On May 27, 2020 Medidata, the global leader in creating end-to-end solutions to support the entire clinical trial process, and a Dassault Systèmes company, reported the online publication of four abstracts at the ASCO (Free ASCO Whitepaper) 2020 Annual Meeting, being held virtually May 29 – 31 (Press release, Medidata, MAY 27, 2020, View Source [SID1234558592]).

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Acorn AI, by Medidata, and its partners – Friends of Cancer Research, Guardian Research Network, Donald and Barbara Zucker School of Medicine of Hofstra/Northwell, Memorial Sloan Kettering Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, and New York Medical College – collaborated on research studies that highlight the importance of integrating multiple sources of data to provide insights into clinical oncology.

"Our research findings demonstrate the value of generating new clinical insights by collecting, combining, and analyzing data in innovative ways," said Glen de Vries, co-founder and co-CEO, Medidata. "We are proud to be working with outstanding research partners, who help bring meaningful contributions to the field and hope to millions of patients."

The published abstracts include use cases that combine omic and clinical data, use real-world data and pooled clinical trial data, and that expand on Medidata’s pioneering work in synthetic control arms. The following are a summary of these abstracts:

Exploring the validity of a synthetic control arm (SCA) for augmentation or replacement of a randomized control in difficult-to-study indications – a case study in relapsed or refractory multiple myeloma (R/R MM) (Abstract e20521)
The study demonstrated that the treatment effect based on a synthetic control arm can mimic the treatment effect from a randomized clinical trial in a study involving patients with relapsed or refractory multiple myeloma; this may have significant implications in speeding drug development and reducing patient burden
Evaluating progression free survival in black and white women with triple negative breast cancer in pooled clinical trials from a Synthetic Control Database (SCD) and real-world electronic medical records (EMR) (Abstract e13102)
A representative pool of cross trial triple negative breast cancer patients demonstrated lower progression free survival in Black patients compared to their non-Black counterparts by using a Synthetic Control Database and real-world EMR data, underscoring the necessity of diversity in clinical trials
Assessing the relationship in relapsed-refractory multiple myeloma between response, progression, and survival between pooled clinical trial subjects and a real-world electronic medical record data source (Abstract e20525)
The study revealed that using pooled clinical trial analyses, together with real-world data, can overcome individual trial sample size limitations and biases; this can expand the range of populations and allow a more comprehensive understanding of the complex oncology treatment landscape
Error-free, automated data integration of exosome cargo protein data with extensive clinical data in an ongoing, multi-omic translational research study (Abstract e16743)
The automatic, efficient, and reliable integration of clinical and omic data was demonstrated in a clinical trial for pancreatic ductal adenocarcinoma (PDAC), an aggressive, difficult to treat malignancy; much-needed diagnostic biomarkers for early detection may now be found in a more expedited, less-resource intensive manner
The Acorn AI/Medidata team invites the oncology community to learn more about these studies at the ASCO (Free ASCO Whitepaper) Industry Expert Theater, which are available starting May 29. This is an opportunity to dive deeper into how the company is bringing data, expertise and technology to the frontlines of decision-making in clinical oncology:

Making Precision Medicine a Reality in Clinical Development, Discovery and Beyond with Bryant Fields, Senior Director, Integrated Evidence Commercial Lead, Acorn AI
Clinical Trial Data meets the Real World: Bridging the Experimental and Post-Launch Worlds with Aaron Galaznik, Head, Acorn AI Labs Boston, Real-World Evidence (RWE)
Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

On May 27, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in fireside chats at the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2020, View Source [SID1234558525]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.

On May 27, 2020 Zionexa USA, a wholly owned subsidiary of Zionexa SAS, and PETNET Solutions, Inc., a wholly owned subsidiary of Siemens Medical Solutions, Inc., reported the Food and Drug Administration (FDA) has approved Cerianna (fluoroestradiol F 18) injection for intravenous use (Press release, Zionexa, MAY 27, 2020, View Source;utm_medium=rss&utm_campaign=zionexa-usa-and-petnet-solutions-announce-fda-approval-of-cerianna-fluoroestradiol-f18 [SID1234558541]). Cerianna (fluoroestradiol F 18) is a molecular imaging agent indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Cerianna (fluoroestradiol F 18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer.

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Cerianna (fluoroestradiol F 18) will be commercially available beginning in late 2020/early 2021 through PETNET Solutions, Inc., Zionexa USA’s manufacturer and exclusive commercial distributor in the U.S. Additional manufacturing sites will be added as each site receives regulatory approval to commence manufacturing.

"Zionexa is pleased to be able to make Cerianna (fluoroestradiol F 18) commercially available through the extensive manufacturing network of PETNET Solutions, Inc.," said Peter Webner, Chief Executive Officer of Zionexa USA. "PETNET has been a great partner to Zionexa and has surpassed our expectations as a contract manufacturer. Cerianna (fluoroestradiol F 18) will provide clinicians with additional, previously unavailable data on the estrogen receptor status of tumors across the patient’s entire body, providing additional data to enhance therapeutic decision-making."

"PETNET Solutions, Inc., is proud to work with Zionexa USA as the exclusive U.S. commercial supplier making Cerianna (fluoroestradiol F 18) accessible to imaging centers and their breast cancer patients," said Barry Scott, head of PETNET Solutions, Inc. "Our extensive network of radiopharmacies enables us to increase access to cutting-edge radiotracers such as Cerianna (fluoroestradiol F 18), helping healthcare facilities address the challenge of recurrent and metastatic breast cancer."

On May 27, 2020 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 12,633,039 shares of its common stock at a price to the public of $11.32 per share and, to certain investors, pre-funded warrants to purchase 2,866,961 shares of its common stock at a purchase price of $11.3199 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, MAY 27, 2020, View Source [SID1234558559]). The aggregate gross proceeds from the offering are expected to be approximately $175.5 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about May 29, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 2,325,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup, Cowen and Evercore ISI are acting as joint book-running managers for the offering. Mizuho Securities is acting as lead manager and Canaccord Genuity is acting as co-manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

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 securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 27, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 8:30 am ET (Press release, Scholar Rock, MAY 27, 2020, View Source [SID1234558577]).

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A webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcasts will be available on the Company’s website for approximately 90 days following the presentation.