On January 8, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the first patient has been dosed in the Phase III GEMSTONE-304 study of the Company’s anti-PD-L1 antibody CS1001 in combination therapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC) (Press release, CStone Pharmaceauticals, JAN 8, 2020, View Source [SID1234552811]). The GEMSTONE-304 trial is a multicenter clinical study designed to evaluate the efficacy and safety of CS1001 in combination with 5-fluorouracil plus cisplatin (FP) doublet chemotherapy in the first-line treatment of unresectable locally advanced, relapsed, or metastatic ESCC.

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According to the GLOBOCAN data released in 2018, there are approximately 307,000 new incidences of esophageal cancer and 283,000 cases of esophageal cancer-related deaths in China annually. The incidence and mortality rates of esophageal cancer are ranked 5th and 4th respectively among all tumor types nationwide. Epidemiological data indicate that 90% of all esophageal cancer cases in China are ESCC, and around 70% of ESCC cases were locally advanced or metastatic at the time of diagnosis. The platinum-based doublet chemotherapy is the current standard of care first-line treatment for patients with advanced ESCC, but it has limited efficacy. Existing data on this first-line treatment for advanced ESCC suggest an objective response rate (ORR) of 35%, a median progression-free survival (PFS) of less than six months, and a median overall survival (OS) of less than one year. There are no alternative treatments for ESCC patients who have failed the first-line treatment.

CS1001 is an investigational anti-PD-L1 antibody developed by CStone. Results released at the 2019 Chinese Society of Clinical Oncology (CSCO) Annual Meeting have shown that, as of July 1, 2019, the Phase Ib trial of CS1001 in combination with the FP chemotherapy regimen in first-line treatment of ESCC achieved an ORR of 77.8% with durable response as well as good overall safety and tolerability.

"Esophageal cancer is one of the tumor types that are particularly prevalent in China, with over 50% of the world’s new esophageal cancer cases and related deaths occurring in the country. Furthermore, the lack of more effective treatments for this patient population has long represented an urgent unmet clinical need," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that we have dosed the first patient in the GEMSTONE-304 trial. I hope CS1001 will continue to demonstrate its clinical promise in its development programs, and soon be proven as a new treatment option for ESCC patients in China."

"Early symptoms of esophageal cancer are relatively silent; as a result, esophageal cancer patients are commonly diagnosed at advanced stages for which there are very limited treatment options. Furthermore, no immunotherapy has been approved for the first-line treatment of ESCC. Recent results from the Phase Ib trial of CS1001 have already demonstrated promising preliminary antitumor efficacy in advanced ESCC. We will continue accelerate this Phase III trial with our best effort. Should this clinical program lead to successful outcomes, it will be a major breakthrough for advanced ESCC patients who are in urgent need of effective therapies," noted Dr. Jason Yang, Chief Medical Officer of CStone.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase 1 dose-escalation study in China, in which the drug showed good tolerability. During Phase 1a and 1b stages of the study, CS1001 produced sustained clinical benefits in multiple tumor types.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase 1 bridging study in the U.S. In China, its clinical program includes one multi-arm Phase 1b study, two pivotal Phase 2 studies, and four Phase 3 studies for several tumor types.

On January 8, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary intratumoral immunotherapy products to kill tumors and increase immune system recognition of solid cancers, reported that Lewis H. Bender, President and CEO, will be a featured panelist on the "Developments in The Oncology Landscape" panel at East/West CEO (Press release, Intensity Therapeutics, JAN 8, 2020, View Source [SID1234552851]). The conference will take place January 11-12, 2020, the weekend before the 38th Annual J.P. Morgan Healthcare Conference, at the Four Seasons Hotel in San Francisco.
The panel, which will examine the next wave of innovations and developments in oncology, will be held on Sunday, January 12, 2020 from 1:45 p.m. to 2:15 p.m. PST.

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On January 8, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a strategic collaboration with Mayo Clinic to enhance the development of clinical diagnostic solutions for oncology (Press release, Personal Genome Diagnostics, JAN 8, 2020, View Source [SID1234552868]). Together, PGDx and Mayo Clinic will focus on technology optimization and clinical utility studies for liquid biopsy and tissue-based genomic applications.

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The two organizations have a shared vision for advancing the capabilities of oncology diagnostics and treatment. This collaboration will combine world-class clinical knowledge and expertise in oncology from Mayo Clinic with leadership in genomic technologies from PGDx to accelerate solutions that deliver on the promise of precision medicine.

"We are proud to enter into this strategic collaboration with Mayo Clinic. Their deep knowledge of establishing standards of care in oncology, the complexity and volume of cancer cases they see, and their expertise in the implementation of testing in a real-world setting are second to none," says Doug Ward, CEO, PGDx. "As we continue our quest to empower the fight against cancer, collaborating with Mayo Clinic will allow us to better assess the impact that our elio liquid biopsy and tissue applications will have on improving clinical insights, and will advance innovations in next-generation sequencing technology."

The shared vision and overall goal for PGDx and Mayo Clinic is to improve patient care by advancing the capabilities of oncology diagnostics testing. With a focus on targetable genomic alterations, this collaboration will take advantage of the clinical and technology expertise of both organizations.

On January 8, 2020 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, is reported to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco on Monday, January 13, 2020 (Press release, Edwards Lifesciences, JAN 8, 2020, View Source [SID1234552886]).

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Michael A. Mussallem, chairman and chief executive officer, is scheduled to speak to conference attendees at 11:00 a.m. PT. A live webcast of the presentation will be available to all interested parties on the Edwards Lifesciences investor relations website at View Source An archived version of the webcast will be available later that day on the Edwards investor relations website.

On January 8, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported the closing of its previously announced acquisition of privately-held, FameWave Ltd (Press release, Kitov Pharmaceuticals , JAN 8, 2020, View Source [SID1234552926]). The acquisition adds CM-24, a first-in-class inhibitor with a unique and differentiated mechanism of action of a multi-role immune checkpoint inhibition, to Kitov’s oncology pipeline. CM-24 has demonstrated a favorable safety and tolerability profile and an initial signal of monotherapy efficacy in a phase 1 clinical study. As previously announced, Kitov, in collaboration with Bristol-Myers Squibb Company, intends to initiate a phase 1b/2a clinical trial of CM-24 in combination with Bristol-Myers Squibb’s nivolumab (Opdivo) in patients with non-small cell lung cancer in the second half of 2020.

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Kitov has acquired 100% of FameWave from its shareholders in exchange for $10 million worth of Kitov’s newly issued ADSs with a long-term lock-up period, priced at $1.23 per ADS, plus 50% warrant coverage based on an exercise price of $1.98 per ADS with a 4-year term. Under the terms of the agreement, OrbiMed, Pontifax and Arkin Holdings, leading life-science focused investment funds, are exchanging their shares in FameWave for Kitov ADSs and warrants, and investing $3.5 million in Kitov in exchange for additional newly issued ADSs of Kitov. OrbiMed, Pontifax and Arkin Holdings will now each hold approximately 11% of Kitov’s shares on a non-diluted basis.

"The closing of the FameWave acquisition and the addition of CM-24 to our emerging oncology pipeline is a significant milestone for our company and seamlessly aligns with our strategic focus on the development of differentiated oncology product candidates," said Isaac Israel CEO of Kitov Pharma.

"CM-24 demonstrated encouraging signs of monotherapy anti-tumor activity in a successfully completed phase 1 trial, in addition to preclinical data that showed CM-24’s synergistic benefit with anti-PD(L)1s. This product candidate is an exciting addition to our pipeline, and we will concurrently continue to focus on advancing NT-219, our novel dual inhibitor of IRS 1/2 and STAT3, into a phase 1/2 trial for the treatment of recurrent or metastatic head and neck cancer, which we expect to commence in 2020. In addition to acquiring this promising asset, this transaction also further strengthens our leadership team and product development capabilities, as we welcome Dr. Michael Schickler, FameWave’s CEO and pharmaceutical industry veteran, to Kitov."

Dr. Schickler will join Kitov Pharma as the Head of Clinical Operations and will lead the clinical development of CM-24 and NT-219. "The initial clinical development work with the CM-24 program has suggested the antibody’s potential in overcoming the immune system exhaustion that mitigates the effectiveness and therapeutic duration of approved checkpoint inhibitors, and I am thrilled with Kitov’s commitment to advancing its development," said Dr. Schickler. "With manufacturing of the antibody well underway and having collaborated with Bristol-Myers Squibb on the phase 1/2 protocol, I look forward to the anticipated initiation of this study in the second half 2020."

This communication does not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities of Kitov will be issued to the selling shareholders in FameWave, and to the investors in the cash investment transaction, on a private placement basis pursuant to applicable exemptions from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). The securities offered have not been registered under the U.S. Securities Act or any U.S. state or Israeli securities laws, and may not be offered or sold in the United States or in Israel, or to, or for the account or benefit of, United States persons or persons in Israel absent registration or any applicable exemption from the registration and/or prospectus requirements of the U.S. Securities Act and applicable U.S. state and/or Israeli securities laws.

About CM-24
CM-24 is a clinical-stage monoclonal antibody blocking CEACAM1, a well-validated target which is highly expressed in many solid tumors as well as on immune cells and plays a pivotal role in the immune system by blocking immune cells’ access to tumors by CEACAM1-CEACAM1 and CEACAM1-CEACAM5 interaction. CEACAM1 was also shown to regulate TIM3 which induce immune fatigue. This unique mechanism of action positions CM-24 with a differentiated inhibitor of a multi-role immune checkpoint. In a monotherapy phase 1 study, CM-24 demonstrated safety and efficacy with standard dose in about 30% of patients.