On April 3, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that Dr. Brian Steadman, Interventional Oncologist at the Southampton University Hospital will present a video training session at the Annual Meeting of the European Conference of Interventional Oncology (ECIO) (Press release, Delcath Systems, APR 3, 2018, View Source;p=RssLanding&cat=news&id=2340763 [SID1234525453]). Dr. Steadman will present an overview of the Percutaneous Hepatic Perfusion (PHP) procedure and potential indications of PHP Therapy, as well as review recent research. The session will be held Tuesday, April 24, 2018 at 3pm local time.

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The ECIO will be held in Vienna, Austria, April 22-25, 2018.

On April 3, 2018 Pfizer Inc. (NYSE:PFE) and Allogene Therapeutics, Inc. (Allogene) reported that the two companies have entered into an asset contribution agreement for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer (Press release, Pfizer, APR 3, 2018, https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_allogene_therapeutics_enter_into_asset_contribution_agreement_for_pfizer_s_allogeneic_car_t_immuno_oncology_portfolio [SID1234525452]).

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Pfizer Inc. (NYSE:PFE) and Allogene Therapeutics, Inc. (Allogene) reported that the two companies have entered into an asset contribution agreement for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer.

Pfizer views this agreement as an attractive opportunity to support the continued development of allogeneic CAR T therapy in a highly focused and skilled manner. Pfizer will continue to participate financially in the development of the CAR T portfolio through a 25 percent ownership stake in Allogene. Separately, Pfizer continues to have an 8 percent ownership stake in Cellectis through an equity agreement entered into in 2014. Allogene, a Two River portfolio company, was formed with Series A financing of $300 million from an investment consortium that includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer and Pfizer, among others. TPG, Vida Ventures, BellCo Capital and Pfizer will be represented on the Allogene Board of Directors. Closing is expected in the second quarter of 2018, subject to closing conditions.

"The allogeneic CAR T platform represents a potentially transformative approach to treating cancer, and we are very excited about what the future may hold for this area of research," said Robert Abraham, Senior Vice President and Group Head, Oncology Research & Development, Pfizer. "We believe that under the strong scientific, clinical development and regulatory expertise of Allogene’s leadership team, the portfolio of CAR T assets contributed by Pfizer will be well-positioned to rapidly advance into potential innovative new therapies, and ultimately to reach patients in need more quickly."

"While there is important work underway across the industry for next-generation autologous cell therapy, Allogene hopes to bring about the next revolution in the field with the successful development of allogeneic cell therapy and the potential for greater and faster patient access," said Belldegrun. "Under the direction of David Chang, an extraordinary scientist, physician and life sciences business executive with over 30 years of unprecedented experience in developing cancer treatments, Allogene is poised to potentially lead the development of one of the most exciting opportunities in our industry today."

"Last year, Kite’s anti-CD19 CAR T therapy became the first autologous CAR T treatment to be approved by the U.S. Food and Drug Administration for adult patients with aggressive non-Hodgkin lymphoma. Many believed the idea was rooted in science fiction, but science fiction became a reality," said Chang. "We believe that this partnership among leaders in the field – visionaries, industry forerunners, venture capitalists and researchers – has the potential to accelerate the development of allogeneic T cell therapy, making it a reality and forever changing how cancer is treated."

"Investing in innovation and R&D has long been a hallmark of who we are as investors, and for many years, we’ve been partnering with dynamic companies that are driving meaningful change in healthcare," said Todd Sisitsky, Managing Partner, TPG Capital. "We believe CAR T is one of the most exciting spaces within the pharmaceutical landscape today, and we are thrilled to partner with a best-in-class management team and industry leaders to invest in this potentially groundbreaking opportunity."

"As a pioneer of the allogeneic approach and expert in gene editing, the Cellectis team is excited by this agreement and eager to continue this groundbreaking work with Allogene’s experienced team, striving to accelerate the development of the portfolio and to continue along the path of making these treatments available to patients as soon as possible," said Dr. André Choulika, Cellectis CEO.

"I believe that the recognized expertise of the Allogene team in the field of CAR T will be of benefit to the development of UCART19, for which Servier is the sponsor of two clinical studies," commented Olivier Laureau, President of Servier Group. "The development of off-the-shelf allogeneic CAR T therapy in the field of oncology initiates a revolution that could potentially expand access of such innovative treatment to a larger number of oncologists and their patients."

Centerview Partners is acting as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Cooley LLP is serving as legal counsel to Allogene, Vida Venture and TPG. Gibson Dunn & Crutcher LLP are also serving as legal counsel to TPG.

Allogeneic CAR T Cell Therapies

Allogeneic CAR T cell therapies have the potential to become the next advancement in one of the most powerful anti-cancer agents, eliminating the need to create personalized therapy from a patient’s own cells. These therapies are developed from cells of healthy donors and stored for "off-the-shelf" use in patients, simplifying manufacturing process and reducing waiting time for patients.

Allogene will receive from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. UCART19 utilizes TALEN gene editing technology pioneered and owned by Cellectis.

Allogene and Servier intend to initiate Phase 2 studies in 2019. Under the terms of the original development agreement, Allogene will have exclusive rights to develop and commercialize UCART19 in the United States, while Servier will retain exclusive rights for all other countries.

Pfizer’s Commitment to Immuno-Oncology

Immuno-Oncology (IO) is a key area of focus within Pfizer’s broad oncology portfolio, with research and development efforts spanning diverse modalities and mechanisms of action that tap into key immune system functions, harnessing the natural ability of the immune system to fight cancer. We believe that the future of IO lies in novel, biologically rational combinations based on unique tumor characteristics. We believe that Pfizer Oncology’s pipeline is in a strong position to help advance the next wave of IO science by developing new targeted therapies and IO combinations – areas in which Pfizer has a robust and proven legacy. We know that great science comes through collaboration, and we actively team up with strategic partners in IO who we believe will strengthen our portfolio and help speed innovative treatments to benefit more patients.

About Allogene Therapeutics

Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.

Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for "off-the-shelf" use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium that includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer and Pfizer, among others. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.

On April 3, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported that preliminary efficacy and safety data from its ongoing Phase 3 VISTA trial of Vicinium in patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG) have been selected for presentation during a plenary session currently scheduled for Monday, May 21, 2018 at 11:00 a.m. PT at the American Urological Association Annual Meeting taking place in San Francisco (Press release, Eleven Biotherapeutics, APR 3, 2018, View Source [SID1234525376]). Vicinium is a fusion protein, designed to be a next-generation ADC, that targets the epithelial cell adhesion molecule (EpCAM) antigens on the surface of bladder cancer cells to deliver a potent cytotoxin into those cells.

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Data, as reported in the abstract published online today, are from a subgroup of the first 75 evaluable carcinoma in situ patients. Within these patients, preliminary findings show that greater than 95 percent expressed EpCAM on the surface of tumor cells, the target of Vicinium. Efficacy data as measured by complete response rates at three-months will be reported during the plenary session. Vicinium has been well-tolerated. Treatment-related adverse events (AEs) were reported in 46 percent of patients, the majority of which were Grade 1 or 2. The most common of these were dysuria (12%), UTI or pollakiuria (10%) and hematuria (7%), which are often associated with catheter-delivered treatments into the bladder and bladder cancer itself. As of the December 2017 data cut off, three treatment-related serious AEs were reported, including renal failure (CTCAE Grade 5) with cholestatic hepatitis (Grade 4) in one patient and acute kidney injury (Grade 3) in a second patient who recovered.

In March 2018, recruitment was completed in the VISTA trial, a single-arm registration study designed in accordance with U.S. Food and Drug Administration’s final guidance for developing treatments for BCG-unresponsive NMIBC.
"When treatment with today’s standard of care, BCG, is no longer an option, the next treatment option is typically removal of the patient’s bladder, a challenging, life-altering procedure that many patients elect not to undergo," said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. "Vicinium has demonstrated that it is a well-tolerated and active agent in patients with BCG unresponsive NMIBC in studies to-date. We are excited to be presenting the first preliminary data from our Phase 3 VISTA trial of Vicinium for patients with NMIBC at this year’s AUA meeting. During our plenary presentation, we will share initial efficacy findings and data supporting the favorable safety we have observed so far with Vicinium. We believe Vicinium holds tremendous potential as a treatment for bladder cancer, and we look forward to sharing these and additional data later in the year."
The company plans to host a conference call in conjunction with the data presentation, with details to follow.
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS, cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) or papillary (cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue), who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease and durability of that response. Patients in the study receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Topline data assessing responses and durability of responses at three-months on treatment are expected in mid-2018, with 12-month data anticipated in mid-2019.

About Vicinium
Vicinium, Eleven Biotherapeutics’ lead product candidate, is a next-generation antibody-drug conjugate developed using the company’s proprietary Targeted Protein Therapeutics platform. Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Topline, three-month data from the trial are expected in mid-2018. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On April 3, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine, reported the publication of a comprehensive genomic landscape analysis illuminating the breadth, frequency and potential disease-driving significance of somatic mutations in RNA splicing factor genes in human cancers (Press release, H3 Biomedicine, APR 3, 2018, View Source [SID1234525375]). The findings demonstrate that splicing factor mutations, which lead to RNA splicing dysregulation, are highly prevalent in many hematologic and solid tumor cancers, suggestive of their role as a hallmark of tumor formation and growth and, thus, opportunities for therapeutic intervention. RNA splicing is the biological process by which pre-cursor messenger RNA (pre-mRNA) is edited into a mature messenger RNA (mRNA). Splicing factors carry out the editing process which is catalyzed by the core spliceosome complex. H3 Biomedicine scientists’ research and findings were published in the most recent online version of Cell Reports. (Seiler M. et al, "Somatic mutational landscape of splicing factor genes and their functional consequences across 33 cancer types"). This manuscript is part of The Cancer Genome Atlas (TCGA) Program, a joint effort of the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI).

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"In recent years, somatic mutations in core splicing factors have been described in certain hematologic malignancies but the breadth of splicing factor mutations has been largely underappreciated. The findings published today give us for the first time a comprehensive understanding of just how common splicing factor mutations are across many types of cancer and of the role they may play in promoting tumor formation and progression," said Markus Warmuth, M.D., President and Chief Executive Officer of H3 Biomedicine Inc. "This knowledge further validates the therapeutic approach of modulating spliceosome dysregulation to control tumor formation and growth, one of our core focus areas at H3 Biomedicine as evidenced by H3B-8800, our small molecule modulator of the SF3b complex, which is currently being evaluated in a Phase 1 clinical trial for patients with hematologic cancers and splicing factor mutations. In addition, the research findings open up an expansive, actionable trove of spliceosome targets that could be explored with novel therapeutic strategies."

Using whole exome and RNA sequencing data in TCGA, H3 data scientists analyzed over 10,000 patient samples across 33 tumor types to identify somatic mutations in RNA splicing factors. The analysis of over 400 splicing factor genes identified 119 genes as having putative driver mutations, including over-representation, recurrent loss-of-function or recurrent hotspot (oncogene-like) mutations.

Mutations in splicing factor genes were found in all 33 tumor
types with the frequency of mutations in multiple splicing factor genes as high as 60% in patient samples of the same tumor types, representing a much larger occurrence than previously reported. In addition, H3 scientists, as exemplified in case studies of five genes, showed that mutations in splicing factor genes led to dysregulated or altered splicing in mutated cells.
"This research and analysis exemplifies our differentiated drug discovery approach. We have the computational power and know-how to mine vast amounts of genomic data and reveal critical insights that we in turn utilize to develop and investigate highly targeted, precision approaches to cancer," said Lihua Yu, Ph.D., Chief Data Science Officer of H3 Biomedicine Inc. "We’re particularly proud of this work because, beyond informing our own drug discovery efforts, it will help advance the entire field’s understanding of the role dysregulated RNA splicing plays in cancer."
H3 Biomedicine is advancing novel cancer therapies that target core splicing factor mutations. A Phase 1 trial is underway in patients with hematologic malignancies for the company’s first spliceosome pathway-targeting cancer therapeutic, H3B-8800, a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complex, a splicing factor gene. The study is evaluating the safety and preliminary efficacy of H3B-8800 in patients with myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who carry mutations in splicing factor genes. Preclinical data demonstrate that H3B-8800 modulates RNA splicing and shows preferential antitumor activity in a range of spliceosome-mutant cancer models.

Splicing modulation is one of several research focus areas of H3 Biomedicine. H3 Biomedicine has two additional investigational therapies in Phase 1 clinical trials, including:

H3B-6545, an oral, first-in-class ESR1 covalent antagonist targeting wild-type and mutant estrogen receptor α in endocrine-therapy resistant metastatic breast cancer patients; and

H3B-6527, an oral, potent and highly selective small molecule covalent inhibitor of FGFR4 for treatment of hepatocellular carcinoma (HCC) patients with overexpression of FGF19.

On April 3, 2018 Cancer Therapeutics CRC (CTX) is reported that appointment of Brett Carter as Chief Executive Officer (Press release, Cancer Therapeutics CRC, APR 3, 2018, View Source [SID1234525374]).

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Brett will succeed Dr Warwick Tong who has led CTX for the past 6 years and who will continue to provide services to the organisation in an advisory capacity. These changes reflect a transition plan agreed between Dr Tong and the CTX Board to evolve the organisation from a Federally supported Cooperative Research Centre (CRC) into an independent and self-sustainable organisation.

Commenting on the appointment, Dr Tony Evans Chair of CTX, said
:
"We are delighted to appoint Brett as Chief Executive Officer. Brett has excellent management skills, extensive industry experience and a track record of executing pharmaceutical deals, making him the ideal candidate to lead CTX moving forward. I would like to thank Warwick for his dedicated leadership of the organisation over the past 6 years. Warwick has made many contributions to CTX however I would like to specifically highlight his involvement in the PRMT5 licensing deal to Merck, which was one of Australia’s largest ever pre-clinical asset licensing deals."

Commenting on the appointment, Mr Carter, said:
"Cancer is Australia’s leading cause of pre-mature death and CTX’s unique and highly successful business model has resulted in the development of drug products that have the potential to provide cures for cancer patients. I am very excited to be taking over the leadership of an organisation with such a strong culture of innovation and delivery.
To move from a medical research hub to a global biotechnology leader, Australia needs organisations like CTX, that build the drug discovery and development capability necessary to translate the country’s world class medical research into clinical and commercial outcomes.

I want to thank Warwick for his mentorship over the past year and I look forward to working with the CTX team and stakeholders as we embark on the next stage of the organisation’s evolution."