On January 31, 2019 GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, reported that it has raised $10 million in a Series A financing led by MedTech Venture Partners with participation from BlueStone Venture Partners (Press release, GT Medical Technologies, JAN 31, 2019, View Source [SID1234532988]). Funds from the round will support the commercialization of GammaTile Therapy, an FDA-cleared, surgically targeted radiation therapy (STaRT) for patients with recurrent intracranial neoplasms (brain tumors). The company recently launched a limited market release of GammaTile Therapy and is making it available at select medical centers in the United States.

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"GT MedTech’s mission is in line with our investment goal of supporting innovative technologies that address unmet needs in vital disease areas," said Radu Cautis, partner and managing director of MedTech Venture Partners. "We are enthusiastic about the potential of GammaTile Therapy to address the shortcomings of current treatments and elevate the standard of care for patients with brain tumors."

Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year.1 Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with brain tumors have improved very little over the past 30 years. Recurrence of brain tumors is common, and about half of all patients treated for brain tumors have their disease recur within a year.

GammaTile Therapy is placed directly at the site of the tumor after excision is complete and immediately begins targeting residual tumor cells before they can replicate. Designed to protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source. GammaTile Therapy is indicated for the treatment of all types of recurrent brain tumors, including primary (benign or malignant) and metastatic tumors.

Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously-treated meningiomas were published last month in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons. Additional clinical data from other types of tumors will be presented at the AANS Annual Scientific Meeting in April.

"GammaTile Therapy was developed by a team of brain tumor specialists who were running out of options for their patients. Their urgency to find a viable solution for these patients led to the creation of GammaTile Therapy, which is designed to be immediate, safe, predictable, and effective," said Matthew Likens, president and CEO of GT MedTech. "With this funding, in addition to adding seasoned industry executives to our team, we look forward to building and expanding our commercialization efforts so that we can offer this new option to patients at brain tumor treatment centers across the United States."

Company Announces Appointments of Seasoned Executives

GT Medical Technologies also announced that Prattipati Laxminarain has joined the company’s Board of Directors, having previously served as the worldwide president of Codman Neuro, a neurosurgical medical device business recently acquired by Integra Life Sciences from Johnson & Johnson for more than $1 billion. Laxminarain had a 30-year career at Johnson & Johnson, spanning international markets. He remains active in the healthcare sector as a board member of the Global Neuro Foundation, Microbot Medical, Oculogica, Stratus Global LLC, and the Brain Aneurysm Foundation.

In addition, Mara Aspinall, co-founder and managing director of BlueStone Venture Partners, has been appointed as an observer to the company’s Board of Directors. Formerly the president and CEO of Ventana Medical Systems, which was acquired by Roche for $3.4 billion, Aspinall brings more than 20 years of industry experience in medical device development, biomedical diagnostics, personalized medicine, and digital health. Aspinall also currently holds various board of director roles, including Blue Cross Blue Shield of Arizona, OraSure Technologies, Allscripts, and others.

"GT MedTech’s innovative technology has the potential to significantly improve the lives of patients with brain tumors and their caregivers," said Aspinall. "By taking part in this funding round and working alongside the Board of Directors, BlueStone Venture Partners hopes to help further advance GT MedTech’s vital technology."

About GammaTile Therapy

GammaTile Therapy is a FDA-cleared, surgically targeted radiation therapy (STaRT) that is placed at the end of brain tumor excision surgery and immediately begins targeting residual tumor cells. GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source. This therapy offers advantages over the most common treatment for patients undergoing surgery for recurrent brain tumors: a course of External Beam Radiation Therapy (EBRT), which requires daily treatments for up to six weeks. Some patients may not be candidates for EBRT, and those patients who are candidates typically have to wait two weeks or more for surgical wound healing before beginning treatment, giving any residual tumor cells a chance to replicate. Patients treated with GammaTile Therapy require no additional trips to the hospital or clinic for radiation therapy. Because the therapy is targeted, patients receive radiation only where it is needed, and may receive a lower overall level of exposure to radiation.

GammaTile Therapy received FDA 510(k) clearance in July 2018 for the treatment of all types of recurrent brain tumors, including primary (benign or malignant) and metastatic tumors, and has an established CMS code for Medicare reimbursement

On January 31, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the fourth quarter and year ending December 31, 2018 on Thursday, February 7, 2019, after the U.S. financial markets close (Press release, Alnylam, JAN 31, 2019, View Source;p=RssLanding&cat=news&id=2385616 [SID1234533005]).

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Management will provide an update on the Company and discuss fourth quarter and year-end 2018 results as well as expectations for the future via conference call on Thursday, February 7, 2019 at 4:30 pm ET. To access the call, please dial 800-667-5617 (domestic) or 334-323-0509 (international) five minutes prior to the start time and refer to conference ID 4263166. A replay of the call will be available beginning at 7:30 pm ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to conference ID 4263166.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

On January 31, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the closing and funding of its previously announced public offering of 15,217,392 shares of its common stock ("Common Stock") at a public offering price of $0.23 per share (Press release, Cancer Genetics, JAN 31, 2019, View Source [SID1234533043]). The Company’s Chairman, John Pappajohn; board director, Ted Cannon; Chief Financial Officer, Glenn Miles; and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are approximately $3.5 million.

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H.C. Wainwright & Co. acted as the sole placement agent for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts required by its lenders and if any proceeds remain available, to pay certain costs previously incurred in connection with its ongoing strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A prospectus supplement describing the terms of the offering was filed with the SEC on January 29, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 31, 2019 DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic cancer clinical trial (Press release, CEND Therapeutics, JAN 31, 2019, View Source [SID1234619594]). In addition, the lead program received orphan-drug designation from the US Food and Drug administration (FDA) in pancreatic cancer. The company also announced a new member of board of directors.

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The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30 patients in the second quarter of 2019. The early results are reportedly encouraging, with high response rates as well as favorable safety profile, with no dose-limiting toxicities. "The progress with the pancreatic cancer trial has exceeded our expectations," said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. "Our near term goal is to validate the CEND-1 platform technology in multiple indications so clinicians can treat patients with cancers with high unmet medical need more effectively."

Receiving the FDA orphan drug designation was also announced today. It is a significant development milestone as it can facilitate the future development through several benefits such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.

Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its Board of Directors. "I am pleased to welcome Heidi Henson to our board, where her extensive expertise in financial management and strategy will be a major asset to DrugCendR as we continue to advance the company programs," said Erkki Ruoslahti, M.D., Ph.D., Founder, President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.

About CEND-1

DrugCendR’s proprietary technology platform is a based on a bifunctional molecular mimicry agent CEND-1. The agent is able to manipulate the tumor microenviroment, effectively making it into a temporary drug conduit. This allows an enhanced delivery and efficacy of various types of co-administered anti-cancer compounds. The action is tumor-specific, thanks to the tumor-homing RGD motif of the molecule. To date the compound has been investigated, by the company founders and by numerous independent groups, in more than 150 publications and it has shown efficacy in more than 40 different cancer models.

About DrugCendR

DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The initial focus of company’s technology is pancreatic cancer because, in addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1 overcomes this obstacle, and the target receptors for are highly expressed in advanced pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is planning for additional clinical trials in other cancer indications for its lead program and has already started a follow-up CEND-2 program, which works through a well-validated immune-oncology pathway.

On January 31, 2019 Repare Therapeutics, Inc., a privately held precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in clearly defined patient populations, reported that it has entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.

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"We’re excited to have ONO as a discovery and development partner," said Lloyd M. Segal, President and CEO of Repare. "This relationship will support our drive to and through the clinic in this important new area of precision oncology therapeutic development."

"ONO identified Repare Therapeutics as the partner of choice for bringing in a potential first-in-class and best-in-class Polθ inhibitor to our portfolio," said Gyo Sagara, President, Representative Director and CEO of ONO. "We are excited to work with Repare for the benefit of cancer patients."

Under the terms of the agreement, ONO will provide an up-front payment and research service payments potentially totaling US $15M, plus additional cost-sharing through IND. Beyond IND, significant clinical, regulatory and commercial milestones are also included in the agreement, with a potential total of US $160M. ONO will also pay to Repare high single-digit to low double-digit tiered royalties based on net sales of the products. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and the EU.

Polθ inhibitor opportunity

DNA Polymerase θ (Polθ) is a unique, multifunctional DNA polymerase essential to repairing DNA breaks, especially in homologous recombination deficient (HRD) cells. HRD, including deficiency in the BRCA1 and BRCA2 genes, is a clinically important feature across a variety of important tumor types, including breast, ovarian, prostate and pancreatic cancers. Polθ gene expression is low in normal cells but elevated across a broad range of tumor types, including those with HRD. Currently, HRD tumors may be treated with Poly(ADP-ribose) Polymerase (PARP) inhibitors, which represent a rapidly growing, multi-billion dollar global market. A significant fraction of patients does not initially respond to PARP inhibitor treatment, and the vast majority of treated patients eventually develop PARP inhibitor resistance. A Polθ inhibitor has potential as both a mono-therapy across multiple tumor types and in combination with PARP inhibitors, where its distinct mechanism of action may help address both forms of PARP resistance. Additional clinical populations may also be attractive for combination treatment with a Polθ inhibitor, including possible combinations with chemotherapy, radiotherapy and Immuno-Oncology agents.