On April 2, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to clinical trials and precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry" will be presented by Dr. Selin Kurnaz, a lead investigator, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, during the Phase I-III Trials in Progress session on April 2nd, 2019 (Press release, Massive Bio, APR 2, 2019, View Source [SID1234534977]).

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The poster (Abstract #CT218), View Source!/6812/presentation/10031 discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We continue active enrollment in this innovative precision oncology and artificial intelligence project, and we are honored and excited to be among the highly selected group of clinical trials to be presented at AACR (Free AACR Whitepaper). Moreover, we are the only company in the market that operationalizes technology – we not only pre-screen patients, we find sites to the patients, eliminate insurance barriers and truly close the last mile in oncology clinical trial enrollment. We clean massive operational inefficiencies and we are making a leap frog in clinical research," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

In addition, today, Massive Bio and Admera Health announced a non-exclusive collaborative agreement as active participants in SYNERGY-AI registry. Under the terms of the agreement, Massive Bio and Admera Health will focus on real world evidence, biomarker data and clinical trial matching in precision oncology studies. In addition, Admera Health also provides genomics and bioinformatics services to customers wishing to conduct research in a CLIA environment.

"By combining the expansive technology and precision oncology capabilities of Massive Bio with Admera Health’s specialization in genomics and bioinformatics, we hope to develop and provide the next wave of molecular-based portfolio of technology innovations and services," stated Jeffrey R. Mitchell, Associate Director of Strategy and Marketing of Admera Health. Mitchell continued, "In addition, given the geographic strengths of our respective companies, there will also be opportunities to expand clinical trials using each other’s proprietary technology around the globe."

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "Massive Bio’s Artificial Intelligence technology platform is extremely well positioned to enable just-in-time clinical trial matching and enrollment, with a targeted therapy and immunotherapy focus, and is proven to accelerate access to innovative therapies, sponsor and CRO efficiency, as well as time to market. We certainly welcome collaborations with all stakeholders in the diagnostics and research space, aiming to close existing gaps in cancer research." Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "With a growing number of successful development applications, it is our goal to continue to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs."

About the Study

The SYNERGY-AI Registry is an international prospective, observational cohort study of adult and pediatric patients with advanced solid and hematological malignancies. Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for optimized matching based on CT allocation and availability. Enrollment is ongoing, with a target of ≥1,500 patients. Please refer to View Source for details.

On April 2019 RhoVac AB ("RhoVac") reported that all prostate cancer patients who participated in the clinical phase I / II study with RhoVac’s drug candidate RV001, have completed their 9- and 12-month’s follow-ups (Press release, RhoVac, APR 2, 2019, View Source [SID1234555933]). This marks the completion of the clinical phase I / II study for the participating patients.

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RhoVac’s clinical phase I / II study was conducted during the period of Q1 2017 to Q1 2019. The 22 patients recruited for this study had been diagnosed with prostate cancer and been treated with prostatectomy. Blood samples were drawn before, during and after the study to analyze the product-mediated immune response to the treatments. The results, reported in August 2018, showed a significant immune response in 86% of patients. The patients also participated in 3-, 6-, 9- and 12-month’s follow-ups to study the duration of the immune response. This follow-up phase is now completed as all 22 patients have had their final follow-up visit at the clinical site.

The last samples from the 9- and 12-month’s follow-up phase have now been sent to the University of Tübingen for immunological analysis. RhoVac expects to report these results mid-2019.

CEO Anders Ljungqvist comments:

– The company’s first clinical study, RhoVac-001, is now completed and only analyzes and final reporting of the follow-up phase remain. I am proud that RhoVac has completed this study within the set timeframe. A result we have largely achieved thanks to the highly dedicated patients who have participated in the study. This combined with an outstanding collaboration with Copenhagen Prostate Cancer Center at University Hospital, Copenhagen; Phase I unit Zelo at Bispebjerg and Frederiksberg Hospital, DanTrials ApS and T-cell Monitoring Group, the Department of Immunology at the University of Tübingen, Germany have all ensured that we have been able to communicate conclusive results according to time frame. Thank you very much to all the participants.

On April 2, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with certain institutional investors to receive gross proceeds of approximately $3.2 million (Press release, Can-Fite BioPharma, APR 2, 2019, View Source [SID1234534907])

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In connection with the offering, the Company will issue 4,923,078 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $0.65 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $0.86 per ADS, will be immediately exercisable and will expire five years from the issuance date. The closing of the offering is expected to take place on or about April 4, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to the offering of such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 2, 2019 Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, reported the completion of a $105 million Series B financing led by Varian and new investor OrbiMed (Press release, Fusion Pharmaceuticals, APR 2, 2019, View Source [SID1234534923]).

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Additional investors participating in the round are Perceptive Advisors, Pivotal bioVenture Partners, and Rock Springs Capital, along with the existing group of leading international investors, that include HealthCap, Adams Street Partners, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), TPG Biotech, Seroba Life Sciences, Genesys Capital, and FACIT.

In conjunction with the new financing, Deepak Khuntia, Senior Vice President (SVP) and Chief Medical Officer (CMO) at Varian, Chau Q. Khuong, Partner at OrbiMed, and Heather Preston, Managing Director at Pivotal bioVenture Partners, will join Fusion’s Board of Directors.

The financing will be used to advance and broaden the scope of Fusion’s ongoing clinical program in targeted alpha therapeutics, and accelerate a pipeline of new radiopharmaceuticals and combination therapy strategies. The company’s lead product candidate [225Ac]-FPI-1434, combines the precision targeting of an antibody with the potency of alpha-particle emitting medical isotopes to specifically attack and eradicate cancer cells across multiple tumor types.

"Fusion is delighted to welcome this group of preeminent healthcare investors to our existing and highly distinguished series A investors. We have made tremendous progress in the last two years, and this financing reflects strong support for our platform, people and pipeline," said John Valliant, Ph.D., Fusion’s Chief Executive Officer. "The investment positions us to implement our clinical and partnering strategies around [225Ac]-FPI-1434, expand our team and fully exploit the unique advantages of our linker technology."

Fusion’s proprietary Fast-Clear Linker Technology Platform promotes the rapid excretion of medical isotopes that are not specifically bound to cancer cells. The Fast-Clear Linker (the "connector" between a molecule and a medical isotope) is engineered to clear medical isotopes at a faster rate, compared to traditional technologies, with the aim of expanding the therapeutic window. Given the power and versatility of the Fast-Clear Platform, Fusion is applying this technology to different classes of molecules.

"We were attracted to Fusion by the excellent science, broad patient applicability, and great promise for its targeted alpha therapeutics, which have the potential to eradicate even the most resistant types of cancer," said Deepak Khuntia, SVP, CMO, at Varian. "The investment will enable Fusion to advance a pipeline of novel therapeutics that can deliver effective and personalized radiation therapies to cancer patients."

"OrbiMed is excited to co-lead the financing of Fusion, which is the industry leader in targeted alpha therapeutics. Fusion has a unique platform and an exciting lead program in early stage clinical trials that holds promise for improving the lives of cancer patients," said Chau Q. Khuong, Partner at OrbiMed. "There is significant re-emerging commercial interest in radiopharmaceuticals given recent advances in the field and Fusion is at the forefront. We are excited to work with the Fusion team to meet the aggressive goals of the company."

On April 2, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Adelene Perkins, Infinity Pharmaceutical’s Chief Executive Officer, will present at the 18th Annual Needham Healthcare Conference on Tuesday, April 9, 2019, at 3:30 p.m. ET at the Westin NY Grand Central Hotel in New York, NY (Press release, Infinity Pharmaceuticals, APR 2, 2019, View Source [SID1234534978]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event

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