On April 6, 2018 AbbVie (NYSE: ABBV) reported its first-quarter 2018 financial results on Thursday, Apr. 26, 2018, before the market opens (Press release, AbbVie, APR 6, 2018, View Source [SID1234525199]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On April 5, 2018 Oncoceutics, Inc. reported that the first patient has been treated in a clinical trial of ONC201 for patients with certain types of advanced endometrial and breast cancer (Press release, Oncoceutics, APR 5, 2018, View Source [SID1234558370]). The Phase II trial is led by Alexandra Zimmer, MD, Assistant Research Physician at the Women’s Malignancies Branch at the National Cancer Institute (NCI) Center for Cancer Research, part of the National Institutes of Health (NIH). The study will enroll up to 94 adult patients using ONC201 as a single-agent and will require tumor biopsies to enable direct evaluation of the activity of ONC201 within the tumor (Trials.cancer.gov Identifier#NCT03394027).

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Early results from ongoing clinical trials with ONC201 in high grade gliomas has shown promising single-agent activity that is related to the ability to target dopamine receptors. This study will extend the evaluation of ONC201 beyond glioma to include additional tumor types. This is the first clinical trial to launch out of a consortium of multiple investigators across different divisions at the NIH who are working with Oncoceutics to create, understand, and translate its novel class of therapies called imipridones to address unmet medical needs in oncology.

Endometrial and breast cancers have emerged as tumors that are sensitive to ONC201 in preclinical models through unique mechanisms of action that will be investigated in this clinical trial. Preclinical findings from a team of NCI investigators led by Stan Lipkowitz, MD, PhD, Chief of the Women’s Malignancies Branch in the NCI’s Center for Cancer Research, have shown that ONC201 has unique deleterious effects on the mitochondria of breast cancer cells. These findings are described in a recent publication (Greer et al., Oncotarget, In Press). This Phase II study continues the effort to understand the mechanism of ONC201, and to provide therapies to patients with metastatic breast cancer that are in need of new treatments.

Independent work led by Victoria Bae-Jump, MD, PhD, at UNC Lineberger Comprehensive Cancer Center, has found that dysregulated expression of dopamine receptors targeted by ONC201 induce tumor cell death in endometrial cancer. These findings were disclosed as an oral presentation at the recent annual meeting of the Society of Gynecological Oncology meeting in New Orleans.

"Unlike many other cancers, endometrial cancer has not gained targeted therapy treatment options despite the clear need for patients who have failed chemotherapy," said Dr. Bae-Jump. "Our recent work shows that endometrial cancer cells harbor altered expression of dopamine receptors that can be targeted by ONC201, creating the potential for an actionable molecular target for this disease."

On April 5, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that it has initiated its rolling submission of a Biologics License Application (BLA) for SL-401 to the U.S. Food and Drug Administration (FDA) (Press release, Stemline Therapeutics, APR 5, 2018, View Source [SID1234532232]). SL-401 is a targeted therapy directed to CD123 that has been granted Breakthrough Therapy designation (BTD) by the FDA.

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Ivan Bergstein, MD, CEO of Stemline, commented, "The start of our rolling BLA submission is a major milestone for Stemline and the BPDCN patient community at large. If successful, SL-401 would be the first drug ever approved for BPDCN. Moreover, we believe that SL-401 may have a transformative impact on the outcomes of patients with this lethal malignancy of high unmet medical need. With this in mind, our clinical, regulatory, manufacturing, and commercial teams continue to work expeditiously to bring SL-401 to patients as quickly as possible."

On April 5, 2018 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics via in-silico design to simultaneously inhibit multiple key orthogonal and synergistic oncotargets for the treatment of cancer, reported the presentation of its novel triple CDK4-6/PI3K/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 5, 2018, http://www.ireachcontent.com/news-releases/signalrx-to-present-on-its-first-in-class-triple-cdk4-6pi3kbrd4-inhibitor-srx3177-for-treating-cancer-at-the-13th-annual-drug-discovery-chemistry-2018-meeting-678885923.html [SID1234527318]). The presentation by Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be at 2:20 pm on Thursday April 5th, 2018, in the Small Molecules for Cancer Immunotherapy session at the Drug Discovery Chemistry 2018 meeting in San Diego, CA. Data related to combinatorial small molecules which strike multiple immune-oncology cancer targets and activate the innate and adaptive anti-tumor immune response will be presented. The Small Molecules for Cancer Immunotherapy session will also be chaired by Dr. Durden.

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Using SignalRx’s proprietary CRIMP technology platform, the company designed SRX3177 to inhibit three key cancer-driving oncotargets with one drug: CDK4/6, PI3K and BRD4. SRX3177 results in synergistic synthetic lethality in cancer cells (e.g., breast cancer, mantle cell lymphoma) because this novel anticancer agent addresses the following critical cancer-driving facts:

PI3K inhibition abrogates resistance to CDK4/6 inhibition.
BRD4 inhibition decreases transcription of cyclin D1 and MYC.
MYC inhibition decreases levels of immuno-oncology targets CD47 and PD-L1.
CDK4/6 inhibition activates the AKT pathway.
"SignalRx designs all its novel chemotypes and drugs in silico. Because not a single chemotype comes from screening commercially available compounds, SignalRx has built and continues to build a strong and proprietary pipeline" said Dr. Donald L. Durden, founder and senior scientific advisor of SignalRx Pharmaceuticals and Professor and Associate Director of Pediatric Oncology at the Moores UCSD Cancer Center.

The profile of in silico designed small-molecule triple inhibitor SRX3177 includes:

Picomolar CDK4 inhibition potency.
Double-digit nM PI3K and BRD4 inhibitory potency.
BRD4-BD1 selective (5 X) vs BRD4-BD2.
5 Fold more potent than Palbociclib as CDK4 inhibitor.
19-80 Fold more potent than Palbociclib in 3 in vitro cancer cell assays.
40 Fold less toxic in normal epithelial cells vs corresponding combination of three separate inhibitors (Palbociclib + BKM120 + JQ1).
Induction of cell cycle arrest and increased apoptosis.
Lethal in 85% of the cancer cell lines tested in NCI 60 cancer-cell panel.
"All our chemotypes are small molecules (no linking moieties used). Because we rationally design all our anticancer agents from the beginning, we know how to tune in and out target affinity in our compounds. We are in an excellent position to also explore CDK4/6-BRD4 and CDK4/6-PI3K single small-molecule inhibitors for cancer and other applications" said Dr. Joseph Garlich, SignalRx’s Chief Scientific Officer.

SignalRx is also seeking partnering opportunities to accelerate the development of its programs and advance novel anticancer therapeutics into first-in-man clinical trials based on the promising profile and mode of action of its inhibitors. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to streamline their development alone and in combination therapies.

On April 5, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) and Celularity Inc. reported that the companies have started screening patients for its leading CD38 chimeric antigen receptor (CAR) T cell therapy drug development program, following FDA review allowing clinical trial initiation (Press release, Sorrento Therapeutics, APR 5, 2018, View Source [SID1234525804]).

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Phase 1, Open-Label, Dose-Escalation, Pharmacokinetic, and Pharmacodynamic Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma (www.clinicaltrials.gov : NCT03464916). IND filing completed. Study cleared for patient enrollment.

The companies’ CD38 CAR-T program is their most advanced program targeting this difficult-to-treat condition. This trial is currently the only active US-based clinical trial targeting CD38 using a CAR-T cell therapy.

The first investigational site at Roger Williams Medical Center, RI, is actively engaged in the clinical study execution, with additional sites to be included.

"Our CD38 CAR-T program has now officially entered clinical stage and will be treating patients as well as collecting valuable data in the upcoming months. This represents a major milestone for Sorrento and Celularity that clearly demonstrates our keen focus on advancing our therapeutics assets as well as our ability to deliver on the timelines we previously communicated" stated Dr. Henry Ji, Chairman and CEO of Sorrento before adding, "we expect to share initial clinical data from this study as soon as it becomes available".

"We are extremely pleased that we can begin this study in our ongoing efforts to improve treatment options for this and other serious diseases. Celularity, created through the contributions from Celgene Corporation, United Therapeutics, Human Longevity Inc., and founding strategic partner Sorrento, is uniquely positioned to combine its platform cellular technology with the vast tool set accessible from Sorrento," said Dr. Robert Hariri, Chairman and CEO of Celularity. "Celularity is building a deep pipeline of immunotherapeutic products from our proprietary placental cells including ‘off-the-shelf’ CAR-T and CAR-NK cell therapies," added Dr. Hariri.

Utilizing available cGMP manufacturing, Sorrento and Celularity estimate they can produce up to 300 patient treatments per year. These existing capacities easily cover the needs of the Phase 1 clinical study and would be sufficient to meet the requirements for subsequent advanced pivotal clinical studies.

Full details about the study available on www.clinicaltrials.gov

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir").

Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin ("RTX") and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients. ZTlido was approved by the FDA on 02/28/18.

For more information visit www.sorrentotherapeutics.com