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Onconova Therapeutics, Inc. Announces $10 Million Registered Direct Offering Priced At-The-Market

On December 31, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova" or the "Company"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has entered into definitive agreements with [two] healthcare-focused institutional investors for the issuance and sale in a registered direct offering of 27,662,518 shares of its common stock at a purchase price of $0.3615 per share, for aggregate gross proceeds of approximately $10 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Onconova, DEC 31, 2019, View Source [SID1234552639]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The offering is expected to close on or about January 3, 2019, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including advancing preparations for a planned New Drug Application (NDA) filing to the FDA for intravenous rigosertib in second-line higher-risk MDS in 2020, and advancing preparations for commercialization if the NDA is approved. The Company surpassed 90% of the required enrollment of the INSPIRE Trial in November 2019 and anticipates reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events. With the additional expected proceeds from the offering and the proceeds from recent warrant exercise, the Company believes that it has the sufficient funds to extend operations and ongoing trials late into the first quarter of 2021.

The shares of common stock described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-221684), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on December 28, 2017. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

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.

C&Cure Co., Ltd., founded by Professor Min Jeong-jun of Chonnam National University College of Medicine, attracts 2 billion won in investment

On December 30, 2019 CNCure, founded by Professor Min Jeong-jun of Chonnam National University College of Medicine, reported the company has attracted an investment of 2 billion won from DT&Investment (Press release, CNCure, DEC 30, 2019, View Source [SID1234649028]).

Founded in August of last year, C&Cure Co., Ltd.’s main business objectives are the development of anticancer drugs based on a bacterial platform and theranostics, which simultaneously conducts diagnosis and treatment.

C&Cure Co., Ltd. is planning to begin clinical trials of bacterial anticancer drugs and radioactive pharmaceuticals that can precisely attack various types of cancer, including colon cancer, melanoma, metastatic cancer, and lung cancer. It has been reported that professors from Chonnam National University College of Medicine and Chonnam National University Hwasun Hospital, who are key researchers in this regard, are participating as shareholders.

In 2017, Professor Min developed a genetically engineered fusion cancer treatment bacteria and announced in the international journal Science Translational Medicine that it could dramatically improve the effectiveness of cancer treatment through immunotherapy, which was selected as the online cover story.

At the time, an experiment on mice transplanted with various cancers caused a great stir in the academic world by showing a cancer cure rate of over 80% in just 23 days.

Professor Min Jeong-jun said, "For the past two years, we have been conducting continuous research to suppress side effects such as mutations using genetic engineering methods, and now that we have achieved a level of technological perfection that we are confident about in clinical practice, we have decided to start a business."

Meanwhile, Professor Min Jeong-jun is currently the Director of the Life Science Research Institute at Chonnam National University Hospital in Hwasun, Director of the Big Data Center for Five Major Cancers, Director of the Molecular Imaging Theranostics Research Institute at Chonnam National University, Director of the World Society of Molecular Imaging, and Director of the Asia Oceania Society of Nuclear Medicine, and is known as a global authority in the field of molecular imaging and theranostics.

HOOKIPA Announces First Patient Dosed in Phase 1/2 Clinical Trial for HB-201 for the Treatment of Human Papillomavirus 16-Positive Cancers

On December 30, 2019 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that the first patient has been dosed in a Phase 1/2 clinical trial (NCT04180215) of HB-201, an immunotherapy for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers. This trial is HOOKIPA’s first clinical trial in immuno-oncology (Press release, Hookipa Pharma, DEC 30, 2019, View Source [SID1234553433]).

HB-201 is a TheraT platform-based vector (replication attenuated) from the arenavirus family expressing a non-oncogenic but highly antigenic E6/E7 fusion protein from HPV16. In preclinical studies, HB-201 was observed to be highly immunogenic, resulting in a robust CD8+ T cell response as compared to the levels induced by other approaches including adoptive cell therapies. In addition to strong immunogenicity, HOOKIPA observed robust anti-tumor activity in mouse models. HOOKIPA believes that HB-201 has the potential to provide therapeutic benefit to patients across the HPV16+ cancer setting.

Joern Aldag, Chief Executive Officer at HOOKIPA, commented: "We are excited to begin first-in-human testing with HB-201, our first clinical trial in immuno-oncology. Translating our promising preclinical data to cancer patients is an important milestone. We believe HOOKIPA’s approach can supercharge the natural defence mechanisms by inducing strong T cell responses to the benefit of patients affected by cancer and infectious diseases."

About the HB-201 Clinical Trial

The HB-201 Phase 1/2 trial is an open-label dose-escalation and dose-expansion trial in 100 patients with treatment-refractory HPV16+ cancers. It is designed to evaluate the safety and tolerability and preliminary efficacy of HB-201 as monotherapy and in combination with an immune checkpoint inhibitor.

For Phase 1 dose escalation, the patient population will be divided into two groups of 20 patients, each: the first group will include patients with progressing HPV16+ tumors who will receive monthly intravenous (IV) administration of HB-201; the second group will include patients with progressing HPV16+ tumors and an accessible tumor site who will receive one intratumoral (IT) administration of HB-201 followed by monthly IV administration of HB-201.

The primary endpoint of the Phase 1 portion of this trial will be to evaluate safety and tolerability to determine the recommended dose for the Phase 2 portion. Secondary endpoints will evaluate anti-tumor activity, as defined by RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, and immunogenicity. The Phase 2 portion of the trial will also investigate the efficacy of HB-201 alone and in combination with a PD-1 inhibitor. HOOKIPA expects to provide interim safety, dose escalation, and efficacy data from HB-201 in late 2020 or early 2021. These data will be supplemented by a series of translational data sets designed to demonstrate the mechanism of action.

About Human Papillomavirus

Human Papillomavirus (HPV) is estimated to cause about 5% of the worldwide burden of cancer including approximately 99% of cervical cancers, 25% to 60% of head and neck cancers, 70% of vaginal cancers and 88% of anal cancers1. The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to becoming cancerous.

Bruker Corporation to Present at the 38th Annual J.P. Morgan Healthcare Conference

On December 30, 2019 Bruker Corporation (Nasdaq: BRKR) reported it will participate in the 38th annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Bruker, DEC 30, 2019, View Source [SID1234552638]). Frank Laukien, Chairman, President & CEO and Gerald Herman, CFO will present on behalf of the company on Monday, January 13th, 2020 at 11:30 AM Pacific Time.

A live audio webcast of the presentation will be available on the Investor Relations section of the Company’s website at View Source . A replay of the presentation will be posted in the "Events & Presentations" section of the Bruker Corporation Investor Relations website after the event and will be available for 30 days following the presentation.

Jazz Pharmaceuticals Announces First Patient Enrolled in Pivotal Phase 2/3 Study Evaluating JZP-458 for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

On December 30, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the first patient has been enrolled in the pivotal Phase 2/3 clinical study for JZP-458, a recombinant Erwinia asparaginase molecule that uses a novel Pseudomonas fluorescens expression platform (Press release, Jazz Pharmaceuticals, DEC 30, 2019, View Source [SID1234552637]). The study, conducted in collaboration with the Children’s Oncology Group (COG), is evaluating JZP-458 as a potential treatment for pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases. Hypersensitivity reactions affect up to 30 percent of patients with ALL and LBL who are treated with E. coli-derived asparaginase.1

"We’re pleased to collaborate with Jazz on this important study," said Dr. Mignon Loh, professor of pediatrics at the University of California San Francisco (UCSF), Deborah and Arthur Ablin Endowed Chair in Pediatric Molecular Oncology and COG’s Acute Lymphoblastic Leukemia Disease Committee Chair.

"This clinical trial represents a tremendously important effort as it is investigating a novel asparaginase, JZP-458, which can be critically important for the treatment of some children with ALL, the most common type of childhood malignancy," stated Dr. Luke Maese, assistant professor at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute.

The single-arm, open-label, multicenter, dose confirmation and confirmatory study of JZP-458 will evaluate pediatric and adult patients with ALL or LBL who have silent inactivation or an allergic reaction to E. coli-derived asparaginases and have not previously received asparaginase Erwinia chrysanthemi. This study is designed to assess the safety, tolerability and efficacy of JZP-458 and is expected to enroll patients in approximately 60 COG institutions in the U.S. and Canada. The primary objective of the study is to determine the efficacy of JZP-458 measured by asparaginase activity.

"When undergoing treatment for ALL with asparaginase, it is critically important for patients to receive all of the necessary doses to maintain therapeutic levels throughout their regimen, something not always possible for patients who have an allergy to E. coli-derived asparaginase," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "Our ongoing collaboration with COG for this JZP-458 study, and the receipt of Fast Track designation from the U.S. Food and Drug Administration in October, are significant because they could potentially allow us to more quickly address this need with a new asparaginase option. Jazz is committed to addressing unmet needs for patients with hematologic cancers and the continued expansion of our asparaginase franchise is an important component of our development programs."

Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04145531).

About JZP-458
JZP-458 is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products. JZP-458 was granted Fast Track designation by the U.S. Food and Drug Administration in October 2019 for the treatment of this patient population.

About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4,5 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.6 The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the United States in 2019.6 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.7 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.8

About the Children’s Oncology Group
The Children’s Oncology Group (www.childrensoncologygroup.org) is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The Children’s Oncology Group (COG) unites almost 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across United States, Canada, Australia, New Zealand, and parts of world in the fight against childhood cancer. Today, more than 90% of the 14,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by the COG institutions over the past fifty years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcome for all children with cancer.