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Samsung Biologics enters into a development and manufacturing partnership with PharmAbcine for oncology and neovascular treatment

On April 5, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders (Press release, Samsung Bioepis, APR 5, 2020, View Source [SID1234556134]). Under this agreement, Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.

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PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease. Olinvacimab, the company’s lead molecule, is currently in phase II clinical trials for a combination therapy to treat cancer with Merck’s Keytruda.

According to PharmAbcine, PMC-402 is expected to enhance the delivery of immune cells and cancer therapeutics to treat tumor cells via active normalization of leaky blood vessels. Attributable to its vessel normalization characteristics, PharmAbcine plans to expand the indication to eye diseases such as wAMD (wet age-related macular degeneration) and DR (diabetic retinopathy).

"The anti-cancer effect of PMC-402, both as a monotherapy and a combination therapy with immuno-cancer drugs, was confirmed through initial research. From this year, we will test the safety of PMC-402 and initiate phase I clinical trial by 2021 through collaboration with Samsung Biologics," said Jin-San Yoo, CEO of PharmAbcine.

"Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clients to reach IND and market Faster & Better," said Tae-Han Kim, CEO of Samsung Biologics. He added, "Through partnership with Samsung Biologics, biotech companies can not only benefit from fast timeline and high-quality products, but also concentrate on discovery activity, a core aspect of their business."

Samsung Biologics has played a significant role in the global biopharma landscape by establishing a global scale bio-ecosystem for biotech companies. With the announced opening of its US CDO R&D center in San Francisco later this year, Samsung expects to support more clients around the globe with maximum client satisfaction.

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]).

"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.

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]).

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]).

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