On September 10, 2020 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies ,reported that the US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma (Press release, Shanghai Junshi Bioscience, SEP 10, 2020, View Source [SID1234565012]). Toripalimab is the first anti-PD-1 antibody from China to receive the Breakthrough Therapy designation, which is another important regulatory milestone for Toripalimab after FDA granted orphan drug designation for this indication in May 2020.

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"The Breakthrough Therapy designation granted by FDA recognizes the significant clinical benefits Toripalimab has shown for the treatment of nasopharyngeal carcinoma," commented Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. "Junshi prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer, but we found that great unmet medical needs also exist in other countries where patients are endangered by this deadly disease. The BTD will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously."

The Breakthrough Therapy designation is derived from the provisions of the US Food and Drug Administration Safety and Innovation Act (FDASIA) and aims to expedite the development and review process of drugs intended to treat a serious condition when preliminary clinical evidence indicates that the drug may result in substantial improvement over available therapies on a clinically significant endpoint. BTD is another important new drug review channel for the FDA following the fast track, accelerated approval, and priority review. According to regulations, the drug development process that has obtained breakthrough drug therapy certification will receive closer guidance and various forms of support, including from senior FDA officials, to ensure that patients are provided with new treatment options in the shortest time. The FDA Breakthrough Therapy designation for Toripalimab for the treatment of nasopharyngeal carcinoma can significantly support and accelerate the commercial development plan of Toripalimab in the United States.

About NPC
Nasopharyngeal carcinoma (NPC) is a malignant tumor that occurs in the mucosal epithelium of the nasopharynx, mostly in the parietal and lateral walls of the nasopharynx, especially in the pharyngeal recess. There were 129,000 new cases worldwide in 2018. NPC is one of the most common malignant tumors in China. The incidence of NPC in Chinese population is significantly higher than the world average. It is particularly higher in certain geographical areas. For example, the annual incidence of NPC in Guangdong is 20 to 40 per 100,000. Early nasopharyngeal carcinoma patients have a good therapeutic effect with 90% can be cured or be tumor-free for a long time. However, early nasopharyngeal carcinoma patients lack specific clinical symptoms. About 80% of them have entered the middle and advanced stage when clinically diagnosed, with lymph node metastasis or distant metastasis. After development of distant metastasis, the 5-year survival rate is less than 50%.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences.

Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019. So far, more than 30 clinical studies covering more than ten indications have been carried out in China, the United States and other countries.

In April 2020, the supplemental New Drug Application ("NDA") of Toripalimab Injection for the treatment of new indications of recurrent/metastatic nasopharyngeal carcinoma after failure of second-line and above systemic treatment has been accepted by the NMPA. The supplemental NDA is the world’s first NDA of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In addition, JUPITER-02 study (NCT03581786), a Phase III clinical study of Toripalimab Injection combined with chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma has completed the enrollment. In May 2020, the supplemental NDA of Toripalimab Injection for the treatment of new indications of locally advanced or metastatic urothelial carcinoma after systemic treatment has been accepted by the NMPA.

In March 2020, Toripalimab in combination with axitinib in the treatment of mucosal melanoma was granted the orphan-drug designation by the FDA. In May 2020, Toripalimab was granted the orphan-drug designation by the FDA in the treatment of nasopharyngeal carcinoma.

On September 10, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported its financial outlook for full year 2020 (Press release, Quest Diagnostics, SEP 10, 2020, View Source [SID1234564921]).

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Since the company reported its financial performance for the second quarter of 2020 on July 23, 2020, organic testing volumes in its base business (excluding COVID-19 molecular and antibody testing and the impact of acquisitions), continued to recover faster than anticipated through the end of August. Organic base testing volumes declined high single digits in July and mid-to-high single digits in August on a percentage basis versus the prior year. COVID-19 molecular and antibody testing volumes remain consistent with the company’s previous outlook.

The company is scheduled to participate in the Wells Fargo Virtual Healthcare Conference today at 1:20 p.m. Eastern Time. The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. During the discussion, the company’s management plans to discuss its current perspective on the impact of the COVID-19 pandemic.

Management continues to believe that the COVID-19 pandemic’s impact on its future operating results, cash flows and/or financial condition will be primarily driven by a number of factors beyond the company’s knowledge and control, including: the pandemic’s severity and duration; the pandemic’s impact on the U.S. healthcare system and the U.S. economy; and the timing, scope and effectiveness of federal, state and local governmental responses to the pandemic.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, a gain on the remeasurement of an equity interest, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts; and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional table attached below includes a reconciliation of non-GAAP adjusted measures to GAAP measures.

On September 10, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the acquisition of two privately held companies that strengthen and complement its OmniAb technology platform (Press release, Ligand, SEP 10, 2020, View Source [SID1234564941]). Ligand acquired xCella Biosciences, Inc. for $7 million in cash plus potential earnouts, and acquired Taurus Biosciences LLC for $5 million in cash plus non-transferable contingent value rights (CVRs) . In addition, Ligand will invest $2.5 million in a new company, Minotaur Therapeutics, which will be led by Taurus Biosciences’ founder, in exchange for royalties on products from future programs.

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With the addition of these two companies, Ligand has secured a technology to further enhance its single B cell screening platform as well as technologies to discover and humanize antibodies from immunized cows or cow-derived libraries. The acquisitions are expected to enable Ligand to secure new license agreements with expanded economics as a result of the addition of tools and intellectual property that Ligand can now offer to partners. Ligand evaluated multiple public and private platforms to acquire in order to continue the expansion of the OmniAb platform and determined xCella and Taurus represented the best fit and opportunity.

"Bringing the capabilities and intellectual property of these two companies into Ligand will strengthen our antibody discovery capabilities, in particular our OmniChicken platform. We are committed to keeping OmniAb at the cutting edge of antibody discovery and development, as exemplified by these deals and our acquisition of Ab Initio Biotherapeutics last year," said John Higgins, Chief Executive Officer of Ligand. "During 2020 we have seen a number of major advancements by partners with OmniAb-discovered programs. We believe the next few years will further highlight the significance of the OmniAb platform to major drug programs and contribute substantially to our financial growth and performance."

Ligand’s OmniAb antibody discovery platform has been formed via five strategic acquisitions of leading antibody discovery tools and intellectual property over the past several years, creating a best-in-class platform to serve a growing portfolio of partners, with:

Potential for two approvals of OmniAb-derived antibodies in 2021 with expected new royalty streams to Ligand;
More than 80 OmniAb-derived programs in Ligand’s diverse and growing portfolio of partnerships;
Approximately 50 completed or on-going clinical trials with OmniAb-derived antibodies;
Leading OmniAb-derived programs in clinical development with Janssen/J&J (Teclistamab), Genentech (Tiragolumab), Gloria Pharmaceuticals and Arcus/Gilead (Zimberelimab), CStone Pharmaceuticals (Sugemalimab), and Immunovant (IMVT-1401).

On September 10, 2020 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported that management will present at the H.C. Wainwright 22nd Annual Virtual Global Investment Conference, on Monday, September 14, 2020, at 12:30 p.m. EDT (Press release, Galectin Therapeutics, SEP 10, 2020, View Source [SID1234564957]).

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A live webcast of the presentation may be accessed on the conference’s website at View Source or on the Company’s website www.galectintherapeutics.com. Management will also be available for one-on-one meetings with investors throughout the conference, which runs September 14 – 16, 2020.

For additional information or to schedule a one-on-one meeting with Galectin, please contact your H.C. Wainwright representative or email [email protected].

On September 10, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies that target specific pathogenic bacteria, reported that Jonathan Solomon, Chief Executive Officer, will participate in the following upcoming investor conferences (Press release, BiomX, SEP 10, 2020, View Source [SID1234564974]).

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Event: HC Wainwright 22nd Annual Global Investments Conference
Date: Monday, Sept. 14, 2020
Time: 12:30 p.m. EDT
Webcast link: View Source

Event: Cantor 2020 Virtual Global Healthcare Conference
Date: Wednesday, Sept. 16, 2020
Time: 11:20 a.m. EDT
Webcast link: View Source

Webcasts will also be available in the Events section of the BiomX website at www.biomx.com. Archived replays will be accessible following each event.