On July 8, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Monday, July 29, 2019 (Press release, Neurocrine Biosciences, JUL 8, 2019, View Source [SID1234537411]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 866-342-8591 (US) or 203-518-9713 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On July 8, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that its second quarter 2019 financial results will be released after market close on Thursday, August 1, 2019. Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update (Press release, Coherus Biosciences, JUL 8, 2019, View Source/news-releases/news-release-details/coherus-biosciences-report-second-quarter-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-second-quarter-financial-results" rel="nofollow">View Source [SID1234537395]).

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After releasing second quarter 2019 financial results, the company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On July 8, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that clinical responses were observed in 3 out of 9 patients in part 1 of the ONCOS-102 and Keytruda combination trial in anti-PD1 checkpoint inhibitor (CPI) refractory advanced melanoma, corresponding to an overall response rate (ORR) of 33% (Press release, Targovax, JUL 8, 2019, View Source [SID1234537412]).

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In this trial, ONCOS-102 immune activation is being tested in patients with advanced, unresectable melanoma who have had disease progression on treatment with anti-PD1 CPI. This is a particularly challenging patient population, with few treatment alternatives available. The nine patients in part 1 of the trial were given three intra-tumoral ONCOS-102 injections during the first week, followed by re-challenge with the anti-PD1 CPI Keytruda. The primary and secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1 resistant patients to respond to re-challenge with an anti-PD1 CPI.

Part 1 safety data shows that the sequential ONCOS-102 and Keytruda treatment regimen is well tolerated. The efficacy is also very encouraging, with three of nine patients demonstrating a clinical response (33% ORR); one patient had a complete response (CR) and two patients had partial responses (PR) according to RECIST1.1 and irRECIST assessment criteria. Although the patient number is small, these results compare favorably to reports from other explorative immunotherapy trials in this hard-to-treat population. Importantly, the data also confirms the hypothesis that ONCOS-102 is able to immune activate treatment resistant tumors to respond to re-challenge with an anti-PD-1 CPI.

ONCOS-102 was also seen to induce profound innate and adaptive immune activation. By week three, prior to starting Keytruda treatment, systemic increases in pro-inflammatory cytokines were observed in all nine patients (IL-6, TNFα and/or IFNγ), demonstrating potent systemic immune activation in response to the intra-tumoral ONCOS-102 injections. At the tumor level, increased infiltration of CD8+ T-cells were found in eight out of nine patients and the relative level of activated CD8+ T-cells (GrzB+) increased in all nine patients. Examples of increased T-cell infiltration into lesions not injected with ONCOS-102 were also observed. In addition, T-cells recognizing specific tumor antigens were found in circulation in four patients (MAGE-A1 and/or NY-ESO-1). These data suggest that the initial innate immune activation is translated into systemic anti-tumor immune responses.

Part 2 of the trial is currently enrolling patients, where safety and efficacy of a more intensive treatment regimen of twelve ONCOS-102 injections will be evaluated. The trial is running at Memorial Sloan Kettering Cancer Centre in New York, Fox Chase Cancer Centre, Philadelphia, and the University of Maryland, Baltimore.

Dr. Alexander Shoushtari, Principal Investigator, Memorial Sloan Kettering Cancer Centre, New York said: "It is encouraging to see clinical responses in this hard-to-treat population of advanced melanoma. Earlier this year, we decided to expand the trial to test a more intensified schedule of ONCOS-102, and it will be interesting to see whether this regimen can generate more and deeper clinical responses."

Dr. Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to confirm our hypothesis that ONCOS-102 has the potential to immune activate checkpoint inhibitor resistant patients to respond to PD-1 blockade with Keytruda. It is promising to see this level of clinical responses after only three ONCOS-102 injections, including a complete response, which is rare in this heavily pre-treated patient population. Based on our experience so far, we speculate that patients will benefit from receiving more ONCOS-102 injections over a longer period of time and we will follow with interest the effect of the intensified dosing regimen in the second patient cohort of the trial."

CONTACT:

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47-922-61-624
Email: [email protected]

Media and IR enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47-9300-1773
Email: [email protected]

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On July 8, 2019 IGM Biosciences, Inc. (IGM), a privately held biotechnology company and a global leader in the research and development of engineered IgM antibodies for therapeutic use, reported the closing of its $102 million Series C financing. New investors included Redmile Group, Janus Henderson Investors, Vivo Capital and another large U.S.-based, healthcare-focused fund. Haldor Topsøe Holding A/S, which has funded IGM since 2010, also participated in the round (Press release, IGM Biosciences, JUL 8, 2019, View Source [SID1234538902]).

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"We are very pleased to have the support of these sophisticated healthcare-focused investors," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We look forward to working with them to realize the potential of our IgM platform to deliver new therapeutic treatments to patients with cancer."

Proceeds from this financing will be used to advance the Company’s IgM platform technology and its proprietary oncology pipeline, including its lead program, a CD20 x CD3 bispecific antibody, which is expected to enter the clinic later this year.

On July 7, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC) (Press release, BeiGene, JUL 7, 2019, View Source [SID1234537401]).

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"This is our second priority review granted by the NMPA for tislelizumab, and our first for a solid tumor indication and first in China for a PD-1/PDL1 antibody for bladder cancer," said Wendy Yan, Senior Vice President, Global Head of Regulatory Affairs, at BeiGene. "Along with the two priority reviews granted for zanubrutinib in China, our regulatory team is working closely with the NMPA as it reviews our applications to treat patients with solid tumors and hematologic cancers. With full global rights to tislelizumab, 13 ongoing pivotal or potentially registration-enabling trials, maturing international clinical and non-clinical data, and advanced manufacturing capabilities, we are excited by the prospects for tislelizumab to help patients in-need around the world."

The sNDA for tislelizumab as a potential treatment for patients with previously treated locally-advanced or metastatic UC was accepted by the NMPA in May 2019. It is supported by a clinical, non-clinical, and Chemistry, Manufacturing and Controls (CMC) data package, including the results from a pivotal Phase 2 study of tislelizumab in 113 Chinese and South Korean patients with previously treated PD-L1+ locally-advanced or metastatic UC (chinadrugtrials.org registration number: CTR20170071). BeiGene is developing tislelizumab as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid and hematologic cancers. An NDA for tislelizumab as a potential treatment for patients with relapsed / refractory (R/R) classic Hodgkin’s lymphoma (cHL) was accepted by the NMPA in August 2018 and granted priority review status in November 2018.

Priority review and approval was established in China to facilitate drug registration management and accelerate the development of new drugs with clinical value. According to the guidance of Opinions on the Reform of the Review and Approval System for Drugs and Medical Devices issued by the State Council in August 2015, and Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval issued by CFDA in December 2017. the regulatory authority will prioritize the review process and evaluation resources for applications under priority review. These applications are expected to have reduced review and approval timelines.

About Urothelial Carcinoma

Urothelial carcinoma (UC), also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer.i In 2018, there was an estimated 82,270 incidences of bladder cancer in China, accounting for 15.0 percent of all incidences worldwide.ii Although UC is most common in the bladder, it can occur in other parts of the urinary system.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; a Phase 2 clinical trial in second- or third-line patients with HCC; and a Phase 1 clinical trial in patients with R/R NK/T-cell lymphomas. The aforementioned trials are enrolling patients in multiple countries, including the United States, Europe, and China.

In addition to a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL) and a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with first-line nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a Phase 3 clinical trial in patients with localized ESCC; and a Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies have been enrolling patients primarily in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted and granted priority review by the China National Medical Products Administration (NMPA, formerly known as CFDA). BeiGene has full development and commercial rights to tislelizumab worldwide.