On September 23, 2019 Auransa Inc., an artificial intelligence (AI)-driven biotechnology company developing precision medicines in areas of significant unmet medical need, reported that new data on AU-409, the company’s novel lead drug candidate being developed for the treatment of hepatocellular carcinoma (HCC), were presented at the 13th Annual Conference of the International Liver Cancer Association (ILCA) in Chicago (Press release, Auransa, SEP 23, 2019, View Source [SID1234635629]). The study results demonstrated promising antitumor activity for AU-409 in a preclinical orthotopic liver cancer model as evidenced by statistically significant reductions in tumor burden. Additionally, the anticancer activity of AU-409 was also demonstrated in culture using cells derived from patients’ tumors. The data were highlighted in an oral presentation at the 2019 ILCA conference by Auransa’s Chief Scientific Officer, Andrew Protter, Ph.D.

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AU-409 is Auransa’s novel lead drug candidate and was generated leveraging the company’s proprietary AI-driven SMarTR Engine. The SMarTR Engine tackles disease heterogeneity and leverages gene expression profiles to predict responder patient populations, as well as compounds that might be effective against those patient populations. Auransa is currently conducting investigational new drug (IND)-enabling studies of AU-409 and expects to initiate first-in-human Phase 1 trials in the first half of 2020.

As part of their work, researchers sought to evaluate the anticancer activity of AU-409 in cell culture. Data demonstrated that AU-409 reduced the viability of HCC cells from a number of patient-derived xenografts, as well as standard HCC stable cell lines.

Additionally, researchers conducted in vivo studies to measure the antitumor activity of AU-409 in an orthotopic mouse model of HCC (Hep3B2.1-7-Luc cells that exhibit bioluminescence measured as total flux, a marker of tumor burden). Following tumor cell implantation into the liver, mice were treated orally with AU-409 (10 mg/kg or 20 mg/kg) or vehicle for four weeks. At Day 28, treatment with AU-409 was associated with a dose-dependent, statistically significant decrease in tumor burden, as compared to vehicle. Tumor burden was reduced by 63% compared to vehicle in the AU-409 10 mg/kg treatment arm (p < 0.001) and 76% compared to vehicle in the AU-409 20 mg/kg treatment arm (p < 0.001).

Treatment with AU-409 in the orthotopic mouse model was well tolerated. There were no clinical observations associated with the treatment. Compared to vehicle, AU-409 treatment was associated with a statistically significant increase in body weight, as well as a decrease in liver enzymes that are indicative of liver toxicity.

"These preclinical data support the development of AU-409 for HCC, as predicted by Auransa’s proprietary AI-driven discovery and development technology platform. The combination of robust anticancer effects in cell culture and in vivo along with evidence of favorable tolerability supports advancing AU-409 into clinical development," said Dr. Protter. "Based on these results, we are working to complete IND-enabling studies for the program with the goal of entering the clinic during the first half of 2020."

"We are pleased by this collection of preclinical data for AU-409 as it offers an early yet important validation of the extent to which Auransa’s SMarTR Engine can accelerate drug discovery and development," stated Pek Lum, Ph.D., chief executive officer of Auransa. "AU-409 is an example of what we believe is possible when we utilize our novel proprietary AI platform to address the drug discovery and development challenges. By interrogating gene expression profiles, we believe we can predict responder patient populations and the potential treatments that may be effective for those patients. We look forward to the ongoing advancement of the AU-409 program, while continuing to build out our broader product pipeline through novel insights generated by the SMarTR Engine."

On September 23, 2021 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it has launched the initial public offering of 8,164,000 shares of its common shares (Press release, ADC Therapeutics, SEP 23, 2019, View Source [SID1234596055]). In addition, ADC Therapeutics has granted the underwriters an option to purchase up to 1,224,600 additional common shares. The initial public offering price is expected to be between $23.00 and $26.00 per common share. The common shares have been approved for listing on the New York Stock Exchange under the ticker symbol "ADCT."

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Morgan Stanley, BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (631) 592-5973 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. In Switzerland, the offering is limited to private placements and there is no intention to publicly offer, sell or advertise, directly or indirectly, these securities in, into or from Switzerland. These securities will not be listed on the SIX Swiss Exchange or on any other exchange or regulated trading venue in Switzerland. Neither this document nor any other offering or marketing material relating to these securities constitutes or will constitute a prospectus as such term is understood pursuant to article 652a of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any other regulated trading venue in Switzerland.

On September 23, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will be making an oral presentation at the San Antonio Breast Cancer Symposium (SABCS) 2019, to be held December 10 – 14, 2019, in San Antonio, Texas, on its Phase III study of oral paclitaxel and encequidar ("Oral Paclitaxel"; f.k.a. Oraxol or oral paclitaxel and HM30181A) in metastatic breast cancer (Press release, Athenex, SEP 23, 2019, View Source [SID1234573886]).

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Presentation Details:

Date: Friday, December 13, 2019
Time: 3:15pm CT
Title: KX-ORAX-001: an open-labeled, multicenter, phase 3 registrational study to determine the safety, tolerability and tumor response of oraxol (HM30181A and oral paclitaxel) and its comparability to iv paclitaxel in patients with metastatic breast cancer (MBC)
Session: General Session 6
Location: Hall 3

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On September 23, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will present several posters highlighting clinical data from three of its ongoing programs for oral paclitaxel and encequidar ("Oral Paclitaxel"; f.k.a Oraxol or oral paclitaxel and HM30181) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 to be held September 27 – October 1, 2019 in Barcelona, Spain (Press release, Athenex, SEP 23, 2019, View Source [SID1234573885]). The posters demonstrate the results from clinical studies of Oral Paclitaxel for patients with a number of advanced solid tumor types as well as in combination with ramucirumab, an anti-VEGFR2 antibody therapy.

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Please see the presentation details below. The abstracts can be found within the conference calendar here.

Poster: 477P
Title: An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors
Session: Poster Display session
Date: September 28, 2019
Time: 12:00 – 13:00 CEST
Location: Poster Area (Hall 4)
Speaker: Edmond Ang (New Zealand)

Poster: 1733TiP
Title: A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010)
Session: Poster Display session
Date: September 28, 2019
Time: 12:00 – 13:00 CEST
Location: Poster Area (Hall 4)
Speaker: Herbert H. Loong (Shatin, Hong Kong PRC)

Poster: 800P
Title: A Phase 1b Study of Oraxol in combination with ramucirumab in patients with gastric or esophageal cancers who failed previous chemotherapy
Date: September 29, 2019
Time: 12:00 – 13:00 CEST
Session: Poster Display session
Location: Poster Area (Hall 4)
Speaker: Ming Huang Chen (Taipei City, Taiwan)

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On September 23, 2019 Flagship Pioneering, a unique life science innovation enterprise, reported that it unveiled Omega Therapeutics – a genomics medicine company focused on selectively directing the human genome to treat and cure disease by precisely controlling genomic expression without changing nucleic acid sequences (Press release, Omega Therapeutics, SEP 23, 2019, View Source [SID1234561269]). Mahesh Karande has been appointed as the company’s President, CEO and member of the Board of Directors. Mr. Karande was the former President and CEO of Macrolide Pharmaceuticals and a long-time Novartis AG executive where he held positions of increasing responsibility running large businesses in the U.S. and internationally. Flagship Pioneering developed and launched Omega Therapeutics through its innovation foundry, Flagship Labs.

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Since its founding in 2017, under the leadership of David Berry, M.D., Ph.D., General Partner of Flagship Pioneering, Omega Therapeutics has created a proprietary platform that precisely tunes Insulated Genomic Domains (IGDs), the fundamental regulator, or GenomStats, of the human genome, which are 3D closed-loop structures of DNA that control genomic activity, to unlock the native power of the genome to cure diseases. This enables the unique, rapid development of specific therapeutics that treat disease and help patients, without altering nucleic acid sequences, with implications across a variety of indications. Engineered genomic modulators, called Omega Controllers, precisely tune genomic activity to desired therapeutic levels to address the biological root of disease. Our therapeutics are designed to be more specific and durable and, as such, potentially more effective therapeutic options for patients.

"By mapping the topology of the human genome and using computational biology, we have been able to identify the correct genomic target for a therapeutic influence. Omega’s proprietary platform technology allows us to develop therapeutics for disease control, and potentially impact the way we treat and manage a broad range of illnesses," said Dr. Berry. "In addition to our own capabilities for therapeutic development, our technology also presents the opportunity to partner and optimize other targeted in vivo and ex vivo therapeutics to enhance their ability to treat disease and further help a wide range of patient populations with significant unmet needs."

Many health conditions, particularly complex diseases, are the result of malfunctions in the regulation of gene expression. Omega leverages the founding Flagship team’s pioneering innovations that extended the breakthrough work on epigenetics by Richard Young, Ph.D., Professor of Biology, Massachusetts Institute of Technology, and Member of the Whitehead Institute, and Rudolf Jaenisch, M.D., Professor of Biology, Massachusetts Institute of Technology and Founding Member of the Whitehead Institute, who first described how genomic activity is controlled by 3D closed-loop structures of DNA, now called Insulated Genomic Domains (IGDs), that contain one or more genes and their regulatory elements.

These insulated, or closed-loop, structures ensure that interaction between the regulatory elements and gene(s) leading to gene expression is contained within the IGD. Diseases often manifest due to alterations in gene expression or changes in IGD structure. As such, the IGD is the fundamental regulator, or GenomStat, of the human genome. Omega is pioneering the discovery and development of precision Omega Controllers to control the GenomStat. By precisely tuning the GenomStat, Omega Controllers regulate single- or multi-gene expressions to desired levels to treat or cure disease. Scientific strategy and research and development will be led by Chief Science Officer, Thomas McCauley, Ph.D., former Shire executive and more recently CSO of Macrolide Pharmaceuticals and CSO of Translate Bio (formerly RaNA Therapeutics).

"Flagship is focused on discovering value and innovating well beyond the boundaries of current research in order to build first-of-their-kind companies. Omega’s proprietary product-platform is taking an entirely new approach to tackling important, unsolved diseases," said Noubar Afeyan, Ph.D., Chief Executive Officer of Flagship Pioneering and Chair of Omega’s Board of Directors. "The executive team, board of directors and scientific advisors have created an unparalleled company that fits the extraordinary scope of the therapeutic potential of Omega Controllers, a new class of medicines."

"The depth and breadth of our platform gives us the ability to create transformative genomic medicines that deliver specificity of targeting, tunability, and durability of single and multi-gene expression, all without altering nucleic acid sequences. Our platform enables us to develop proprietary Omega Controllers, a new class of therapeutics targeting the control of a wide range of diseases in unprecedented ways," said Mr. Karande. "With a team of world-class scientists, founders and advisors, we are already executing several ambitious early-stage discovery programs in the near-term, as we strengthen our platform to address the vast opportunity of treating diseases resulting from genomic malfunction or dysregulation."

Omega Therapeutics is targeting the biological root of disease and designing novel therapeutics and optimizing current therapies to potentially address a wide range of disease categories, including rare genetic diseases, immunology, inflammation, metabolic diseases and oncology.

The Omega Therapeutics Board of Directors:

– David Berry, M.D., Ph.D., General Partner, Flagship Pioneering, Co-founder, Omega Therapeutics

– Richard Young, Ph.D., Professor of Biology, Massachusetts Institute of Technology, Member, Whitehead Institute

– Paul-Peter Tak, M.D., Ph.D., Chief Executive Officer, Kintai Therapeutics, Venture Partner, Flagship Pioneering, former Senior Vice President and Global Head of R&D for Immuno-inflammation, Oncology and Infectious Disease, as well as Chief Immunology Officer, GlaxoSmithKline (GSK)

– Mary Szela, Chief Executive Officer, TriSalus Life Sciences, former Chief Executive Officer, Novelion Therapeutics, and Chief Executive Officer, Melinta Therapeutics

– Mahesh Karande, President and Chief Executive Officer, Omega Therapeutics

– Noubar Afeyan Ph.D., Co-founder and Chairman of the Board, Omega Therapeutics, CEO Flagship Pioneering

ABOUT MAHESH KARANDE, PRESIDENT AND CHIEF EXECUTIVE OFFICER

Mahesh Karande is deeply experienced in running biopharma businesses across discovery, preclinical development, clinical development, commercialization and product life-cycle management stages. He has strong leadership and operational experience combined with a global work history spanning the United States, Europe, Asia and Africa. Most recently, Mr. Karande, as President and CEO, took Macrolide Pharmaceuticals, from discovery into early development. Earlier, Mr. Karande spent several years at Novartis, leading various U.S. and international business units. Mr. Karande left Novartis to join Intarcia Therapeutics as VP and General Manager to lead the launch of their first product; a role he left to take the helm at Macrolide.