On May 16, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the first quarter 2024 (Press release, AIM ImmunoTech, MAY 16, 2024, View Source [SID1234643384]). As previously announced, the Company will host a conference call and webcast today, Thursday, May 16, 2024, at 8:30 AM ET (details below).

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"AIM is making fundamental progress across our clinical development programs and continues to be encouraged by Ampligen’s potential. We recently reported encouraging top-line data across our pipeline. We also recently completed cGMP manufacturing of 9,000 vials of Ampligen. Both of these successes are extremely important as we seek commercial partners. We remain focused on the continued execution of our operational, clinical and regulatory initiatives and seek to generate – through such progress – a basis for increased stockholder value," commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

Completed cGMP manufacturing of clinical vials of Ampligen
Announced first dose level is generally well-tolerated in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer
Announced appointment of Charles Lapp, MD as a Consulting Medical Officer for AIM’s ME/CFS and Long COVID programs
Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer:
In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. Objective Response Rate includes complete response and partial response to treatment. There was a total Clinical Benefit Rate of 55% when including patients who experienced stable disease. Researchers also reported a median Progression-Free Survival of 7.8 months.
Released multiple CEO Corner segments highlighting Company news and clinical programs
Expected Upcoming Pipeline Milestones

Q2 2024

Final dataset for Post-COVID Conditions (AMP-518)
2024

Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First Subject Dosed
Publications of data in scientific journals
Summary of Financial Highlights for First Quarter 2024

As of March 31, 2024, AIM reported cash, cash equivalents and marketable securities of $10.9 million.
Research and development expenses for the three months ended March 31, 2024, were $2.0 million, compared to $2.1 million for the same period in 2023.
General and administrative expenses were $3.8 million for the three months ended March 31, 2024, compared to $2.3 million for the same period 2023.
The net loss from operations for the three months March 31, 2024, was $5.8 million, or $0.12 per share, compared to $3.7 million, or $0.08 per share, for the three months ended March 31, 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q1 2024 operational and financial results today, May 16, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On May 15, 2024 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing N-myristoyltransferase (NMT) inhibitors as targeted therapies for the treatment of hematologic cancers and solid tumors, reported that it will be attending the Biotechnology Innovation Organization (BIO) International Convention taking place June 3-6, 2024, at the San Diego Convention Center, in San Diego, California, USA (Press release, Pacylex Pharmaceuticals, MAY 15, 2024, View Source [SID1234645049]). The BIO Convention is the premier life sciences networking conference in the world, bringing together leaders, innovators and investors from the pharmaceutical, biotech and medical device industries.

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Pacylex’s Chief Executive Officer, Dr. Michael Weickert, will be attending the conference and participating in the BIO One-on-One Partnering system. He will be available to review Pacylex’s recent clinical progress with zelenirstat currently being dosed in patients in two Phase 2a studies, in refractory and relapsed B-cell non-Hodgkin’s lymphoma and in advanced refractory colorectal cancer patients, at 4 clinical sites in Canada. He will also share new data describing how zelenirstat works in different cancers by inhibiting the myristoylation required for assembly, translocation, and/or function of validated targets like B-cell receptor, EGFR, and VEGFR. Zelenirstat also blocks Complex I formation in mitochondria of cancer cells which shuts down oxidative phosphorylation, especially critical for metastasis and cancer stem cells.

"We are learning from laboratory and clinical studies that inhibiting myristoylation appears to be an efficient way to turn off many cancer-critical processes with one switch", said Dr. Michael Weickert, CEO of Pacylex. "That may explain why Phase 1 zelenirstat patients with heavily pretreated and refractory ovarian, appendiceal, and colorectal cancer had 6 to 15 months of stable disease when treated with our recommended phase 2 dose. "

Registered attendees can discuss investment and licensing opportunities with Dr. Weickert by scheduling a meeting using the BIO One-on-One Partnering system. If there are no compatible time slots available, please contact Dr. Weickert directly to schedule a meeting.

On May 15, 2024 Merck, a leading science and technology company, reported a good start to fiscal 2024 (Press release, Merck KGaA, MAY 15, 2024, View Source [SID1234644741]). The Healthcare business sector performed strongly. Electronics also delivered solid organic sales growth, mainly driven by Semiconductor Solutions. Life Science recorded sales and earnings declines compared with the particularly high base of the year-earlier quarter.

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On May 15, 2024 Eisai reported its financial results for year 2023, Fiscal Year Ended March 31, 2024 (Presentation, Eisai, MAY 15, 2024, View Source [SID1234644700]).

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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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On May 15, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2024 Congress (Press release, Immutep, MAY 15, 2024, View Source [SID1234643394]). This lead-in represents the first ever 90mg dosing of eftilagimod alpha ("efti"), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.

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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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Efficacy

The poster titled "Testing a higher dose (90 mg s.c.) of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003" details positive results in six metastatic breast cancer (MBC) patients, who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The data shows a confirmed 50% overall response rate, including one complete response and two partial responses, and a 100% disease control rate, with three patients having stable disease as best overall response per RECIST 1.1.

Complete Response Patient Case Study

The patient with a confirmed complete response (CR) was diagnosed with triple-negative breast carcinoma (TNBC) in 2019 and has failed multiple lines of therapy including a CDK 4/6 inhibitor for ER+/PR+ metastasis. During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR. This patient’s ongoing CR has been maintained since stopping paclitaxel and being treated with efti monotherapy.

Safety & Pharmacodynamic Effects

The lead-in has also shown that the first-ever 90mg efti dosing in combination with weekly paclitaxel continues to be well tolerated with a favourable safety profile. As of the data cut-off (April 3), no dose-limiting toxicities and no treatment-emergent adverse events of grade 3 or higher severity were recorded.

The 90mg efti dosing leads to a higher maximum concentration of efti in the blood as compared to lower efti doses in past clinical trials, and efti remains detectable at a pharmacologically active level (>1 ng/mL) up to 96 hours after administration. Pharmacodynamic effects also showed an increase of circulating levels of immune cells such as CD8 & CD4 T cells and plasma Th1 biomarker levels. All patients in the AIPAC-003 safety lead-in had a ≥1.4-fold change in interferon-gamma (IFN-g) and ~83% had a ≥1.4-fold change in CXCL10 after a single 90mg efti dose.

Dr. Serafin Morales Murillo, University Hospital Arnau de Vilanova, Lleida, Spain, and AIPAC-003 investigator stated, "It is encouraging to see the high efti dose of 90mg with weekly paclitaxel continue to be safe and well tolerated in these metastatic breast cancer patients. It is also positive at this early stage to see high response and disease control rates, including a complete response, in these patients who have unfortunately all seen their cancers progress after endocrine therapy including CDK 4/6 inhibitors. We are looking forward to further data emerging from this study."

The randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is underway and focused on whether 90mg efti dosing is more efficacious than 30mg dosing. This portion of the trial has enrolled 35 patients to date. Importantly, the determination of the optimal dose in AIPAC-003 is directly tied to the FDA’s Project Optimus initiative and is relevant for the entire efti program.

Further data updates in terms of safety and efficacy from AIPAC-003 are expected in CY2024. The ESMO (Free ESMO Whitepaper) Breast 2024 poster will be available on the Posters & Publications section of Immutep’s website.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-g and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).