeutic molecule for human pancreatic cancer cells expressing Toll-Like Receptor 3
Presenting Author: Hassana El Haddaoui, Ph.D., Erasmus University Medical Center
Poster Number: EP02C-111
Presentation Type: E-Poster Presentation
Session: 2C- Pancreas Tumours
Date: Saturday, April 2, 2022

"We are encouraged by the data demonstrated by Ampligen and its potential to offer beneficial anti-tumor effects in pancreatic cancer patients. Importantly, the direct effect of Ampligen on tumor cells and its ability to boost the anti-tumor immune response via TLR-3 present in immune cells provides the validation needed to further evaluate its potential to offer therapeutic effect to pancreatic cancer patients," commented Thomas Equels, Chief Executive Officer of AIM.

For the study, three PDAC cell lines (CFPAC-1, MIAPaCa-2, and PANC-1) were treated with various concentrations of Ampligen and their corresponding vehicle control. The proliferation and migration effects were examined using in-vitro assays and the molecular effect was examined by targeted gene expression profiling. Additionally human PDAC samples were used to validate the expression of toll-like receptor 3 (TLR3) by immunohistochemistry.

Dr. El Haddaoui added, "TLR-3 signaling has been linked to cancer cell survival and migration. Based on these results, treating pancreatic cancer with Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3. We look forward to further evaluating Ampligen for the treatment of pancreatic cancer."

Results from the study demonstrated Ampligen decreased the proliferation and migration ability of CFPAC-1 cells. In addition, it decreased the proliferation of MIAPaCa-2 cells and the migration of PANC-1 cells. However, it did not have a dual effect in MIAPaCa-2 and PANC-1 cells. Interestingly, TLR3 was highly expressed in CFPAC-1 cells, low expressed in MIAPaCa-2 and not expressed in PANC-1. Gene expression analysis revealed the upregulation of interferon-related genes, chemokines, interleukins and cell cycle regulatory genes. The heterogeneity of TLR3 expression was confirmed in human PDAC samples.

On March 28, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported positive preliminary efficacy and safety results from a phase 1 clinical trial for their lead drug candidate, Silmitasertib (CX-4945), in patients with advanced Basal Cell Carcinoma (Press release, Senhwa Biosciences, MAR 28, 2022, View Source [SID1234611074]). These findings were presented within an e-poster on March 27 at the 2022 annual meeting of the American Academy of Dermatology (AAD) held in Boston, Massachusetts, from March 25-29, 2022.

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The American Academy of Dermatology is the largest, most influential, and representative dermatology group in the United States. The poster features preliminary findings on disease control from a phase 1 study, evaluating the safety and efficacy of Silmitasertib in patients with advanced BCC.

"We are very pleased with the preliminary results of this phase 1 study and we look forward to the final results at the conclusion of the study," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

BCC is the most common type of skin cancer. Most basal cell carcinomas can be surgically removed; however, for unresectable tumors there are two approved targeted drugs and both are characterized as smoothened inhibitors (SMOi). SMOi target the Hedgehog (Hh) pathway and have been approved for the treatment of patients with locally advanced BCC (laBCC) or metastatic BCC (mBCC).

Unfortunately, drug resistance to SMOi is common but targeting the signaling cascade downstream of SMOi could avoid this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting GLI-1 stability and GLI-1’s interaction with target genes. Given the interplay between CK2 and GLI-1 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered due to its oral formulation. Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase I/II studies of Silmitasertib.

The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.

On March 28, 2022 EXACT Therapeutics AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that its Board of Directors has today appointed Dr Per Walday as Chief Executive Officer (CEO) (Press release, Exact Therapeutics, MAR 28, 2022, View Source [SID1234611044]).

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A successful senior executive in the healthcare industry, Per has experience from research to commercialization of therapeutics and medical devices globally, including drug-device combination within the field of oncology. As CEO of PCI Biotech (OSE: PCIB), Per built an effective organization that progressed the platform technology into a pipeline of assets including in late stage clinical programs through FDA and EMA regulatory paths. Prior to this, Per spent almost two decades with Nycomed Imaging and GE Healthcare based in Norway where, as Global Head Project Management, he was responsible for all development programs of new pharmaceutical products. These included R&D efforts within the field of ultrasound and microbubbles which paved the way for what would become years later EXACT-Tx’s Acoustic Cluster Therapy (ACT). Per has a six months’ notice period; start date with EXACT-Tx to be agreed.

Dr Masha Strømme, Executive Chair of the Board, commented: "The Board and I are very excited to welcome Per as CEO of EXACT-Tx: He brings intimate knowledge of ultrasound along with therapeutic expertise and strong leadership. We are thrilled to have Per lead EXACT-Tx through the next phase of its development".

Dr Per Walday, Chief Executive Officer-designate of EXACT-Tx, said: "I am very excited to be joining EXACT-Tx and very impressed by the potential of its proprietary technology. Remarkable innovation and progress have been made with the ACT platform since I led the development of related ultrasound technology initially aimed for diagnostic use in GE Healthcare. The global ambitions and the potential of ACT to meet current needs in both immuno-oncology and neurology harmonise well with my background and interests. I aim to further maximise the value of the innovative ACT platform for ultrasound mediated drug enhancement and accelerate our journey towards becoming a leading precision health company."

On March 28, 2022 Primmune Therapeutics a biotech company harnessing the power of the innate immune system to treat solid tumors in the advanced cancer setting and for clearing human papilloma virus-driven pre-cancerous cervical lesions, reported that they will present interim Phase 1 clinical data for PRTX007, a novel, orally administered, small molecule toll-like receptor 7 (TLR7) specific agonist, at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The AACR (Free AACR Whitepaper) annual meeting will be held in New Orleans from April 8-13 (Press release, Primmune Therapeutics, MAR 28, 2022, View Source [SID1234611060]). An e-poster will be made available online Friday, April 8 at 1 p.m. ET.

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Presentation details:

Title: PRTX007, an Optimized TLR7 Agonist for Systemic Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s: Interim Analysis of Phase I Study in Healthy Volunteer
Presenting Author: Curtis Scribner, M.D.
Abstract Number: 8165
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 12, 9 a.m. CT to 12:30 p.m. CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33

About PRTX007
PRTX007 is Primmune’s lead clinical development candidate that is designed to provide well tolerated, controlled, long-term stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely activates plasmacytoid dendritic cells (pDCs), leading to a systemic immune poly-IFN response without stimulating production of NF-κB driven proinflammatory factors like IL-6, TNFα or IL-1β. This is functionally equivalent to administering a cocktail of all Type I/III IFN while avoiding the associated side effects and adverse events. PRTX007 is being rapidly advanced towards clinical trials for solid tumors in the advanced cancer setting and for clearing human papilloma virus-driven pre-cancerous cervical lesions.

On March 28, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported positive preliminary efficacy and safety results from a phase 1 clinical trial for their lead drug candidate, Silmitasertib (CX-4945), in patients with advanced Basal Cell Carcinoma (Press release, Senhwa Biosciences, MAR 28, 2022, View Source [SID1234611074]). These findings were presented within an e-poster on March 27 at the 2022 annual meeting of the American Academy of Dermatology (AAD) held in Boston, Massachusetts, from March 25-29, 2022.

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

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The American Academy of Dermatology is the largest, most influential, and representative dermatology group in the United States. The poster features preliminary findings on disease control from a phase 1 study, evaluating the safety and efficacy of Silmitasertib in patients with advanced BCC.

"We are very pleased with the preliminary results of this phase 1 study and we look forward to the final results at the conclusion of the study," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

BCC is the most common type of skin cancer. Most basal cell carcinomas can be surgically removed; however, for unresectable tumors there are two approved targeted drugs and both are characterized as smoothened inhibitors (SMOi). SMOi target the Hedgehog (Hh) pathway and have been approved for the treatment of patients with locally advanced BCC (laBCC) or metastatic BCC (mBCC).

Unfortunately, drug resistance to SMOi is common but targeting the signaling cascade downstream of SMOi could avoid this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting GLI-1 stability and GLI-1’s interaction with target genes. Given the interplay between CK2 and GLI-1 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered due to its oral formulation. Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase I/II studies of Silmitasertib.

The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.