On September 7, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer, reported that Maria Zannes, President and CEO, will present a corporate update and hold meetings with institutional investors during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 (Press release, BioAffinity Technologies, SEP 7, 2023, View Source [SID1234635011]).

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Institutional investors interested in arranging a meeting with bioAffinity Technologies management can register to attend the conference virtually or in-person at the Lotte New York Palace Hotel or contact Tirth Patel at LHA at [email protected].

On September 7, 2023 AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, reported the first patient has been dosed in a Phase 2 clinical trial, G203, evaluating safusidenib in patients with Grades 2 or 3 recurrent or progressive mutant isocitrate dehydrogenase 1 (mIDH1) glioma, one of the most common types of adult primary brain cancer (Press release, AnHeart Therapeutics, SEP 7, 2023, View Source [SID1234635010]).

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Oncogenic mutations in IDH1 are frequently found in gliomas and current treatment options, including chemotherapy and radiotherapy, can cause significant impact on neurocognition and quality of life. Safusidenib is a novel, selective, potent, oral mIDH1 inhibitor. Safusidenib has shown high blood-brain barrier penetration in both pre-clinical and clinical studies. Encouraging anti-tumor activity was observed in a Phase 1 clinical trial in patients with recurrent IDH1-mutant gliomas.

"IDH1 mutations are now known to be a key driver in the development of IDH-mutant gliomas and we are excited by the potential of IDH targeted therapy for our patients, who tend to be in the prime of their life at diagnosis," said Professor David Reardon, the leading Principal Investigator of the G203 clinical trial and Clinical Director at the Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston. "Early data suggest safusidenib may have a role in IDH1-mutant gliomas, notably in high-risk populations, and we look forward to further evaluating this investigational therapy in the G203 trial."

"This marks an important milestone for AnHeart, as we now have two investigational precision therapies in late-stage clinical trials," said Jerry Wang, PhD, Chief Executive Officer of AnHeart. "Our mission is to improve the lives of people with cancer. Our strategy is to target known genetic drivers of cancer with the goal of bringing next-generation medicines that raise the bar for what patients should expect from cancer treatment. We look forward to sharing additional updates as we continue to progress our clinical programs."

About the G203 Phase 2 Safusidenib Trial

G203 (NCT05303519) is a global Phase 2, multicenter, open-label, two-part clinical trial evaluating the efficacy and safety of safusidenib as a monotherapy in approximately 95 patients with recurrent or progressive WHO Grade 2 or Grade 3 IDH1-mutant glioma. The trial is divided into two parts. Part 1 is designed to confirm the optimal dose of safusidenib. Part 2 will evaluate the efficacy and safety of safusidenib in Grade 2 or Grade 3 glioma. Currently, patients are being enrolled in the United States, with expansion to other countries planned for Part 2 of the trial.

About Safusidenib

Safusidenib is a novel, selective, potent, oral mIDH1 inhibitor. Safusidenib has shown high blood-brain barrier penetration in both pre-clinical and clinical studies. Encouraging anti-tumor activity was observed in a Phase 1 clinical trial (NCT03030066) evaluating safusidenib in patients with recurrent or progressive WHO Grades 2 to 4 IDH1-mutant gliomas. In the trial, the objective response rate (ORR) was 33% (4/12) and 17% (6/35) in patients with contrast non-enhancing and enhancing tumors, respectively. Tumors that show enhancement on MRI scans tend to have more vascularization and disruption to the blood-brain barrier and are generally associated with a higher degree of malignancy compared with non-enhancing tumors.

Safusidenib demonstrated a tolerable safety profile. Most adverse events (AEs) were Grades 1 or 2. 43% of patients experienced at least one Grade 3 treatment emergent AE. No Grade 4 or 5 AEs or serious treatment-related AEs were reported.

AnHeart licensed safusidenib from Daiichi Sankyo in 2020 and owns global rights for safusidenib, excluding Japan where Daiichi Sankyo retains development and commercial rights.

About Glioma

Glioma is the most common type of adult brain cancer. Approximately 30,000 patients are diagnosed with IDH1-mutant gliomas in the United States, Europe, and China annually. Patients are typically diagnosed in the prime of their life in their mid-forties to early-fifties. IDH1 mutations are present in the majority of Grade 2 or 3 diffuse gliomas and IDH-mutant gliomas are recognized as distinct tumor subtypes by the World Health Organization (WHO).

There are no targeted treatments approved for IDH-mutant glioma. Current treatment options include surgery, radiation, and chemotherapy, which can cause significant impact on neurocognition and quality of life.

On September 7, 2023 Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, reported that Dr. Phil Campbell, Professor of Biomedical Engineering at CMU, presented his talk, "Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy" at the 5th Exosome Based Therapeutic Development Summit in Boston, MA this morning (September 7, 2023) (Press release, Coya Therapeutics, SEP 7, 2023, View Source [SID1234635009]). The presentation can be accessed here.

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Coya and CMU entered into a Research Collaboration Agreement and Option Agreement in 2022 to develop a unique patented technology intended to advance the potential use of exosomes for the treatment of diseases of unmet need.

In this study, it was demonstrated that by using a proprietary cholesterol DNA tether technology, Treg exosome membranes could be engineered to controllably immobilize CTLA-4, a membrane surface active protein, onto the Treg exosome surface resulting in stable CTLA-4-Treg exosomes. It was also demonstrated that CTLA-4-Treg exosomes exhibited far better cell uptake then non-modified Treg EVs in representative immune cells, macrophages (J7774 murine cell line) and T-cells (human Jurket cell line).

Previously, using the same technology, CMU demonstrated applications in Oncology by engineering mesenchymal derived exosomes with an immunomodulatory apoptotic inducing protein, Fas Ligand (FAS-L). The results demonstrate that targeted delivery of FASL-exosomes substantially increases its therapeutic effect with enhanced apoptosis in tumor cells and suppression of alloreactive T cells in mice, while minimizing potential off target effects. This publication is available here.

Tregs are important immunomodulatory cells, with a key role controlling inflammation, enabling self-tolerance, and promoting regenerative processes. Treg-derived exosomes share many of the properties of the parent Treg cells making them able to modulate physiological and pathophysiological processes. The proprietary technology generates Exosome Polymer Hybrids (EPHs) which allow for efficient and versatile method of engineering and customizing cargos of Treg-derived exosomes using oligonucleotide tethers. Delivering EPHs to sites of inflammation or epitopes that drive specific diseases, while delivering customized loads, enables the next generation of selectively targeted and potent Treg-derived exosomes.

Engineered exosomes may have multiple advantages, including low immunogenicity, improved stability, increased plasma retention after systemic delivery and increased residence time following local delivery, enhanced biodistribution, improved cell binding and uptake, and enhanced targeted therapeutic response.

Dr. Fred Grossman, President and Chief Medical Officer of Coya stated, "This proprietary technology expands Coya’s pipeline to include autoimmune disorders and cancer. These engineered exosomes are a cell – free drug delivery system without genetic modification that can travel throughout the body unimpeded, including through the blood brain barrier, to provide specific targeted therapies."

On September 7, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancers with high unmet medical needs, reported that data on the company’s leading program fostroxacitabine bralpamide (fostrox) and its potential effect on hepatocellular carcinoma (HCC), will be presented at the International Liver Cancer Association (ILCA) Annual Meeting, September 7-9 in Amsterdam (Press release, Medivir, SEP 7, 2023, View Source [SID1234635007]).

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An abstract, titled "Combinations of fostrox (MIV-818), a novel nucleotide prodrug, with lenvatinib or sorafenib, shows increased efficacy in non-clinical hepatocellular carcinoma (HCC) models in vivo" where the study results show the potential of obtaining improved antitumor effect when fostrox is combined with a kinase inhibitor, is presented by Fredrik Öberg, Chief Scientific Officer at Medivir.

– "Kinase inhibitors, such as Lenvima (lenvatinib) and sorafenib, exert inhibition of the formation and growth of vessels, an anti-angiogenesis effect, which induces oxygen deficiency in the cells/tumor environment, so-called hypoxia. This mechanism increases the prospect of greater efficacy of fostrox as hypoxia increases conversion to fostrox active metabolite, resulting in a higher cytotoxic activity. In line with this, our preclinical results show that fostrox has the potential to enhance anti-tumor activity together with kinase inhibitors such as Lenvima or sorafenib", says Fredrik Öberg.

– "Although existing combination therapies for HCC can prolong patients’ lives, far from all patients respond to treatment. Fostrox, with its unique, liver-targeted approach, opens up for completely new combinations to effectively treat HCC. The enhanced anti-tumor activity with kinase inhibitors in non-clinical tumor models supports the encouraging clinical results we see in the ongoing phase 1b/2a study with fostrox + Lenvima", says Pia Baumann, Chief Medical Officer at Medivir.

The abstract and poster will be available on Medivir’s website after the presentation.

As a reminder, Medivir will be hosting an Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC later this week on Friday September 8th at 13:00 CET/07:00 EST. Dr Pia Baumann, CMO at Medivir, will also participate in the webcast and provide additional comments regarding the development of fostrox and data.

The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations
The presentation will be available on Medivir´s website after the webcast.

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox
Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On September 7, 2023 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the Phase 1 clinical study (NCT05652686) of PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47 for the treatment of small cell lung cancer and other neuroendocrine tumors (Press release, Phanes Therapeutics, SEP 7, 2023, View Source [SID1234635006]). PT217 is a common light chain bispecific antibody discovered through Phanes’ research engine and was granted orphan drug designation (ODD) for the treatment of small cell lung cancer by the FDA last year.

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PT217 is expected to directly kill tumor cells via both the ADCP activity of macrophages and ADCC activity of NK cells, and by targeting both DLL3 and CD47 expressed on the surface of tumor cells, it can broaden the tumor killing spectrum. Additionally, PT217 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into phagocytotic antigen presenting cells (APCs) and stimulate adaptive immune system by indirectly activating T cell killing of DLL3 expressing tumor cells through recognition of tumor neoantigens. The anti-CD47 arm of PT217 is differentiated and has demonstrated minimum binding to human red blood cells while maintaining strong binding activity to CD47 on tumor cells. "Small cell lung cancer is one of the most devastating and aggressive solid tumor cancers with patients lacking effective therapies to treat their disease. With the advancement of PT217, we offer a potential new option for these patients. PT217 is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies," said Dr. Ming Wang, Founder and CEO of Phanes.

The multi-center Phase I clinical trial of PT217 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 in patients with unresectable or small cell lung cancer (SCLC), large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

For more information on the study please visit ClinicalTrials.gov (NCT05652686).