On June 17, 2019 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) reported that it will offer up to $12 Million of its common stock in public offering (Press release, Ampio, JUN 17, 2019, View Source [SID1234537126]). Ampio has entered into purchase agreements for the purchase of an aggregate 25,320,000 common shares of the Company at an offering price of $0.40 per Common Share for aggregate gross proceeds of $10.1 million, before placement agent fees and other offering expenses. Ampio anticipates an additional 4,680,000 shares of its Common Stock will be sold at the same price at the close of the offering. The offering is expected to close on or about June 19, 2019.

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The Company intends to use the net proceeds from this offering for the full cost of its AP-013 clinical trial pursuant to its recently announced Special Protocol Assessment and other general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the exclusive placement agent for this transaction.

All of the common stock in this offering were offered on a reasonable best efforts, any and all basis pursuant to an effective shelf registration statement. A prospectus supplement relating to the offering was filed by the Company with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from ThinkEquity, 17 State Street, 22nd Floor, New York, NY 10004 (646) 968-9355, Email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 17, 2019 Candel Therapeutics (a.k.a. Advantagene, Inc.) reported that it has completed enrollment of the "ULYSSES" trial, a Phase 2 study of ProstAtak for prostate cancer patients choosing Active Surveillance (PrTK04- NCT02768363) (Press release, Candel Therapeutics, JUN 17, 2019, View Source [SID1234537124]). Enrollment is still open for prostate cancer patients choosing radiation therapy as their primary treatment (PrTK03- NCT01436968). ProstAtak is Gene Mediated Cytotoxic Immunotherapy (GMCI – aglatimagene besadenovec (AdV-tk) plus oral valacyclovir) for treatment of prostate cancer. GMCI is an "off the shelf", low-toxicity immunotherapy that stimulates a patient’s own immune system to generate a robust and precise response against their cancer.

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In the USA, about 175,000 men are diagnosed with localized prostate cancer each year. Approximately one third of these patients choose Active Surveillance (AS), a strategy to monitor rather than radically treat their disease. If the disease progresses, radical surgery or radiation are still options. AS is chosen primarily to avoid or postpone the significant risk of urinary incontinence and sexual dysfunction often associated with radical treatments. The number of patients on AS has been steadily increasing over the past 5 years.

The ULYSSES study enrolled 190 patients at 22 clinical sites. The size of the study was expanded from an originally planned 156 patients due to investigator and patient demand. The primary endpoint for the trial is change in tumor-risk markers such as tumor grade and extent of disease. Other endpoints of interest include time to radical treatment and safety. Topline data is expected late next year.

"Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy," said Dr. Scott Eggener, Professor of Surgery and Radiology and Director of the Prostate Cancer Program at University of Chicago and a lead investigator in the Ulysses study. "It would be very exciting if there was an easily delivered and safe intervention that significantly lowers the likelihood of these men ever requiring surgery or radiation."

Candel is also conducting PrTK03, a registration trial with ProstAtak for the treatment of intermediate-high risk localized prostate cancer patients undergoing radiation under a Special Protocol Assessment approved by the U.S. Food and Drug Administration. If proven efficacious, ProstAtak will be the first and only therapeutic pharmaceutical available for newly diagnosed prostate cancer. The company is conducting additional GMCI clinical studies in pancreas, lung, and brain cancers with impressive clinical results to date.

"We are thrilled with the progress of the Ulysses study," stated Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel, "we are grateful to the patients and doctors that are participating and are very hopeful that their efforts will result in better outcomes for future cancer patients. With side effects similar to those of a flu shot, ProstAtak could one day become a first-line ‘Pro-Active Surveillance’ option for the thousands of men diagnosed with low-risk prostate cancer every year."

On June 17, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the clinical results of CT103A, the potential best-in-class therapy of fully-human BCMA CAR-T co-developed by Innovent and Nanjing IASO Biotherapeutics (IASO BIO), was presented by oral presentation and poster at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the 24th Congress of the European Hematological Society (EHA) (Free EHA Whitepaper) [Abstract #S827; Saturday, June 15, 12:35 PM – 12:45 PM CEST] and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago Illinois [Abstract #8013; Tuesday, June 4, CDT] (Press release, Innovent Biologics, JUN 17, 2019, View Source [SID1234537123]). The IIT study was conducted at Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology.

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CT103A is an anti-BCMA CAR-T co-developed by Innovent and IASO BIO for the treatment of Relapsed/Refractory Multiple Myeloma (RRMM). The data of CT103A presented at both conferences show an impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%. The data are especially encouraging for patients who relapsed from a prior CAR-T treatment with mouse-based antibody, thus providing a viable option for this group of tough-to-treat patients.

Multiple myeloma is a malignant hematologic cancer with abnormal proliferation of clonal plasma cells, which has no medical cure so far. In many countries, myeloma is the second most common blood cancer. The American Cancer Society estimates that in the United States (U.S.), about 32,110 new cases will be diagnosed this year. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018. Among them, 40 percent of patients are diagnosed with moderate or high-risk multiple myeloma, and their median survival is less than five years.

As of the data cutoff (22 May 2019), the objective response rate (ORR) was 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in-vivo. All patients (100%) experienced CRS. The onset of CRS occurred within 2-5 days (median-2.6) and resolved within 14 days. Mostly grade 1 and 2, at the lowest dosage levels, CRS was routinely managed with Tocilizumab and steroids. Interestingly, the 11 patient study included 4 patients having previously relapsed from a prior CAR-T therapy, a murine anti-BCMA CAR-T.

"RRMM is associated with a poor prognosis," said Dr. Chunrui Li of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. "Many patients who receive CAR-T treatments have had their disease recurrence, and with a non-human scFv, re-treatment may not be an option due to immunogenicity. With a fully-human BCMA scFv, CT103A provides an effective option for these patients. This data suggests they should not be excluded from the benefit of future trials."

About RRMM

For newly treated patients with multiple myeloma, the common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient’s condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are patients who have reappeared after complete remission of the disease. Refractory patients are patients with primary drug resistance or the patients who have finished with first-line treatment do not achieve remission, or the patients whose disease progress within 60 days after achieving minimal response. For the majority of patients with effective treatment, they will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.

About CT103A
CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with RRMM who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully-human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.

About Nanjing IASO Biotherapeutics

Founded in 2017, IASO BIO is a clinical stage biotechnology company advancing the development of innovative therapies for cancer. IASO BIO stands out in fierce competition through innovation, a world class facility, and an internationally renowned clinical research team. IASO BIO is dedicated to curing cancer using engineered autologous/allogenic T cell therapies designed to enhance the immune system’s ability to recognize and eradicate cancer cells. Currently, IASO BIO is developing over 10 high-potential high-end biopharmaceutical products, targeting hematological tumors, solid tumors and virus associated tumors. For more information, please visit： www.iasobio.com.

On June 17, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that a review article in Cancer Cytopathology, a journal of the American Cancer Society, details how new RNA whole-transcriptome sequencing-based genomic testing is helping physicians overcome a range of challenges in the diagnosis and treatment of thyroid cancer (Press release, Veracyte, JUN 17, 2019, View Source [SID1234537122]). The article describes how the technology behind Veracyte’s Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas (XA) is helping to reduce unnecessary surgeries in thyroid cancer diagnosis, and also inform surgery and treatment decision-making using the same minimally invasive patient sample. The article is highlighted on the cover of the June print issue, which is scheduled to be available the week of June 17, 2019.

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Challenges involved in the management of thyroid nodules include: Differentiating benign from malignant thyroid nodules when cytopathology results are indeterminate; determining the extent of initial thyroid surgery needed; and identifying targeted treatments for patients with thyroid cancers that do not respond to standard treatment.

"New advances in genomic technology and our understanding of the genomic underpinnings of thyroid disease are changing the landscape for how physicians diagnose and treat patients with thyroid nodules and cancer," said William C. Faquin, M.D., Ph.D., pathologist at Massachusetts General Hospital and Editor-in-Chief of Cancer Cytopathology. "In the last 10 years, physicians have increasingly used genomic testing to help reduce unnecessary thyroid surgeries when the cytopathology sample is indeterminate for cancer. Now, genomic technology can identify gene mutation drivers of disease to inform the type of surgery to be performed. Increasingly, molecular testing may also help guide the use of targeted therapies that are available or in development for patients who do not respond to standard treatment."

The article, titled "Extending Expressed RNA Genomics from Surgical Decision Making for Cytologically Indeterminate Thyroid Nodules to Targeted Therapies for Metastatic Thyroid Cancer," describes the development of and evidence behind the Afirma GSC and XA. Both tests leverage RNA whole-transcriptome sequencing technology to measure gene expression in potentially cancerous thyroid nodules. The authors note that RNA transcriptome technology may provide advantages over DNA-based genomic findings because it reflects a nodule’s current genomic activity, as compared to DNA-based approaches, which may show inactive gene mutations.

Two targeted therapies are now approved by the U.S. Food and Drug Administration for treating thyroid cancer patients: a combination of dabrafenib plus trametinib for BRAF V600E-mutated anaplastic thyroid cancer; and larotrectinib for solid tumors harboring a NTRK gene fusion, regardless of cancer type. Additionally, multiple other recent clinical trials have investigated therapies with specific targets that are relevant for thyroid cancer. These include two compounds targeting RET alterations, which were the subject of new data presentations at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The Afirma XA identifies these gene alterations, which can help physicians determine which patients could benefit from these cutting-edge new treatments.

"We believe that our novel RNA whole-transcriptome sequencing platform uniquely enables our Afirma offering to answer important clinical questions that can guide various points in a patient’s journey, helping to improve outcomes," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Further, by providing this comprehensive information from the original biopsy used in diagnosis, we can streamline workflows and enable patients to get the answers they need faster and more easily."

About Afirma Genomic Testing

The Afirma GSC and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis and individualization of care. Veracyte developed the Afirma GSC with RNA whole-transcriptome sequencing and machine learning. The test helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. Afirma GSC testing is widely used in thyroid cancer diagnosis and is covered by Medicare and most of the nation’s leading private health insurers. The Afirma XA provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma XA includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

About Thyroid Cancer

The American Cancer Society estimates that 52,070 people in the United States will be diagnosed with thyroid cancer this year. Each year in the United States approximately 525,000 patients undergo FNA biopsies to evaluate thyroid nodules for cancer. Up to 30 percent of these patients receive indeterminate results – meaning they are not clearly benign or malignant – and, historically, most were directed to diagnostic surgery even though 70 percent to 80 percent of the time the nodules ultimately proved to be benign.

On June 17, 2019 Resolution Bioscience, Inc., reported the publication of a blinded performance evaluation between two cell-free DNA (cfDNA) next-generation sequencing (NGS) assays (Press release, Resolution Bioscience, JUN 17, 2019, View Source [SID1234537121]). The publication reports that the team of scientists, led by lung cancer researchers and clinicians at Dana-Farber Cancer Institute, found that the Resolution ctDx-Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test. The peer-reviewed manuscript, "Sensitivity of next-generation sequencing assays detecting oncogenic fusions in plasma cell-free DNA," was released online ahead of publication in Lung Cancer.

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Plasma genotyping has shown the ability to identify actionable, targetable mutations to drive personalized therapy for patients with advanced non-small cell lung cancer (NSCLC). However, leading commercial platforms have generated variable results when detecting complex variations, such as oncogenic gene fusions or copy number variations. In this comparison study, a cohort of 169 NSCLC patients with Guardant360 plasma results was screened for the presence of gene fusions based on previous tumor tissue analysis. Scientists at Dana-Farber used the Resolution kit in their lab to analyze the plasma of 16 patients who had a rearrangement in their tumor. All personnel involved in sample analysis were blinded to tumor genotype and Guardant360 results.

The Resolution assay detected 13 out of 16 (81.3%) fusions (allele frequency range 0.17-62.8%), while the Guardant360 test detected only seven (43.8%) fusions (allele frequency range 0.3-8.2%). For cases detected by both assays, the Resolution technology identified the mutation at a median of 7% higher allele frequency, which is indicative of a higher capture rate of breakpoint bearing cfDNA that increases overall sensitivity. For the six patients in which a fusion was detected by the Resolution assay but not by Guardant360, the average time to treatment discontinuation was 15.2 months (full range of 3-34 months).

"The Resolution liquid biopsy platform is designed to provide a fast, accurate, and non-invasive solution for mutationally comprehensive tumor genotyping," said Mark Li, CEO of Resolution Bioscience. "While this was a small study, we measure our success one patient at a time. Two patients with a fusion undetected by Guardant360 were on treatment for more than 30 months."

Dana-Farber scientists hypothesized that the Resolution assay offers more efficient hybridization to cfDNA fragments due to its use of tiled, short (˜40 nt) capture probes rather than more common 120 nt probes.

"Our targeted sequencing platform was designed from the ground up for analysis of cfDNA fragments. The shorter probes maintain high specificity while allowing better detection of the low amounts of mutation-bearing fragments often found in plasma," said Li. "Importantly, scientists at the Dana-Farber Cancer Institute performed the assay within their lab, demonstrating the potential of a distributed model."

Scientists presented the early results of this retrospective liquid biopsy comparison study between Resolution’s ctDx-Lung assay and Guardant Health’s Guardant360 test at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. To view the full manuscript, please visit View Source

About Resolution Bioscience’s Technology

The Resolution liquid biopsy assays are powered by the company’s patented cfDNA NGS analysis platform, which includes proprietary targeted capture NGS chemistry and tightly coupled, cloud-based bioinformatics. Resolution’s technology has now been recognized as novel by the US Food and Drug Administration and has been cited in several important research publications and presentations. For example:

The Resolution HRD assay was recently granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
The company was the first to demonstrate detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
Resolution recently published 97% clinical response data with Memorial Sloan Kettering Cancer Center for non-small cell lung cancer patients who received plasma-directed therapy selection from Resolution’s assay. With more than 950 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
In a recent AstraZeneca publication, Resolution had the highest positive predictive value (PPV) and lowest false positive rate amongst four leading NGS liquid biopsy companies in a blinded comparison study.