On April 18 2019 Bexion Pharmaceuticals, Inc., a clinical stage oncology company, reported the initiation of an open-label Phase 1 Safety Study of BXQ-350 (Press release, Bexion, APR 18, 2019, View Source [SID1234535542]). The first US site is Cincinnati Children’s Hospital Medical Center. This clinical trial will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in the pediatric population with recurrent solid tumors, brain tumors and diffuse intrinsic pontine gliomas (DIPG).

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Phase 1 Adult Dose Ranging Study
In a Phase 1 Part 1 Adult Dose Ranging Study, BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and no serious adverse events attributed to the therapy. Preliminary data in Part 2 of the Phase 1 support a safe and tolerable drug profile. Information about the Phase 1 Study of BXQ-350 in Adult Patients with Advanced Solid Tumors trial can be found at View Source

Phase I Pediatric Protocol
In December 2018, the FDA cleared a Phase I Pediatric Protocol as part of Bexion’s current IND to move BXQ-350 into the pediatric population.

"With this initiation of Pediatric Phase 1 studies, we are confirming our commitment to the pediatric patient community," stated Dr. Ray Takigiku, Founder and CEO of Bexion. "It is our goal to develop BXQ-350 as quickly as possible for both adult and pediatric cancer patients, particularly those with difficult to treat tumors including high grade gliomas and other brain tumors. We are very grateful to the patients, participating clinical trial sites, and our partners for their engagement and their support."

Technology supporting BXQ-350 was discovered over 15 years ago
The technology supporting BXQ-350 was discovered over 15 years ago by Dr. Xiaoyang Qi, a then faculty member at Cincinnati Children’s. CancerFree KIDS, a non-profit focused on eradicating cancer a life-threatening disease in children, provided the first grant that supported this discovery. Cincinnati Children’s licensed the technology to Bexion to continue development and ultimately commercialize the discovery.

"The very first research grant CancerFree KIDS ever awarded was to Dr. Qi in 2004", explained Ellen Flannery, Founder and Executive Director of CancerFree KIDS. "It was for the study that eventually led to the formation of Bexion Pharmaceuticals. We have followed this research and Bexion since that time, waiting for this pivotal moment of the initiation of a Pediatric Phase I trial. It is rare for a pediatric trial to happen so early in the development of a new treatment. CancerFree KIDS is grateful to Bexion, Cincinnati Children’s and CTI Clinical Trial and Consulting Services, Bexion’s Clinical Research Organization for initiating this trial as quickly as feasibly possible. This means we have an opportunity to get this extremely promising new treatment approved for the children who need it as quickly as possible."

Additional Sites Are Planned
Additional sites are planned, including Nationwide Children’s Hospital in Columbus, Ohio and several children’s hospitals in the western United States.

On April 18, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported plans to report first quarter 2019 financial results on May 2, 2019 (Press release, Ligand, APR 18, 2019, View Source [SID1234535198]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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First Quarter 2019 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates
When: Thursday, May 2, 2019
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 6375579

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On April 18, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present data from a Phase 1b/2 combination study of SD-101 and pembrolizumab for patients with advanced melanoma and for patients with recurrent or metastatic head and neck squamous cell carcinoma, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Dynavax Technologies, APR 18, 2019, View Source [SID1234535220]).

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Abstract Number and Title: #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"
Poster Session Title: Head and Neck Cancer
Session Date and Time:Sat, Jun 01, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #28

Abstract Number and Title: #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #105

Abstract Number and Title: #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #126

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On April 18, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, May 2, 2019 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2019, recent business developments, revenue guidance for the second quarter of 2019, and financial outlook for full year 2019 (Press release, Emergent BioSolutions, APR 18, 2019, View Source;p=RssLanding&cat=news&id=2394937 [SID1234535221]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 8099738

Live Webcast Information:
Visit View Source for the live webcast feed.
A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

On April 18, 2019 Castle Biosciences, Inc. and American Cancer Society’s newly formed philanthropic fund, BrightEdge, reported that BrightEdge participated in a recent convertible note financing of Castle Biosciences of approximately $12 million (Press release, Castle Biosciences, APR 18, 2019, View Source [SID1234535222]). The investment is BrightEdge’s first since its formation to invest in companies developing promising cancer-related therapeutics, diagnostics, devices and technologies.

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Castle Biosciences is a commercial stage dermatological cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. Last year, the company processed tests for more than 13,000 patients. To date, it has received over 40,000 diagnostic orders.

"Since the company’s founding in 2008, we have developed and commercialized what we believe are some of the industry’s most innovative skin cancer diagnostics designed to improve treatment options and, ultimately, patient outcomes," said Castle Biosciences’ founder, president and CEO Derek Maetzold. "As the recipient of BrightEdge’s first investment, we are more committed than ever to the mission we share with the American Cancer Society to fight for a world without cancer."

Castle Biosciences’ lead product, DecisionDx-Melanoma, is a proprietary gene expression profile (GEP) test designed to help doctors assess treatment options for patients with invasive cutaneous (skin) melanoma. The company also markets DecisionDx-UM, a GEP test that predicts metastatic risk for patients with uveal melanoma, a rare and deadly eye cancer. Both are commercially approved and covered by several private insurers. Medicare recently approved both tests for reimbursement coverage under policies administered by two of its insurance contractors, Palmetto GBA and Noridian Healthcare Solutions.

"The significance of this investment goes well beyond simply representing BrightEdge’s first deal," said Bob Crutchfield, managing director of BrightEdge. "Castle Biosciences met the key criteria of our new impact fund. It both has potential to deliver a strong financial return and moves us forward in BrightEdge’s ultimate mission to drive innovation and win the fight against cancer."

The American Cancer Society expects to raise an additional $100 million from private donors to augment its initial $25 million commitment to BrightEdge to make mission investments that advance innovation.

About BrightEdge

BrightEdge is the American Cancer Society’s donor-funded, philanthropic impact fund. The fund is led by a board comprised of the Society’s leaders and a management team with expertise in investment and venture capital. BrightEdge operates under a charitable fund model that invests in for-profit companies developing novel cancer-focused therapies and technologies. The fund relies on the expertise of the Society’s medical and science professionals to evaluate the mission value of its investments. The fund’s goal is to accelerate delivery of promising cancer-related solutions through capital investment, market awareness and a shared commitment to eradicate cancer. BrightEdge is based in Atlanta. For more information, visit www.brightedgefund.org.

(The American Cancer Society is the sole member of BrightEdge, LLC. An investment or other finance vehicle does not constitute an expressed or implied endorsement of any products or services of the company.)

About the American Cancer Society

The American Cancer Society is a global grassroots force of 1.5 million volunteers dedicated to saving lives, celebrating lives, and leading the fight for a world without cancer. From breakthrough research, to free lodging near treatment, a 24/7/365 live helpline, free rides to treatment, and convening powerful activists to create awareness and impact, the Society is the only organization attacking cancer from every angle. For more information, go to www.cancer.org.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a GEP test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied on more than 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes.

The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including more than 780 patients. The consistent high performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.