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Monopar Therapeutics Inc. Announces Closing of Initial Public Offering of Common Stock

On December 23, 2019 Monopar Therapeutics Inc. reported the closing of its initial public offering of 1,277,778 shares of common stock, including the underwriters’ exercise of its over-allotment option, at a public offering price of $8.00 per share before underwriting discounts and commissions (Press release, Monopar Therapeutics, DEC 23, 2019, View Source [SID1234552583]).

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Total gross proceeds were approximately $10.2 million. Total net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, are approximately $9.3 million from the initial public offering.

The shares began trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR."

JonesTrading Institutional Services LLC acted as Lead Bookrunning Manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Co-Manager for the offering.

The offering of these securities was made only by means of a prospectus. Copies of the final prospectus may be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. 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 shares in any state in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any state.

Invicro LLC Announces Dr. Matthew Silva as New Chief Executive Officer and Dr. Jack Hoppin is Named President of Konica Minolta Precision Medicine

On December 23, 2019 Invicro LLC, a Konica Minolta company, reported, Dr. Matthew Silva has been appointed as the new Chief Executive Officer. Dr. Silva will assume the day-to-day leadership responsibilities of the Company and will join Invicro’s Board of Directors, effective immediately. Dr. Jack Hoppin, co-founder of Invicro, will move on from his role as Invicro’s CEO to be the President of Konica Minolta Precision Medicine (KMPM) (Press release, Immudex, DEC 23, 2019, View Source [SID1234552582]). Dr. Hoppin will remain on Invicro’s Board of Directors, as well as continue to serve on the KMPM Board.

Konica Minolta, Inc. acquired Invicro LLC and Ambry Genetics Corporation in September 2017 to accelerate its strategic vision to transform personalized medicine through the delivery of diagnostic services via genetics, imaging and digital pathology capabilities. Konica Minolta Precision Medicine was formalized as a result of bringing these three entities together.

"It has been an extreme honor to serve as Invicro’s CEO, since co-founding the company in 2008," stated Dr. Hoppin. "This is an exciting time for Invicro, Ambry and KMPM, as we are all working together to support the medical research community through integrated AI technology platforms that allow molecular-level testing and analysis offering insights to advance translational medicine."

In his new role, Dr. Hoppin will work to synergize the companies under KMPM to help pharmaceutical sponsors and clinicians accelerate the development of targeted therapies through genetic and molecular profiling.

"I’m looking forward to seeing the next chapter for KMPM and Invicro," said Mr. Kiyotaka Fujii, president of Konica Minolta Global Healthcare and CEO of KMPM. "As KMPM continues to focus on revolutionizing personalized healthcare via the strengths of Konica Minolta, Invicro and Ambry, Jack will be instrumental in leading and realizing the Konica Minolta Precision Medicine mission. I have full confidence that Matt will seamlessly transition to his new role and continue to lead Invicro into new breakthroughs that will help advance the discovery and development of life-changing medicines."

Dr. Silva will carry on Invicro’s strategic mission to support the drug discovery and development community. Invicro will continue to leverage its industry-leading imaging, chemistry, and analysis expertise that span discovery through clinical research across multiple therapeutic areas, including the central nervous system, oncology, rare disease, and other systemic diseases. Further, Invicro will continue to invest in its data informatics platforms, enabling management, visualization, and analysis of pathological and radiological imaging data and ensuring alignment with KMPM.

"First, I want to thank Jack for leading Invicro to the great success it is today. I’m honored, humbled and extremely excited to assume this new role and carry on the mission," said Dr. Silva. "It’s an exciting time for Invicro, as we continue to make great strides with our pharma services capabilities offering imaging biomarkers, advanced analytics, innovative chemistry and technologies, and global core lab services. Thanks to Invicro’s dedicated team and our pharma sponsors—we are together helping the development of new medicines that will improve the lives of patients in need."

With 20 years of diverse imaging experience, Dr. Silva first joined Invicro in 2012 and most recently was EVP of Scientific Applications, where he led strategic efforts to expand the clinical oncology drug development and clinical trials. Dr. Silva’s pharma industry experience includes scientific and leadership positions at Vertex, Amgen, Millennium and Takeda Pharmaceuticals. Dr. Silva holds a Ph.D. and a master’s degree in Biomedical Engineering from Worcester Polytechnic Institute.

Idera Pharmaceuticals Announces Private Placement Up To $97.7 Million

On December 23, 2019 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or the Company, reported entering into an agreement with funds affiliated with an institutional investor providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of Series B1 convertible preferred stock and warrants to purchase common stock for aggregate gross proceeds of $3.9 million (Press release, Idera Pharmaceuticals, DEC 23, 2019, View Source [SID1234552581]). In connection with the agreement for the private placement, the investors in the private placement will pay Idera an upfront option fee of approximately $6.2 million. Under the agreement, Idera also agreed to sell to the investors, at their option and subject to certain conditions including stockholder approval to increase Idera’s authorized shares of common stock, shares of Series B2, Series B3 and Series B4 convertible preferred stock and warrants to purchase common stock for aggregate gross proceeds of up to an additional $87.6 million over a 21 month period after stockholder approval is received. The Company has the right to decline the Series B4 investment if its common stock trades at $7.60 for 20 days out of 30 days subsequent to the closing of the Series B3 investment.

The transaction was priced at-the-market under the Nasdaq rules. The Series B1 convertible preferred stock and associated warrant had a combined purchase price on an as converted basis of $1.645. The warrants to purchase common stock have an exercise price of $1.52 per share and an exercise period commencing on issuance and a term of seven years.

The Company plans to use the proceeds from the financing primarily to fund the completion, of the ongoing ILLUMINATE-301 clinical trial of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma. The Company also plans to use the subsequent proceeds, if exercised, to fund the potential NDA filing and commercial launch of tilsotolimod along with the ongoing ILLUMINATE-206 trial, and for general corporate purposes.

The shares of convertible preferred stock and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. Idera has granted the purchasers resale registration rights for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

About Tilsotolimod (IMO-2125)

Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, provide benefit for some patients, but these therapies are limited in patients whose immune responses are missing or weak. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

Anixa Biosciences to Present at Biotech Showcase 2020

On December 23, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that its chief executive officer, Dr. Amit Kumar, will present at the Biotech Showcase 2020 conference being held January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California (Press release, Anixa Biosciences, DEC 23, 2019, View Source [SID1234552578]).

During the presentation, Dr. Kumar will highlight recent corporate and commercial achievements, including the U.S. launch of Anixa’s Cchek Prostate Cancer Confirmation (Cchek PCC) test, as well as anticipated milestones for its CAR-T based ovarian cancer therapeutic and breast cancer vaccine programs.

Details of the presentation are as follows:

Event:

Biotech Showcase 2020

Date:

Monday, January 13, 2020

Time:

11:00 a.m. (PST)

Track:

Franciscan A

Location:

Hilton San Francisco Union Square

Anixa will also host one-on-one meetings with investors and industry stakeholders during the event. Please contact Miriam Miller at Tiberend Strategic Advisors for availability or to follow-up after the conference.

Biotech Showcase is one of the industry’s largest annual healthcare investor and partnering conferences, bringing together biopharmaceutical and life sciences company executives, investors, sector analysts, bankers and industry stakeholders. More than 400 presentations from mid-, small- and micro-cap public and private companies are expected to present at the event. Qualified investors and buy- and sell-side analysts are invited to request a complimentary registration to attend Biotech Showcase and its sister event, Digital Medicine & Medtech Showcase. For more information click here.

Akari Therapeutics Announces Initiation of Pivotal Phase III Trial of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA) Following the Opening of its IND

On December 23, 2019 Akari Therapeutics, Plc (Nasdaq:AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported that a U.S. Food and Drug Administration (FDA) investigational new drug application (IND) is open for its multicenter Phase III study for the treatment of pediatric HSCT-TMA with nomacopan, allowing clinical sites to open in the first quarter of 2020 (Press release, Akari Therapeutics, DEC 23, 2019, View Source [SID1234552577]).

"With the pediatric HSCT-TMA IND now open we look forward to starting the pivotal Phase III study of nomacopan in HSCT-TMA, a potential treatment for a high risk pediatric population that suffer very high death rates and for which there are currently no approved therapies. If successful, we expect HSCT-TMA to be a gateway into a range of other poorly treated orphan TMAs," commented Clive Richardson, CEO of Akari Therapeutics. "In addition, following the recent successful completion of our Phase II bullous pemphigoid study, we expect data from our Phase I/II atopic keratoconjunctivitis trial in early 2020 and interim data from our Phase III paroxysmal nocturnal hemoglobinuria trial in the first half of 2020."

HSCT-TMA is an orphan hematological condition that occurs in up to 30% of patients who have received a hematopoietic stem cell transplant (HSCT). There are no approved treatments for pediatric HSCT-TMA, and it has an estimated mortality rate of more than 80% in children with the severe form of the disease1. It is this severe form that is being targeted with nomacopan which is a bifunctional inhibitor of complement C5 and leukotriene B4 (LTB4). Following the recent end-of-Phase II meeting with the FDA, Akari has now opened an IND to initiate its pivotal pediatric HSCT-TMA study based on a single arm responder-based design. Recruitment will be focused on specialist pediatric sites in the U.S. and Europe where treatment tends to be concentrated in specialist centres.

Whilst the role of complement inhibition is understood to play an important role in pediatric HSCT-TMA, the Company believes LTB4 may also be an important target in reducing epithelial activation in both TMA and graft versus-host disease2 (GVHD) which often occur simultaneously. The Company believes daily dosing with nomacopan may also be of particular advantage in facilitating more complete complement suppression, especially in HSCT-TMA patients with high transfusion requirements.

As previously announced, this two-part pivotal Phase III study of nomacopan in pediatric patients with HSCT-TMA is based on guidance from the Company’s end-of-Phase II meeting with the FDA. Part A of the trial is a dose confirmation study. Part B of the trial is a single arm responder-based efficacy study that will follow an interim analysis of Part A and a meeting with the FDA. Akari has both FDA fast track and orphan status for this program.

1 Sonata Jodele, et al. New approaches in the diagnosis, pathophysiology, and treatment of pediatric hematopoietic stem cell transplantation associated thrombotic microangiopathy. Transfus Apher Sci . 2016 April; 54(2): 181–190

2 Takatsuka, et al. Predicting the severity of intestinal graft-versus-host disease from leukotriene B4 levels after bone marrow transplantation. Transplantation 2000, 26: 1313-1316