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.

On July 8, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported a strong business activity for the first half of 2020 (unaudited figures) (Press release, MEDIAN Technologies, JUL 8, 2020, View Source [SID1234561765]).

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As of June 30th, Median Technologies’ revenue reached €5.9 million, up 49.7% compared with the first half of 2019 (€4 million). In total, the company’s revenues have been consistently growing over the past seven quarters. Median’s iCRO1 Business Unit, which provides imaging solutions and services for clinical trials in oncology, accounts for 100% of the company’s revenue. The iBiopsy activity is still in the R&D investment phase and does not generate any income at this stage.

As of June 30th, 2020, the order backlog2 stood at €53.6 million, i.e. €15.3 million more than as of December 31st, 2019, and €9.2 million more than as of March 30th, 2020. Over a one-year period, the order backlog increased by 74.6% (Median’s order backlog was of €30.7 million as of June 30th, 2019, a €22.9 million increase in one year). Median’s order backlog increased over the first semester mainly thanks to very large orders in Europe, for phase III studies involving major pharmaceutical companies. The company’s order backlog allows to approach the coming quarters with full confidence in terms of expected revenue.

Cash and cash equivalents are expected to reach around €19.4 million as of June 30th, 2020. That amount includes a received payment of €15 million, as part of the first installment of a €35 million loan granted to the company by the European Investment Bank (EIB). This loan aims to boost investments in Median’s imaging phenomics platform, iBiopsy. The amount of cash and cash equivalents also takes into account a Research Tax Credit of €1.4 million, which was cashed by the company. During the first half of 2020, and excluding impacts from the EIB first tranche disbursement and the Research Tax Credit reimbursement, Median spent €4.6 million in cash, with a burn rate of €3.7 million in the first quarter, dropping to €0.9 million in the second quarter.

In the first half of 2020, Median increased investments in the development and validation of its imaging phenomics platform, iBiopsy; signed its first partnership with Assistance Publique – Hôpitaux de Paris (AP-HP); structured iBiopsy around three clinical development plans, for which the first clinical validation stages have been launched. Median also announced promising first validation results for its iBiopsy technology, as part of a study assessing the risk of recurrence for patients with primary liver cancer (HCC – hepatocellular carcinoma).

Median’s iCRO Business Unit continued to develop itself in China, where it is now fully operational to manage projects contracted with Chinese companies. As of June 30th, iCRO order intake worldwide had largely exceeded the compan’s first-half forecasts, despite the health crisis caused by Covid-19.

"These first-half results show a significant increase of our order backlog, up €15.3 million over the period, including an acceleration of the trend during the second quarter. As anticipated, the Covid-19 health crisis had an extremely limited impact on our results in the first half of 2020. This impact was limited to payment delays, which were resolved in the second quarter. We’re also recording a 47.9% revenue increase compared with the first half of 2019, as our sales remarkably grew for the 7th consecutive quarter," said Fredrik Brag, CEO and co-founder of Median. "With major events, such as the signing of a collaboration agreement with AP-HP, the receipt of the first payment from our EIB loan and the publication of promising first validation results, the first six month of 2020 also brought very positive news for iBiopsy. And we’re confident that these trends will continue."

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the period ending June 30th, 2020 and are subject to revision based upon the Company’s H1 closing procedures and upon the completion and external audit of the Company’s half year financial statements. Actual results may differ materially from these preliminary results as a result of the completion of H1 closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the first half of 2020, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On July 8, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, and Telix Pharmaceuticals Limited (ASX: TLX), a radiopharmaceutical company developing molecularly-targeted radiation (MTR) products, reported a strategic collaboration to investigate the clinical utility of combining the companies’ technologies to improve treatment for high-risk or recurrent prostate and aggressive kidney cancers (Press release, RefleXion Medical, JUL 8, 2020, View Source [SID1234561764]).

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Under the agreement, the parties will evaluate several new positron emission tomography (PET) tracers, including 68Ga-PSMA-11 for prostate cancer and 89Zr-Girentuximab for kidney cancer1, to evaluate their potential in guiding BgRT to treat disease.

"The Telix tracers show considerable potential for detecting metastatic disease," said Phuoc Tran, M.D., Ph.D., professor of radiation oncology and molecular radiation sciences, oncology and urology at the Johns Hopkins School of Medicine. "Combining them with RefleXion’s BgRT, which is designed to treat metastatic disease, could bring us a step closer to improving outcomes for these cancer types."

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide external-beam radiotherapy (EBRT). As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct BgRT to each tumor and destroy it, even in moving tumors. The most commonly used PET tracer is 18F-fluorodeoxyglucose (FDG), which can detect many different cancer types. However, its performance in certain tumor types and organs remains limited, particularly for kidney and prostate cancers. Telix’s new PET tracers are designed to target specific cancer types and are expected to be more accurate in this clinical setting.

"Telix’s cancer-specific PET tracers may provide a more complete and robust signal to guide BgRT for difficult-to-treat cancers of the prostate and kidney," said Thorsten Melcher, Ph.D., chief business officer at RefleXion. "This collaboration is an important step in providing proof-of-concept that PET-based tumor emissions can guide our BgRT using different tracers and in different cancer types."

Prostate specific membrane antigen (PSMA) imaging with 68Ga-PSMA-11 is suited for imaging high-risk or recurrent prostate cancer due to its ability to detect the spread of cancer outside the prostate bed. PSMA imaging is emerging as a potential new standard of care for detecting and staging prostate cancer, subject to approval by regulators2. For renal cancer applications, Telix’s 89Zr-Girentuximab, the first zirconium-labeled PET tracer in late-stage clinical development, targets carbonic anhydrase IX (CA9), an antigen that may differentiate renal cancer, including metastases, from benign disease.

"The use of Telix’s cancer-specific PET tracers may enable us to guide RefleXion’s BgRT in patients with more advanced forms of prostate and kidney cancer," said Christian Behrenbruch, Ph.D., CEO at Telix. "This collaboration also allows us to leverage the investment we’ve made in these tracers by expanding both their indications and overall procedure volumes."