On January 10, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients (Press release, Bio-Path Holdings, JAN 10, 2024, View Source [SID1234639180]).

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"We are delighted to safely complete this first dose cohort and to advance BP1002 into the next cohort as it brings us one step closer to providing access to this very promising treatment for the most vulnerable patients who have limited therapeutic options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to advancing this study into higher dose cohorts with the expectation that increased levels of BP1002 will prove even more efficacious and continue its safety profile in these sickest of sick patients."

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and Bio-Path believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

In the Phase 1 trial, refractory/relapsed CLL patients, including those who have failed or relapsed from venetoclax-based frontline therapy, as well as refractory/relapsed lymphoma patients, will be treated with BP1002. Venetoclax targets the Bcl-2 protein based on neutralizing the protein’s BH3 domain and is a frontline treatment for CLL patients and newly diagnosed, elderly acute myeloid leukemia (AML) patients. With the exception of some patients treated with allogeneic hematopoietic cell transplantation, patients treated with venetoclax-based therapies frequently relapse, primarily due to BH3 domain mutations over time. Bio-Path’s BP1002 also targets the Bcl-2 protein, but its activity is based on blocking the Bcl-2 messenger RNA and the expression of the Bcl-2 protein, and not the BH3 domain. As a result, Bio-Path believes that BP1002 could provide an alternative treatment for venetoclax refractory/relapsed CLL patients. Bio-Path also believes there may be AML patients who fail or relapse from venetoclax-based frontline treatment for the same reason, potentially representing an additional opportunity for Bio-Path to treat those patients with BP1002.

The Phase 1 clinical trial is being conducted at several leading cancer centers, including the Georgia Cancer Center, The University of Texas Southwest and New York Medical College. Locke Bryan, M.D., Associate Professor of Medicine at the Georgia Cancer Center, is serving as National Principal Investigator for the Phase 1 trial. A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days. Enrollment is now open for patients for the second dose cohort of 40 mg/m2. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002.

On January 10, 2024 Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported it has submitted an application with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 trial of 123I-ATT001, its Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma (Press release, Ariceum Therapeutics, JAN 10, 2024, View Source [SID1234639178]).

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The application comes shortly after Ariceum acquired Theragnostics Ltd, announced in June 2023, the private UK-based biopharmaceutical company which undertook the initial development work on 123I-ATT001. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics said: "Glioblastoma is the most aggressive and most common type of malignant brain tumour in adults, with a very poor prognosis for survival and currently no cure. 123I-ATT001 is a targeted Auger electron therapy that has demonstrated promising pre-clinical results, and we are delighted to be in a position to file for clinical trial authorisation in the UK so soon after integrating Theragnostics into Ariceum Therapeutics. Not only is this an important step towards finding a cure for glioblastoma patients but it paves the way for Ariceum to further investigate this powerful molecular radiotherapy for the treatment of other solid tumour indications."

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair themselves. This radioisotope then emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a regular cyclotron.

Ariceum is exploring 123I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.

The announcement comes as Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, is in San Francisco attending the Biotech Showcase from 8-10 January 2024. Please get in touch if you would like to arrange a meeting.

On January 10, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that it will present an overview of its business and clinical programs at the Sidoti Micro-Cap Virtual Conference, taking place January 17-18, 2024 (Press release, Anixa Biosciences, JAN 10, 2024, View Source [SID1234639177]). Anixa Chairman and CEO Dr. Amit Kumar will present on Wednesday, January 17, 2024, at 12:15 PM ET.

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Details are as follows:

Presentation:

Wednesday, January 17, 2024, at 12:15 PM ET

Presentation link:

Click here to register; available live and on demand

Conference registration:

Available on the conference website

1×1 meetings:

Open to all investors upon conference registration

During his presentation, Dr. Kumar will provide an overview of Anixa’s clinical programs including vaccines to prevent cancer and a CAR-T cell therapy to treat cancer. He will also review recently announced positive results from the Phase 1 clinical trial of Anixa’s breast cancer vaccine. The vaccine is designed to direct the immune system to destroy triple negative breast cancer (TNBC) cancer cells through a mechanism that has never previously been utilized for cancer vaccine development.

On January 10, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that enrollment is open at Erasmus Medical Center ("Erasmus MC") in a Phase 1b/2 clinical trial combining AIM’s Ampligen (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of pancreatic cancer (the "DURIPANC Study") (Press release, AIM ImmunoTech, JAN 10, 2024, View Source [SID1234639176]). Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy.

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AIM announced in January 2023 that it had entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect." The primary objective of the Phase 1b portion is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, "While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence that rintatolimod treatment enhances the immune response by activating immune cells in advanced PDAC, as well as highlighting its potential synergy with ICI therapy. Therefore, we are excited about the promise of combining Ampligen with durvalumab in a clinical study and we believe this approach could make a positive impact in the current treatment landscape for patients with metastatic pancreatic cancer and extend overall and progression free survival."

AIM recently received a U.S. patent for the use of Ampligen as part of a combination therapy with an anti-PD-L1 antibody.

AIM Chief Executive Officer Thomas K. Equels stated: "We believe that Ampligen has potential as both a monotherapy and a combination therapy, but a combination therapy could be much more enticing as a partnership or buyout target, as Ampligen would be enhancing an already approved drug in an established and successful Big Pharma market. Essentially, we are working to show that combining Ampligen treatment with an already established cancer treatment could help save even more lives."

Hear more from Tom Equels about the significance of this news in the latest "What this Means" video.

The DURIPANC Study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 patients in its Phase 2 portion. Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

On January 9, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that it successfully completed its pre-IND advice meeting with the US regulator, the Food and Drug Administration (FDA), discussing plans for the further clinical development of NOX-A12 as a treatment of aggressive adult brain cancer, glioblastoma (Press release, TME Pharma, JAN 9, 2024, View Source [SID1234639198]). Based on the feedback received, TME Pharma confirms that it is on track with preparations to file its Investigational New Drug (IND)1 application and the expedited regulatory pathway request on a timeline that will allow successful completion of both by the end of Q1 2024.

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"The informative discussion with the FDA allows our team to prepare an IND application that fits with the requirements of the US regulator in areas where there has been recent evolution in recommendations by the FDA’s Oncology Center of Excellence, such as the selection of the appropriate therapeutic dose of new oncology drugs2," said Aram Mangasarian, CEO of TME Pharma. "As a result, we are confident to be able to meet our target of having an FDA approved clinical trial protocol in glioblastoma with an expedited regulatory path in the US by the end of Q1 2024 in order to secure the funding for the necessary clinical trial via partnership, investment or other strategic transaction types. While the company plans to provide further updates on the status of applications during the ongoing discussions, the final trial design will be shared once the FDA has completed its assessment. We believe that the combination of a defined regulatory path and the mature data from the GLORIA brain cancer trial will, together, form an attractive package for potential partners."