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BioNTech Announces Commencement of Initial Public Offering

On September 24, 2019 BioNTech SE ("BioNTech"), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported that it has filed a registration statement on Form F-1 with the United States Securities and Exchange Commission (the "SEC") to offer 13,200,000 American Depositary Shares ("ADSs") representing its ordinary shares to the public (Press release, BioNTech, SEP 24, 2019, View Source [SID1234539732]). BioNTech also intends to grant the underwriters a 30-day option to purchase up to an additional 1,980,000 ADSs. The initial public offering price is expected to be between $18.00 and $20.00 per ADS, and BioNTech expects to raise approximately $250 million at the midpoint of the range. BioNTech has applied to list its ADSs on the Nasdaq Global Select Market under the symbol "BNTX."

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J.P. Morgan, BofA Merrill Lynch, UBS Investment Bank and SVB Leerink are acting as lead joint book-running managers for the offering. Canaccord Genuity, Bryan, Garnier & Co. and Berenberg are acting as joint book-running managers for the offering and Wolfe Capital Markets and Advisory, Kempen and Mirae Asset Securities are acting as co-managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (866) 803-9204, or by e-mail at [email protected]; BofA Securities, Inc., NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by e-mail at [email protected]; UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at (888) 827-7275, or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

A registration statement relating to these securities has been filed with the SEC 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 a 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 the registration or qualification under the securities law of any such state or jurisdiction.

Evotec and Takeda enter collaboration agreement to discover clinical candidates across multiple therapeutic areas

On September 24, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported a strategic, multi-year drug discovery collaboration with Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Evotec, SEP 24, 2019, View Source;announcements/press-releases/p/evotec-and-takeda-enter-collaboration-agreement-to-discover-clinical-candidates-across-multiple-therapeutic-areas-5847 [SID1234539731]). Under the collaboration, the parties aim to establish at least five drug discovery programmes with the goal of Evotec delivering clinical candidates for Takeda to pursue into clinical development.

"Collaborating with world-class drug discovery partners like Evotec is central to our model for discovering and developing transformative medicines," said Steve Hitchcock, Ph.D., Global Head of Research at Takeda. "Takeda has a long history of working with Evotec and is confident in Evotec’s capabilities."

The collaboration combines Evotec’s ability to effectively drive fully integrated drug discovery programmes with Takeda’s strategic insights into transformative therapeutic approaches in Takeda’s four core therapeutic areas: Oncology, Gastroenterology, Neuroscience and Rare Diseases, as well as Takeda’s development and commercialisation expertise. Evotec will leverage its industry-leading discovery platform to validate therapeutic hypotheses and advance small molecule programmes with Takeda having options to assume responsibility at lead series and upon Evotec delivering a pre-clinical candidate.

Under the terms of the collaboration, Takeda will pay Evotec a one-time, upfront fee to access its platforms. Additionally, Evotec is eligible to receive pre-clinical, clinical, and commercial milestones that can total in excess of $ 170 m per programme as well as tiered royalties on future sales.

Dr Craig Johnstone, Chief Operating Officer of Evotec, added: "We are pleased to enter into another collaboration with Takeda, whose values are aligned with Evotec’s, including a shared commitment to translating highest quality science into highly innovative medicines. We believe this collaboration will be very fruitful for both parties and we are excited to combine our resources and skills to produce novel therapies."

Crescendo Biologics Reaches Fifth Milestone in its Strategic Collaboration with Takeda

On September 24, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T cell enhancing therapeutics, reported that it has achieved a fifth milestone in its collaboration with Takeda Pharmaceutical Company Limited (Takeda) (Press release, Crescendo Biologics, SEP 24, 2019, View Source [SID1234539730]).

Under the global, strategic, multi-target collaboration and license agreement with Takeda that was announced in October 2016, Crescendo’s proprietary transgenic platform and engineering expertise is used to identify and configure Humabody-based therapeutics against certain targets selected by Takeda.

Under the terms of the agreement, Crescendo has successfully delivered three novel oncology-targeted Humabody lead molecules. Takeda has taken exclusive licenses to both of the first two programmes in this highly productive collaboration.

Theodora Harold, CEO of Crescendo Biologics, commented:

"Reaching this fifth technical milestone marks our continued progress towards our joint goal with Takeda of creating the next generation of differentiated cancer therapies and provides strong validation of the work being done at Crescendo."

Hot Company Activity Around European Society of Medical Oncology (ESMO 2019) Congress

The European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2019) congress takes place in Barcelona, Spain between 27th Sep – 01st Oct 2019.

This conference features more than 2000 abstracts and a global presence of companies ranging from big pharma to smaller innovative global companies with the likes of CStone Pharmaceuticals (China), Rainer Therapeutics (USA), Puma Biotechnology (USA) and Noxxon (Germany) plus many more presenting data.

Read more below on the latest and hottest from companies like AstraZeneca, Merck & Co or any of the selection of companies generating heat about their presence at ESMO (Free ESMO Whitepaper) 2019.

Auransa Presents New Preclinical Data on AU-409, a Novel, AI-Derived Drug Candidate for the Treatment of Hepatocellular Carcinoma

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.

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."