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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 17, 2019 Provectus (OTCQB: PVCT) reported that data from clinical trials of lead investigational cancer agent PV-10 will be presented on two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago, IL from May 31-June 4, 2019 (Press release, Provectus Biopharmaceuticals, APR 17, 2019, View Source [SID1234535201]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers, stimulating tumor-specific reactivity in circulating T cells1-4 that may lead to a functional recruitment of the immune system.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Abstract #1:

Presentation: A Phase 1 Study of Oncolytic Immunotherapy of Metastatic Neuroendocrine Tumours using Intralesional Rose Bengal Disodium: Cohort 1 results
Poster session: Gastrointestinal (Noncolorectal) Cancer (Monday, June 3, 9-11 AM)
Abstract number: 4102
Abstract #2:

Presentation: Phase 1b Study of PV-10 and PD-1 Blockade in Advanced Cutaneous Melanoma
Poster session: Melanoma/Skin Cancers (Monday, June 3, 1:15-4:15 PM)
Abstract number: 9559
About PV-10

PV-10 causes acute oncolytic destruction of injected tumors, releasing damage associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. T cell function can be further augmented by combining PV-10 with immune checkpoint inhibition.

PV-10 is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver (including metastatic symptomatic neuroendocrine tumors and metastatic uveal melanoma) and preclinical study for pediatric cancers like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10’s active pharmaceutical ingredient is rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), a small molecule halogenated xanthene. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to identify and control these substances is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of active pharmaceutical ingredient that is suitable for clinical trial and commercial pharmaceutical use. US patent numbers are 8,530,675, 9,273,022, and 9,422,260; patent expirations range from 2030 to 2031.

On April 17, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported that it is scheduled to present at the following investor and scientific conferences in April and May 2019 (Press release, ImaginAb, APR 17, 2019, View Source [SID1234535165]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

AIM at Melanoma

April 26-28, 2019, Hotel L’Echiquier Opera Paris, 38 Rue De L Echiquier, Paris

Dr. Anna Wu, Founder, and Board Director, and Ivan Plavec, CBO will be attending and making a presentation on ImaginAb at the 26th International Myeloma Working Group meeting in Paris.

Anglo-Nordic Life Science Conference

May 9, 2019, The County Hall, Belvedere Road, London

Ian Wilson, CEO, will be a panelist at the ‘Technologies and Treatments – What’s on the horizon’ discussion at 13.30 BST.

Bio€quity Europe 2019

May 20-21, 2019, Crowne Plaza Fira Center, Barcelona

Ian Wilson, CEO, and Ivan Plavec, CBO, will be attending and hosting meetings.

2019 ASCO (Free ASCO Whitepaper) Annual Meeting

May 31-June 4, 2019, McCormick Place, Chicago

Ian Wilson, CEO, Ivan Plavec, CBO, and Ron Korn CMO, will be attending and hosting meetings.

Inquiries:

ImaginAb

Ian Wilson

Email: [email protected]

Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur

Email: [email protected]

Phone: +44 20 3950 9144

On April 17, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy (Press release, Intensity Therapeutics, APR 17, 2019, View Source [SID1234535185]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are extremely pleased to receive this Fast Track designation, which validates the potential of INT230-6 to treat patients with relapsed or metastatic triple negative breast cancer as a single agent," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Finding improved therapies for this disease is a critical unmet medical need, and we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication."

Approximately 15-20% of breast cancers test negative for estrogen receptors, progesterone receptors, and excess HER2 protein, qualifying them as triple negative. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer, mainly because there are fewer targeted medicines. According to a study published in the Journal of Clinical Oncology, patients who fail two lines of therapy for TNBC typically progress within nine weeks. Those who have failed three lines progress within four weeks.

"This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research," said Ian B. Walters, M.D., Chief Medical Officer of Intensity Therapeutics. "The Fast Track designation will allow us to engage robustly with the Agency to most effectively and efficiently develop our new cancer treatment approach, as well as help us determine other potential indications to pursue for INT230-6. To date, our ongoing Phase 1/2 trial has treated patients with more than 14 different types of advanced solid tumors including TNBC, and we look forward to evaluating use of INT230-6 in other areas for potential registration-enabling studies."

The FDA’s Fast Track program facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantage over available therapy. Fast Track designation allows early and frequent communication between the FDA and a drug company, often leading to earlier drug approval and access by patients. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

On April 17, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 14 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019 (Press release, Genmab, APR 17, 2019, View Source [SID1234535166]). The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 15, 2019. A list of accepted industry sponsored abstracts is provided below, and includes ten daratumumab abstracts, two of which were accepted for oral presentations, one abstract on enapotamab vedotin, and two abstracts on tisotumab vedotin (Trial in Progress abstracts).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased that once again a wide selection of abstracts concerning Genmab proprietary and partnered programs was selected for presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting. We are especially looking forward to the first full presentations of data from the COLUMBA and CASSIOPEIA daratumumab Phase III trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are equally excited to begin sharing with the oncology community early data from enapotamab vedotin and ongoing trials in progress for tisotumab vedotin."

Representatives from Genmab will be in attendance at ASCO (Free ASCO Whitepaper), booth #24159.

List of Industry Sponsored Abstracts:

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Vs VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: CASSIOPEIA Part 1 Results – Oral presentation, Sunday, June 2, 10:45 AM – 10:57 PM CDT

Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Sunday, June 2, 11:09 AM – 11:21 AM CDT

Efficacy of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in Transplant-eligible Newly Diagnosed Multiple Myeloma Based on Minimal Residual Disease Status: Analysis of the CASSIOPEIA Trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Stem Cell Yield and Transplantation Results from Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in the Phase 3 CASSIOPEIA Study –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Impact of age on efficacy and safety of daratumumab in combination with lenalidomide and dexamethasone (D-Rd) in patients with transplant-ineligible newly diagnosed multiple myeloma: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Faster and sustained improvement in health-related quality of life for newly diagnosed multiple myeloma patients ineligible for transplant treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) vs Rd alone: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) in relapsed or refractory multiple myeloma based on cytogenetic risk: updated subgroup analysis of CASTOR – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, lenalidomide, and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma: updated subgroup analysis of POLLUX based on cytogenetic risk – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with transplant-eligible newly diagnosed multiple myeloma: a multicenter, randomized, phase 3 study (PERSEUS) – Poster, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy: a multicenter, randomized, phase 3 study (CEPHEUS) – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Tisotumab vedotin (Submitted by Seattle Genetics):
SGNTV-001: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or
Metastatic Disease in Solid Tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Phase 2 Trial of Tisotumab Vedotin in Platinum-Resistant Ovarian Cancer (innovaTV 208) – Poster presentation, Saturday, June 1, 2019, 1:15 PM – 4:15 PM CDT

Enapotamab vedotin:
First-in-human, dose-escalation, phase 1 trial to evaluate safety of anti-Axl antibody–drug conjugate enapotamab vedotin in solid tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Ofatumumab (Submitted by Novartis):
Long-term follow-up of previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) treated with ofatumumab and chlorambucil: Final analysis of the phase 3 COMPLEMENT 1 trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT