On May 23, 2022 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported new data from Cohort 2 of the ongoing Phase 1 study evaluating JK07, the Company’s lead drug candidate, for the treatment of heart failure with reduced ejection fraction (HFrEF) (Press release, Salarius Pharmaceuticals, MAY 23, 2022, View Source [SID1234614954]). The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.

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"Our study of JK07 in heart failure with reduced ejection fraction continues to demonstrate favorable safety and promising signals of clinical activity, and we look forward to gaining further insights as we enter Cohort 3," said Sam Murphy, Chief Executive Officer of SalubrisBio. "In addition, we’re thrilled to announce that the first CTA has been filed in Europe for JK08, to evaluate this novel CTLA-4/IL-15 antibody fusion protein in the treatment of solid tumors. We have made considerable progress this year across our pipeline and remain laser-focused on advancing these important programs to bring differentiated complex biologics to patients with unmet needs," concluded Murphy.

New Cohort 2 Data for JK07 Shows Favorable Safety and Further Promising Activity in Patients with HFrEF

In this ongoing randomized, double-blind, placebo-controlled, dose-escalation Phase 1b study evaluating JK07, patients treated in Cohort 2 (n=5) demonstrated a favorable safety profile and encouraging signals of clinical activity. In addition, dose-dependent increases in biomarker surrogates of target engagement have been observed across the two completed cohorts. Enrollment in Cohort 3, of five planned cohorts, has commenced in this Phase 1b study and SalubrisBio plans to report additional data from this study at future medical meetings.

CTA for JK08 Submitted in Europe

The first CTA has been filed in Europe seeking approval to initiate a Phase 1/2 study evaluating JK08 monotherapy for the treatment of advanced solid tumors. JK08 augments the T-regulatory cell targeting of a CTLA-4-specific antibody with an IL-15/sushi domain fusion peptide, which locally induces NK cell activation and antibody-dependent cellular cytotoxicity (ADCC), two biological hallmarks predictive of response to CTLA-4 targeted therapy. The study will assess the safety, pharmacokinetics, and anti-tumor activity of JK08 at multiple dose levels and will include multiple expansion cohorts following selection of the optimal biologic dose. Upon obtaining regulatory approvals, the Company plans to initiate recruitment during the third quarter of 2022.

Appointment of Arian Pano, MD as Chief Medical Officer

Dr. Pano comes to SalubrisBio from Kiniksa Pharmaceuticals, where he served as SVP of Clinical Development, overseeing all functional groups, including medical, research, clinical operations, regulatory, safety, biometrics, and medical writing. Previously he served as SVP of Clinical Development for Galapagos NV, and concurrently served as the US country head and Global Head of Safety. Dr. Pano has an extensive background in research and development with a focus on cardiovascular, metabolic rare diseases, inflammation and fibrosis. He earned his MD degree from the University of Tirana, Albania, completing fellowships in invasive cardiology and pediatrics. In addition, he holds an MPH in Healthcare Management from Harvard’s School of Public Health.

"Since clinical data is the currency of our industry, and as we are now generating meaningful clinical results, the time was right to expand and strengthen the leadership team by bringing on Ari to build our clinical organization, chaperone our drugs through mid- and late-stage development, and ensure our data management and pharmacovigilance functions support future planned regulatory filings," added Murphy.

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF and undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

About JK08

JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and an IL-15 fusion domain. The JK08 design builds upon a breadth of clinical studies with CTLA-4 antibodies and recombinant IL-15 molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has exhibited potent stimulation of NK cell expansion and enhancement of ADCC in pre-clinical and clinical studies. Through the incorporation of a CTLA-4 antibody and IL-15 into a single molecule, JK08 can channel the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards depletion of T-regulatory cells and targeted reversal of immunosuppression which may contribute to cancer progression.

On May 23, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported acceptance of its abstract titled, "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" for presentation of a poster at this year’s Tumor Myeloid-Directed Therapies Summit (Press release, Navidea Biopharmaceuticals, MAY 23, 2022, View Source [SID1234614934]).

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The 2nd annual Tumor Myeloid-Directed Therapies Summit meeting will be held June 14-16, 2022 in Boston, MA. The presentation will take place Tuesday, June 14. Meeting information can be found on the conference website (View Source).

The poster will present information related to the synthesis of two novel bisphosphonate drugs that have been attached to Navidea’s CD206-targeted drug delivery platform molecule, Manocept. These constructs use a novel degradable linker to release the therapy only once they have been internalized into a CD206-expressing cell, such as a tumor associated macrophage. The new therapeutic constructs were evaluated in human macrophage cell culture assays to compare the ability of the new constructs with unbound free therapy to shift the phenotype of macrophages toward a proinflammatory gene expression pattern. The new drug delivery constructs successfully shifted the phenotypes of human macrophages towards a proinflammatory state and compared favorably to the unbound free therapy. The new drug constructs also induced a highly significant reduction in macrophage expression of signal regulatory protein alpha ("SIRPα"), the receptor for the "don’t eat me" signal that, when activated, suppresses the ability of macrophages to attack and phagocytize disease associated cells such as cancer cells. The ability to induce this type of phenotypic change in macrophages could have far-reaching applications in cancer immunotherapy.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "These new therapeutic constructs demonstrate the power of our adaptable platform technology to deliver a wide array of small molecule payloads in a targeted fashion to macrophages involved in the propagation of a variety of severe illnesses including cancer."

On May 23, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it will present new data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 in Chicago (Press release, Guardant Health, MAY 23, 2022, View Source [SID1234614955]). Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy.

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"We look forward to sharing an array of robust data at ASCO (Free ASCO Whitepaper) that demonstrate the utility of our blood tests to help healthcare professionals optimize care for patients at all stages of the disease—from detecting early-stage cancers to identifying the presence of residual disease and delivering insights that inform treatment to improve outcomes," said Helmy Eltoukhy, Guardant Health co-CEO. "We’ll be presenting data from retrospective and real-world analyses that show how blood-based tests provide critical insights at every step of a patient’s treatment journey, and analytics that contribute to the broader scientific community’s understanding of some of the most challenging cancers."

Full List of Guardant Health Presentations

Guardant360

Circulating tumor DNA profiling and serial analysis in salivary gland carcinomas reveal unique mutational subsets and actionable alterations (Abstract 6097)
Co-occurring alterations across molecular pathways in metastatic colorectal cancer (mCRC) (Abstract 3590)
Characterization of genomic landscape using comprehensive circulating cell-free tumor DNA next generation sequencing in advanced thyroid carcinoma (Abstract 3045)
Using cell-free circulating tumor DNA (cfDNA) to identify guideline-relevant biomarkers for therapy selection in 14,000 patients (pts) with metastatic colorectal cancer (mCRC) (Abstract 3601)
Prevalence of incidental pathogenic germline variants detected in cfDNA in patients with oncogene-driven non-small cell lung cancer (Abstract 10569)
KIT resistance mutations identified by circulating tumor DNA and treatment outcomes in advanced gastrointestinal stromal tumor (Abstract 11514)
RAS co-mutation and early onset disease represent an aggressive phenotype of atypical (non-V600) BRAF mutant metastatic colorectal cancer (Abstract 3592)
Variation in liquid biopsy cfDNA yield predicted by somatic mutation and clinical phenotypes across primary cancers (Abstract 13553)
Circulating tumor DNA profile in pancreatic ductal adenocarcinoma (PDAC) and potential targeted therapy (Abstract 4152)
Phase 3 trial of lorlatinib in treatment-naïve patients (Pts) with ALK-positive advanced non-small cell lung cancer (NSCLC): Comprehensive plasma and tumor genomic analyses (Abstract 9070)
Guardant Reveal

Clinician utilization of a plasma-only, multiomic minimal residual disease (MRD) assay in 2,000 consecutive patients with colorectal cancer (CRC) (Abstract 15586)
Guardant360 Response

Circulating tumor DNA (ctDNA) in HER2 exon 20 insertion mutations and responses in NSCLC HER2 exon 20 insertion treated with poziotinib (Abstract 3051)
Prognostic value of molecular response via ctDNA measurement in predicting response of systemic therapy in patients with advanced solid cancer (Abstract 13001)
GuardantINFORM

Use of real-world data (RWD) to assess the utility of cell-free circulating tumor DNA (cfDNA) in identifying resistance to early treatment in advanced breast cancer (aBC) (Abstract 1011). Oral presentation during Clinical Science Symposium.
GuardantOMNI

Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor-positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis (Abstract 1005). Oral presentation during Metastatic Breast Cancer session.
Serena-1: Updated analyses from a phase 1 study (parts C/D) of the next-generation oral SERD camizestrant (AZD9833) in combination with palbociclib, in women with ER-positive, HER2-negative advanced breast cancer (Abstract 1032)
Shield LDT – CRC Screening

Validation of a multi-modal blood-based test for the detection of colorectal cancer with sub single molecule sensitivity (Abstract 3627)
Next generation Shield – Multi-Cancer Screening

Development of a highly-sensitive targeted cell-free DNA epigenomic assay for integrated screening of lung and colorectal cancer (Abstract 3542)
Trial in progress: Screening for high frequency malignant disease (SHIELD) (Abstract TPS1602)
The full abstracts will be available on the official ASCO (Free ASCO Whitepaper) website on May 26, 2022.

On May 23, 2022 (the "Effective Date"), CASI Pharmaceuticals, Inc. ("CASI") reported that entered into a Business Loan Agreement, Commercial Security Agreement, Commercial Pledge Agreement and a Promissory Note (collectively, the " Agreement") with East West Bank ("EWB") (Filing, 8-K, CASI Pharmaceuticals, MAY 23, 2022, View Source [SID1234614975]). Under the Agreement, EWB made available to the Company a revolving line of credit up to a maximum of USD $10.0 million. The Agreement contains customary representations, warranties, financial covenants and ratios, reporting and other covenants, and events of default. The Agreement will mature on December 31, 2022, unless extended to April 30, 2024 subject to certain conditions as defined in the Agreement. Proceeds received under the Agreement are intended to finance short-term working capital needs.

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In general, amounts borrowed under the Agreement are secured by a lien on the Company’s assets, including first priority security interest in accounts receivable and inventory and pledge of available-for-sale securities. Under the Agreement, CASI shall maintain at least $2,500,000 cash on deposit at EWB. EWB shall, when certain conditions are met, partially or fully release this cash deposit requirement.

Upon the Effective Date, the Company was required to pay a closing fee equal to $50,000. Amounts borrowed under the Agreement bear interest, payable monthly. Such interest shall accrue based upon the daily Wall Street Journal Prime Rate (as quoted in the "Money Rates" column of The Wall Street Journal (Western Edition)) plus 0.35 % with a floor rate of 3.85%. Interest is calculated by applying the ratio of the interest rate over a year of 360 days, multiplied by the outstanding principal balance, multiplied by the actual number of days the principal balance is outstanding.

The foregoing description of the Agreement does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.

On May 23, 2022 Chia Tai‑Tianqing Pharma (CTTQ), a Nanjing subsidiary of Sino Biopharma, reported that it will acquire global rights to an anti-LAG3 mAb from Symphogen A/S of Denmark (Press release, ChinaBio, MAY 23, 2022, View Source [SID1234615011]). Sym022 is a mAb that binds LAG3 to block the interaction with MHCII, which increases T cell proliferation and production of cytokines . In two Phase I trials, Sym022 proved itself to be safe and well-tolerated as a monotherapy and in combination with checkpoint inhibitors. Financial details of the transaction were not disclosed. Symphogen is the Antibody Center of Excellence for Servier, a privately held French biopharma.

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