On July 24, 2018 A-Alpha Bio reported that it has been awarded a National Science Foundation Phase I Small Business Innovation Research (SBIR) grant for $225,000 to develop AlphaSeq: a cell-based platform that will accelerate cancer drug development by enabling high-throughput and quantitative characterization of protein-protein interactions (Press release, A-Alpha Bio, JUL 24, 2018, View Source [SID1234636894]).

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Proteins bind to one another, like Lego pieces, to form complex biological machines. In cancer cells, these machines are dysregulated, causing cell-survival and uncontrolled growth. Pharmaceutical companies are developing drugs that kill cancer cells by blocking key protein-protein interactions. However, blocking any of the millions of protein-protein interactions that occur in healthy cells could cause serious side-effects, making specificity a major concern.

"A-Alpha Bio’s AlphaSeq technology is a game-changer for preclinical drug screening," said Randolph Lopez, CTO and Co-founder of A-Alpha Bio. "It lets us measure the effect of a drug on thousands of protein-protein interactions simultaneously, instead of having to measure each one individually. Pharmaceutical companies will not have to limit their preclinical testing to a small number of likely off-target effects. With AlphaSeq, they can avoid costly and potentially life-threatening surprises during clinical trials by screening their drugs against whole protein networks"

Protein interactions are already widely recognized as being critically important for the development of many different types of drugs. AlphaSeq provides a unique advantage over existing approaches by combining high accuracy and throughput, which is enabled by advances in the fields of synthetic biology and DNA sequencing. This SBIR grant is aimed at expanding the capabilities of AlphaSeq for screening interactions with challenging proteins and insoluble small molecule drugs. Once completed, A-Alpha Bio will be eligible to apply for a Phase II grant (up to $750,000) for pilot testing and scale-up.

On July 24, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2018 second quarter financial results on Tuesday, August 7, 2018, after the close of the financial markets (Press release, Jazz Pharmaceuticals, JUL 24, 2018, View Source;p=RssLanding&cat=news&id=2359741 [SID1234527844]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EDT/9:30 p.m. IST to discuss second quarter 2018 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at View Source Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 4989706

A replay of the conference call will be available through August 14, 2018 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 4989706

On July 24, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program (Press release, Celyad, JUL 24, 2018, View Source [SID1234532513]). The FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.

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Dr. Christian Homsy, CEO of Celyad: "We are pleased to have achieved this important milestone. Celyad is the first company clinically evaluating a non-gene edited CAR-T candidate, which, we believe, offers significant advantages over gene edited approaches. Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR-T products."

CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s auto-logous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufac-turing process that is highly similar to Celyad’s well established process for its clinical au-tologous CAR-T cell products.

While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.

On July 24, 2018 F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies (mAb²), reported that FS118 has successfully reached the first clinical milestone in its collaboration with Merck, a leading science and technology company (Press release, f-star, JUL 24, 2018, View Source [SID1234527845]).

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FS118 is a first-in-class antagonist mAb² which simultaneously targets the LAG-3 and PD-L1 immuno-suppressive pathways and which has the potential to overcome tumour resistance and restore the natural anti-cancer immune response.

In May 2018, FS118 entered into a Phase I study in patients with advanced malignancies that have progressed on PD-1/PD-L1 therapy.

"Achieving this clinical milestone is a significant step in our alliance with Merck" said John Haurum, CEO of F-star. "FS118 is uniquely positioned as a first-in-class treatment for cancer patients. We are pleased with the progress being made and look forward to advancing our next mAb² molecules into the clinic."

Under the collaboration, which was announced in June 2017, Merck has an exclusive option to acquire FS118 and a further four early stage immuno-oncology bispecific antibody programmes which are under discovery and development by F-star. Further payments are contingent on option exercise and achievement of clinical and commercial milestones with a potential total deal value reaching over €1B.

FS118 was generated using F-star’s proprietary Modular Antibody Technology by incorporating an anti-LAG-3 Fcab (Fc-region with antigen binding) into a PD-L1-specific antibody. Further information about the ongoing Phase I clinical trial is available on clinicaltrials.gov NCT03440437.

On July 24, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that two abstracts highlighting data from ongoing clinical studies of sitravatinib will be presented as Proffered Papers in oral presentations at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Mirati, JUL 24, 2018, View Source [SID1234527849]).

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Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018 at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018 at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.