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, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three- and nine-month periods ended January 31, 2018 (Press release, Cotinga, APR 3, 2018, View Source [SID1234533156]). Recent highlights include:

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Advanced the clinical development of COTI-2:

In November 2017, Cotinga announced pharmacokinetic (PK) data from its ongoing Phase 1 trial of COTI-2, which showed that COTI-2 exhibited rapid absorption, long half-life and lack of long-term drug accumulation, which support the potential for daily oral dosing and the continued development of COTI-2 as a potential treatment for patients;
In December 2017, Cotinga announced pharmacodynamic (PD) data and positive signals of efficacy from its ongoing Phase 1 trial of COTI-2, which suggest COTI-2 may be a potentially efficacious treatment for patients;
In January 2018, Cotinga announced publication of positive data from a preclinical study demonstrating that combining COTI-2 with commonly used chemotherapeutic agents improves efficacy and exhibits favorable drug resistance and toxicity profile in human cancer cell lines, which suggest COTI-2 may be potentially efficacious as a combination therapy;
Subsequent to the reporting quarter, in March 2018, Cotinga announced that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2. The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of solid tumor cancers.
Solidified identity as a clinical-stage pharmaceutical company:

In January 2018, the Company changed its name to Cotinga Pharmaceuticals Inc. The new brand signified the Company’s evolution from a technology-driven company to a clinical-stage pharmaceutical company. The name is derived from the Cotingas, one of the world’s largest and most diverse bird species, and symbolizes the Company’s focus on developing innovative therapies to treat a wide spectrum of cancers.
"We were excited to announce multiple meaningful clinical and corporate developments in the third fiscal quarter," said Alison Silva, President & Chief Executive Officer. "The encouraging interim clinical data we announced over the past several months, along with the positive preclinical data we published earlier this year, facilitated a thorough assessment of our clinical development strategy for COTI-2. Based on the findings of that assessment, we submitted a regulatory package to the FDA to expand our ongoing Phase 1 trial to evaluate COTI-2 as a combination therapy in a broad patient population. We are eager to explore the potential of combination therapy with COTI-2 in the clinic, and look forward to implementing this new trial design in the months ahead. Working towards securing sufficient funds to support this clinical development strategy was a top priority during the fiscal quarter and remains so in the fourth quarter. We will report on our progress as those financing efforts advance."

Financing
In December 2017, Cotinga announced it had entered into an agreement with a U.S. investment bank to act as exclusive placement agents on a best-efforts basis for a cross-border private placement equity financing. The objectives of the financing include broadening the investor base to include institutional and other sophisticated investors in the life sciences sector. The Company’s ability to advance its programs is highly dependent upon the outcome of its financing efforts, which are targeted to close in April 2018. The proceeds from the equity financing are intended to primarily support the continued clinical development of COTI-2. The results of the equity financing may require the Company to reprioritize or alter its strategies in respect of its programs.

Upcoming Milestones
COTI-2:

Implementation of protocol amendment to expand ongoing Phase 1 trial of COTI-2 to evaluate COTI-2 as a combination therapy in an expanded patient population expected to commence mid-calendar year 2018.
Readout of additional exploratory endpoint data from the dose escalation portion of the Phase 1 trial in gynecological malignancies expected mid-calendar year 2018;
Initiation of additional combination studies with standard of care chemo- and radiotherapeutics in multiple oncology indications expected in calendar year 2018.
COTI-219:

Continuation of GMP manufacturing work and further mechanism of action preclinical studies to enable an IND filing.
Financial Results
The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1 clinical trial of COTI-2 in gynecological malignancies and HNSCC.

For the three-months ended January 31, 2018, the Company incurred a net loss of $1.279 million, or $0.08 per share, compared to a net loss of $1.238 million, or $0.08 per share, for the three-months ended January 31, 2017. The comparable net loss during the three-month period is primarily due to a decrease in Research and Development ("R&D") expense and General and Administration ("G&A") expense, offset by a lower favorable swing in the valuation of the warrant liability.

For the nine-months ended January 31, 2018, the Company incurred a net loss of $3.301 million, or $0.21 per share, compared to a net loss of $4.302 million, or $0.29 per share, for the nine-months ended January 31, 2017. The decrease in net loss during the nine-month period is primarily due to a decrease in G&A expense and a favorable swing in the valuation of the warrant liability, partially offset by an increase in R&D expense.

There was no revenue for the three- and nine-month periods ended January 31, 2018 or in the comparative periods in the year prior.

Operating expenses in the three- and nine-month periods ended January 31, 2018 decreased by $0.632 million and $0.408 million respectively over the same periods in the year prior, primarily due to a decrease in G&A expense and Sales and Marketing ("S&M") expense, partially offset by an increase in R&D expense and lower investment tax credits.

R&D expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.123 million and increased by $0.182 million respectively over the same periods in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses, synthesis and miscellaneous R&D expenses and share-based compensation, partially offset by an increase in in vivo/in vitro testing and salaries and benefits. The increase in R&D expense in the nine-month period is primarily due to an increase in synthesis and miscellaneous R&D expenses, in vivo/in vitro testing, and salaries and benefits, partially offset by a decrease in clinical trial expenses and share-based compensation.

G&A expense in the three- and nine-month periods ended January 31, 2018 decreased $0.519 million and $0.572 million respectively over the same period in the year prior due to a reduction in salaries and benefits, share-based compensation expense, and marketing and travel. These decreases were partially offset by an increase in professional fees, corporate governance, rent and insurance.

S&M expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.026 million and $0.116 million respectively compared to the same periods in the year prior due to a decrease in professional fees and marketing and travel. These decreases were partially offset by an increase in other S&M expenses.

ITC income for the three- and nine-month periods ended January 31, 2018 decreased by $0.037 million and $0.098 million respectively compared to the same periods in the year prior due to a decrease in eligible R&D expenditures.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three- and nine-month periods ended January 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On April 3, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients using the novel small molecule trans sodium crocetinate (TSC) in conjunction with standard radiation and chemotherapy, reported 2017 financial results and provides a business update. Diffusion’s lead clinical trial program, the INvestigation of TSC Against Cancerous Tumors (INTACT) trial, is a Phase 3 study expected to enroll a total of 236 patients, with half in the treatment arm and half in the control arm (Press release, Diffusion Pharmaceuticals, APR 3, 2018, View Source [SID1234525158]). The design of INTACT is based on an almost four-fold increase in overall survival at two years demonstrated in inoperable GBM patients in the preceding Phase 2 study.

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"We began opening clinical sites for the INTACT trial in December as planned, and started enrolling and dosing patients in January while continuing to open more clinical sites," said David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals. "We believe that the INTACT trial can provide a promising new treatment option for the thousands of patients who each year are newly diagnosed with inoperable GBM brain cancer and who, because of their poor prognosis, may be excluded from other clinical trials."

In January 2018 the Company conducted a public offering, raising gross proceeds of approximately $12.0 million from the sale of common stock and warrants. In conjunction with this capital raise, all the Company’s preferred stock was converted into common stock, eliminating the obligation for future dividend payments and certain restrictive provisions contained therein.

In January 2018 the Company, along with researchers from the University of California Los Angeles (UCLA) and the University of Virginia (UVA), presented an abstract at the International Stroke Conference in Los Angeles describing a Phase 2 trial design to test TSC for use in acute stroke. The planned Phase 2, randomized, double-blind, placebo-controlled trial calls for the administration of TSC by specially-trained Emergency Medical Technicians to ambulance-transported patients within two hours of the onset of a suspected acute stroke, potentially overcoming the current severe timing obstacle in the treatment of stroke patients. The trial, which has been named the Pre-Hospital Ambulance Stroke Trial – TSC (PHAST-T) is expected to commence in late 2018, subject to funding.

The Company further expanded its intellectual property portfolio in 2017, with the allowance of key patents that increased coverage of the therapeutic use of TSC and related compounds. The new areas include congestive heart failure, chronic renal failure, acute lung injury, chronic obstructive pulmonary disease and respiratory distress syndrome. Additional claims were also allowed relating to the treatment of a number of cancer types including brain and pancreatic, using TSC along with chemotherapy and radiation therapy.

Financial Results for the Year Ended December 31, 2017

We had cash and cash equivalents of $8.9 million as of December 31, 2017. Subsequent to the close of the year, on January 22, 2018 we closed an underwritten public offering of stock and warrants, raising approximately $12.0 million in gross proceeds.

We recognized $5.1 million in research and development expenses during 2017, compared with $7.3 million during 2016. This decrease was primarily attributable to a decrease of $1.3 million related to animal toxicology studies, a decrease of $0.9 million of pancreatic expenses, a decrease of $0.6 million related to stock-based compensation expense and a decrease of $0.3 million in manufacturing-related expenses. We also recognized a $1.0 million impairment charge upon our abandonment of future development efforts related to our RES-440 IPR&D asset in 2016. These decreases were offset by increases in GBM trial expenses of $1.6 million as we prepared for the Phase 3 clinical trial for TSC and increases in salaries and wages expenses of $0.2 million as a result of an increase in headcount. We currently expect our research and development expenses to increase significantly in future periods due to costs associated with our Phase 3 clinical trial for TSC, the Phase 2 trial for pre-hospital stroke therapy and overall efforts to advance the research and development of our technologies and product candidates.

General and administrative expenses were $6.2 million during 2017, compared with $11.1 million during 2016. The decrease was primarily due to a decrease of $3.2 million in professional fees incurred in 2016 in connection with preparations to operate as a public company and a $2.5 million decrease in non-cash litigation settlement fees, offset by increases in salary and wages and stock-based compensation expense of $0.4 million and $0.4 million, respectively, due to our increase in headcount.

In connection with the private placement of our Series A convertible preferred stock and common stock warrants in March 2017, we determined the warrants to be classified as liabilities and subject to remeasurement at each reporting period. As such, during 2017 we recorded a $22.1 million non-cash gain for the change in fair value of our common stock warrant liabilities, which was primarily attributable to the decrease in the market price for our common stock. We also recognized $10.2 million in excess fair value of the common stock warrants over the gross proceeds from our private placement and $2.9 million in placement agent commissions and other offering costs.

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 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company and its collaborators from MD Anderson Cancer Center and Northwestern Medicine will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1 trial, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 taking place April 14-18, 2018 in Chicago, Illinois (Press release, Cotinga, APR 3, 2018, View Source [SID1234533157]).

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Presentation Title: Safety and early efficacy signals for COTI-2, an orally available small molecule targeting p53, in a phase I trial of recurrent gynecologic cancer
Presentation Date and Time: Sunday April 15th, 2018 1:00 PM – 5:00 PM Central Time
Presentation Location: McCormick Place South, Hall A, Poster Section 42

Phase 1 Trial of COTI-2
The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and HNSCC. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy. In March 2018, the Company submitted a protocol amendment to expand the trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval and subject to sufficient financing, the Company expects to implement the protocol amendment mid-calendar year 2018.