On August 28, 2018 NuCana plc (NASDAQ: NCNA) reported that its financial results for the second quarter ended June 30, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 28, 2018, View Source [SID1234529093]).

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As of June 30, 2018, NuCana had cash and cash equivalents of £81.5 million compared to £81.3 million as of March 31, 2018 and £86.7 million as of December 31, 2017. This increase in cash and cash equivalents during the second quarter of 2018 reflects the weakening of the UK pound sterling relative to the US dollar and the fact that NuCana holds a portion of its cash in US dollars. NuCana reported a loss of £1.3 million for the quarter ended June 30, 2018, compared to £2.7 million for the quarter ended June 30, 2017 as the Company continued to advance its various clinical programs. Basic and diluted loss per share was £0.04 for the quarter ended June 30, 2018, compared to £0.11 per share for the comparable quarter in 2017.

"We have made excellent progress with our development programs during the first half of 2018 and look forward to providing additional clinical updates later in the year," said Hugh Griffith, NuCana’s Founder and Chief Executive Officer. "The high response rates achieved in the first cohort of eight patients with biliary tract cancers, which were reported earlier this year at ASCO (Free ASCO Whitepaper) GI, has led us to prioritize this indication for rapid development. We are also excited about opening our combination Phase 1b study with NUC-3373 for patients with colorectal cancers and taking our third ProTide, NUC-7738, into the clinic later this year."

Mr. Griffith continued: "We are also pleased to announce that we have had three posters accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held in Munich, Germany on October 19 to 23, 2018. These posters include additional data from the ongoing Phase 1b study of Acelarin plus cisplatin in front-line advanced biliary tract cancer (the ABC-08 study), additional data from the ongoing Phase 1 study of NUC-3373 in advanced solid tumors (the NuTide:301 study) and a study status update from the ongoing Phase 3 study of Acelarin compared to gemcitabine in front-line pancreatic cancer patients (the Acelarate study)."

Anticipated Second Half 2018 Milestones

Acelarin is NuCana’s ProTide transformation of gemcitabine. Over the remainder of 2018, NuCana anticipates a number of data read-outs and milestones including:

Reporting additional Phase 1b data of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer at ESMO (Free ESMO Whitepaper) on October 21, 2018 (the ABC-08 study). This will include additional data on the eight patients reported at ASCO (Free ASCO Whitepaper)-GI in January 2018, data from the six patients in the 725mg/m2 dose cohort, and interim data from the additional six patients in an expansion cohort at the selected 625mg/m2 dose.

Initiating a Phase 3 study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.

Continuing to enroll and follow-up with patients in the Phase 2 platinum-resistant ovarian study (the PRO-105 study).

Reporting current study status of the ongoing Phase 3 study of Acelarin compared to gemcitabine as a first-line treatment of patients with metastatic pancreatic cancer at ESMO (Free ESMO Whitepaper) on October 21, 2018 (the Acelarate study).

NUC-3373 is NuCana’s second ProTide in clinical development, a transformation of 5-fluorouracil (5-FU). In 2018, NuCana expects to:

Report additional Phase 1 data in advanced solid tumors at ESMO (Free ESMO Whitepaper) on October 22, 2018 (the NuTide:301 study).

Initiate a Phase 1b study in patients with advanced colorectal cancer in combination with other approved agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan (the NuTide:302 study).

NUC-7738 is NuCana’s ProTide transformation of cordycepin, a novel nucleoside analog that has shown potent anti-cancer activity in preclinical studies across a range of different human cancer cell lines. NuCana expects to initiate a First-In-Human Phase 1 clinical study of NUC-7738 in patients with solid tumors later in 2018 (the NuTide:701 study).

On August 28, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that the Company will be presenting at the Rodman & Renshaw 20th Annual Global Investment ConferenceSeptember 4-6, 2018 at The St. Regis New York (Press release, Onconova, AUG 28, 2018, View Source [SID1234529094]). Steven M. Fruchtman, M.D., President and Chief Medical Officer of Onconova, Ramesh Kumar, CEO and Mark Guerin, CFO will attend the conference and be available to meet with investors.

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Presentation details
Date/Time: Wednesday, September 5th at 3:00p ET
Venue: The St. Regis New York, 2nd Floor: Fontainebleau Room
Presenter: Steven M. Fruchtman, M.D.

On August 28, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that two peer-reviewed papers reporting clinical studies of SD-101 have been published by Cancer Discovery, a journal publication from American Association of Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Dynavax Technologies, AUG 28, 2018, View Source [SID1234530119]). The investigators report clinical activity and broad immune activation in the tumor microenvironment when SD-101 is administered in combination with either low dose radiation in patients with indolent lymphoma or in combination with PD-1 blockade in patients with unresectable or metastatic melanoma. Top-line results from these studies have previously been presented at major oncology conferences.

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"Promising data from multiple trials studying intratumoral administration of TLR9 agonists indicate that stimulating the innate immune system through the TLR9 pathway can enhance the adaptive immune response to both injected and non-injected tumors," said Antoni Ribas, M.D., Ph.D., Director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center. "TLR9 agonists are showing potential as an important component of combination immuno-therapy for the treatment of cancer. With further research we hope to realize the full value that this approach can create for immuno-oncology."

Dr. Ribas is the lead author for the paper titled SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase 1b, Multicenter Study. This trial evaluated 22 patients who received intratumoral SD-101, a synthetic CpG-oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with a PD-1 inhibitor in patients with unresectable or metastatic malignant melanoma. The combination was well tolerated and the most common adverse events related to SD-101 were injection site reactions and transient, mild-to-moderate "flu-like" symptoms. Durable tumor responses were seen in both peripheral and visceral lesions. Among the 9 patients naïve to anti-PD-1 therapy, the overall response rate (ORR) was 78%. The estimated 12 month progression free survival (PFS) rate was 88%, and overall survival (OS) rate was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR was 15%. These clinical responses were supported by biomarker data indicating the induction of broad immune activation in the tumor microenvironment, including increased NK cells, cytotoxic cells, dendritic cells, B cells and CD8+ T cells and T cell infiltration. Increases in CD4+ and CD8+ T cells generally correlated with tumor responses. The paper can be found online here.

Ronald Levy, M.D., Robert K. and Helen K. Summy Professor in the School of Medicine at Stanford University, is the lead author of the paper titled In situ vaccination with a TLR 9 agonist and local low dose radiation induces systemic responses in untreated indolent lymphoma. It reports on a phase 1/2 multicenter study in which 29 patients received 4 Gy of radiation followed by five weekly intratumoral injections of SD-101 at a single tumor site. The paper can be found online here.

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On August 28, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of the management team will participate in three upcoming investor conferences (Press release, Syndax, AUG 28, 2018, View Source [SID1234529095]). The details for the three conferences are:

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B. Riley FBR Healthcare Conference at the New York Marriott East Side on Tuesday, September 4, 2018. Panel discussion at 11:20 a.m. ET.

Citi’s 13th Annual Biotech Conference at the Four Seasons Hotel Boston on Wednesday, September 5, 2018.

Morgan Stanley 16th Annual Global Healthcare Conference at the Grand Hyatt Hotel New York on Friday, September 14, 2018. Fireside chat at 12:15 p.m. ET.

A live webcast of the Morgan Stanley 16th Annual Global Healthcare Conference fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On August 28, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company is scheduled to present at the Citi 13th Annual Biotech Conference in Boston on Wednesday, September 5, 2018 at 8:00 a.m. ET (Press release, Agios Pharmaceuticals, AUG 28, 2018, View Source [SID1234529116]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.