On August 8, 2018 OncoPep, Inc. reported the initiation of a Phase 1b clinical trial evaluating the safety and tolerability of PVX-410, an investigational multi-peptide cancer vaccine, for patients with smoldering multiple myeloma (SMM). Smoldering multiple myeloma is an early precursor to a rare blood cancer known as multiple myeloma, which affects plasma cells (Press release, OncoPep, AUG 8, 2018, View Source [SID1234528552]). The open-label investigator-sponsored study, led by Noopur Raje, M.D. at Massachusetts General Hospital, will assess two different combinations of the study drugs; a combination of PVX-410 along with an investigational histone deacetylase (HDAC 6) inhibitor, citarinostat (CC-96241, Celgene) and a triple combination of the PVX-410 vaccine, citarinostat, and lenalidomide.

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"Currently, there are no active treatment options for smoldering multiple myeloma and standard care for patients diagnosed with SMM is ‘watchful waiting’," said Dr. Raje, Director of the Center for Multiple Myeloma at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. "This Phase 1b clinical trial will further evaluate the safety and tolerability of PVX-410 in combination with the HDAC 6 inhibitor, citarinostat, with or without the immunomodulatory drug, lenalidomide, in hopes that the combination will supplement a targeted immune-mediated attack against MM cells."

The study is expected to enroll approximately 20 patients at multiple trial sites, including Massachusetts General Hospital. More information on the trial can be found at clinicaltrials.gov, identifier number NCT02886065.

"OncoPep’s Phase 1b clinical trial of PVX-410 in SMM is an important advance for the multiple myeloma cancer community and we are pleased to again be working with Dr. Raje’s team," said Doris Peterkin, Chief Executive Officer of OncoPep. "Given the extremely limited therapeutic options available for patients diagnosed with SMM who are likely to progress to multiple myeloma, we believe PVX-410 has the opportunity to make a significant impact on this patient population."

About Smoldering Multiple Myeloma
Smoldering multiple myeloma (SMM) is a plasma cell proliferative disorder with a high risk of progression to multiple myeloma (MM). It is estimated that SMM accounts for approximately 15% of all newly diagnosed cases of MM, and the annual risk of progression from SMM to symptomatic MM requiring treatment is estimated to be 10%. The current standard of care for SMM is watchful waiting, and approaches that intend to delay or prevent progression to symptomatic MM are needed.

About PVX-410
PVX-410 is a novel investigational therapeutic cancer vaccine currently in Phase 1b clinical trials in smoldering multiple myeloma and triple negative breast cancer. PVX-410 consists of four peptides from unique regions of three tumor -associated antigens which may act to help stimulate an immune response to the targeted tumor cell. PVX-410 was granted orphan drug designation from the U.S. Food and Drug Administration in 2013 for the treatment of multiple myeloma.

On August 8, 2018 TOT BIOPHARM Company Limited ("TOT BIOPHARM"), headquartered in Suzhou Industrial Park, China, reported the completion of a Series B financing round, raising US$102 million in capital (Press release, Tot Biopharm, AUG 8, 2018, View Source [SID1234528578]). The financing round was supported by China Universal (Cayman) GP Limited and several renowned domestic and foreign investors, as well as investors who had participated in earlier rounds, including Center Laboratories Group, Vivo Capital, Chengwei Capital, Yuanta Financial Holdings Group and Cathay Capital. TOT BIOPHARM focuses on the R&D, manufacturing and marketing of high-end anti-tumor drugs. The company now has over 10 drugs in the R&D stage, including three biologics and three small molecules, which have received investigational new drug application (IND) approvals, as well as one antibody-drug conjugate (ADC), which is expected to receive approval soon. All project pipelines are meeting their milestones and all products on the roadmap are expected to reach the market according to their planned timelines.

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TOT BIOPHARM general manager Gloria Huang said, "With the completion of this round, we are very pleased to see that our achievements to date as well as what we foresee for the future have been recognized by several renowned domestic and foreign investors and continue to receive the support of our existing shareholders. The financing will allow us to accelerate development of our key pipelines. TOT BIOPHARM is taking advantage of the high-speed growth opportunities in China’s oncology market. In the future, we will also utilize the existing advantages of our established platforms to expand multi-perspective partnerships and cooperation at different levels, so that the benefits of resource integration will be maximized."

Vivo Capital, a major shareholder of TOT BIOPHARM, has partnered with the Series B investment team spanning several projects across multiple sectors. Existing shareholders and several renowned investors participated in the Series B round, fully demonstrating that investors have confidence in TOT BIOPHARM’s current achievements and future prospects. As a hi-tech company with the advantage of having built an integrated product R&D, manufacturing and marketing platform in the Chinese anti-tumor drug market, TOT BIOPHARM has been at the forefront of technological innovations and expansion into international markets for many years, and, as a result of having held steadfast to this approach, has achieved solid and steady progress. The firm has entered into strategic partnerships with several top-tier companies in the global anti-tumor sector. The completion of the Series B round will serve to accelerate the R&D of new products as well as the commercialization of existing ones, greatly improving TOT BIOPHARM’s competitive power and value."

TOT BIOPHARM recently announced results of the Phase I clinical trial (double-blind, head-to-head pharmacokinetics and safety comparisons) of Bevacizumab biosimilar, TAB008, at ASCO (Free ASCO Whitepaper) 2018, demonstrating that both in pharmacokinetics and safety indicators, TAB008 shows high similarity to Avastin. TAB008 is now in Phase III clinic trial, and, in terms of progress, TOT BIOPHARM is among the top three firms in China competing to get the drug on market. The financing will further accelerate the progress of TAB008’s Phase III study, as well as other R&D programs. The IND application for TAA013, an ADC, submitted by TOT BIOPHARM, is currently in the review process. With the higher threshold for manufacturing ADCs, the number of companies in China that can produce such drugs is quite limited. However, TOT BIOPHARM has its own manufacturing technologies and capability. The firm is in the process of ramping up production of its third-generation innovative oncolytic virus drug TVP211. Combined with its domestically leading BSL-2 certified virus manufacturing plant, TOT BIOPHARM plans to further accelerate the development program, taking a leadership position in this promising technology sector.

The construction of TOT BIOPHARM’s second-phase project – the monoclonal antibody R&D and manufacturing base was completed and put into operation in May 2018. The base, with a planned cell culture scale of up to 16,000L, was built in full compliance with international standards. Plans call for the establishment of three preparation production lines, responsible for the filling of drugs with different specifications. The facility also plans to successively launch a pre-filled preparation line, a lyophilized preparation line and a Grade OEL-5 plant for the mass production of ADC. The facility also has the flexibility to expand production capacities and adjust the layout of the production areas. Combining the existing 500L pilot plant, the facility is prepared to meet all demands for biologic drugs, from upstream R&D, pilot manufacturing, and clinical trial drugs to commercial production.

The completion of the financing is a major milestone in TOT BIOPHARM’s efforts to accelerate commercialization of product pipelines. Together with the international standards-compliant monoclonal antibody R&D and manufacturing base, TOT BIOPHARM will open its platforms for collaboration, making it the most distinctive company and the best strategic partner in the high-end oncology field.

On August 8, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines that control the expression of genes, reported that its Chief Financial Officer Joseph J. Ferra will present a corporate overview at the 2018 Wedbush PacGrow Healthcare Conference (Press release, Syros Pharmaceuticals, AUG 8, 2018, View Source [SID1234528843]). Details are as follows:

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2018 Wedbush PacGrow Healthcare Conference
Date: Wednesday, August 15
Presentation Time: 10:20 a.m. ET
Location: Parker New York 119 West 56th St., New York, NY

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the presentation.

On August 8, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2018 (Press release, Nektar Therapeutics, AUG 8, 2018, View Source [SID1234528537]).

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Cash and investments in marketable securities at June 30, 2018 were $2.1 billion as compared to $353.2 million at December 31, 2017. This includes the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our Bristol-Myers Squibb collaboration for the global development and commercialization of NKTR-214.

"Over the past few months, we have reported significant progress across all areas of our pipeline, with notable milestones for our immuno-oncology, immunology and pain programs," said Howard W. Robin, President and CEO of Nektar. "Together with Bristol-Myers Squibb, we plan to initiate 20 registrational studies in nine tumor settings under our joint development plan with the first wave of studies in melanoma, renal cell carcinoma, and urothelial cancers starting this year. We initiated our first study of NKTR-358 in patients with lupus with our partner Eli Lilly. And importantly, we recently achieved a significant milestone for our pain program, with the FDA’s acceptance of the NDA filing for NKTR-181, a first-in-class opioid analgesic."

Revenue in the second quarter of 2018 was $1.088 billion as compared to $34.6 million in the second quarter of 2017. Year-to-date revenue for 2018 was $1.126 billion as compared to $59.3 million in the first half of 2017. Revenue was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

Total operating costs and expenses in the second quarter of 2018 were $114.1 million as compared to $85.2 million in the second quarter of 2017. Total operating costs and expenses in the first half of 2018 were $238.9 million as compared to $164.4 million in the first half of 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the second quarter of 2018 was $88.3 million as compared to $60.3 million in the second quarter of 2017. For the first half of 2018, R&D expense was $187.8 million as compared to $121.3 million in the first half of 2017. R&D expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $20.3 million in the second quarter of 2018 as compared to $16.0 million in the second quarter of 2017. G&A expense in the first half of 2018 was $38.9 million as compared to $28.0 million in the first half of 2017. G&A expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net income in the second quarter of 2018 was $971.5 million or $5.33 diluted earnings per share as compared to a net loss of $59.9 million or $0.39 basic and diluted loss per share in the second quarter of 2017. Net income in the first half of 2018 was $875.7 million or $4.91 diluted earnings per share as compared to a net loss of $123.7 million or $0.80 basic and diluted loss per share in the first half of 2017.

Second Quarter 2018 and Recent Business Highlights

In July, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.
In June, Nektar presented data for NKTR-181 at the 80th Annual Scientific Meeting of the College on Problems of Drug Dependence. The data show that NKTR-181 consistently demonstrates low abuse potential.
In June, Nektar presented data from the Phase 1 dose escalation and preliminary data from the Phase 2 dose expansion phase of the ongoing PIVOT study for NKTR-214 in combination with Opdivo (nivolumab) at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. This data showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. Nektar and Bristol-Myers Squibb expect to initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.
In May, Nektar announced a clinical collaboration with Syndax Pharmaceuticals to evaluate NKTR-214 in combination with entinostat, an oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 agent.
In May, Nektar began dosing patients with systemic lupus erythematosus in a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.
The company also announced the following upcoming presentations during the second half of 2018:

American Chemical Society Annual Meeting, Boston, MA:

Oral Presentation: "Confronting the Opioid Epidemic: Novel Treatments for Chronic Pain"
Presenter: Stephen Doberstein, Ph.D., Nektar Therapeutics
Date: Monday, August, 20, 2018, 1:35 p.m. – 2:05 p.m., Eastern Daylight Time
SMI Immuno-Oncology Conference, London, UK:

Oral Presentation: "Enhanced cancer vaccine effectiveness with NKTR-214, a CD122-biased cytokine"
Presenter: Loui Marakamutil, Ph.D., Nektar Therapeutics
Date: September 26, 2018, 11:00 a.m., British Summer Time
Ninth American Conference on Pharmacometrics, San Diego, CA:

Poster: "NKTR-255 Exhibits Target Mediated Drug Disposition and Stimulates Proliferation of Cytotoxic Immune Cells in Cyonomolgous Monkeys", Bhasi, K., et al.
Date: October 6-12, 2018
ESMO 2018 Congress, Munich, Germany:

Poster 362TiP: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs treatment of physician’s choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC).", Tripathy, D., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Poster 446TiP: "REVEAL: A phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-262 [TLR 7/8 agonist] plus NKTR-214 [CD122-biased agonist] with or without nivolumab (nivo) in patients (pts) with locally advanced or metastatic solid tumor malignancies.", Diab, A., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Conference Call to Discuss Second Quarter 2018 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Wednesday, August 8, 2018.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, September 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)

Passcode: 7099844 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On August 8, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months and six months ended June 30, 2018 (Press release, Quanterix, AUG 8, 2018, View Source [SID1234528553]).

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"We are continuing to achieve strong momentum, as made evident by our performance in this second quarter, showing steady growth in terms of both product and company revenue," said Chief Executive Officer, President and Chairman, Kevin Hrusovsky. "We are at a pivotal point in our industry, where biomarkers are being recognized as increasingly representing a critical opportunity for accelerating drug approvals and helping to fuel demand for our technology for pharma services and drug development."

Second Quarter 2018 Financial Highlights
Key financial results for the second quarter are shown below:

Q2 revenue of $8.6M versus prior year Q2 of $5.2M, an increase of 66%.
Q2 product revenue was $5.2M versus prior year Q2 of $3.3M, an increase of 56%.
Q2 Service and Other revenue totaled $3.2M versus prior year Q2 of $1.6M, an increase of 97%.
YTD 2018 Financial Highlights
Key financial results for 2018 YTD are shown below:

YTD revenue of $16.2M versus prior year $10.6M, an increase of 53%.
YTD product revenue of $9.9M versus prior year $6.8M, an increase of 47%.
YTD Service and Other revenue of $5.7M versus prior year $3.3.M, an increase of 75%.
Second Quarter 2018 Business Highlights

SR-X platform momentum continues to build, with 22 assays now available
Cadence of publications continued to increase with 40 new publications featuring Simoa technology in Q2 alone, bringing total to >250
Continued commercial acceleration in Pharma Services, including significant build out of CLIA lab capabilities to handle increased sample volume
Major presence at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Conference, broadening reach into oncology and liquid tumor biopsy market
Kevin Hrusovsky invited to speak at PULSE: The Atlantic Summit on Healthcare
Attendance at 10 industry tradeshows and conferences in North America and Europe spanning multiple therapeutic areas
Created new integrated marketing and inside sales lead generation team to fuel accelerated pipeline development
Developed and began promoting a major webinar scheduled in September on "Disrupting Drug Development with Digital Biomarkers" featuring Kevin Hrusovsky, CEO and Chairman of Quanterix, Dr. Henrik Zetterberg of the University of Gothenburg, and Dr. Andy Nixon of Duke University
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on August 8, 2018, at 4:30 p.m. EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4299369.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.