On July 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model (Press release, AIM ImmunoTech, JUL 24, 2024, View Source [SID1234645033]).

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!

"Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.

AIM Medical Officer David Strayer, MD, stated: "This new pre-clinical data further demonstrates Ampligen’s therapeutic potential when used with dendritic-cell vaccines, with anti-PD-L1 checkpoint inhibitors, or in combination with both. The data supports AIM’s belief that we are on the right path in our ongoing development of Ampligen as an anti-tumor therapy."

On July 23, 2024 ICE Bioscience reported that the company has successfully closed its B++ round of financing (Press release, ICE Bioscience, JUL 23, 2024, View Source;catname=icenews [SID1234647428]). This achievement marks another substantial endorsement from the capital markets, following our significant fundraising effort in August 2023.

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!

As a high-growth CRO, this new funding will enable us to expand our cutting-edge services to the global pharmaceutical industry, enhancing our ability to support our clients in drug discovery and development.

We are grateful for the trust and commitment from our financial partners as we continue to innovate and grow. Stay tuned for more updates as we further our mission to drive progress and support the pharmaceutical sector.

On July 23, 2024 Orange Grove Bio, a leading integrated biopharmaceutical company, and the University of Chicago’s Polsky Center for Entrepreneurship and Innovation reported a strategic partnership to catalyze the successful commercialization of novel therapeutics and life sciences technologies (Press release, Orange Grove Bio, JUL 23, 2024, View Source [SID1234645078]).

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!

This collaboration will combine Orange Grove Bio’s expertise in evaluating and financing novel therapeutics with the University of Chicago’s cutting-edge research capabilities. Orange Grove Bio plans to license promising life sciences technologies from the University of Chicago, developing them into new products to enhance human health. The company will provide its scientific expertise and business acumen to support early company formation.

"The University of Chicago boasts superior academic prowess and researchers who are at the top of their field," said Rich Ganz, Senior Venture Partner at Orange Grove Bio. "Our shared resources will maximize the chances of moving groundbreaking work from the lab to the clinic with the goal of benefiting patients in need."

The partnership encompasses several key aspects designed to foster innovation and collaboration. This includes new educational opportunities, such as workshops, seminars, networking events, and mentoring. Additionally, Orange Grove Bio will lead a PhD internship program, offering students valuable career exploration opportunities.

"This partnership will give the team at Orange Grove Bio an inside look at the novel work being done at the University of Chicago and provide our researchers with opportunities to gain industry-informed perspectives on their innovations," said Samir Mayekar, managing director of The University of Chicago’s Polsky Center. "We share a commitment to advancing scientific discoveries and strengthening the biotech ecosystem in Chicago, particularly on the South Side."

This strategic partnership represents a significant step forward in bridging regional gaps in venture capital funding and accelerating the translation of scientific breakthroughs into life-changing treatments. To further these goals, Orange Grove Bio plans to establish a presence on the South Side of Chicago, enabling close interaction with the academic teams at the University and amplifying its commitment to the Midwest biotech ecosystem.

"This partnership is a valuable addition to the University’s resources," said Jeffrey Hubbell, Professor at the University of Chicago’s Pritzker School of Molecular Engineering and founder of several life science companies. "The detailed feedback the Orange Grove Bio team is able to provide helps inform what additional studies or data we should pursue to empower successful external financing."

On July 23, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens (Press release, MAIA Biotechnology, JUL 23, 2024, View Source [SID1234645029]).

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!

The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

6 patients remain on treatment following at least 12 months of therapy.
Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.
"Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options."

https://www.sciencedirect.com/science/article/pii/S0169500217304373

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On July 23, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported the signing of a clinical research collaboration with University College London (UCL) (Press release, Blue Earth Therapeutics, JUL 23, 2024, View Source [SID1234645028]). The collaboration is centered on a Phase 1/2 trial designed to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of the company’s 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. The work will be conducted at the UCL Cancer Institute in London, UK, by the Treatment Resistance Group under the leadership of Professor Gerhardt Attard, MD PhD FRCP. Professor Attard is the John Black Charitable Foundation Endowed Chair in Urological Cancer Research, and is a highly regarded prostate cancer clinical trialist.

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!

225Ac-rhPSMA-10.1 is the second compound in Blue Earth Therapeutics’ investigational pipeline. It is based on innovative radiohybrid PSMA technology, which allows for development of therapeutic radiopharmaceuticals that may be labelled with either beta- or alpha-emitting isotopes. The pharmacokinetic profile of rhPSMA-10.1 was carefully optimised during development to maximise the retention of radioactivity in tumour deposits whilst sparing normal tissue as far as possible. Pairing these properties with longer lived isotopes like 225Ac may allow the delivery of very high radiation doses to the cancer cells. Blue Earth Therapeutics has an ongoing clinical trial underway that uses the beta-emitting radioisotope lutetium 177 (177Lu) to radiolabel rhPSMA-10.1, and is building on that work by now radiolabelling the compound with the alpha-emitting radioisotope 225Ac.

"Our goal at Blue Earth Therapeutics is to deliver precise, targeted therapy specific to a patient’s condition," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Therapeutics. "This collaboration aims to rapidly translate alpha-labelled rhPSMA-10.1 from the laboratory to the clinic, with the hope to help patients who have advanced prostate cancer. We are delighted to collaborate with an illustrious academic institution such as UCL which is regularly ranked in the top 10 academic institutions globally, and look forward to working with Professor Attard and his group on this important UK clinical research initiative."

"We are pleased to enter into this broad research collaboration with UK-based Blue Earth Therapeutics, as both of our institutions share a vision to improve cancer treatment for patients," said Professor Attard, MD PhD FRCP. "Despite the development of several new therapeutic options for castration resistant prostate cancer in the last 20 years, treatment resistance is common and leads to thousands of premature deaths annually in the UK. Precision-delivered radiation therapy using radioligands provides an opportunity for selectively targeting resistant prostate cancer. We believe that delivery of radiation by means of alpha particles is a very promising area of research and we look forward to starting clinical testing of rhPSMA-10.1 for patients with aggressive, treatment-resistant prostate cancer."

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand, which is internalised by prostate cancer cells, which can be radiolabelled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu‐rhPSMA‐10.1 and 225Ac-rhPSMA-10.1. rhPSMA compounds for therapeutic use are investigational agents and have not received regulatory approval.