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 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), is a clinical stage biopharmaceutical development company utilizing proprietary artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, reported that dipeptidyl peptidase (DPP) 8/9 inhibition, the primary mechanism of action of its lead immuno-oncology candidate, BXCL701, was highlighted in an article in the July 2018 edition of the peer-reviewed journal Nature Medicine (Press release, BioXcel Therapeutics, JUL 24, 2018, View Source [SID1234527859]).

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BXCL701 is a potential first-in-class, highly potent oral small molecule immuno-modulator that has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. It is designed to stimulate both the innate and acquired immune systems by inhibiting DPP8/9 and blocking immune evasion by inhibiting Fibroblast Activation Protein (FAP).

The paper titled "DPP8/DPP9 inhibitor-induced pyroptosis for treatment of acute myeloid leukemia" by Darren C. Johnson, et al., concluded that activation of caspase recruitment domain-containing protein 8 (CARD8) acts as an inflammasome sensor to activate caspase-1 and mediates DPP8/9 inhibitor-induced cell death in myeloid cells(1). This therapeutic strategy serves as a potential pathway for direct cytotoxicity of acute myeloid leukemia (AML) cells and indirect response to solid tumors. Multiple prior studies have established DPP8/9 as a novel immune checkpoint that controls the activation of the innate immune system(2),(3)

"BXCL701 is novel in its ability to stimulate both the innate and acquired immune systems by inhibiting DPP8/9 and blocking immune evasion by inhibiting FAP," said Vimal Mehta, PhD, Chief Executive Officer of BTI. "This publication highlights one component of BXCL701’s dual mechanism of action, providing valuable insights on the effects of DPP8/9 inhibition. BXCL701 differentiates itself by activating the innate immune system and stimulating neutrophils, natural killer cells and effector T cells. The paper provides further mechanistic understanding of DPP8/9 inhibition and validates its importance as a promising therapeutic approach, not only for solid tumors but for hematologic malignancies as well."

BTI expects to initiate Phase 2 proof of concept studies evaluating BXCL701 in pancreatic cancer and tNEPC later this year. BTI is also evaluating BXCL701’s potential in additional indications, both as a monotherapy and in combination with other immuno-oncology agents and partnering strategies.

Vincent J. O’Neill, MD, Chief Medical Officer of BTI added, "BXCL701 has generated compelling preclinical data in pancreatic cancer and a variety of other tumor models. Particularly exciting is its ability to block immune evasion and aid in the formation of memory T-cells, which may support long-term immunity in certain types of cancer as presented by BTI at ASCO (Free ASCO Whitepaper) 2018(4)."

This study in AML led by Dr. Bachovchin’s team at the Memorial Sloan Kettering Cancer Center and the Weil Cornell Graduate School of Medical Sciences, demonstrates that the therapeutic potential of a DPP8/9 inhibitor such as BXCL701 can extend beyond solid tumors into hematologic malignancies.

Dr O’Neill concluded, "We look forward to further evaluating BXCL701 in our lead indications, and potentially expanding its application to other cancer types."

(1) Johnson, DC, et al. DPP8/DPP9 inhibitor-induced pyroptosis for treatment of acute myeloid leukemia." Nat Med (2018), PMID: 29967349; DOI:10.1038/s41591-018-0082-y

(2) Okondo, Marian C., et al. "DPP8 and DPP9 inhibition induces pro-caspase-1-dependent monocyte and macrophage pyroptosis." Nat Chem Biol 13.1 (2017): 46-53. PMID: 27820798; DOI:10.1038/nchembio.2229

(3) Okondo, Marian C., et al. "Inhibition of Dpp8/9 activates the Nlrp1b inflammasome." Cell Chem Biol 25.3 (2018): 262-267. PMID: 29396289; DOI:10.1016/j.chembiol.2017.12.013

(4) Rastelli et al., Presented at ASCO (Free ASCO Whitepaper) 2018, Illinois, Abstract #3085

On July 24, 2018 Sutro Biopharma, Inc., reported that it has signed a collaboration and licensing agreement with Merck, known as MSD outside the United States and Canada, to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders (Press release, Sutro Biopharma, JUL 24, 2018, View Source [SID1234529410]).

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The research and development activities will leverage Sutro’s proprietary cell-free protein synthesis andsite-specific conjugation platforms, which facilitate precision design and rapid empirical optimization of protein conjugates, to discover and develop best-in-class immune-modulating cytokine derivativesfor both oncology and autoimmune indications.

Under the agreement, Sutro will be primarily responsible for preclinical research and Merck will gain exclusive worldwide rights to therapeutic candidates derived from the collaboration.

Sutro will receive an upfront payment of $60 million and is eligible for milestone payments totaling up to $1.6 billion associated with the development and sale of all therapeutic candidates and all possible indicationsidentified under the collaboration, as well as tiered royalties on the sale of products.

"There’s an urgent need for novel, targeted and well-tolerated therapies with improved therapeutic profiles for cancer and autoimmune disease," Sutro CEO Bill Newell said. Dr. Joe Miletich, Senior Vice President, Discovery, Preclinical and Early Development, Merck Research Laboratories, said: "Sutro has an impressive suite of technologies that make possible the discovery, characterization and manufacture of novel therapeutic proteins in a timely manner. We look forward to collaborating with Sutro to further expand our pipeline of promising candidates targeting oncology and autoimmune diseases."

On July 24, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the second quarter ended June 30, 2018 (Press release, Quest Diagnostics, JUL 24, 2018, View Source [SID1234527834]).

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"Once again, we grew revenues and delivered strong earnings growth in the second quarter," said Steve Rusckowski, Chairman, President and CEO. "We continue to strengthen our strategic relationship with UnitedHealth Group and are excited to serve as a national in-network lab provider for UnitedHealthcare members beginning January 1, 2019. Overall, we remain focused on delivering on our two-point strategy and have updated our outlook for the full-year 2018 to reflect our confidence in achieving our commitments for the year."

Net revenues and selling, general and administrative expenses for the three and six months ended June 30, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a retrospective basis. Under the new rules, the Company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

The updated outlook for 4% to 4.5% revenue growth in 2018 represents management’s estimates for 2018 versus 2017 reported revenues adjusted to reflect the impact of new revenue recognition rules that became effective January 1, 2018. Full year 2017 revenues adjusted to reflect the new rules were $7,402 million. See note 5 of the financial tables attached below.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as restructuring and integration charges, excess tax benefit ("ETB") associated with stock based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed in listen-only mode by dialing 773-756-0467, passcode 3214469. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 24, 2018 until midnight Eastern Time on August 7, 2018. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 24, 2018 Amgen (NASDAQ:AMGN) reported that it will report its second quarter 2018 financial results on Thursday, July 26, 2018, after the close of the U.S. financial markets (Press release, Amgen, JUL 24, 2018, View Source;p=RssLanding&cat=news&id=2359722 [SID1234527838]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.