On March 21, 2019 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will showcase ongoing studies and data on chimeric antigen receptor (CAR) T cell therapy, immunotherapy against solid tumors and more at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting from March 29 through April 3 in Atlanta (Press release, City of Hope, MAR 21, 2019, View Source [SID1234534536]).

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"We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

More than 22,500 scientists, advocates and clinicians from around the globe are expected to attend the 2019 AACR (Free AACR Whitepaper) meeting at the Georgia World Congress Center to discuss the latest advances in immunotherapy, artificial intelligence, targeted therapy, liquid biopsy, science policy and cancer health disparities.

"City of Hope’s physicians and scientists will share their discoveries and leading-edge expertise with colleagues in the cancer field," said Michael Caligiuri, Deana and Steve Campbell Physician-in-Chief Distinguished Chair, president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president.

Highlights of City of Hope’s significant contribution to discovering breakthroughs in cancer diagnosis, prevention and treatment include the following:

The immunotherapy arsenal: Ecology of the tumor microenvironment in breast cancer

Monday, April 1, from 3 to 5 p.m. in Room A311

To destroy a tumor, physicians shouldn’t just target the cancer cells, said Peter P. Lee, M.D., Billy and Audrey L. Wilder Professor in Cancer Immunotherapeutics at City of Hope. Doctors should also develop treatments that target or alter the tumor microenvironment. "Think of the tumor microenvironment as an ecosystem or a game of Jenga," Lee said. "The building blocks of a tumor comprise not just cancer cells, but also support (stromal) cells, immune cells, as well as an extracellular matrix. If you target any of the critical building blocks that support the cancer cells, you would still be able to get the tumor ecosystem to collapse."

For the past three years, Lee has led a convergent science team to study the Ecology of the Tumor Microenvironment in Breast Cancer through the support of Stand Up to Cancer. His team of biomedical scientists, physician-scientists, physicists, mathematicians and computer scientists has generated petabytes of data about the impact of the spatial interplay between components of the tumor microenvironment on disease progression. They have published papers in Nature Communications and the Proceedings of the National Academy of Sciences (PNAS); they are currently working on several additional manuscripts.

How population differences and environmental exposures affect tumor biology

Tuesday, April 2, from 10:30 a.m. to 12:30 p.m. in Room B206

Scientists are beginning to learn how environmental exposures like culture and individual life choices influence the biology of tumors and specific cell mechanisms. Research shows that more aggressive tumors with worse prognoses are sometimes the result of population differences and increased exposure to disease risk factors. Rick A. Kittles, Ph.D., associate director of Health Equities at City of Hope’s comprehensive cancer center, will discuss an ongoing study that looks at the role of vitamin D in prostate cancer. He will elaborate on how vitamin D intake can serve as a biomarker for prostate cancer risk. Victoria L. Seewaldt, M.D., Ruth Ziegler Chair in Population Sciences at City of Hope, will discuss breast cancer and how health disparities can result in obesity and inflammation, both of which improve the chance of incurring aggressive tumors in the breast.

How global health research advances cancer health equity in the U.S.

Friday, March 29, from 3 to 6 p.m. at Morehouse School of Medicine

Rick A. Kittles, Ph.D., director of the Division of Health Equities at City of Hope, and other scientists will discuss how global efforts to eliminate cancer contributes to the advancement of cancer health equity in the United States. Kittles will explore the impact different environments have on genes. In particular, he will talk about the African diaspora, which moved millions of people from western and central Africa to the Americas and the Caribbean. Genetically, these individuals are not very different, but different environmental and social experiences across the lifespan resulted in varied disease susceptibility and health outcomes.

Natural killer cells

Wednesday, April 3, from 7 to 8 a.m. in Room A311

Michael Caligiuri, M.D., president of City of Hope National Medical Center and former AACR (Free AACR Whitepaper) president, will detail natural killer cells and the findings his scientific teams have made in the past 25-plus years in this field. His research in natural killer cells and other topics led the AACR (Free AACR Whitepaper) Academy to induct Caligiuri as a fellow last year to recognize his significant scientific contributions that have propelled consequential innovation and progress against cancer.

The protein CD27+ may mark just how effective CAR T cell products are

Monday, April 1, from 1 to 5 p.m.

City of Hope researchers continue to make headway in developing more efficient CAR T cell treatments and are using a new preclinical study finding to try to refine its ongoing clinical trial of CAR T cell therapy against glioblastomas. Dongrui Wang, a Ph.D. candidate at the institution, Christine Brown, Ph.D., Heritage Provider Network in Immunotheraphy and associate director of the T Cell Therapeutics Research Laboratory at City of Hope, and others found that the immune T cell surface protein CD27 makes CAR T cells better tumor killers through interaction within its signaling molecule CD70. Specifically, CAR T cells enriched for CD27+ cells exhibited enhanced memory function and were able to perform their antitumor activity longer both in vitro and in vivo. "This study is a big step toward refining our CAR T cell manufacturing processes: We should preserve the CD27+ population to magnify the immunotherapy’s therapeutic applications," Wang said. "Our study also suggests that CD27+ can be used as a biomarker to predict how effective and potent an immunotherapy will be in specific patients in City of Hope’s clinical trials."

The glioblastoma clinical trial Wang referenced earlier opened in 2015 and is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope.

Poster session title: 2321 / 20: Dual-function of CD27-CD70 costimulatory signal in CAR T cell therapy

Combining engineered autologous T cells with enhanced T cell receptors in combination with a monoclonal antibody to treat solid tumors in advanced lung cancer

Tuesday, April 2, from 1 to 5 p.m.

Leading the path into the next stage of immunotherapy, City of Hope is enrolling patients in an autologous T cell clinical trial that aims to re-engineer and use a patient’s own immune T cells to attack solid tumors in their body. Enhanced T cell therapy has been successful in treating hematologic (blood) cancers and is in early development for solid tumors.

The randomized 1a/2b study will investigate the safety and efficacy of enhancing a patient’s own T cells with NY-ESO-1/LAGE-1a antigens so that their immune system will better attack advanced nonsmall cell lung cancer. The therapy, of course, can be used only in people whose tumors express the NY-ESO-1 and/or LAGE-1a receptors.

Today’s standard of care for advanced non-small cell lung cancer leads to long-term benefits for about 10 percent of patients, said Karen Reckamp, M.D., M.S., co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope and principal investigator of the ongoing clinical trial. The majority of patients with this disease have few treatment options. "T cell therapy is a high priority for City of Hope," Reckamp said. "We hope to move enhanced T cell therapy forward in solid tumors, especially in lung cancers."

In the ongoing clinical trial, the patient’s engineered T cells, called GSK3377794, will be used alone and in combination with pembrolizumab, a monocolonal antibody that blocks PD-1/PD-L1 interaction and increases the antitumor function of T cells. The synergistic treatment potentially can help certain patients with Stage 3 or Stage 4 nonsmall cell lung cancer – people who have tried other treatments but have not been able to find their way back to health.

The study is a part of the California Institute for Regenerative Medicine-sponsored Alpha Stem Cell Clinic at City of Hope. It is supported by GlaxoSmithKline and is a collaboration with Merck & Co., Inc.

Poster session title: CT225 / 19: A Phase 1b/2a randomized pilot study to investigate the safety and tolerability of autologous T cells with enhanced T cell receptors specific to NY-ESO-1L/LAGE-1a (GSK3388894) alone, or in combination with pembrolizumab, in advanced non-small cell lung cancer

Moving diagnostic technology into today’s world using artificial intelligence and 3D imaging

Monday, April 1, from 8 a.m. to noon

City of Hope and its affiliate Translational Genomics Research Institute (TGen) is collaborating with others to create the future of oncologic radiology – what City of Hope’s Syed Rahmanuddin, M.B.B.S., calls "the mammogram of pancreatic cancers." His team is using top-of-the-line technology to create artificial intelligence algorithms that compile a detailed 3D image of pancreatic cancer. The purpose is to enable physicians to identify the volume of blood flow (perfusion kinetics) of tumors and learn how effective a treatment is, facilitating adjustments to regimens to allow for improved targeted cancer therapy. Right now, the standard of care is flat, black-and-white multiphase computed tomography (CT) imaging. "Our new, patient-centered 3D imaging approach is like the transition from thinking the world is flat to understanding that the world is a globe: It opens up a whole world of possibility," Rahmanuddin said. "Our pilot study suggests that change in 3D volume and perfusion (blood flow) are important imaging markers that correlate with tumor progression, regression and aggression, which could be very helpful for the early detection of pancreatic cancer."

Daniel Von Hoff, M.D., physician-in-chief and distinguished professor of TGen, and Ronald Korn, M.D., Ph.D., of Imaging Endpoints were key contributors to this research.

Poster session title: 1622 / 20: Role of 3d volumetric and perfusion imaging for detecting early changes in pancreatic adenocarcinoma

Molecule found in orange peel slows down breast cancer tumor growth in mouse models

Wednesday, April 3, from 8 a.m. to noon

A molecule found on the skin of citrus fruits appears to inhibit the growth of breast cancer tumors in a mouse model. Compared to control mice with xenografted breast cancer cells, those who received 2’-Hydroxyflavanone (2HF) experienced reduced viability and proliferation of breast cancer cells. In addition, 2HF inhibited the expression of RLIP, a protein that is overexpressed in breast cancer cells. "While more research is needed to see if what we found in our mouse models can be translated to human subjects, it is important to note that natural compounds extracted from, say, orange peels is not toxic and has been shown to be beneficial, including lowering glucose triglycerides and cholesterol levels," said Sharad Singhal, Ph.D., lead author of the study and research professor in medical oncology at City of Hope. "In the distant future, it’s possible that 2HF supplements can be taken by breast cancer patients to enhance the effectiveness of medical treatment."

Poster session title: 4801 / 15: 2’-Hydroxyflavanone, a diet-derived citrus bioflavonoid, inhibits in vitro and in vivo growth of breast cancer cells by targeting RLIP.

On March 21, 2019 In an article published today by SAGE Publishing, investigators from The Nagourney Cancer Institute and The Albert Einstein Israelite Hospital in São Paulo, Brazil, reported a new approach to identifying effective treatments for patients with advanced metastatic cancers (Press release, Nagourney Cancer Institute, MAR 21, 2019, View Source [SID1234534558]). A drug commonly used to treat kidney and liver cancer was discovered effective for breast cancer, which may open new drug therapies to patients regardless of tumor type. The full article can be found at View Source

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The study reports the use of 3-dimensional-human-tumor derived organoids that were isolated directly from a patient’s drug resistant breast cancer. The drug identified, sorafenib (Nexavar), is widely used for the treatment of kidney and liver cancers but has not been found active, used, nor approved for patients with breast cancer.

"The finding of sorafenib activity was unexpected," said Dr. Robert Nagourney, one of the authors of the paper and the director for the laboratory where the studies were conducted.

When the patient with disease that had spread throughout her body had a near complete remission with only two months of oral therapy, a remission that lasted for over a year, the researchers examined possible mechanism for the response and believe that it reflects an entirely new form of cancer cell death known as "ferroptosis." This iron-mediated process of cancer cell death is uniquely activated by sorafenib.

"Of the many targeted drugs that we tested on the cancer cells from a woman who had few options remaining, it was only sorafenib that had this effect, prompting our colleagues in São Paulo to begin therapy immediately," said Dr. Nagourney. "We are fortunate to have fantastic collaborators in Brazil who tested this therapy to such good effect."

The results could not have been more dramatic as the patient showed compete metabolic response by PET/CT only weeks later.

"We are witness to a new concept in cancer medicine where drugs can be identified and selected for individual patients in the laboratory regardless of the tumor type, that is, breast versus kidney versus lung. Drugs do not know what disease for which they were invented," he added.

The drug selection technique employed by Dr. Nagourney was developed by scientists in his laboratory in California. It uses fresh biopsies removed directly from patients to study each cancer patient’s biology to select from amongst dozens of drugs and combinations, those that will work the best. This is but one more example of what is known as repurposing drugs, allowing physicians to outsmart cancers by going around their defenses.

"It is the availability of the EVA/PCD testing platform that for this first time is making it possible to make rational drug choices for cancer patients based upon each individual’s unique features," Nagourney concluded.

On March 21, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported its financial and operational results for year ending December 31, 2018 (Press release, IMV, MAR 21, 2019, View Source [SID1234534539]).

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"IMV made significant advances in 2018," said Frederic Ors, Chief Executive Officer. "Foundational changes, including shifting the name of the corporation to IMV and listing on Nasdaq, are enabling us to access to a larger pool of investors and allow us to better communicate our value proposition globally. However, the evolution of our clinical program is an even more important accomplishment: we entered into a collaboration with Merck across five tumor types; opted, based on DECIDE clinical data, to pursue DPX-Survivac as a monotherapy in ovarian cancer; and published studies clearly demarcating the T cell-activating novel mechanism of action of our DPX platform. With these milestones achieved, we are looking forward to a strong 2019 in which we will continue to advance our pipeline, drive value for investors, and support unmet patient needs."

IMV will host a conference call and webcast tomorrow at 8 a.m. ET. The dial-in number for the conference call is (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 9647179. A live audio webcast will be available through IMV’s website on the ‘Events and Presentations’ page at View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

Recent Clinical Updates & Expected Milestones

Phase 1b/2 DPX-Survivac monotherapy and combination trial in ovarian cancer (DECIDE)

The first 13 patients with advanced recurrent ovarian cancer have been enrolled in the phase 2 portion of the study. Six patients were randomized on DPX-Survivac monotherapy and seven were randomized on the DPX-Survivac/epacadostat combination. The Corporation is planning to provide an update on the preliminary clinical data by the end of Q1 2019.

Enrollment of an additional 15 patients in a population with lower tumor burden is ongoing and the corporation is planning to provide another clinical update on this cohort in Q2 2019.

Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPIREL)

Seven patients have been enrolled and treated across four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data in Q2 2019.

Phase 2 Basket Trial in Combination with KEYTRUDA in Multiple Solid Tumors

Screening and enrollment of patients is ongoing at multiple clinical sites across the U.S. and Canada for patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker. The first patients have been dosed in the ovarian and lung cancer cohorts. IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.

2018 Highlights

Clinical Programs – DECIDE1/2 Advanced Ovarian Cancer Trial

Updated Phase 1b data shared via an oral presentation at the 2018 ASCO (Free ASCO Whitepaper) Meeting and topline data from the first two Phase 1b dosing cohorts highlighted at the 2018 ESMO (Free ESMO Whitepaper)-IO Meeting
Based on these data, IMV opted to develop DPX-Survivac as a monotherapy in certain ovarian cancer patients defined by BTB (baseline tumor burden), an indication of tumour size
Additional analyses were conducted that correlated DPX-Survivac’s novel MOA – the level of T cell infiltration – with clinical response
Met with the U.S. Food and Drug Administration (FDA) and submitted an updated DECIDE trial protocol; in addition, IMV discussed with the FDA the need for accelerated approvals in advanced ovarian cancer and received guidance on clinical design considerations for different lines of therapy and platinum-sensitive and resistant patients
Additional Clinical Highlights

First clinical data obtained from the combination of DPX-Survivac and mCPA with Keytruda (SPIREL Trial), which came from an investigator-sponsored phase 2 trial in patients with persistent or recurrent/refractory DLBCL; data from the combination signaled significant anti-cancer activity in three of the first four evaluable patients as well as a tolerable safety profile
Announced a collaboration with Merck in a phase 2 basket trial evaluating the safety and efficacy of DPX-Survivac, low-dose cyclophosphamide, and Keytruda (pembrolizumab) in patients with select advanced or recurrent solid tumors across five different indications: bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors with the microsatellite instability high (MSI-H) biomarker
R&D Milestones

Research published in the Journal of Biomedical Science demonstrated the association between IMV’s proprietary immune-targeted delivery technology and enhanced efficacy in slowing tumor progression
New data presented at the 2018 AACR (Free AACR Whitepaper) Meeting highlighted the novel MOA underscoring the Corporation’s T cell-activating DPX technology and the potential for heightened anti-cancer activity of combination therapies based on IMV’s proprietary delivery platform
Operational Highlights:

Completion of two public offerings: In February 2018 and in March 2019 for a total of approximately $43.9 million
Nasdaq listing and share consolidation: IMV’s common shares commenced trading on the Nasdaq Stock Market LLC on June 1, 2018
Corporate name change: Because the MOA of DPX-based candidates signals a new class of immunotherapies that is differentiated from vaccines, IMV leadership changed the corporation’s name from Immunovaccine to IMV to better reflect the true potential of its therapeutic candidates
Addition of Julia P. Gregory and Dr. Markus Warmuth to the Corporation’s Board of Directors: Ms. Gregory is a seasoned biotechnology executive, having served as Chief Executive Officer and of ContraFect Corporation and the immuno-oncology company Five Prime. Dr. Warmuth brings to the Board more than 20 years of drug discovery experience with a strong focus on targeted therapy and immuno-oncology programs
Expansion of management team: IMV named Joseph Sullivan as the Corporation’s first Senior Vice-President, Business Development. Mr. Sullivan brings with him over 25 years of global pharmaceutical experience with Merck & Co. Inc. to IMV
Opening of new facility in Dartmouth, Nova Scotia: Nearly tripling the functional workspace, the new premises feature upgraded facilities and equipment as well as increased laboratory size to support long-term growth
Cash position: As of December 31, 2018, cash and cash equivalents and short-term investments were $14.9 million (excluding the $29.5 million financing completed in March 2019) compared to $14.9 million as of December 31, 2017
Overview of Year-End 2018 Financial Results

The net loss and comprehensive loss of $21,935,000 ($0.50 per share) the year ended December 31, 2018 was $9,908,000 higher than the net loss and comprehensive loss for the year ended December 31, 2017.

Research and development expenses increased by $6,914,000 for the year ended December 31, 2018, compared to 2017. These increases are mainly due to higher enrollment in the phase 1b/2 Incyte trial in ovarian cancer; milestone payments for the phase 2 study in DLBCL; and expenses related to the initiation of the basket trial. The increase is also attributable to manufacturing activities to support the increased clinical activity, which included purchasing raw materials and contract manufacturing organization costs.

General and administrative expenses increased by $2,039,000 for the year ended December 31, 2018 compared to 2017. This increase is mainly due to the various expenses related to the Nasdaq listing (legal, audit and consulting fees as well as listing fees) that are non-recurring expenses, the filing of a shelf prospectus, the increase in insurance premiums following the Nasdaq listing, consulting and professional fees, regulatory fees, the increase of the rent, lease interest accretion, and utilities related to the new facility.

Business development and investor relations expenses increased by $781,000 for the year ended December 31, 2018 compared to 2017. These increases are mainly explained by the hiring of a Senior Vice President, Business Development in January 2018 and a Senior Director of Investor Relations and Communications in November 2018.

At December 31, 2018, the Corporation had cash and cash equivalents of $14,895,000 (excluding the $29.5 million financing completed in March 2019) and working capital of $12,247,000, compared with $14,909,000 and $13,627,000, respectively at December 31, 2017. For the year ended December 31, 2018, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $18.4 million. IMV expects research and development expenditures to increase over time due to the continuing development of product candidates and other clinical, preclinical, and regulatory activities.

As of March 21, 2019, the number of issued and outstanding common shares was 50,594,260 and a total of 2,008,057 stock options, warrants, and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2018 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

On March 21, 2019, MabVax Therapeutics Holdings, Inc. (the "Company") reported that it filed a voluntary petition for reorganization relief under Chapter 11 of Title 11 of the United States Bankruptcy Code (the "Bankruptcy Code") in the United States Bankruptcy Court for the District of Delaware (the "Bankruptcy Court") (Case No. 19-10603 (CSS)) (Press release, Blueprint Medicines, MAR 21, 2019, View Source [SID1234537257]). The Company continues to manage and operate its business as a debtor in possession pursuant to Bankruptcy Code Sections 1107 and 1108. The Company intends to sell substantially all of its assets pursuant to Section 363 of the Bankruptcy Code in the sixty days following the filing of its Chapter 11 petition under a Bankruptcy Court supervised sales process and, subject to sales proceeds and remaining assets, could convert its case to Chapter 7, at which point a Chapter 7 trustee will be appointed by the Bankruptcy Court.

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On March 21, 2019 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibody-based medicines generated by its proprietary platforms, reported a comprehensive program to target TNFR2 for therapy of cancer (Press release, BioInvent, MAR 21, 2019, View Source [SID1234534525]). Using the n-CoDeR & F.I.R.S.T. platforms, the company has generated a broad panel of highly specific anti-TNFR2 antibodies, including the lead candidate antibody BI-1808, that may have broad utility in the treatment of solid cancers. BI-1808 is currently in preclinical development, and expected to enter clinical trials in the first half of 2020.

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Tumor necrosis factor 2 (TNFR2) is viewed as a highly promising receptor to target to overcome immune resistance in the tumor microenvironment. TNFR2 is found predominantly on regulatory T cells (Treg cells) in tumor tissue and has in several studies been associated with the most suppressive Treg cells. TNFR2 is known to play an important role both in the proliferation and function, as well as phenotypic stability of Treg cells. TNFR2 is also strongly associated with so called myeloid derived suppressor cells (MDSCs) in the tumor milieu and has been shown to both drive their accumulation and suppressive function. Its relatively selective expression together with its important function in the overall immune suppressive tumor microenvironment make TNFR2 a very compelling immune oncology target. Supporting preclinical data are expected to be submitted for publication in a peer-reviewed journal late 2019.

Björn Frendéus, CSO of BioInvent, said, "We believe targeting TNFR2 for cancer therapy holds great promise. Thanks to our proprietary n-CoDeR & F.I.R.S.T. platforms we have been able to generate first-in class anti-TNRF2 antibodies that are highly specific. We are pushing our first lead candidate BI-1808 towards the clinic, and are on track to commence clinical development in the first half of 2020."