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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On April 18, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that Jeff Wolf, Chief Executive Officer, is scheduled to present at the ThinkEquity Conference on Thursday, May 2nd, at 8:00 AM Eastern Time, which is being held at The Mandarin Oriental Hotel in New York City (Press release, Heat Biologics, APR 18, 2019, View Source [SID1234535223]).

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Additional information on the conference is available at, View Source

On April 18, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the Q1 Announcement 2019, presenting all material developments up to 31 March 2019 and the Company’s current outlook (Press release, 4SC, APR 18, 2019, View Source [SID1234535203]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continued to deliver on its targets in the first quarter of 2019, moving our products through clinical trials and towards market approval. In particular, the SENSITIZE and EMERGE studies of domatinostat are progressing well and we expect data read-outs for both during the course of this year. Both studies are expected to provide the foundation for clinical trials in the aggressive rare skin cancer Merkel cell carcinoma (MCC). Furthermore, we have recruited more than two-thirds of patients in the pivotal RESMAIN study of resminostat in the rare cancer cutaneous T-cell lymphoma (CTCL), with positive safety outcomes so far, and expect top-line data in the first half of 2020."

Key highlights in Q1 2019 and beyond

More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage CTCL; positive safety outcomes to date.
Started third dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma.
Started investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors.
Dynavax Technologies Corporation (Dynavax) presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) on the combination of orally available domatinostat with Dynavax’s intra-tumoral TLR9 agonist SD-101. Dynavax also compared domatinostat to other class‑I-selective HDAC inhibitors, with domatinostat demonstrating the most significant benefit in combination with SD‑101.
A clinical cooperation partner presented preclinical data at the AACR (Free AACR Whitepaper) that confirmed domatinostat’s mode of action in the aggressive skin cancer Merkel cell carcinoma.
As part of the agreement concluded in September 2016 to sell 4SC’s non-core immunology portfolio, 4SC now became a small shareholder of Immunic Inc. (NASDAQ: IMUX) and continues to be entitled to receive royalties.
Business outlook

Top-line data of the pivotal RESMAIN study expected in H1 2020.
Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
SENSITIZE study expected to complete in H1 2019.
Safety data of EMERGE expected in Q3 2019 and early efficacy data in Q4 2019.
Expand development for domatinostat and initiate clinical trials in MCC.
Development of cash balance in Q1 2019 and financial forecast

As of 31 March 2019, 4SC holds cash balance/funds of €21.2 million as compared to €25.0 million as of 31 December 2018. The monthly use of cash from operations amounted to €1.263 million on average in the first quarter of 2019 (Q1 2018: €1.812 million) and was below the range of €1.4 million and €1.6 million forecast for 2019.

The decrease in the monthly use of cash as compared to Q1 2018, and the decrease in cash balance/funds in the first quarter of 2019 as compared to the end of 2018, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE.

The Management Board of 4SC believes that these funds should be sufficient to finance 4SC into Q2 2020.