On August 3, 2018 IMPACT Therapeutics, Inc. (IMPACT), a China-based clinical-stage biopharmaceutical company dedicated to the discovery and development of "best-in-class" medicine for the treatment of cancer and other life-threatening diseases, reported the completion of $30 million in series C financing (Press release, Impact Therapeutics, AUG 3, 2018, View Source [SID1234528890]). The series C round was led by Decheng Capital (Decheng), with participation from existing investor Lilly Asian Ventures (LAV). Proceeds from the series will be used for the clinical development of IMP4297, a potential best-in-class PARP inhibitor, and to advance IMPACT’s integrated programs targeting DNA Damage Response (DDR).

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PARP inhibitors are targeted therapies for cancer patients with defects in DNA repair mechanisms, such as with BRCA1 and BRCA2 mutations. Three PARP inhibitors, which have been shown to be tolerable and effective in clinical studies, have already been approved for marketing outside of China. IMP4297 has demonstrated an excellent safety profile and good preliminary efficacy in phase I clinical trials in Australia and China, which is consistent with the high potency and large therapeutic window found in pre-clinical studies.

"We are grateful for the faith our new and existing investors have shown in us, and for sharing our vision of developing the best potential treatments for cancer patients with DNA repair defects," commented Dr. Ye Edward Tian, CEO of IMPACT. "Decheng and LAV are renowned global VC firms in the biomedical industry. With the capital and resources provided by Decheng and LAV, we will be able to advance the clinical development of IMP4297 and enrich our pipeline."

"IMPACT is committed to the discovery and development of best-in-class therapeutics to treat cancer and other life-threatening diseases. Our data indicates that IMP4297 could be more efficacious and/or less toxic than other PARP inhibitors currently in the market, making it a potential best-in-class drug," added Dr. Sui Xiong Cai, SVP and CTO of IMPACT. "With this series C financing, we are well-positioned to achieve key data milestones as we accelerate the clinical development of IMP4297, in the hope of bringing it to market and patients soon."

"IMP4297 has shown potential to be a best-in-class drug in both pre-clinical studies and clinical trials. IMPACT is an excellent Chinese company with products that can compete globally," said Dr. Xiangmin Cui, Founder and Managing Director of Decheng. "We are very happy to collaborate with the IMPACT team and to support IMPACT’s growth."

"IMPACT is advancing its IMP4297 program steadily," said Dr. Fei Chen, Managing Partner of LAV. "We have seen excellent results from the clinical trials of IMP4297. As an existing investor from the previous two rounds of financing, LAV will continue to support IMPACT with capital and resources."

About Decheng Capital

Founded in 2012, Decheng is a leading VC firm investing in the biomedical and healthcare sectors. With more than $1 billion in capital under management, Decheng provides financial and strategic support to entrepreneurs, innovators and startup companies to take advantage of opportunities in China’s fast-growing healthcare, biomedical and pharmaceutical industries. Well placed to capitalize on revolutionary breakthroughs in life-science innovation worldwide, Decheng has offices in Shanghai and Silicon Valley.

About Lilly Asia Ventures

Founded in 2008 and headquartered in Shanghai, LAV is a leading VC firm investing in the biomedical, pharmaceutical and medical devices/diagnostics industries. LAV provides early-to-growth-stage companies with capital, professional expertise and valuable resources. LAV has offices in northern California, Shanghai and Hong Kong.

On August 2, 2018 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC) (Press release, Medivir, AUG 2, 2018, View Source [SID1234528308]). This clinical study will be conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir will be providing remetinostat drug supply for this study, and will have full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on the overall response rate in a cohort of BCC patients and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL. Further details of the study can be found at www.clinicaltrials.gov with the reference NCT03180528.

"This study highlights the potential of remetinostat to be used in conditions beyond early-stage cutaneous T-cell lymphoma," said Christine Lind, CEO of Medivir. She continues, "We look forward to the completion of the study and communication of the clinical outcomes."

For further information, please contact:
Christine Lind, CEO, Medivir AB, phone: +46 (0)8 5468 3100
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors.

On August 2, 2018 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that it will release second quarter 2018 financial results on Wednesday, August 8, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EDT on the same day to review the second quarter 2018 financial results and to provide an update on key research and development and business objectives for the remainder of 2018.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4768019.

A replay of the call will be available approximately two hours after the live call concludes through August 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4768019. The webcast will also be archived on the Company’s website.

On August 2, 2018 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that William G. Rice, Chairman, Ph.D., President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the Canaccord Genuity 38th Annual Growth Conference being held from Wednesday, August 8th to Thursday, August 9th, 2018, at the Intercontinental Hotel, Boston, MA (Press release, Aptose Biosciences, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361651 [SID1234528373]).

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Dr. Rice will provide a corporate overview of the Company’s recent activities and strategic direction.

Time: 12:30 p.m. ET
Date: Thursday, August 9, 2018
Location: Intercontinental Hotel, Boston, MA
A live webcast of the Aptose presentation will be accessible by visiting:

View Source

The webcast will be archived shortly after the live event and will be available for 90 days through the Aptose website at www.aptose.com

On August 2, 2018 Evelo Biosciences, Inc. (Nasdaq:EVLO) (Evelo), a clinical stage biotechnology company developing monoclonal microbials designed to act on the gut-body network for the treatment of a wide range of diseases, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Evelo Biosciences, AUG 2, 2018, View Source [SID1234528391]).

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"Our recent accomplishments represent important progress across our business, as we entered the clinic with our first monoclonal microbial, EDP1066, and continued to advance our broad portfolio of preclinical product candidates in a range of inflammatory and oncology indications," said Simba Gill, Ph.D., President and Chief Executive Officer of Evelo. "Looking to the second half of 2018, we are focused on advancing EDP1815 and EDP1503 into their first clinical trials in inflammatory disease and oncology, respectively, as we seek to advance our diversified portfolio of monoclonal microbials toward ten potential clinical readouts between 2019 and 2020 across different diseases and underlying biologies. We are also committed to further understanding of the gut-body network more broadly, as highlighted by our recently-signed research collaboration with world-leaders at Harvard University, which will enable us to further explore the gut’s role in modulating immune activity throughout the body."

Second Quarter and Recent Business Highlights:

Pipeline:

In May 2018, the U.S. Food and Drug Administration accepted an Investigational New Drug application to begin a 70-patient open-label Phase 2 clinical trial of EDP1503, a monoclonal microbial for the treatment of cancer. The University of Chicago will conduct this investigator-sponsored open-label clinical trial, which is designed to evaluate the safety, tolerability, and efficacy of EDP1503 in combination with a checkpoint inhibitor in patients with metastatic melanoma.
In April 2018, Evelo dosed the first subject in its 96-subject Phase 1 clinical trial of EDP1066, a monoclonal microbial for the treatment of inflammatory diseases. This clinical trial is designed to evaluate the safety and tolerability of a range of daily doses of EDP1066 in healthy volunteers and in patients with psoriasis and atopic dermatitis. Additional exploratory endpoints include the effect of EDP1066 on validated clinical measures of disease and on an integrated set of biomarkers.
Harvard University Research Collaboration:

In June 2018, Evelo entered into a research collaboration with scientists at Harvard University to study the gut-body network. Evelo will work with three of the world’s leading experts in immunology and microbiology at Harvard Medical School: Diane Mathis, Ph.D., the Morton Grove-Rasmussen Professor of Microbiology and Immunobiology, Christophe Benoist, M.D., Ph.D., the Morton Grove-Rasmussen Professor of Immunohematology, and Dennis Kasper, M.D., the William Ellery Channing Professor of Medicine and Professor of Microbiology and Immunobiology. The collaboration aims to further elucidate the mechanisms by which microbes acting on cells in the gut have the potential to treat disease elsewhere in the body. Under the multi-year agreement, Evelo has an exclusive option to license from Harvard intellectual property rights that may arise from this research collaboration.
Corporate:

In June 2018, Evelo was added to the Russell 3000, Russell 2000 and Russell Microcap Indexes as part of the Russell Investments’ annual reconstitution.
In May 2018, Evelo completed its initial public offering of common stock at $16.00 per share, raising $75.8 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
Upcoming Anticipated Milestones:

Initiation of the University of Chicago’s investigator-sponsored, open-label Phase 2 clinical trial of EDP1503 in combination with a PD-1 inhibitor in patients with metastatic melanoma expected in the second half of 2018.
Initiation of a Phase 1 clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in patients with psoriasis and atopic dermatitis in the fourth quarter of 2018.
Initiation of a Phase 2 clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019.
Initial clinical data from ongoing Phase 1 clinical trial of EDP1066 in patients with psoriasis and atopic dermatitis in the first half of 2019.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash and cash equivalents were $178.9 million, as compared to cash and cash equivalents of $38.2 million as of December 31, 2017. This increase was due to net proceeds of $81.3 million from the issuance of Series C Preferred Stock, net proceeds of $75.8 million from Evelo’s initial public offering and $5.0 million of additional drawings from Evelo’s existing debt facility, partially offset by cash used to fund operating activities for the first half of 2018. Evelo expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.
Research and Development Expenses: R&D expenses were $10.2 million for the three months ended June 30, 2018, compared to $4.7 million for the three months ended June 30, 2017. The increase of $5.5 million was due primarily to increases in costs related to Evelo’s inflammation and gut-body network platform expenses as well as increased personnel costs.
General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended June 30, 2018, compared to $1.5 million for the three months ended June 30, 2017. The increase of $3.6 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing organization and public company infrastructure.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $16.7 million for the three months ended June 30, 2018, or $0.85 per basic and diluted share, as compared to a net loss attributable to common stockholders of $7.8 million for the three months ended June 30, 2017, or $2.09 per basic and diluted share.