On August 6, 2018 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-targeted therapies, reported financial results and provided a business update for the second quarter of 2018 (Press release, Neon Therapeutics, AUG 6, 2018, View Source [SID1234528483]).

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"The first half of 2018 was transformative for Neon, highlighted by the successful completion of our initial public offering. The capital raised will enable the continued execution of our strategy to develop neoantigen-targeted therapies that have the potential to transform patient lives," said Hugh O’Dowd, President and Chief Executive Officer of Neon. "We are pleased by the continued progress across our entire product portfolio of vaccine and T-cell programs, including completion of enrollment of our first Phase 1b clinical trial for NEO-PV-01. In addition, updated data from this trial will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2018."

Second Quarter Business Highlights

Neon achieved several key operational milestones during the second quarter of 2018, including the following:

· In June 2018, Neon completed its initial public offering of common stock, raising $100 million in gross proceeds.

· In May 2018, Neon announced that the first patient was dosed in NT-002, its Phase 1b clinical trial evaluating the company’s personal neoantigen vaccine, NEO-PV-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), along with chemotherapy.

· In April 2018, Neon presented updated data from NT-001, its Phase 1b clinical trial of NEO-PV-01 in the metastatic setting, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Pipeline Overview and Upcoming Milestones

NEO-PV-01

· NT-001: Phase 1b Clinical Trial of NEO-PV-01 in the Metastatic Setting

· Updated data expected in October 2018 at ESMO (Free ESMO Whitepaper)

· 52-week data expected in the first half of 2019

· NT-002: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer

· 52-week data expected in the second half of 2019

· NT-003: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Melanoma Combinations

· Trial initiation expected in the second half of 2018

· NT-004: Phase 1b Clinical Trial of NEO-PV-01 in earlier disease setting

· Planning ongoing

NEO-PTC-01

· Phase 1 Clinical Trial in Solid Tumor Setting: Neon intends to submit a European Clinical Trial Application (CTA) for NEO-PTC-01, a personal neoantigen T-cell therapy, in the first half of 2019.

NEO-SV-01

· Phase 1 Clinical Trial in Subset of ER+ Breast Cancer: Following the completion of target validation and preclinical product development work, Neon expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first half of 2019.

Second Quarter 2018 Financial Results

· Cash Position: As of June 30, 2018, cash, cash equivalents and marketable securities were $138.6 million, as compared to cash, cash equivalents and marketable securities of $79.7 million as of December 31, 2017.

· R&D Expenses: R&D expenses were $14.8 million for the quarter ended June 30, 2018, as compared to $7.3 million for the same quarter last year. The increase of $7.5 million was due primarily to increased costs related to the advancement of NEO-PV-01, including increased external manufacturing and other external costs to support our ongoing and planned clinical trials, as well as increased personnel-related costs due to additional headcount to support the growth of our research and development organization.

· G&A Expenses: G&A expenses were $4.3 million for the quarter ended June 30, 2018, compared to $2.4 million for the same quarter last year. The increase of $1.9 million was driven by increased personnel-related costs due to additional headcount, as well as increased consulting and professional fees.

· Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $22.1 million for the quarter ended June 30, 2018, or $7.84 per basic and diluted share, as compared to a net loss attributable to common stockholders of $12.1 million for the same quarter last year, or $7.55 per basic and diluted share.

Financial Guidance: Based on its current operating plan, Neon expects that its cash, cash equivalents and marketable securities as of June 30, 2018, including the proceeds from its initial public offering, will enable it to fund its operating expenses and capital expenditure requirements into at least the first quarter of 2020.

On August 6, 2018 Immune Biosolutions Inc. (IBio), a JLABS @ Toronto resident company, reported a research collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Immune Biosolutions, AUG 6, 2018, View Source [SID1234528459]). The agreement, facilitated by Johnson & Johnson Innovation LLC, will focus initially on the discovery and development of therapeutic antibodies in oncology.

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The collaboration will utilize IBio’s proprietary Nebula antibody discovery platform to advance oncology targets that historically have been a challenge for therapeutic development. "IBio’s Nebula platform provides a new angle to antibody discovery with four families of technologies integrated within a single platform to deliver innovative antibody therapies in key disease areas. We are excited to be working with Janssen in this promising new area which we believe has the potential to transform and improve human health," said Frédéric Leduc, chief executive officer of Immune Biosolutions.

Financial terms of the agreement are not being disclosed.

On August 6, 2018 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended June 30, 2018, and provided an overview of recent accomplishments and plans for its research and development programs (Press release, CytRx, AUG 6, 2018, View Source [SID1234528834]).

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"To date, 2018 has been marked by several important achievements, most notably the launch of Centurion BioPharma Corporation, which is focused on personalized medicine in advancing our albumin binding ultra high potency LADR (Linker Activated Drug Release) drug candidates and platform technology, and the filing of a provisional patent application covering our breakthrough companion diagnostic to be used alongside the LADR assets," said Eric Curtis, CytRx’s President and Chief Operating Officer. "We are extremely excited about the opportunity these innovative assets can offer to the oncology field and we are diligently working to secure a strategic partnership to advance them further."

"On the corporate and financial front, we have been executing on several key initiatives, including increasing our participation at institutional investor conferences, substantially reducing our cash burn rate, and strengthening our balance sheet. These efforts, combined with our addition to the Russell Microcap Index, leave us well positioned to achieve our corporate objectives for the remainder of 2018," concluded Mr. Curtis.

Second Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
Breakthrough Personalized Medicine Companion Diagnostic Filed for Albumin-Binding LADR Drug Candidates. In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from the treatment with the Company’s lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any albumin-binding drugs the Company may generate in the future.
Launched Centurion BioPharma Corporation. In June 2018, Centurion BioPharma Corporation, a private wholly owned subsidiary, was launched by CytRx to focus on the advancement of the LADRTM drug candidates and technology platform. The subsidiary may develop novel drug candidates on its own while out-licensing other assets for larger patient populations. Eric L. Curtis serves as Centurion BioPharma’s President and Chief Executive Officer.
CytRx Corporation
Paid Off Hercules Long-Term Loan Facility. In August 2018, CytRx announced that it made the final scheduled payment under a long-term loan facility agreement with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. As of August 1, 2018, the Hercules loan was paid in full, which extinguished all of CytRx’s outstanding debt.
Expiration of the Majority of Its Outstanding Warrants. In July 2018, CytRx announced the expiration of warrants for approximately 3.2 million shares of its common stock. CytRx believes the expiration of these warrants, the majority of which were associated with a public offering in December 2016, eliminates overhang and provides additional common share float stability.
Aldoxorubicin Included in New NantCell Inc. Triple Negative Breast Cancer Clinical Trial. In June 2018, CytRx highlighted that aldoxorubicin licensee NantCell, Inc. had dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with triple negative breast cancer. This new trial represents the third NantCell study evaluating aldoxorubicin combined with immunotherapy or high affinity natural killer cell therapy in high unmet need cancer indications.
Added to the Russell Microcap Index. In June 2018, CytRx announced that it had been added to the Russell Microcap Index, effective upon the market open on Monday, June 25, 2018. The Russell indexes are broadly referenced as benchmarks by active investment strategists and institutional investors for index funds. CytRx’s inclusion in the index highlights the growth CytRx has made as a company.
Aldoxorubicin Reviewed in Future Oncology. In June 2018, CytRx highlighted data on licensee NantCell Inc’s aldoxorubicin, which was published in the peer-reviewed journal Future Oncology. The paper, published June 5, 2018, is entitled "Aldoxorubicin therapy for the treatment of patients with advanced soft tissue sarcoma" and can be accessed online here. The paper discusses the albumin-binding mechanism of action, pharmacokinetics, preclinical studies, clinical trial data and the safety profile of aldoxorubicin. It also discusses the potential relevance in the future treatment of patients with sarcoma, or who have other anthracycline sensitive tumor types, while avoiding cardiotoxicity.
Aldoxorubicin Data Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting. In June 2018, CytRx highlighted NantCell Inc’s aldoxorubicin abstract selected for poster presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. The presented data showed that aldoxorubicin, alone or in combination with ifosfamide, lacks cardiotoxicity with doxorubicin equivalent doses beyond 1000 mg/m2. The data, obtained from two clinical trials of aldoxorubicin, contributes to the growing body of evidence showing that aldoxorubicin may be able to improve antitumor activity without typical doxorubicin-associated cardiac toxicity.
Eric L. Curtis named as President and Chief Operating Officer. In May 2018, CytRx announced the appointment of Eric L. Curtis as President and Chief Operating Officer. Mr. Curtis is a seasoned professional with 25 years of experience in both oncology and orphan diseases, including development and commercialization of approved drugs Votrient, Doxil, Velcade, Benlysta and Tykerb. CytRx has been utilizing Mr. Curtis’s extensive life science leadership to further the LADRTM development program by working to secure a strategic alliance for Centurion BioPharma Corporation.
Presented Statistically Significant Breakthrough LADR Drug Candidate Data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting. In April 2018, CytRx presented three posters highlighting breakthrough data relating to its LADR drug candidates at the AACR (Free AACR Whitepaper) 2018 Annual Meeting in Chicago. The posters describe the positive scientific findings that led to the Company’s decision to select auristatin E (AE) derivatives LADR-7 and LADR-8, and maytansine derivatives LADR-9 and LADR-10, as the LADR candidates eligible to advance toward IND-enabling studies. The compounds demonstrated excellent, long-term antitumor activity across a wide range of human solid tumor cancer types, including lung, breast, ovarian, head and neck, renal cell, and melanoma. PDF copies of the presented posters (abstracts #1657, #2661, and #3703) can be accessed here.
Participated in Three Institutional Investor Conferences. Over the past quarter, CytRx participated in three institutional investor conferences, including the Singular Research Summer Solstice 2018 Conference in New York City, the OneMed NYC Oncology Investor Conference 2018 in New York City and the 8th Annual LD Micro Invitational Conference in Bel-Air, California. At each conference, CytRx executive management made a formal presentation and had one-on-one meetings with institutional investors.

Second Quarter 2018 Financial Results

During this quarter CytRx substantially reduced its monthly cash burn rate, and expects to continue to manage its cash effectively.
CytRx reported cash and cash equivalents of $36.4 million as of June 30, 2018.

Net loss for the quarter ended June 30, 2018, was $3.0 million, or $(0.10) per share, compared with a net loss of $14.4 million, or $(0.60) per share, for the comparative 2017 period, a reduction of $11.4 million, or approximately 79 percent. During the second quarter of 2018, the Company recognized a non-cash gain of $0.1 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to a non-cash loss of $4.3 million during the second quarter of 2017 related to these now expired warrants.

Research and development (R&D) expenses were $0.8 million for the second quarter of 2018, which represents primarily $0.6 million of expenses for the development of the albumin companion diagnostic (ACDx) and $0.2 million of non-cash expenses. In the second quarter of 2017, R&D expenses of $6.2 million included $4.3 million related to our aldoxorubicin program and $0.9 million for non-cash expenses.
General and administrative (G&A) expenses were $1.7 million for the second quarter of 2018, compared with $3.1 million for the second quarter of 2017, including non-cash stock-compensation expense of $0.4 million for the second quarter of 2018 and $0.5 million for the second quarter of 2017. G&A expenses decreased by approximately 46 percent primarily due to a decrease in professional fees.
Conference Call and Webcast
CytRx will be hosting a conference call and webcast today beginning at 11:00 am Eastern Time (8:00 am Pacific Time). To access the conference call, dial (+1)844-358-6753 (U.S. and Canada) or (+1)216-562-0397 (international callers) and enter the conference ID number: 5991089. A live and archived webcast will be available in the News and Events/Events Calendar section of the Company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1)855-859-2056 (U.S. and Canada) or (+1)404-537-3406 (international callers) and enter the conference ID number: 5991089.

On August 6, 2018 Foundation Medicine, reported the publication of the results of a large study demonstrating that its novel, investigational assay to measure blood tumor mutational burden (bTMB) can help predict response to the anti-PD-L1 immunotherapy, atezolizumab, (TECENTRIQ) in patients with previously treated non-small cell lung cancer (NSCLC) (Press release, Foundation Medicine, AUG 6, 2018, View Source [SID1234528460]). The study, published in the journal Nature Medicine, was the result of a collaboration between Foundation Medicine and Genentech, a member of the Roche Group, and demonstrates the potential of bTMB to expand precision oncology approaches for patients with advanced cancers, including metastatic lung cancer. In addition, these results show that bTMB may be an independent predictor of clinical benefit, regardless of PD-L1 expression as assessed by immunohistochemistry.

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"A significant proportion of patients with advanced lung cancer do not have adequate tissue for traditional biomarker testing. These study results represent an important advance for the liquid biopsy field and suggest that measuring TMB in the blood with our novel assay can help identify patients more likely to benefit from anti-PD-L1 immunotherapy," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "We look forward to further developing this assay through ongoing clinical trials and ultimately as a companion diagnostic to help oncologists make the most informed decisions possible, even when a tissue sample is not feasible."

In the study, clinical data for the novel bTMB assay was reported from a retrospective analysis of more than 1,000 samples from patients with previously treated, advanced NSCLC who participated in Genentech’s Phase II POPLAR and Phase III OAK clinical trials. The study used samples from the POPLAR trial to identify a range of bTMB thresholds that correlated with clinically meaningful outcomes, which were then confirmed using samples from the OAK study. Within the OAK study, patients with bTMB ≥ 16 total mutations (14 mut/Mb) showed significantly improved progression-free survival when treated with atezolizumab as compared to those patients with bTMB ≥ 16 total mutations (14 mut/Mb) treated with docetaxel chemotherapy (Hazard Ratio=0.65 [95% CI: 0.47, 0.92]; p=0.013). According to the study’s first author, David Gandara, M.D. of the UC Davis Comprehensive Cancer Center, "These are exciting times in lung cancer immunotherapy. Having a blood test that can identify those patients most likely to benefit would be a huge advantage for both physicians and patients. This publication is the first step toward what I anticipate will be full clinical application of this assay."

This bTMB assay is being prospectively evaluated in two Genentech studies: in the Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay to validate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients, and in the single arm Phase II Blood First-Line Ready Screening Trial (B-F1RST) evaluating atezolizumab monotherapy in first-line NSCLC.

In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation for Foundation Medicine’s new liquid biopsy assay, which will expand upon its current liquid biopsy assay to include genomic biomarkers for microsatellite instability (MSI) and bTMB. If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.

On August 6, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it has entered into a research collaboration agreement with the University of California, Los Angeles (UCLA) on behalf of Roger S. Lo, M.D., Ph.D. and his research team (Press release, OncoSec Medical, AUG 6, 2018, View Source [SID1234528629]). Dr. Roger S. Lo, Professor of Medicine and Molecular and Medical Pharmacology in the UCLA David Geffen School of Medicine, Associate Chief of Dermatology and a member of the UCLA Jonsson Comprehensive Cancer Center, is a preeminent physician-scientist widely recognized for his work in understanding treatment-resistant melanoma.

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Under the research collaboration, Dr. Lo and his research team will perform genetic, transcriptomic and methylomic analyses of patients in OncoSec’s PISCES/KEYNOTE-695 Phase 2b clinical trial, which is evaluating TAVO (tavokinogene telseplasmid) in combination with KEYTRUDA (pembrolizumab) for the treatment of metastatic melanoma in patients that have progress after receiving all available treatments including anti PD-L1 checkpoint immunotherapy.

"UCLA and Dr. Lo represent an ideal collaborator for OncoSec to augment our ongoing PISCES/KEYNOTE-695 Phase 2b clinical program with specialized research designed to pinpoint the genetic and epigenetic mechanisms that correspond to specific clinical outcomes in the treatment of metastatic melanoma with TAVO in combination with pembrolizumab," said Christopher G. Twitty, Chief Scientific Officer of OncoSec. "The PISCES/KEYNOTE-695 Phase 2b study continues to progress as planned with enrollment in Stage 1 expected to be complete in the third quarter 2018 and topline data anticipated prior to year-end. Our collaboration with Lo Lab has the potential to not only offer important insights into the mechanism of action of TAVO in combination with pembrolizumab for the treatment of metastatic melanoma, but could be applicable across our clinical pipeline, including the ongoing KEYNOTE-890 Phase 2b trial of TAVO in combination with pembrolizumab in triple negative breast cancer."

Under Dr. Lo’s direction, his research team focuses on genomic, epigenomic and immunologic factors that shape the cancer’s evolution on molecularly targeted therapies and/or immune checkpoint inhibitors. Dr. Lo’s research has received funding from the National Cancer Institute, American Skin Association, Melanoma Research Alliance, The Melanoma Research Foundation, Ressler Family Foundation, and Steven C. Gordon Family Foundation.