On July 2, 2019 Immunicom, Inc., a biotechnology company awarded FDA Breakthrough Device Designation for its non-pharmaceutical solution for treating late-stage metastatic cancer, reported that raised $11 million in a Series B investment round (Press release, Immunicom, JUL 2, 2019, View Source [SID1234537372]). Several private equity family offices participated in the Series B financing which now increases Immunicom’s overall capital raised to $20 million.

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"Proceeds from this financing will help fund the 170-patient, randomized, multi-center, triple-negative breast cancer clinical trial we began May 31, while also fueling continued expansion of Immunicom’s global strategic partnerships," said Amir Jafri, the company’s Founder and CEO. "We are making great strides towards our vision of introducing a cancer immunotherapy that has the potential to be safer than most presently available treatments and very cost-effective. We truly appreciate the ongoing support of our investment partners for enabling us to achieve a rapid growth trajectory."

The revolutionary new immunotherapy treatment Immunicom has developed is called Immunopheresis and offers the potential to revitalize a cancer patient’s immune system to naturally fight tumor cells without introducing any new chemicals, proteins or antibodies into the body. Performed utilizing out-patient procedures analogous to standard dialysis treatments for removing unwanted waste products from a patient’s bloodstream through external filtration, Immunopheresis uses Immunicom’s proprietary blood filtering device technology to extract tumor-produced proteins in the bloodstream that inhibit the body’s natural immune system from attacking and eradicating tumors. This approach provides for a potentially robust immune response against the tumor cells and is intended to function also as an ideal adjunct therapy to existing treatments.

"Immunicom is uniquely positioned to have a fundamental impact on improving the lives of cancer patients worldwide," added David Schlotterbeck, Chairman of Immunicom and the former Co-Chairman of Cardinal Health. "Successfully bringing to market a medical device that not only has strong potential to treat a wide variety of cancer types, but with relatively straightforward design modifications may be reconfigured to treat other major illnesses as well, would be an industry game-changer. And that is precisely the objective our organization strives to achieve."

On July 2, 2019 Oxford Vacmedix UK Limited (OVM), the UK-based biopharma company focused on the development of cancer vaccines, reported the award of an Innovate UK grant to CHAIN Biotechnology Ltd (CHAIN) and the University of Oxford to develop live biotherapeutics that support oral delivery for OVM’s recombinant overlapping peptide (ROP) cancer vaccines (Press release, Oxford Vacmedix, JUL 2, 2019, View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" target="_blank" title="View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" rel="nofollow">View Source [SID1234537356]). The research will use CHAIN’s proprietary microbiome technology and the world-class research facilities in the University’s department of Oncology.

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The project will initially focus on OVM-100 in a research project titled "Mucosal delivery of Clostridium spores encoding recombinant overlapping peptides (ROPs) of HPV antigen as therapeutic vaccines for cervical cancer". This will bring together University of Oxford’s expertise and CHAIN’s innovative microbial delivery platform to establish the effectiveness of delivering ROPs to the colon for the treatment of cervical cancer.

Spun out from the University of Oxford, OVM holds an exclusive licence for the ROP technology. The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune-oncology agents. OVM is developing two cancer vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at cervical cancer. OVM-200 represents a new type of vaccine utilising survivin, a protein inhibitor of apoptosis, to target solid tumours.

Dr Shisong Jiang, Principal Investigator in the Department of Oncology and Founder of OVM, said:

"We are delighted to have this opportunity to work with CHAIN on this exciting project. The importance of effective and controlled delivery is key to the development of new cancer vaccine and we are very pleased to have support and funding from Innovate UK for this work on our immunotherapy cancer vaccines"

Dr Edward Green, Chief Executive and Founder of CHAIN added:

"This project provides a further opportunity to exemplify our Clostridium-Assisted Drug Development (CADDTM) platform for targeted gut delivery of therapeutic peptides. We look forward to a successful collaboration with OVM and to establishing a combination approach that simplifies and accelerates the development of oral cancer vaccines providing significant patient benefits."

For more information or to arrange an interview, please contact:
William Finch, CEO, Oxford Vacmedix
T: +44 (0) 1865 742087 | M: +44(0)7769 903711 | E: [email protected]
View Source

On July 2, 2019, Iovance Biotherapeutics, Inc. (the "Company") presented its corporate presentation (Presentation, Iovance Biotherapeutics, JUL 2, 2019, View Source [SID1234537373]).

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On July 1, 2019 Varian (NYSE: VAR) reported it has signed an asset purchase agreement to acquire the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumors (Press release, Varian Medical Systems, JUL 1, 2019, View Source [SID1234537374]). When completed, this acquisition, in combination with the recent acquisitions of Endocare and Alicon, will expand Varian’s portfolio of multidisciplinary integrated cancer care solutions.

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Varian’s planned acquisition of the Boston Scientific portfolio of drug-loadable microsphere (Oncozene/Embozene Tandem) and bland embolic (Embozene) bead products will enable Varian to extend its new interventional oncology platform, and the Company will benefit from the products’ regulatory clearances in more than 35 countries worldwide.

"This acquisition from Boston Scientific will strengthen Varian’s growing position in the high-value interventional oncology segment and is consistent with our long-term strategy to become a global leader in multidisciplinary, integrated cancer solutions," said Dow Wilson, president and chief executive officer of Varian. "We look forward to completing this acquisition and are excited to add these drug-loadable microsphere and bland embolic bead products to our portfolio to provide our clinical partners with expanded advanced treatment options."

Varian will not acquire any of the Boston Scientific operations. While Varian implements a plan to manufacture and distribute these products, it will work with Boston Scientific under transition services agreements to ensure uninterrupted delivery to customers.

Transaction and Financial Details

Varian is financing the purchase price of $90 million using cash and proceeds from borrowings. The transaction, which is expected to close around August 2019, is subject to the satisfaction or waiver of customary closing conditions, including approval of the U.S. Federal Trade Commission and the closing of the proposed acquisition of BTG PLC by Boston Scientific Corporation.

The combined assets generated revenue of $21.2 million in calendar 2018. Varian expects this transaction to have an immaterial impact on fiscal year 2019 financial results, and the assets to be accretive to GAAP and Non-GAAP earnings per share in fiscal 2020.

Varian has provided more information regarding this asset purchase on its investor relations website by updating the presentation regarding its recent acquisitions in interventional oncology. To view the presentation, visit www.varian.com/investors.

On July 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported an update on the regulatory path for LN-145 in advanced cervical cancer (Press release, Iovance Biotherapeutics, JUL 2, 2019, View Source;p=RssLanding&cat=news&id=2402832 [SID1234537358]). Based on an End of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA), the FDA has acknowledged that the ongoing innovaTIL-04 study of TIL therapy LN-145 may be sufficient to support registration in the treatment of patients with advanced cervical cancer. The study is being enrolled with a prospective definition of objective response rate (ORR) read out by a Blinded Independent Review Committee (BIRC) as the primary endpoint. In accordance with the FDA’s recommendation, the new version of the protocol will further define the patient population. Iovance plans to include in the Biologics License Application (BLA), patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which constitutes almost all of the more advanced patients enrolled to date. In addition, the company announced that the innovaTIL-04 study is expected to enroll a total of 75 to 100 patients in order to support a BLA submission.

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"The FDA’s agreement to consider acceptability of the ongoing study in patients with cervical cancer significantly accelerates our path to BLA submission for LN-145," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "This feedback is encouraging. The ability to use the current study, as well as the Breakthrough Therapy designation recently granted to LN-145, allows us to plan on a path to BLA submission in the second half of 2020."