On June 14, 2019 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) ("Ampio"), reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Ampio, JUN 14, 2019, View Source [SID1234537096]). Ampio expects to grant the underwriters a 45-day option to purchase additional shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Ampio intends to use the net proceeds from the proposed offering for working capital and general corporate purposes, including funding for its clinical trial (AP-013).

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-217094) relating to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (SEC) and is effective. This press release shall not constitute an offer to sell or the 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.

A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the SEC’s website at View Source

Safe Harbor

This press release contains forward-looking statements regarding the proposed public offering and the intended use of proceeds from the offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including those risks disclosed in under the caption "Risk Factors" in the preliminary prospectus supplement related to the offering and our Annual Report on Form 10-K filed with the SEC on March 18, 2019, our Quarterly Report on Form 10-Q filed with the SEC on May 10, 2019 and our other filings with the SEC. Ampio Pharmaceutcials, Inc. cautions readers not to place undue reliance on any forward-looking statements and it does not undertake, and specifically disclaims any obligation, to update

On June 14, 2019 Flatiron Health reported that Dr. Michael Vasconcelles, a practicing oncologist and senior biotechnology and pharmaceutical executive, has joined as Chief Medical Officer, effective August 2019 (Press release, Flatiron Health, JUN 14, 2019, View Source [SID1234537095]). Dr. Vasconcelles will be responsible for defining and executing the company’s strategic vision for real-world evidence, providing thought leadership and guidance around novel clinical research methods, and partnering with clients and stakeholders, including government agencies, to further the use of real-world data derived from electronic health records.

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"As an industry, we are seeing rigorous discussions, development of standards and concrete applications of real-world data for cancer research," said Zach Weinberg, COO and co-founder, Flatiron Health. "Dr. Vasconcelles’s deep clinical, development and regulatory experience will help drive these efforts industry-wide, and we are excited to bring that experience to bear so we can continue to serve our partners and patients across the oncology landscape."

As Chief Medical Officer, Dr. Vasconcelles will work cross-functionally to drive the overall strategy and execution of Flatiron’s research business. Dr. Vasconcelles will focus on Flatiron’s research, quality and regulatory offerings, and Dr. Bobby Green will continue to serve as Chief Medical Officer focusing on the clinical development of Flatiron’s suite of technology and services for community oncology.

"We are at a defining moment in oncology, where cancer research and clinical treatment are informing one another, driving a holistic learning healthcare system," said Dr. Michael Vasconcelles. "Flatiron has been at the forefront of developing real-world data for cancer research, and I am excited at the opportunity to be able to contribute to their mission of improving lives by learning from the experience of every cancer patient."

Dr. Vasconcelles most recently served as chief medical officer at Unum Therapeutics, a Cambridge-based oncology biotech focused on developing engineered autologous T cells for the treatment of cancer. Previously, as a member of their respective oncology business unit and R&D management teams, Dr. Vasconcelles was directly accountable for the research and development strategy and execution at Takeda/Millennium and Genzyme for their oncology portfolios, from discovery through product licensure and post approval. Following Sanofi’s acquisition of Genzyme, Dr. Vasconcelles joined Sanofi Oncology as head of the personalized medicine and companion diagnostics division.

Dr. Vasconcelles currently serves as a clinical instructor in medicine at Harvard Medical School, where he has taught since 1996, and is a practicing oncologist and associate physician at the Dana-Farber Cancer Institute and Brigham & Women’s Hospital in Boston.

Flatiron’s former chief medical officer, Dr. Amy Abernethy, joined the U.S. Food & Drug Administration as principal deputy commissioner in early 2019.

To learn more about Flatiron, visit www.flatiron.com or follow us @FlatironHealth.

On June 14, 2019 Mawdsleys and Meabco A/S reported that have launched a Named Patient Supply program to allow Oncologists within the European Union (EU) to obtain access to BP-C1 on an unlicensed basis for the treatment of metastatic breast cancer and incurable pancreatic cancer (Press release, Meabco, JUN 14, 2019, View Source [SID1234537094]).

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BP-C1 is a new benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride developed for patients suffering from metastatic breast cancer

The Named Patient Supply program for the EU will allow physicians early access to BP-C1 for their patients. Mawdsleys’ Director of Specialty Pharma, David Regan, comments "We are pleased to be working with Meabco to add BP-C1 to our growing portfolio of oncology and rare disease medicines which Mawdsleys can make available on an early access basis to help provide new treatment options to patients with serious unmet medical needs."

Healthcare professionals can obtain further details about the BP-C1 Named Patient Supply program using the contact details below.

NOTES TO EDITORS

About BP-C1

BP-C1 is an anti-neoplastic agent with palliative properties and is based on Meabco’s patented polyphenolic technology platform. BP-C1 offers a combination of immunomodulation and tumor control in one product. Usually, immunomodulation and tumor control are obtained separately by using two or more drugs.

BP-C1 has been tested in a wide range of animal trials as well as in human phase II clinical trials. The safety profile is high with very low toxicity. BP-C1 acts apoptotic, anti-proliferative and anti-angiogenic on tumor cells, while at the same time contributing to anti-cancer immune regulatory activities. Opposite to other kind of chemotherapy, BP-C1 is given as one daily intramuscular injection in the outpatient clinic or at home by a nurse or the patient himself.

BP-C1 has been tested in close to 300 breast and pancreatic cancer patients in seven countries with promising results. It is noteworthy, that more than 80% of breast cancer patients and more than 60% of pancreatic cancer patients responded to the therapy. BP-C1 is aimed at fighting the cancer combined with strengthening the body’s immune system.

On June 14, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST (Press release, Blueprint Medicines, JUN 14, 2019, View Source [SID1234537093]). Currently, no effective therapy exists for either population. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST.

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Print

Avapritinib has received Breakthrough Therapy Designation from the FDA for the treatment of patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation, as well as Fast Track Designations for the treatment of patients with GIST harboring a PDGFRα D842V mutation regardless of prior therapy, and patients with GIST who have progressed following treatment with imatinib and a second tyrosine kinase inhibitor.

Blueprint Medicines has requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

"There is an important need for new treatment options that offer durable responses for PDGFRA Exon 18 mutant and fourth-line GIST patients," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "By targeting the underlying molecular drivers of GIST, avapritinib has the potential to help these patients realize the benefits of precision therapy. We plan to work closely with the FDA to bring avapritinib to appropriate GIST patients as quickly as possible."

About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the gastrointestinal (GI) tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.

Most GIST cases are caused by a spectrum of clinically relevant mutations that force the KIT or PDGFRA protein kinases into an increasingly active state. Because currently available therapies primarily bind to the inactive protein conformations, certain primary and secondary mutations typically lead to treatment resistance and disease progression.

In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Mutational testing is critical to tailor therapy to the underlying disease driver and is recommended in expert guidelines. Currently, there are no approved therapies for patients with KIT-driven GIST whose disease progresses beyond imatinib, sunitinib and regorafenib. In patients with metastatic PDGFRα D842V-driven GIST, progression occurs in a median of approximately three to four months with available therapy.

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRα D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.

On June 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported updated results from a pivotal Phase 2 study of tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) in a poster at the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 13-16, 2019 in Amsterdam (Press release, BeiGene, JUN 14, 2019, View Sourcenews-releases/news-release-details/beigene-announces-updated-results-pivotal-phase-2-study" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-updated-results-pivotal-phase-2-study" rel="nofollow">View Source [SID1234537092]).

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"The encouraging clinical results from this study further support our new drug application for tislelizumab in patients with R/R cHL that is currently under priority review in China," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We hope that this potentially differentiated anti-PD-1 antibody could become a new treatment option for cancer patients in China and across the world."

"Tislelizumab demonstrated high anti-tumor activity in patients with R/R cHL – evidenced by an overall response rate of 87% and a complete response rate of 63%, and was generally well tolerated in these patients," said Yuqin Song, M.D., Ph.D., Associate Professor of Medical Oncology, Deputy Director of the Lymphoma Department at Peking University Cancer Hospital in China, and the presenting author of the study.

Summary of Clinical Results

Abstract Number: PF469

This single-arm, multi-center, pivotal Phase 2 study of tislelizumab as a monotherapy in Chinese patients with R/R cHL (clinicaltrials.gov identifier: NCT03209973) enrolled 70 patients who were either R/R to autologous stem cell transplantation (ASCT), or received at least two prior lines of systemic therapy for cHL and were not candidates for ASCT. Patients were treated with tislelizumab, dosed at 200 mg intravenously every three weeks. The primary endpoint of the trial is overall response rate (ORR) assessed by independent review committee (IRC) according to the Lugano Classification 2014.

As of November 26, 2018, 70 patients with R/R cHL were evaluable for efficacy. Thirteen patients received prior ASCT, and the remaining 57 patients were ineligible for ASCT. Patients had a median of three prior lines of systemic therapy (2-11). Results included:

With a minimum of 23.8 weeks of follow-up and a median follow-up time of 13.9 months at the data cutoff, the ORR by IRC was 87.1% (61/70); 44 patients (62.9%) achieved a complete response (CR), and 17 patients (24.3%) achieved a partial response (PR);

The median duration of response (DOR) has not been reached;

Twelve-month progression-free survival (PFS) was estimated at 73.8% and median PFS has not been reached;

The majority of adverse events (AEs) were grade 1 or 2 in severity. The most frequently reported treatment-emergent adverse events (TEAEs) of any grade include pyrexia (57.1%), weight increase (34.3%), upper respiratory tract infection and hypothyroidism (32.9% each), pruritus, white blood cell (WBC) count decreased, and cough (18.6%, each);

Grade ≧3 TEAEs occurred in 30% of patients, with the most frequently reported being hypertension, pneumonitis, neutrophil count decrease, upper respiratory tract infection, and weight increase (2.9%, each); only 2.9% of patients reported grade 4 TEAEs and there were no fatal TEAEs.

Four patients (5.7%) discontinued treatment due to TEAEs, including pneumonitis (n=2), focal segmental glomerulosclerosis (n=1), and organizing pneumonia (n=1); and

Immune-related (ir) TEAEs reported in more than 5% of patients included thyroid disorder (22.9%), skin adverse reactions (8.6%)*, and pneumonitis (7.1%).
Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Classical Hodgkin Lymphoma

Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin lymphoma, the most common form representing about 95% of patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is being studied in a broad clinical program. BeiGene has completed a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL). Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; a Phase 3 trial in patients with Stage III NSCLC; a Phase 2 clinical trial in second- or third-line patients with HCC; and a Phase 2 clinical trial in patients with R/R NK/T-cell lymphomas. The aforementioned studies are enrolling patients in multiple countries, including the U.S., Europe, and China.

Additionally, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic UC; and a pivotal Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies are enrolling patients in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and the R/R cHL filing has been granted priority review. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).