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Accord de collaboration entre ORPHELIA Pharma et Gustave Roussy

On July 2, 2019 ORPHELIA Pharma, a biopharmaceutical company whose mission is to develop and market pediatric medicines in the fields of neurology and oncology, reported that it has signed a collaboration and licensing agreement with Gustave Roussy, a leading cancer center in Europe, to develop Kimozo, the first pediatric formulation of temozolomide (Press release, ORPHELIA Pharma, JUL 2, 2019, View Source [SID1234538116]).

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Temozolomide is an essential anti-cancer drug for the treatment of malignant gliomas in children. Unfortunately, there is no suitable pediatric formulation, which forces caregivers to open the adult capsules and disperse their contents into a food to administer the treatment to the children. The medical need has been underlined by the European Medicines Agency (EMA), in its document "Draft Inventory of paediatric therapeutic needs – EMA / 381728/2014".

"Temozolomide is one of the cancer drugs for which the need for a formulation for children is the strongest," says Professor Gilles Vassal, Director of Clinical Research Gustave Roussy. "This need has been recognized by the international pediatric oncology community and has led us to develop innovative, child-friendly hospital care."

Kimozo was developed on the basis of the hospital preparation developed by Gustave Roussy. The first pediatric formulation of temozolomide, Kimozo comes in the form of an oral suspension with taste masking, in a sealed bottle. Five oral syringes (for a 5-day course) will allow the drug to be administered effectively and safely. Kimozo is being industrialized by ORPHELIA Pharma.

"When the adult capsule is used, children may regurgitate the product, the dose administered is not precisely known, and finally, the family and caregivers may be exposed to this cytotoxic agent during pregnancy. preparation. Gustave Roussy has developed a hospital preparation that is extremely useful for children and on which we rely for Kimozo ", commented Jérémy Bastid, ORPHELIA Pharma’s Development Director.

"There is a significant medical need in pediatrics," says Hugues Bienayme, Founder and CEO of ORPHELIA Pharma. "In addition to malignant gliomas, temozolomide is prescribed in several rare solid cancers of the child. The uses of Kimozo will therefore be multiple. "

Celyad to Host Conference Call to Review Clinical Update from ESMO 21st World GI Congress

On July 2, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that Professor Dr. Eric Van Cutsem from Universitair Ziekenhuis Leuven (UZ Leuven) will present data from the NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, JUL 2, 2019, https://www.celyad.com/en/news/celyad-to-host-conference-call-to-review-clinical-update-from-esmo-21st-world-gi-congress-1 [SID1234537378]). Following the oral and poster presentations at WCGIC, Celyad’s management team will host a conference call to discuss the initial clinical results from the SHRINK and alloSHRINK trials.

Filippo Petti, CEO of Celyad noted "We are honored to have Professor Dr. Van Cutsem present preliminary data from our SHRINK and alloSHRINK trials, including an initial glimpse of data from the industry’s first off-the-shelf investigational non-gene edited CAR-T candidate, CYAD-101. The comparable trial designs investigating similar NKG2D-based CAR-T therapies should provide for a unique comparison of an autologous and allogeneic engineered cell therapy approach for the treatment of metastatic colorectal cancer."

Poster Oral Presentation

Title: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Abstract: SO-009

Presenter: Eric Van Cutsem, M.D., Universitair Ziekenhuis Leuven (UZ Leuven)

Date: Friday, July 5, 9:00 a.m. CEST

Location: Auditorium B, Level 0

The poster (same title, same number) will be presented in the Exhibit Hall, Level 0 on Friday, July 5, 2019 from 10:35am – 11:05am CEST and 04:35pm – 05:05pm CEST.

Conference Call / Webcast Details

A conference call including a Q&A session will be held by the Company on Friday July 5, 2019 at 2:00 pm CEST / 8:00 am EDT.

The conference call can be accessed using the details below:

United States: +1 877 407 9208

International: +1 201 493 6784

Conference ID: 13692101

Alternatively, participants may also access an audio webcast of the event using the link below: View Source

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex, which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.

Varian to Expand Interventional Oncology Portfolio with Purchase of Embolic Bead Assets

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.

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.

Iovance Biotherapeutics, Inc., Corporate Presentation – July 2019

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

Immunicom Secures $11 Million in Series B Investment Round

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.

"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."