On July 8, 2020 On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, reported that it has announced that it has enrolled the first patient in the ELUCIDATE Trial, a Phase 3 clinical trial evaluating the efficacy and safety of pafolacianine sodium (formerly OTL38) in the intraoperative detection of lung cancer lesions (Press release, On Target Laboratories, JUL 8, 2020, View Source [SID1234561770]).

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"This pivotal study is pioneering the use of fluorescence guidance to intraoperatively identify lung cancer in real-time," said Sunil Singhal, M.D., Vice Chair, Translational Research and the William Maul Measey Associate Professor in Surgical Research in the Perelman School of Medicine at the University of Pennsylvania and a member of Penn’s Abramson Cancer Center and principal investigator of the study. "Using a fluorescent imaging marker with high affinity and specificity for lung cancer allows surgeons to more effectively remove all the malignant tissue and have greater confidence in a complete resection."

The Phase 3 study will assess the efficacy, safety, and tolerability of pafolacianine sodium in patients with lung cancer. This multi-center trial is expected to enroll up to 130 patients. Top-line data from the trial are expected in 2021.

"Treating our first patient in the ELUCIDATE Phase 3 Trial is an enormous achievement for On Target Laboratories," said Chris Barys, CEO of On Target Laboratories. "We believe this transformational technology should become the standard of care and look forward to bringing it to market so more lung cancer patients can benefit from the improved outcomes associated with more complete tumor resections."

About Fluorescence-guided Surgery

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target’s first novel compound, pafolacianine sodium, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via intravenous infusion prior to surgery, allowing the surgeon to identify malignant tissue during the procedure using a near-infrared camera.

On July 8, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2020 financial and operating results on Wednesday, August 5, 2020, before the U.S. financial markets open (Press release, Regeneron, JUL 8, 2020, https://www.prnewswire.com/news-releases/regeneron-to-report-second-quarter-2020-financial-and-operating-results-and-host-conference-call-and-webcast-on-august-5-2020-301089994.html [SID1234561769]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On July 8, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) ("Qualigen" or the "Company"), reported it has entered into a definitive agreement with a single institutional investor for the purchase and sale for $8,000,000 of (i) 1,200,000 Common Shares, (ii) 780,198 Pre-Funded Warrants and (iii) 1,980,198 Common Warrants at a combined purchase price of $4.165 ($4.04 per Common Share and inclusive of $0.125 per Common Warrant) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Qualigen, JUL 8, 2020, View Source [SID1234561768]). The Common Warrants will have an exercise price of $5.25 per share, are exercisable immediately and have a term of two years. The closing of the offering is expected to occur on or about July 10, 2020, subject to the satisfaction of customary closing conditions.

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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. 333-232798) 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].

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 July 8, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully dosed in a Phase 1b clinical trial (CIBI391A101) of TYVYT (sintilimab injection) plus surufatinib in China (Press release, Innovent Biologics, JUL 8, 2020, View Source [SID1234561767]).

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CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimab plus surufatinib in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of surufatinib in combination with TYVYT (sintilimab injection).

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "Sintilimab is an anti-PD-1 monoclonal antibody drug jointly developed by Innovent and Lilly. It has been proven effective and safe in a variety of tumors including classic Hodgkin lymphoma, lung cancer, esophageal cancer, etc. Surufatinib selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis and CSF-1R, which regulates tumor-associated macrophages. Therefore, the combination of sintilimab and surufatinib may result in synergistic anti-tumor activity, and we are looking forward to the positive results of the clinical trials of sintilimab plus surufatinib, and hope the therapy could benefit more patients."

About CIBI391A101

CIBI391A101 is a Phase 1b clinical study to evaluate the safety, tolerability, and initial anti-tumor efficacy of sintilimab plus surufatinib in patients with advanced malignancies.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

About Surufatinib

Discovered and developed solely by Chi-Med (Hutchison China MediTech Limited), Surufatinib (HMPL-012) is a novel, oral drug candidate that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis and CSF-1R, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib’s unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

In China, an NDA for surufatinib for the treatment of non-pancreatic neuroendocrine tumors (NET) was accepted for review (and subsequently granted Priority Review status) by the NMPA in November 2019 after the SANET-ep Phase 3 study successfully met its primary endpoint of improved progression-free survival. A second NDA is being submitted after the SANET-p Phase 3 study in pancreatic NET also successfully met its primary endpoint of PFS in January 2020. Surufatinib is in several other proof-of-concept clinical trials in China.

In the United States, starting in late 2020 Chi-Med plans to submit an NDA for surufatinib in NET, following an agreement with the U.S. FDA that it will be based on the successful SANET-ep and SANET-p studies, and existing surufatinib U.S. clinical data. Surufatinib was recently granted Fast Track Designations for both pancreatic and non-pancreatic NET, and Orphan Drug Designation for pancreatic NET.

Chi-Med currently retains all rights to surufatinib worldwide.

On July 8, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported a webcast and conference call highlighting its progress and key accomplishments in the first half of 2020 (Press release, Zymeworks, JUL 8, 2020, View Source [SID1234561766]).

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"I’m proud to say we’ve taken a major step towards achieving our goal of bringing an important new therapeutic to patients with HER2-expressing cancers," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "ZW25, which we will now refer to as zanidatamab, has started its first registration-enabling trial in HER2+ 2L biliary tract cancer targeting a potential BLA in 2022."

Dr. Tehrani added, "This achievement, supported by the updated zanidatamab clinical data in BTC and GEA as well as the two partnership updates, highlights a productive first half of 2020 and sets the stage for more to come in the second half of the year."

Zanidatamab Clinical Updates

Registration-Enabling Trial in HER2+ Biliary Tract Cancer
Zymeworks initiated a global Phase 2 trial of single agent zanidatamab in patients with previously treated HER2 gene amplified BTC to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety. This study may enable filing of a BLA as early as 2022.

Updated Single Agent Biliary Tract Cancer Data
In 15 response-evaluable refractory BTC patients, the response rate with single agent zanidatamab was 47% with a disease control rate of 67%. Results compare favorably to the single digit response rates typically seen with chemotherapy in this setting.

Updated Single Agent Gastroesophageal Adenocarcinoma Data
In 34 response evaluable patients with HER2-expressing GEA, zanidatamab continues to demonstrate exciting single agent anti-tumor activity with a 38% response rate, and 62% disease control rate in patients who have received a median of 3 prior lines of treatment, including Herceptin.

Updated Chemotherapy Combination Gastroesophageal Adenocarcinoma Data
Twenty response-evaluable HER2-expressing GEA patients were treated with zanidatamab in combination with either paclitaxel or capecitabine, both of which are used as single agent chemotherapies for patients with progression after first line treatment. The overall response rate was 55%, including a 60% response rate in combination with paclitaxel. As a comparator, the response rate for paclitaxel alone in 2nd line HER2+ GEA is ~ 20%. Responses were observed in patients with FISH+ and FISH- disease.

Business Highlights

New Azymetric Partnership with Merck
Zymeworks signed a new licensing agreement with its long-term partner Merck to develop additional multispecific antibody therapeutic candidates using the Azymetric and EFECT platforms. Zymeworks is eligible to receive up to US$411 million in option exercise fees and clinical development and regulatory approval milestone payments and up to US$480 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

Expanded Partnership with Bristol-Myers Squibb
BMS (formerly Celgene) expanded its Azymetric collaboration with Zymeworks, gaining access to the EFECT platform and extending its research term, with the objective of developing up to 10 therapeutic candidates as per the original agreement. The expanded partnership resulted in a US$12 million upfront payment to Zymeworks. Milestones remain at up to US$1.7 billion plus tiered royalties on global sales.