Dilon Technologies® Inc. acquires the DuneMedical’s MarginProbe®

On April 3, 2020 Dilon Technologies Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes reported that it has acquired substantially all the assets of Dune Medical, including Marginprobe’s "MarginProbe" (Press release, Dune Medical Devices, APR 3, 2020, View Source [SID1234560783]).

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"With the acquisition of the MarginProbe, Dilon will now offer the only FDA approved device for identifying positive margins during breast conservation surgery. MarginProbe’s patented RF technology differentiates cancerous versus healthy tissue in real-time. This allows surgeons to immediately remove additional tissue, helping to reduce avoidable surgeries" said Dilon’s Chairman, Bob Moussa, who continued, "The synergy between Dilon’s Navigator Gamma Probes and the MarginProbe will help patients and physicians answer the question, "did we get it all?" when that answer is most needed. In addition to the advantages to the patients, the reduction in re-excision rate will provide major savings to health care systems."

As a global provider of breast cancer solutions, Dilon’s Navigator Gamma Probes are used for radio-guided lymphatic mapping and tumor localization world-wide. "The combination of Dilon’s class leading Navigator Gamma Probes with the MarginProbe is a natural fit. Dilon’s already strong sales network is synergistic and well suited to expand the MarginProbe’s potential as the products are literally used side by side by the same physician; now they will be sold that way as well. The market in the United States alone exceeds $150m annually, and as a US based company, Dilon has a home field advantage in the MarginProbe’s biggest market. Luminaries and thought leaders have already adopted MarginProbe as their standard of care in the US. Our goal is to make MarginProbe the standard of care worldwide."

venBio Closes $394 Million Life Sciences Venture Capital Fund

On April 3, 2020 venBio Partners LLC reported the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise (Press release, Venbio Partners, APR 3, 2020, View Source [SID1234556205]). The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

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Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team typically leads or co-leads investments and takes an active role with each of their portfolio companies.

"We are grateful for the tremendous support we have received from our current investors during this fundraise," said Dr. Adelman. "We appreciate their ongoing commitment and welcome the broad range of new top-tier investors who have joined them."

"We remain committed to our founding strategy at venBio, namely to turn great science into impactful medicine," said Dr. Goodman. "Our investment thesis, regardless of stage of company, remains to look for investment opportunities with a 3- to 5-year time horizon."

"In addition to generating strong financial returns, we’re proud of the impact our portfolio companies have made on patients," said Dr. Royston. "We’ve actively helped build three companies that have developed approved drugs that are on the market today."

In conjunction with the new fund, venBio has promoted Richard Gaster M.D., Ph.D., to Partner. Dr. Gaster was previously head of translational medicine at Pliant Therapeutics and a Senior Associate at Third Rock Ventures. Prior to Third Rock, he was a resident physician in Harvard’s Plastic and Reconstructive Surgery Program and received his M.D. and Ph.D. degrees from Stanford University in the Medical Scientist Training Program.

Cytovant Sciences Announces $23.5 Million Financing Led by BNH Investment

On April 3, 2020 Cytovant Sciences, a biopharmaceutical company founded by Roivant Sciences focused on developing and commercializing innovative cellular therapeutics in Asia, reported the completion of a fundraising round with a $23.5 million investment from BNH Investment, POSCO Capital, Mirae Asset Venture Investment, Smilegate Investment, and other leading Korean healthcare and venture capital investors (Press release, Cytovant Sciences, APR 3, 2020, http://www.cytovant.com/d69 [SID1234556173]).

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Cytovant’s lead cell therapy program for the treatment of acute myeloid leukemia (AML), CVT-DC-01, is based on dendritic cell (DC) vaccine technology in-licensed from Medigene in April 2019. Medigene recently reported positive topline data from a Phase 1/2 study in which 20 AML patients were treated with their DC vaccine FDC101 for 24 months following induction or consolidation therapy. Treatment with the vaccine was shown to be feasible, safe and well-tolerated over the 2-year treatment period, and the secondary outcome measures of overall survival rate (OS) and progression free survival rate (PFS) were shown to be 80% (N = 16, 95% CI: 55-92%) and 55% (N = 11, 95% CI: 31-74%), respectively.

Cytovant intends to use the proceeds of this funding round to advance both CVT-DC-01 and its lead TCR- transgenic T-cell (TCR-T) candidate, CVT-TCR-01, into the clinic in Asia.

"Asian patients have unique immunologic features and are treated in healthcare systems that may differ markedly from their Western counterparts. Our strategy is to develop treatments to address those needs precisely," said Dr. John Xu, President of Cytovant. "This financing will rapidly accelerate the development of our medicines for patients in China, Korea, and Japan."

"Cytovant has quickly established itself as one of the most innovative companies in the fast-growing cell therapy space," said Myeong Hwan Kim, CEO of BNH Investment. "With its strong technology platform and territory-specific approach, we believe the company is well-positioned to become a leader in this important area of medicine. We are very pleased to partner with Cytovant and to help them bring vital new medicines to patients across East Asia."

SBP Announces Pause in Enrollment of Clinical Trial of SBP-101 for Patients with Pancreatic Cancer

On April 3, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported it will pause enrollment in its ongoing clinical trial of SBP-101 (Press release, Sun BioPharma, APR 3, 2020, View Source [SID1234556142]).

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The COVID-19 pandemic has affected the conduct of clinical trials at our US and Australian sites. Some cancer centers have redeployed resources to prioritize COVID-19 patient care activities.

Michael T. Cullen, MD, MBA, Sun BioPharma’s President and CEO, noted today the Company would follow the lead of other pharmaceutical companies in instituting a recruitment delay of new patients in its current Phase 1 dose escalation and expansion study of SBP-101 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma. Patients currently enrolled in the clinical trial will continue to be treated.

"Given the uncertainties associated with the COVID-19 pandemic including the risk to our supply chain and the limitation and redistribution of clinical resources at our investigative sites, we will pause recruitment through at least May 15th," said Dr. Cullen. He noted that the timeline could be extended depending on the course of the pandemic

Shenogen enters into an Exclusive License with BioArdis to Develop and Commercialize Novel FGFR4 Kinase Inhibitor for Asian Market

On April 3, 2020 Shenogen, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in China and beyond, reported that it has entered into an exclusive collaboration and licensing agreement with Shanghai BioArdis Co., Ltd. and BioArdis LLC for the development and commercialization of BioArdis’ novel FGFR4 (fibroblast growth factor receptor 4) kinase inhibitor, BIO-1262/SNG-203, either as monotherapy or combination therapy in Mainland China, Hong Kong, Macau and Taiwan (Press release, Shenogen, APR 3, 2020, View Source [SID1234556133]). BioArdis will retain all rights to the licensed product in the rest of the world.

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BIO-1262 is being evaluated as a potential new treatment for hepatocellular carcinoma (HCC) and other solid tumors positive for FGFR4 and KLB (klotho beta) expression. HCC is the most common form of liver cancer. Fibroblast growth factor receptors (FGFRs) play a key role in regulating cell survival and proliferation, and a growing body of evidence suggests they also play a role in cancer progression.

Pursuant to the terms of the agreement, Shenogen will be responsible for conducting all development and commercialization activities in the territory related to the licensed product.

"Founded by seasoned executives with deep global and regional development experience and with a growing portfolio of potentially complementary cancer therapies, Shenogen is an ideal partner in China," said Ian Wisenberg, Chief Business Officer of BioArdis. "With recent regulatory reforms in China and the emergence of innovative companies like Shenogen, we believe this forward-looking collaboration has the potential to expand our ability to address significant patient needs in Greater China while supporting global development of BIO-1262/SNG-203."

"We are very excited about the exclusive co-development opportunity for BioArdis’ selective FGFR4 inhibitor BIO-1262/SNG-203," commented Dr. Meng Kun, chairman of Beijing Shenogen Pharmaceutical Group. "Icaritin from Shenogen is currently in late stage of phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC) as a single agent and in combination therapies. The addition of clinical development of BIO-1262/SNG-203 will strategically solidify our company’s leading position in the field of hepatocellular carcinoma treatments. We believe that BIO-1262/SNG-203 as a potentially best-in-class FGFR4 selective inhibitors can provide superior efficacy and better meet the needs of Chinese patients."

According to the Centers for Disease Control and Prevention, liver cancer is the fifth most common form of cancer worldwide, with disease rates in Asia approximately 30 percent higher than in the U.S. due in part to untreated hepatitis B infections.