ADC Therapeutics Announces Launch of Initial Public Offering

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.

Athenex to Present at the 2019 San Antonio Breast Cancer Symposium

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.

Athenex to Highlight Oral Paclitaxel Clinical Programs Targeting Various Solid Tumors at the ESMO Congress 2019

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.

Flagship Pioneering Unveils Omega Therapeutics and Appoints Seasoned BioPharma Executive Mahesh Karande as President and Chief Executive Officer

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.

A Deeper Dive into the Nature Research Scientific Report on TUSC2 and Triple-Negative Breast Cancer

On September 23, 2019 Genprex recently reported that independent researchers found that company’s TUSC2 (tumor suppressor candidate 2) prevented tumor growth in triple-negative breast cancer (TNBC) (Press release, Genprex, SEP 23, 2019, View Source [SID1234551277]). These independent researchers have no affiliation with Genprex.

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Genprex takes a deeper dive into the data of the study to provide analysis and a better understanding of what the study found and what it means for TUSC2.

The study, "MicroRNA-138 is a Prognostic Biomarker for Triple-Negative Breast Cancer and Promotes Tumorigenesis via TUSC2 repression," takes a look at one particular subtype of breast cancer, triple-negative breast cancer (TNBC).

Triple Negative Breast Cancer

According to the National Breast Cancer Foundation, TNBC occurs in about 10-20 percent of diagnosed breast cancers, and is more likely to affect younger patients (under the age of 50 years old), African Americans, Hispanics and those with a BRCA1 gene mutation.1,5

A diagnosis for TNCB means that the patient does not have any of the three most common types of receptors that enable breast cancer growth, including estrogen, progesterone and the HER2 gene, thus the name for triple-negative breast cancer.1 TNBC progresses rapidly and is more likely to metastasize to the brain and viscera relative to HER2+ cancers.5

Treating TNBC with today’s emerging targeted therapies and immunotherapies are typically ineffective because these receptors are not present. This makes TNBC difficult to treat, and as an aggressive cancer, it is increasingly a feared diagnosis. With few treatment options, most TNBC patients must undergo a lumpectomy, a mastectomy, radiation, chemotherapy or a combination of these treatments.2TNBC patients are significantly less likely to survive than other breast cancer patients following the first metastatic event.5

The Role of MicroRNA-138

MicroRNA, or miRNA, help to downregulate gene expression in a variety of manners.3Thousands of miRNAs have been identified, and miRNAs possess the capacity to target between tens and hundreds of genes simultaneously. They perform a key role in tumorigenesis as important modulators in cellular pathways by regulating target gene expression through translation repression or mRNA degradation.4

Increased miR-138 expression is highly specific to TNBC, and the Nature report notes that miR-138 correlates with poor prognosis in patients, and it is functionally relevant to cancer progression.

The independent researchers explored the role of miR-138 in TNCB and found that it is a specific molecular signature of TNBC and a prognostic biomarker for breast cancer pathogenesis. Researchers also found miR-138 to be a pro-survival oncomiR for TNBC, meaning that overexpression of the gene leads to cancerous tumor growth.6Lastly, when miR-138 is depleted, it leads to apoptotic cell death in vitroand prevents tumorigenesis in vivo. In finding a way to deplete miR-138, this could lead to cancer cell death.

The Role of TUSC2

The independent researchers also found that TUSC2, which is the active agent in Genprex’s lead drug candidate, was a direct target downregulated by miR-138. TUSC2 expression is elevated and TUSC2 protein levels are enhanced following miR-138 knockdown.In TNBC mouse model studies using TUSC2, tumors were barely detectable under miR-138 knockdown conditions, and the implantation of TUSC2 overexpressing cells yielded tumors that are significantly smaller than those in the control group. TUSC2 expression was found to substantially mimic miR-138 knockdown and prevent tumor growth, revealing a potential new treatment for TNBC.