On April 12, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company has entered into a clinical trial support agreement (the "Agreement") with Janssen Research & Development, LLC ("Janssen") to enable evaluation of ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with prostate cancer (Press release, ESSA, APR 12, 2023, View Source [SID1234630020]).

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Under the terms of the Agreement, ESSA will sponsor and conduct a Phase 1 clinical trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetate plus prednisone. Janssen will supply apalutamide and abiraterone acetate. ESSA will retain all rights to EPI-7386.

Cohort A of the Phase 1 clinical trial will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer ("mCRPC") and high-risk metastatic castration-sensitive prostate cancer ("mCSPC"). Cohort B is a Window of Opportunity study in which patients with non-metastatic CRPC will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide.

"We are pleased to have this agreement in place in order to further investigate EPI-7386 in combination with apalutamide and abiraterone acetate plus prednisone in a variety of prostate cancer patient populations," said David R. Parkinson, President and Chief Executive Officer of ESSA. "Preliminary clinical data from EPI-7386 combination studies with standard-of-care antiandrogens in mCRPC patients have shown a favorable safety profile and encouraging early signs of anti-tumor activity. We look forward to examining EPI-7386 with apalutamide and abiraterone acetate with prednisone in additional prostate cancer populations to assess the safety, tolerability, optimal dose(s) and preliminary anti-tumor activities of these approaches."

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with castration-resistant prostate cancer ("CRPC") whose tumors have progressed on standard-of-care therapies. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA is also conducting a Phase 1/2 clinical trial (NCT05075577) of EPI-7386 in combination with enzalutamide in metastatic CRPC patients who have not yet been treated with second-generation antiandrogen therapies. ESSA retains all rights to EPI-7386 worldwide.

On April 12, 2023 ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and radiopharmaceutical therapies (RPT), reported the execution of a new non-exclusive License and Supply Agreement with Leucid Bio (Leucid), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company’s proprietary Lateral CAR Platform (Press release, ImaginAb, APR 12, 2023, View Source [SID1234630019]).

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Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb’s investigational CD8 ImmunoPET tracer, 89Zr crefmirlimab berdoxam, to Leucid for use in its basket study in solid tumors, with LEU011 targeting NKG2DL, Autologous CAR T-cells.

Ian Wilson, Chief Executive Officer of ImaginAb, said: "We are delighted that Leucid Bio will use our investigational CD8 ImmunoPET for the first time in conjunction with CAR-T therapies. This agreement with Leucid Bio is an opportunity for ImaginAb to continue expanding our partnerships and showcases the increasing adoption of our CD8 ImmunoPET technology."

Artin Moussavi, Chief Business Officer of Leucid Bio, commented: "This is an exciting partnership for Leucid as this cutting edge technology will provide evidence of the biodistribution of LEU011 CAR T-cells. This will be the first time this technology will be used in a solid tumor CAR-T clinical setting allowing Leucid to generate data that demonstrates the tracking of LEU011 to tumor sites in the first phase of the trial. This data would validate, in humans, the significant improvements already demonstrated with LEU011 in preclinical studies.

On April 12, 2023 Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, reported that Molecular Cancer Therapeutics (an American Association for Cancer Research (AACR) (Free AACR Whitepaper) journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521 (Press release, Byondis, APR 12, 2023, View Source [SID1234630018]).

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The article, "Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate," suggests that BYON3521 has an encouraging safety/efficacy window with potential for clinical benefit in patients. A First-in-Human dose escalation study is currently ongoing to determine the maximum tolerated dose and recommended dose for expansion (NCT05323045). The study is enrolling patients in leading oncology centers in Belgium, Italy, the Netherlands and the United Kingdom.

The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels. In addition, the nonclinical safety evaluation showed that BYON3521 is well tolerated, predicting a substantial clinical therapeutic window.

"The c-MET/HGF pathway is one of the most dysregulated pathways in human solid tumors and is generally associated with a poor prognosis," said Byondis Chief Scientific Officer Wim Dokter, Ph.D. "Being able to use that pathway to deliver clinical benefit to patients will therefore be extra rewarding."

c-MET (also called tyrosine-protein kinase MET [Mesenchymal Epithelial Transition] factor or HGFR [Hepatocyte Growth Factor Receptor]) is a receptor expressed on the surface of epithelial cells of many different organs. Binding of the growth factor HGF to c-MET leads to normal cell division, growth and differentiation, important in the generation of new tissue, e.g., during the development of a fetus, or during growth or wound repair.

But in many tumor cells, c-MET activation is dysregulated: too much c-MET is expressed, c-MET is mutated or c-MET is active even without the binding of HGF. c-MET is overexpressed in a variety of solid tumors, such as renal cell cancer, uveal (ocular) melanoma, non-small cell lung cancer and head and neck squamous cell cancer.

BYON3521, a Next Generation Antibody-Drug Conjugate

BYON3521 is comprised of the humanized IgG1 c-MET-targeting monoclonal antibody, SYD2884, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA or SYD980). The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized. After proteolytic cleavage of the linker in the lysosome, the inactivated cytotoxin is activated, binds to the DNA and DNA damage is induced, eventually resulting in tumor cell death. BYON3521 is considered a form of targeted chemotherapy.

Byondis’ Distinctive, Proprietary Linker-Drug and Site-Specific Conjugation Technology

BYON3521 incorporates Byondis’ distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine and its site-specific conjugation technology ByonShieLD. The characteristic design of the selectively cleavable linker connecting the antibody to the duocarmycin drug leads to high stability in circulation and induces efficient release of the cytotoxin in the tumor. Uptake of the activated payload by neighboring tumor cells with lower or no c-MET expression may improve the efficacy potential through the so-called bystander effect.

On April 12, 2023 Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of personalized therapeutic cancer vaccines (PTCV), reported that it has secured $5 million in its Series A3 round (Press release, Geneos Therapeutics, APR 12, 2023, View Source [SID1234630017]). This financing adds 3B Future Health Fund (3B FHF) to Geneos’ investor syndicate. Further, Dr. Roberto DePonti, managing director and general partner of 3B FHF, joins Geneos as a board observer, adding decades of pharmaceutical drug development experience to the company.

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Proceeds Will Fund Expansion of Phase 1b/2a GT-30 Program
GT-30 is evaluating safety, immunogenicity, and efficacy of PTCV (GNOS-PV02 plus plasmid-encoded IL-12) administered in combination with the immune checkpoint inhibitor pembrolizumab, in patients with unresectable or metastatic hepatocellular carcinoma (HCC) who progress on, or are intolerant to, first line tyrosine kinase inhibitors (sorafenib or lenvatinib). The company previously reported data from the first 24 patients enrolled showing strong tumor reductions including three complete responses (complete disappearance of tumor), and four patients with a partial response. Based on these encouraging results, the study enrollment was expanded to 36 patients. Geneos plans to report the efficacy and durability of response data from the full cohort of 36 patients in 2023.

"We are excited to contribute to the development of Geneos’ advanced approach to treat, patients with HCC as well as multiple additional types of cancer in the future," stated Riccardo Braglia, general partner of 3B Future Health Fund II. "We are encouraged by the very promising results in the current clinical trial and look forward to working closely with the talented Geneos team."

"We are delighted to welcome Roberto and 3B FHF into our investor syndicate. We look forward to working with 3B FHF and their strong worldwide pharmaceutical development expertise and broad network in advancing our novel personalized therapeutic cancer vaccines," stated Niranjan Sardesai, PhD., president and chief executive officer of Geneos Therapeutics.

On April 12, 2023 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it will be presenting new preclinical data on its NAV-001 antibody-drug conjugate (ADC) and NAV-003 bispecific programs at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference in Orlando, Florida on April 17 and 18 (Press release, Navrogen, APR 12, 2023, View Source [SID1234630016]).

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NAV-001 and NAV-003 both target mesothelin, a cell surface protein over-expressed on various malignancies, including breast, colon, lung and mesothelioma cancers. Certain ADCs and therapeutic antibodies targeting mesothelin are negatively affected by Humoral Immuno-Oncology (HIO) factors that are produced in the tumor microenvironment. These HIO factors are able to directly bind to affected antibody-based agents and suppress their immune-effector activities as well as suppress target cell internalization, thereby lowering their therapeutic efficacy. To overcome this mechanism of suppression, Navrogen has employed its proprietary HIO factor screening and block-removed immunoglobulin technology (BRITE) platforms to engineer HIO refractory mesothelin-targeting agents. NAV-001 and NAV-003 both have the BRITE feature integrated to avoid suppression by HIO factors, while NAV-001 contains a novel highly toxic payload, and NAV-003 is configured to have an optimized anti-CD3/anti-MSLN bispecific format to elicit robust CD3-redirected T-cell mediated cytotoxicity. These drug candidates have demonstrated significant in vivo efficacy across a wide array of mesothelin-positive cancer models.

"We look forward to sharing scientific data around our programs and technology platforms with the AACR (Free AACR Whitepaper) community", said Dr. Luigi Grasso, Navrogen’s Chief Scientific Officer. "Based on the efficacy and preliminary safety data, we are advancing our NAV-001 and NAV-003 programs forward for clinical testing in HIO suppressed cancers identified by diagnostic screens of various cancer types".