Deciphera Pharmaceuticals, Inc. to Report Clinical Data with DCC-2618 at the Upcoming 2018 American Society for Clinical Oncology (ASCO) Annual Meeting

On April 25, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that an abstract highlighting DCC-2618, the Company’s KIT and PDGFRα inhibitor, has been selected for poster presentation and discussion at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 1-5, 2018 in Chicago, IL (Press release, Deciphera Pharmaceuticals, APR 25, 2018, View Source [SID1234525689]).

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Details of the presentation on DCC-2618 are as follows:

Poster Title: Mutation profile of drug resistant gastrointestinal stromal tumor (GIST) patients (pts) enrolled in the phase 1 study of DCC-2618.

Author: Suzanne George, Dana-Farber Cancer Institute
Session: Sarcoma, Poster and Discussion Session
Abstract #: 11511
Poster Board #: 256
Date & Time: Saturday June 2, 20183:00 PM – 4:15 PM CT
Location: Hall A, S404, McCormick Place, Chicago, IL

About DCC-2618

DCC-2618 is a KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and glioblastoma multiforme. DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα. DCC-2618 is a KIT and PDGFRα inhibitor that blocks initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST as well as the primary D816V exon 17 mutation involved in SM. DCC-2618 also inhibits primary PDGFRα mutations in exons 12, 14,and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

PROVECTUS BIOPHARMACEUTICALS AND PEDIATRIC ONCOLOGY EXPERIMENTAL THERAPEUTICS INVESTIGATORS’ CONSORTIUM (POETIC) ANNOUNCE ACCEPTANCE OF PV-10 POSTER PRESENTATION AT AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING

On April 25, 2018 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers, and the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium ("POETIC"), a group of North American academic medical centers developing new pediatric cancer therapies, reported that preclinical data from ongoing pediatric cancer research into PV-10 will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting held in Chicago, IL from June 1-5, 2018 (Press release, Provectus Pharmaceuticals, APR 25, 2018, View Source [SID1234525706]). The presentation is entitled "In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors."

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The session title is Pediatric Oncology (Saturday, June 2, 8:00-11:30 AM), the topic is Pediatric Solid Tumors, the poster board number is 230, and the abstract number is 10557.

The preclinical pediatric cancer research was led by Aru Narendran, MD, PhD and researchers at the POETIC Laboratory for Pre-Clinical and Drug Discovery Studies at the University of Calgary (Canada), together with Tanya Trippett, MD, Director of POETIC, and researchers at Memorial Sloan Kettering Cancer Center. Further details regarding the presentation will be announced closer to the ASCO (Free ASCO Whitepaper) conference.

About PV-10

Provectus’ lead investigational cancer drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

About the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium

The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) was founded in February 2003 by Dr. Tanya Trippett at Memorial Sloan Kettering Cancer Center and Dr. Lia Gore at the University of Colorado Cancer Center. POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive cancer care and research that provide the collaborative and research strength needed to complete intensive phase I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and adolescent populations. POETIC’s assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH-funded pediatric and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science and translational research programs at the institutions allows focus on the development and evaluation of new therapeutic strategies for patients with cancer and related disorders. POETIC’s pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and evaluate novel agents and/or combinations of therapies early in clinical development as well as new approaches to targeted delivery. For additional information about POETIC, please visit the Consortium’s website at www.poeticphase1.org.

CrystalGenomics to co-develop immuno-oncology combination therapy with US firm

On April 25, 2019 CrystalGenomics, a Korean biopharmaceutical company reported it has signed a co-development agreement with U.S.-based CBT Pharmaceuticals for an investigational combination therapy of CG200745 and CBT-501 across a variety of solid tumors with high unmet medical needs (Press release, CrystalGenomics, APR 25, 2018, View Source;year=2018&no=263708 [SID1234539164]).

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CG200745 from CrystalGenomics is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer and Phase Ib for myelodysplastic syndrome in Korea.

CBT-501 from CBT Pharmaceuticals is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety and efficacy in patients with advanced solid tumors, recurrent or refractory to standard of care therapies.

Under the exclusive agreement, the duo will be responsible for the co-development and global commercialization of the combination of CG200745 and CBT-501 in multiple tumor types, including hepatocarcinoma correlated with poor prognosis.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) have been proven effective but many patients do not respond due to resistance. Recent reports suggest immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501, according to CBT Pharmaceuticals.

Shares of Kosdaq-listed CrystalGenomics finished Wednesday down 2.8 percent at 26,000 won ($24.06).
By Shin Chan-ok and Minu Kim

Shire and Takeda come to terms with a $64B deal, the biggest pharma M&A in years

Late Tuesday, after a fifth buyout offer from Takeda, Shire said the Japanese drugmaker had finally landed on a proposal worth recommending to shareholders (Press release, Shire, APR 25, 2018, http://www.fiercepharma.com/pharma/shire-takeda-agree-to-preliminary-deal-and-analysts-agree-other-bidders-aren-t-coming?utm_source=internal&utm_medium=rss [SID1234525690]). It’s a cash-and-stock bid now worth $64 billion or so, about $4 billion more than its first offer.

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The deal still has to be approved by both boards and is subject to due diligence. The U.K.’s takeover board, which has strict rules for the timing and disclosure of bids, extended a deadline to give Takeda and Shire until May 8 to wrap it up.

In per-share terms, Takeda would fork over 0.839 new Takeda shares and $30.33 in cash for each Shire share. Based on Takeda’s share price at Monday’s close, that’s £49 per share, Shire said in a statement—and £5 per share more than its first bid.

That share price is a moving target, though; Takeda’s stock plummeted by 7% on the news Wednesday morning.

Structured this way, the deal "seems to be much more of a merger," Bernstein analyst Ronny Gal pointed out in a note to clients. Shire shareholders will receive 50% of the value of the combined company, and the companies will do reciprocal due diligence before any deal closes.

RELATED: Fifth and final bid? A determined Takeda said to be nearing $60B-plus Shire deal

At least one analyst isn’t so sure Shire shareholders will be interested.

"Are SHPG shareholders willing to accept an offer that is in effect 44% cash and 56% equity?" Jefferies’ David Steinberg wrote in a note to clients. While the latest bid is much more heavily weighted toward cash than Takeda’s third bid—just 38% cash—"we still wonder if it is enough to satisfy SHPG shareholders, who would still bear some not insignificant risk going forward as ~50% owners of NewCo," he wrote.

Gal, on the other hand, figures the deal will go through.

"The risk to the deal is unlikely in our view to come from Shire shareholders or anti-trust authorities," he wrote, noting that its Takeda’s shareholders, not Shire’s., that have sent the stock downward throughout the bidding process. Still, he pegged the probability of the deal going through at between 80% and 90%.

"Short of Takeda stock price imploding a deal is likely," he added.

RELATED: What would a Shire buy look like for Pfizer, Amgen or AbbVie? Analysts lay out pros and cons

Both analysts agree on one thing, though: Another bidder, which some industry watchers previously expected, probably won’t come out of the woodwork at this point.

"We expect Shire bankers to have left no stone unturned looking for other bidders," Gal wrote, with Steinberg adding that "we continue to think any potential group of buyers to be very limited … it’s arguably less than a 50% chance that another suitor emerges

Immune Design to Report First Quarter 2018 Financial Results and Provide Corporate Update

On April 25, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that it will report first quarter 2018 financial results after the close of U.S. financial markets on Wednesday, May 2, 2018 (Press release, Immune Design, APR 25, 2018, View Source [SID1234525707]). Immune Design management will host a webcast conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on May 2, 2018 to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 1088768.