On August 9, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a pharmaceutical company focused on the development and commercialization of its proprietary immune modulator, tilsotolimod, for the treatment of cancer, reported that the company will participate in a fireside chat, led by Vincent Milano Idera’s Chief Executive Officer at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018 at 10:20 a.m. Eastern Time at the Parker Hotel in New York City (Press release, Idera Pharmaceuticals, AUG 9, 2018, View Source [SID1234528704]).

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Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On August 9, 2018 Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that Dr. Michael Sofia, Arbutus’ Chief Scientific Officer, will present a corporate update at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 2:30 pm – 3:00 pm ET in New York (Press release, Arbutus Biopharma, AUG 9, 2018, View Source [SID1234528814]).

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A live webcast of the presentation can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. A replay of the webcast will be available for 90 days following the live presentation.

On August 9, 2018 Molecular Templates, Inc. (Nasdaq:MTEM, "Molecular" or "Molecular Templates"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the second quarter of 2018 (Press release, Molecular Templates, AUG 9, 2018, View Source [SID1234528837]). As of June 30, 2018, Molecular’s cash and cash equivalents totaled $41.6 million. Molecular’s current cash balance is expected to fund operations into 4Q2019.

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"We have been very encouraged by the clinical results generated to date with MT-3724 in heavily-pretreated diffuse large B-cell lymphoma patients and we are excited to initiate multiple Phase II studies for this program by year-end, which will start yielding clinical results in 2019," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Furthermore, we expect to advance three new ETBs into clinical trials in the next twelve months."

Company Highlights and Upcoming Milestones

Corporate

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June 2018, interim results from a Phase I and Phase Ib extension study of MT-3724 (an ETB targeting CD20) in B-cell non-Hodgkin’s lymphoma (NHL) patients were presented. These results included a preliminary objective response rate in diffuse large B-cell lymphoma (DLBCL) patients with low serum Rituxan levels at study entry (N=10) of 30%, with a disease control rate of 70%, including two stable disease patients that had tumor reductions of 47% and 49%.
Also at the ASCO (Free ASCO Whitepaper) annual meeting in June 2018 was a poster presentation of the pharmacokinetic profile of evofosfamide in patients with advanced pancreatic cancer. The data presented showed that there was a significant reduction in drug exposure observed between the Phase II ("404") study and the Phase III ("MAESTRO") trials, which used a new ethanol-based formulation of evofosfamide. Molecular plans to explore potential partnership opportunities for further development of evofosfamide.
MT-3724

Molecular expects to initiate Phase II combination studies with MT-3724 in earlier lines of DLBCL in 2H18.
Molecular also expects to provide an update on the Phase Ib extension study in 4Q18 and to start a Phase II monotherapy study at the end of 2018 which has the potential to be a pivotal study.
MT-4019

MT-4019 (an ETB candidate designed to target CD38-expressing myeloma cancer cells) has completed IND enabling studies.
Takeda and Molecular are evaluating CD38 ETBs and could potentially select a drug candidate for development by the end of 3Q18. If the two companies do not select a joint candidate for development, Molecular anticipates filing an IND application for MT-4019 in 3Q18 and initiating a Phase I clinical trial in 2H18.
Research

Molecular expects to file an IND application for an ETB targeting HER2 in 1Q19.
Molecular expects to file an IND application for an ETB targeting PD-L1 (with antigen seeding) in 3Q19.
Several other ETB candidates are in pre-clinical development, targeting both solid and hematological cancers.
Takeda Multi-Target Collaboration

In December 2017, Takeda selected two targets for further research using Molecular’s ETBs. This triggered $4.0 million in milestone payments, which were paid by Takeda in 2Q18.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2018 was $9.7 million, or $0.36 per basic and diluted share. This compares with a net loss attributable to common shareholders of $4.5 million, or $20.76 per basic and diluted share, for the same period in 2017.

Revenues for the second quarter of 2018 were $1.4 million, compared to $42,000 for the same period in 2017. Revenues for the second quarter of 2018 were comprised of grant revenue from the Cancer Prevention & Research Institute of Texas, and revenues from collaborative research and development agreements. Total research and development expenses for the second quarter of 2018 were $7.7 million, compared with $1.2 million for the same period in 2017. Total general and administrative expenses for the second quarter of 2018 were $3.7 million, compared with $2.4 million for the same period in 2017.

The net loss attributable to common shareholders for the six months ended June 30, 2018 was $18.4 million, or $0.68 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.1 million, or $28.32 per basic and diluted share, for the same period in 2017.

Revenues for the six months ended June 30, 2018 were $1.8 million, compared to $1.9 million for the same period in 2017. Revenues for the six months ended June 30, 2018 were comprised of grant revenue from the Cancer Prevention & Research Institute of Texas, and revenues from collaborative research and development agreements. Total research and development expenses for the six months ended June 30, 2018 were $14.4 million, compared with $2.3 million for the same period in 2017. Total general and administrative expenses for the six months ended June 30, 2018 were $6.6 million, compared with $4.2 million for the same period in 2017.

On August 9, 2018 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, Aviragen Therapeutics, AUG 9, 2018, View Source [SID1234528574]).

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"We are encouraged by the recent publications in Vaccine and the Journal of Clinical Investigation Insight recognizing the unique ability of our oral recombinant vaccines to elicit both systemic and mucosal immune responses, further validating the value of our proprietary platform," said Wouter Latour, M.D., chief executive officer of Vaxart. "Our team is fully focused on advancing our vaccine programs, and we are on track to initiate our Phase 1 norovirus bivalent study and Phase 2 norovirus challenge study later this year."

Second Quarter 2018 and Recent Highlights:

Corporate:

· On May 31, 2018, the Company presented additional data on the previously disclosed Phase 1 norovirus vaccine trial in a poster presentation at the American Society of Microbiology 2018. As described in the poster, the Vaxart GI.1 norovirus tablet vaccine generated IgG and IgA antibodies in serum that were highly cross-reactive against other GI genotypes, specifically GI.3 and GI.4.

· On June 4, 2018, Vaxart reported the topline results from a Phase 2 clinical trial evaluating teslexivir, a small-molecule antiviral for the treatment of condyloma that Vaxart obtained in the acquisition of Aviragen earlier in 2018, in which the primary efficacy endpoint was not achieved.

· On June 27, 2018, the Company announced the publication of preclinical results from its oral F-protein based Respiratory Syncytial Virus (RSV-F) vaccine in Vaccine. As described in the article, the oral RSV-F vaccine candidate provided complete sterilizing protection against RSV infection in the cotton rat challenge model at the target dose.

· On July 12, 2018, Vaxart announced the publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation Insight. As reported in the article, the vaccine generated robust systemic and mucosal immune responses, including mucosal IgA, memory B cells, and serum blocking antibody titers (BT50), all potential correlates of protection.

Second Quarter 2018 Financial Results

· Vaxart ended the quarter with cash and cash equivalents of $23.9 million compared to $17.5 million at March 31, 2018. The increase was primarily due to $12.0 million received from royalty payments offset by cash used in operations.

· Revenue for the quarter was $0.6 million compared to $1.9 million in the second quarter of 2017. The decrease was due to lower revenues from the contract with HHS BARDA, where activities are winding down.

· Research and development expenses were $5.0 million for the quarter compared to $4.3 million for the second quarter of 2017. The increase was due to additional personnel, amortization of intangibles and clinical trial costs resulting from the merger with Aviragen, offset by lower expenditures on the HHS BARDA activities and Vaxart’s norovirus Phase 1 clinical trial.

· General and administrative expenses were $1.8 million for the quarter compared to $0.7 million for the second quarter of 2017. The increase was due to the additional costs of being a public company, including the costs of additional personnel and higher legal and other services.

· During the quarter, Vaxart recognized an impairment charge of $1.6 million resulting from the write-off of the teslexivir intangible asset acquired in the merger with Aviragen.

On August 9, 2018 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 first patient was dosed in a Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy, as a potential first-line treatment in China for patients with Stage IIIB or IV squamous non-small cell lung cancer (NSCLC) (Press release, BeiGene, AUG 9, 2018, View Source;p=irol-newsArticle&ID=2363006 [SID1234528591]).

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Tislelizumab is also being studied in global Phase 3 trials in solid tumors, including second-line NSCLC, first-line hepatocellular carcinoma, and second-line esophageal squamous cell carcinoma; two global Phase 2 trials in previously treated advanced hepatocellular carcinoma and relapsed/refractory mature T- and natural killer-cell lymphomas; a Phase 3 trial in China in non-squamous NSCLC; and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin’s lymphoma and second-line urothelial cancer.

"With the start of this important Phase 3 trial in China for patients with squamous NSCLC, our broad development program for tislelizumab, an advanced immuno-oncology therapy, continues to make great progress in China and globally. More than 1,500 patients have been enrolled in clinical trials with tislelizumab over the past three years, and we are excited to evaluate its potential when combined with both paclitaxel and carboplatin, the worldwide standard of care, or nab-paclitaxel (ABRAXANE) and carboplatin, a newer regimen which has not yet gained approval in China but is approved in other geographies," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology at BeiGene.

"Despite some recent developments, available data indicate that outcomes in patients with squamous NSCLC may be worse than those in patients with other forms of lung cancer. As shown by most recent data with other checkpoint inhibitors, combining immunotherapy and chemotherapy consisting of platinum and paclitaxel or nab-paclitaxel improves anti-tumor activity and significantly improves outcomes for patients with advanced squamous NSCLC. This Phase 3 study, in addition to our Phase 3 first line trial in China for patients with non-squamous NSCLC, will assess the impact of tislelizumab given in combination with chemotherapy, as a potential way to improve outcomes in Chinese patients with advanced lung cancer, for whom prognoses are typically quite poor," commented Lai Wang, Ph.D., Head of China Development at BeiGene.

The Phase 3, open-label, multi-center trial is expected to enroll approximately 340 chemotherapy naïve patients with Stage IIIB or IV squamous NSCLC in mainland China who will be randomized to receive i) carboplatin and paclitaxel, ii) carboplatin, paclitaxel and tislelizumab, or iii) carboplatin, nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in China) and tislelizumab. The trial is designed to compare progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) per RECIST v1.1. Key secondary endpoints include overall survival, overall response rate, duration of response, PFS by investigator assessment, and safety and tolerability.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Non-Small Cell Lung Cancer

In China, there were an estimated 733,300 new cases of lung cancer in 2015.[1] Lung cancer is the leading cause of cancer-related death in both men and women, with an estimated 610,200 deaths in China in 2015.[1] According to the American Cancer Society, about 80 to 85 percent of lung cancers are non-small cell lung cancer (NSCLC) and there are three main subtypes: adenocarcinoma, squamous cell (epidermoid) carcinoma and large cell (undifferentiated). For patients with advanced NSCLC, five-year survival rates are approximately 26 percent for Stage IIIB, 10 percent for Stage IVA, and 1 percent for Stage IVB.[2]

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab 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. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).