On April 30, 2018 Synthorx Inc. reported the completion of a $63 million Series C financing, led by OrbiMed and joined by new investors, Medicxi and Osage University Partners, and existing investors, Avalon Ventures, RA Capital Management, and Correlation Ventures (Press release, Synthorx, APR 30, 2018, View Source [SID1234525867]). In addition, Peter Thompson, M.D., private equity partner at OrbiMed, and Vickie Capps, an independent advisor with extensive financial and audit experience, will join the Synthorx board of directors. The proceeds of the financing will be used to advance the company’s pipeline of Synthorin cytokines, including an IL-2 tuned specifically for activity on certain immune cells. Using the company’s expanded genetic alphabet technology based on a breakthrough in synthetic biology, Synthorin cytokines are designed to selectively tune receptor pharmacology and extend half-life. These properties allow for efficacious immune system activation with convenient dosing schedules and without safety limitations to enhance the antitumor activity of leading immuno-oncology approaches, including checkpoint inhibitors, cancer vaccines, CAR-T therapies, and oncolytic viruses.

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"The ability to activate tumor-fighting immune cells has been a tremendous breakthrough in curing cancer in some patients, but the rate of responses leading to long-term remission and overall survival is still limited. Combination therapies are needed that demonstrate improved efficacy but are safe and convenient for patients. IL-2 has proven activity but limited use due to safety issues," said Laura Shawver, Ph.D., president, CEO, and director of Synthorx. "Our investors immediately recognized the remarkable ability of our lead molecule, Synthorin IL-2, to deliver sustained cancer-killing activity without the safety liability through our unique ability to modify protein therapeutics for tuning receptor pharmacology and extending half-life."

"Since its discovery nearly 40 years ago, IL-2 is the most studied cytokine and potentially the most valuable molecule for boosting the efficacy of immuno-oncology therapies," said Marcos Milla, Ph.D., who was recently promoted to chief scientific officer of Synthorx. "To make the best IL-2 we have seen to date, the scientific team at Synthorx applied the company’s expanded genetic alphabet technology to create specific receptor interactions with great precision that bias IL-2’s activity to immune activation versus repression."

"We are impressed with the data for Synthorin IL-2 and how the Synthorx technology platform can specifically identify and select protein modifications that result in the desired therapeutic effect and pharmacokinetics. It is easy to see how this platform could be applied to a variety of protein therapeutics," said Dr. Thompson.

About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $14 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, royalty/credit funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, with the flexibility to provide equity and debt capital solutions that are tailored to the unique needs of our portfolio companies. The firm’s global team of over 80 professionals brings the resources and experience required to be an exceptional long-term partner in building world-class healthcare companies. For more information, please visit www.orbimed.com.

On April 30, 2018 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers, reported that the open-access journal PLOS ONE published results from an H. Lee Moffitt Cancer Center and Research Institute ("Moffitt") study investigating cancer combination therapy with intralesional ("IL") PV-10 and immune checkpoint blockade (anti-CTLA-4, anti-PD-1 and anti-PD-L1 antibodies) in murine melanoma models.1,2 The authors also examined the role of specific immune cell populations in eliciting and controlling tumor-specific response (Press release, Provectus Pharmaceuticals, APR 30, 2018, View Source [SID1234525865]).

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The Moffitt authors noted, "In this study, we have shown the impact of combining systemic checkpoint blockade (PD-1, PD-L1) with the tumor-specific immune response induced by IL PV-10. Treatment with IL PV-10 and anti-PD-1 antibody resulted in a delay in tumor growth and enhanced T cell activation in the M05 tumor model. Similar effects were observed with IL PV-10 and anti-PD-L1 antibody in the B16 tumor model. The effect of combination therapy with IL PV-10 and PD-1 blockade is mediated by CD8+ T cells, and depletion of either CD4+ T cells or CD4+CD25+ Tregs enhances anti-tumor immunity in the M05 melanoma model. Together these results support further development of clinical trials to assess safety and anti-tumor T cell responses in patients after IL injection of PV-10 in combination with checkpoint blockade."

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "We are grateful to our research collaborators, like those at Moffitt, who continue to independently establish PV-10 as an oncolytic immunotherapy in both monotherapy and combination therapy settings."

Mr. Rodrigues added, "This PLOS ONE work established the rational clinical foundation for our ongoing Phase 1b/2 study PV-10 in combination with anti-PD-1 drug KEYTRUDA for patients with Stage IV melanoma. Moffit’s work also builds on the foundation for future combinations of PV-10 and anti-PD-L1 agents as well as other potential combinations and permutations of cancer therapies that include PV-10 as a key element."

About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Stage IV Melanoma

The Phase 1b portion of the study continues to enroll patients with metastatic melanoma at clinical sites in the U.S. (NCT02557321). Stage IV patients with at least one injectable lesion who are candidates for KEYTRUDA are eligible. A total of up to 24 patients would receive the combination of IL PV-10 and KEYTRUDA every three weeks for five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability; objective response rate and progression-free survival are key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).

About PV-10

Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On April 30, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Bloom Burton & Co. Healthcare Investor Conference taking place May 2-3, 2018 in Toronto, Canada (Press release, Zymeworks, APR 30, 2018, View Source [SID1234525864]).

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The Company will present on May 2, 2018 at 10:30 a.m. ET. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

On April 30, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that it will release first quarter 2018 financial results after the market closes on Monday, May 7, 2018 (Press release, Xencor, APR 30, 2018, View Source [SID1234525863]). Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number 5056978. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 90 days.

On April 30, 2018 Triumvira Immunologics, Inc., a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack multiple types of cancers, reported that it will present an abstract at the International Society for Cellular Therapy Annual Meeting (ISCT) in Montreal, and a company overview at the Bloom Burton & Co. Healthcare Investor Conference in Toronto, both on Thursday, May 3 (Press release, Triumvira Immunologics, APR 30, 2018, View Source [SID1234525860]).

At the ISCT, Dr. Chris Helsen, Director of Platform Development, will be presenting during the "Cancer Immunotherapy" breakout plenary on May 3, 11:00am – 12:15pm ET. The abstract is titled T cells engineered with T-Cell Antigen Coupler (TAC) receptors display robust efficacy against solid and liquid tumor xenografts in the absence of any toxicity.

At the Bloom Burton & Co. conference, President and Chief Executive Officer Dr. Paul Lammers will provide an overview of Triumvira and the improvements the company is making over current therapies with its novel immuno-oncology platform T Cell-Antigen Coupler (TAC). Dr. Lammers will also be giving updates on Triumvira’s lead drug, CD19-TAC01, which is targeted to enter clinical development in Q1 2019 for the treatment of patients with CD19 positive B-cell malignancies. Dr. Lammers will be presenting May 3, at 3:00pm ET and will be available for private meetings during the day.

About the ISCT
The International Society of Cellular Therapy is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients’ lives. ISCT Members gain access to an influential global community of peers, experts, and organizations invested in cell therapy. ISCT offers a unique collaboration between academia, regulatory bodies, and industry partners in cell therapy translation.

About the Bloom Burton & Co. Conference
The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentation and private meetings.