On February 9, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will host a virtual Investor Day for institutional investors and financial analysts on Thursday, March 11, 2021 at 9:00 a.m. ET.
During the event, Steve Rusckowski, Chairman, CEO and President, Mark Guinan, Executive Vice President & Chief Financial Officer, and other senior executives will provide updated views of the U.S. laboratory market and the company’s growth and capital deployment strategies (Press release, Quest Diagnostics, FEB 9, 2021, View Source [SID1234574789]).

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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

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To access the live webcast, including audio, video and presentation slides, register here. Securities analysts and institutional investors are advised to register in advance.

Investors and analysts will have an opportunity to ask questions in live Q&A sessions with speakers. Participants who would like to ask a question can dial 888-455-0391 within the U.S. and Canada, or (773) 756-0467 internationally, using the passcode "7895081."

Interested parties unable to watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on the Quest Diagnostics Investor Relations website following the conclusion of the event.

On February 9, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada (Press release, Arch Oncology, FEB 9, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-to-collaborate-with-merck-on-phase-1-2-clinical-trial-of-anti-cd47-antibody-ao-176-in-combination-with-keytruda-pembrolizumab-in-patients-with-select-solid-tumors [SID1234574788]).

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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

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Under this collaboration, Arch Oncology is expanding its ongoing Phase 1/2 clinical trial to evaluate AO-176, the Company’s novel anti-CD47 antibody, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with select solid tumors. This part of the study will include patients with relapsed, platinum-resistant ovarian cancer, endometrial cancer, and gastroesophageal cancer. The open-label, multi-center, dose-escalation study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary efficacy of AO-176, first as a monotherapy, then in combination with chemotherapy (paclitaxel), and now in combination with KEYTRUDA (pembrolizumab). As a monotherapy, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity in patients with select solid tumors.

"This collaboration with Merck is part of our commitment to conducting a broad clinical development program to evaluate AO-176’s potential for patients," said Jackie Walling, MBChB, Ph.D., Chief Medical Officer of Arch Oncology. "In our Phase 1 trial, we saw encouraging anti-tumor activity for AO-176 as a single agent. These results led us to expand our clinical development program to explore different combination therapy approaches. Combining either PD-1 or PD-L1 checkpoint inhibition with a CD47 blockade has strong scientific rationale and in our preclinical studies resulted in enhanced anti-tumor activity over monotherapy alone. We are excited to advance AO-176 as we aim to deliver new cancer treatments to broader groups of patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at View Source

AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).

On February 9, 2021 China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma, HKEX: 950), and Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE), reported that its anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer (Press release, Sorrento Therapeutics, FEB 9, 2021, View Source [SID1234574787]).

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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

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The NMPA established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits as compared to existing therapies. Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

"China NMPA granted socazolimab breakthrough therapy designation in recognition of both significant unmet medical need and positive and promising clinical results of socazolimab treatment for patients with recurrent or metastatic cervical cancer," said Dr. Benjamin Li Xiaoyi, Chief Executive Officer of Lee’s Pharma. "Cervical cancer is the fourth most lethal cancer in women worldwide and the third cause of cancer-related death in developing countries. There is currently no recommended standard of care treatment for this disease in China. Socazolimab has the potential to be the leading anti-PD-L1 antibody in the treatment of this indication. Socazolimab has demonstrated outstanding efficacy and safety profile in the clinical trials so far in treating cervical cancer patients."

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, "We at Sorrento are happy with the collaboration with our colleagues at Lee’s Pharma and are satisfied with the clinical advance of our first therapeutic antibody partnership in socazolimab. We currently plan to expand our partnership with Lee’s Pharma and are in discussions regarding the co-development of additional therapeutic antibodies from Sorrento to treat hematologic and solid tumors."

Lee’s Pharma plans to file a new drug application to China NMPA and request a fast-track conditional approval of socazolimab for the treatment of cervical cancer in Q2 2021.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

On February 9, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into securities purchase agreements with two healthcare-dedicated institutional investors for the purchase and sale of 4,000,000 shares of its common stock at a purchase price of $6.25 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, FEB 9, 2021, View Source [SID1234574786]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions.

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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

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory (R/R) hematologic malignancies (Press release, Curis, FEB 9, 2021, View Source [SID1234574785]).

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"In dosing the first patient in this Phase 1 study evaluating CA-4948 and ibrutinib, we are taking a highly anticipated step forward in bringing a potent oral therapeutic regimen to patients with relapsed or refractory hematologic malignancies," said James Dentzer, President and Chief Executive Officer of Curis. "BTK inhibitors are an approved category of therapies for patients with various lymphatic cancers yet they only target one of the two main pathways activating NF-κB in B-cell malignancies. CA-4948 targets the other main NF-κB-activating pathway by shutting down signaling through the Myddosome. We have shown highly encouraging increased tumor-reducing activity when combining both covalent and non-covalent BTK inhibitors with CA-4948 in preclinical models."

Mr. Dentzer continued, "We observed single-agent activity in the non-Hodgkin’s lymphoma (NHL) monotherapy study, with the majority of patients treated at 300mg twice daily experiencing at least some reduction in tumor volume. We coordinated with our trial partners to amend the protocol of our existing study to include combination therapy starting at a previously demonstrated therapeutic dose. This will allow us to leverage the clinical sites and staff currently active in our monotherapy study and should save significant time and resources as we advance through the clinic."

"Given the profile CA-4948 has demonstrated in existing studies, it is a promising candidate for combination with a proven BTK inhibitor such as ibrutinib," said Dr. Erel Joffe, M.D., Assistant Attending with the Lymphoma Service at Memorial Sloan Ketting Cancer Center and a lead investigator on the study. "We believe there may be important synergies given that IRAK4 controls the critical TLR pathway that is parallel and complementary to the BTK pathway and that both of these pathways are primary and independent oncogenic activators of NF-κB in lymphoma and leukemia. Effective dual targeting of both independent pathways that drive excessive B-cell proliferation via NF-κB could potentially provide significantly improved outcomes over either treatment in a monotherapy setting."

About the CA-4948+ibrutinib Phase 1 Combination Study

The Phase 1 trial is a two-part, multicenter, open-label, dose escalation and expansion study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, clinical activity, and biomarker correlations of CA-4948 and ibrutinib patients with relapsed or refractory hematologic malignancies. Part 1 of the study is a dose escalation using a 3+3 design. Approximately 18 patients will be enrolled in Part 1 and will receive a starting dose of 200mg CA-4948 BID with subsequent escalation to 300mg BID, both of which have been observed to be safe and effective in the NHL monotherapy study, combined with ibrutinib doses appropriate for their respective NHL subtype. The primary endpoints of Part 1 will be safety and tolerability, maximum tolerated dose, and the recommended Phase 2 dose. Secondary objectives will be pharmacokinetics and preliminary efficacy. Exploratory objectives will include biomarker correlations, such as MYD88-L265P mutations and IRAK4 pathway and NFκB inhibition.

Part 2 of the study will enroll patients across an expansion basket of four cohorts: marginal zone lymphoma (MZL), ABC-DLBCL, primary central nervous system lymphoma (PCNSL), and NHL with adaptive ibrutinib resistance. An interim futility analysis will be conducted after approximately 15-20 patients are enrolled in each cohort. Primary endpoints of Part 2 will be complete response or objective response rate and duration of response compared to historical controls. Secondary objectives will be safety and tolerability, progression-free survival, and population PK sampling for CA-4948. Exploratory objectives will include response correlation with biomarkers including MYD88-L265P or other genetic mutations, gene expressions, cell of origin, IRAK4 signaling, and resistance.