On September 14, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 from September 16 – 21, 2021 (Press release, Aprea, SEP 14, 2021, View Source [SID1234594085]).

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Details for the ESMO (Free ESMO Whitepaper) 2021 mini oral presentation are as follows:

Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies
Speaker: Haeseong Park, Washington University in St. Louis
Presentation #: 516MO
Session: Mini oral session – Developmental therapeutics
Date and Time: Monday, September 20, 2021; 17:35 – 17:40 CEST (11:35 – 11:40am EDT)

On September 14, 2021 Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics reported they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development (Press release, Emergent BioSolutions, SEP 14, 2021, View Source [SID1234587669]). In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

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Under the terms of the five-year agreement, Emergent will provide current Good Manufacturing Practice (cGMP) manufacturing services for two presentations of the PTX-COVID19-B vaccine product, both the formulated bulk drug substance and finished drug product (fill/finish), at Emergent’s facility in Winnipeg, MB, Canada. Additional process and analytical development services will occur from Emergent’s Center of Excellence for Development Services in Gaithersburg, Maryland. The baseline agreement signed between Emergent and Providence Therapeutics is valued at approximately $90 million, covering manufacturing services, studies to support global supply chain activities, as well as facility and equipment investments.

"Emergent’s commitment to fight the COVID-19 pandemic is anchored in our partnerships with innovators who share the same mission to address public health threats around the world," said Adam R. Havey, executive vice president and chief operating officer at Emergent BioSolutions. "This collaboration is a testament to Emergent’s long heritage and experience in Canada. We are proud that Providence has chosen our Winnipeg team and site to manufacture its Canadian mRNA technology in Western Canada, one of the few facilities in the country manufacturing large quantities of mRNA COVID-19 vaccine doses today."

As commented by Brad Sorenson, Providence CEO, "Providence is very pleased to have the resources necessary to ramp up commercial manufacturing of its COVID vaccine here in Canada. We look forward to working side-by-side with Emergent to deliver tens of millions, and potentially hundreds of millions of doses of our world-class vaccine to developing countries across the globe. It has always been Providence’s mission to produce the highest quality medicines at affordable prices, and with Emergent’s help we are closer to achieving this goal."

To date, Emergent has partnered with numerous pharmaceutical and biotech innovators, as well as the U.S. government and non-government organizations in providing critical contract manufacturing services (drug substance manufacturing, drug product manufacturing and development services) in response to the COVID-19 pandemic.

On September 14, 2021 TumorGen Inc., a biotechnology company, and PhenoVista Biosciences LLC, a specialized contract research organization, reported that they are partnering to characterize metastatic cancer cell clusters (MCCCs) (Press release, TumorGen, SEP 14, 2021, View Source [SID1234587686]). By revealing the traits that govern MCCCs, they hope to identify potential therapeutic targets and catalyze efforts to develop much-needed anti-metastatic drugs.

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"The analytical imaging power PhenoVista can bring to our MCCC capture technology is essential," said TumorGen Founder, President and CEO, Jeffrey K. Allen, Ph.D. "Working directly with PhenoVista will help leverage our MCCC capture capabilities to identify unseen drug targets. With this data, TumorGen will be well-positioned to begin commercialization efforts and establish partnerships with biopharmaceutical companies focused on emerging anti-metastatic therapeutics."

TumorGen will use its microfluidic platform to capture MCCCs from patient blood. PhenoVista will apply its specialized cell analysis technologies to illuminate how these clusters hold together and avoid the body’s immune response. Revealing these inter-cellular signals will change how we understand metastasis, leading to new therapies.

"Characterizing MCCCs with our high-content imaging technology could reveal the critical inter-cellular communication within the cluster that makes it so deadly," said James Evans, Ph.D., PhenoVista Biosciences CEO. "Illuminating the complex interactions between cancer cells and immune cells, such as macrophages, and neutrophils, will reveal how MCCCs evade immune surveillance and form new tumors."

Metastasis (the spread of malignant cells throughout the body) causes over 90% of cancer deaths. Scientists have known MCCCs drive this spread but have lacked easy methods to investigate these critically important cell clusters. Also significant is that MCCCs contain both cancer and immune cells, thus providing the opportunity to develop cutting-edge therapies based on immuno-oncology which can inhibit metastasis.

"Understanding MCCC cell status, including whether immune cells are tumor suppressive or tumor supportive, is critically important," said Darren Finlay, Ph.D., Director of Tumor Analysis at Sanford Burnham Prebys Medical Discovery Institute, an NCI-Designated Cancer Center. Finlay is co-investigator on TumorGen’s recent SBIR grant from the National Cancer Institute. "These findings could provide huge insights to leverage the immune system to develop first-in-class, anti-metastatic drugs."

On September 14, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company’s Focal One and ExactVu technologies were featured in several poster presentations at the American Urological Association (AUA) 2021 Annual Meeting, which was held virtually from September 10-13 (Press release, EDAP TMS, SEP 14, 2021, View Source [SID1234587704]). EDAP was a Gold sponsor of the event.

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Details of two noteworthy presentations are as follows:

Title: Focal Ablation Versus Radical Prostatectomy for Intermediate-Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial

Lead author: Eduard Baco, MD, Oslo University Hospital, Norway

Summary: This is the first randomized controlled clinical trial comparing focal therapy with robotic surgery. The data suggest that at one-year post treatment, Focal One achieved good oncological efficacy while preserving erectile function and urinary continence better than radical prostatectomy.

Title: High-Intensity Focused Ultrasound (HIFU) vs Radical Prostatectomy (RP) in the Curative Treatment of ISUP 1-2 Localized Prostate Cancer: Oncological Intermediate Results of the HIFI Study

Lead author: Pascal Rischmann, MD, Toulouse University Hospital, France

Summary: In this prospective comparative study sponsored by the French Association of Urology and financed by the French Ministry of Health, 3364 patients (HIFU: 1988, radical prostatectomy: 1376) were prospectively included across 42 French treatment centers. The intermediate results presented show a salvage-treatment-free survival rate significantly higher in the HIFU arm (97.5%) compared to the radical prostatectomy arm (90.3%).

"The data from these studies presented at this year’s AUA Annual Meeting once again strongly support high intensity focused ultrasound as an alternative to far more invasive radical prostatectomy," stated Marc Oczachowski, Chairman & Chief Executive Officer of EDAP. "In terms of both efficacy and long-term survival, Focal One offers patients a superior treatment option without the debilitating side effects associated with surgery. Data such as these, together with the growing roster of healthcare institutions in the US and elsewhere who champion our technology and the progress we are making securing reimbursement, are key to our long-term growth and we are pleased to add to the expanding body of evidence at this prestigious urology conference showing the many benefits of HIFU."

On September 14, 2021 Avalo Therapeutics, Inc. ("Avalo" or the "Company") (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology, immuno-oncology, and rare genetic diseases, reported that it intends to offer for sale shares of its common stock in an underwritten public offering (Press release, Avalo Therapeutics, SEP 14, 2021, View Source [SID1234587735]). Avalo intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the proposed offering of up to 15% of the aggregate number of shares of common stock. All of the shares of common stock will be offered by Avalo. 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, or as to the actual size or terms of the offering.

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Jefferies and RBC Capital Markets are acting as joint book-running managers for the offering.
Avalo intends to use the net proceeds of the offering for working capital and other general corporate purposes.

This offering by Avalo is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254000), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on March 8, 2021 and declared effective by the SEC on March 19, 2021, and the accompanying prospectus contained therein. The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC’s website at View Source or by contacting Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at [email protected] or by calling (877) 547-6340; and RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098 or by telephone at 877-822-4089 or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Avalo has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Avalo and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the shares of common stock described herein, nor shall there be any sale of these shares of common stock 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.