On July 10, 2019 Geneos Therapeutics, a clinical-stage biotech company, a spin-out of Inovio Pharmaceuticals (NASDAQ: INO), reported that the first cancer patient was dosed using the company’s GT-EPIC Neoantigen-Targeting Personalized Vaccine Technology (Press release, Geneos Therapeutics, JUL 10, 2019, View Source [SID1234537471]). In this first-in-human treatment – part of a clinical collaboration between Geneos and Washington University School of Medicine in St. Louis – a patient with Anaplastic Astrocytoma, a form of advanced brain cancer, is being treated on a Compassionate Use basis with the patient’s own tumor-derived neoantigen vaccine. The target neoantigens were identified using Washington University’s proprietary neoantigen prediction algorithm – pVAC-Seq. The vaccine, which targets 30 antigens including all 27 tumor specific neoantigens and 3 tumor antigens identified from the patient’s tumor, was designed and administered based on the GT-EPIC Platform.

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Dr. Niranjan Y. Sardesai, Geneos’ Chief Executive Officer, said "This first-in-human treatment is an important milestone for Geneos as it demonstrates the company’s rapid biopsy-to-treatment implementation of its GT-EPIC technology platform to target cancer neoantigens on a personalized basis. Geneos is pleased to collaborate with Washington University, a pioneer in developing neoantigen-targeting therapies, in this first-in-human treatment. This collaboration highlights some of the key advantages of the GT-EPIC platform such as the ability to move rapidly into the clinic to treat cancers and to target upwards of all (30+) targetable antigens in the patient in a single administration."

The patient’s treatment is led by neurosurgeon Dr. Gavin Dunn and medical oncologist Dr. Tanner Johanns, who treat patients at Siteman Cancer Center at Washington University and Barnes-Jewish Hospital. "We partnered with Geneos to use its technology in building a personalized cancer vaccine tailored to the mutated proteins found in this patient’s tumor. We were drawn to the speed and versatility of the Geneos platform, along with its safety record and clinical immunogenicity data from previous human studies in both cancer and infectious diseases. Therefore, we approached Geneos about supporting our effort to make the experimental treatment available to this patient who otherwise has limited treatment options. We look forward to expanding this collaboration and evaluating the same technology to generate personalized neoantigen vaccines for the treatment of additional tumor types," Johanns said.

Cancer neoantigens – the mutations and genomic changes that accumulate as tumors develop – have been recognized as important targets in the development of immune mediated treatments for cancer. These neoantigens are recognized by the immune system as being foreign and generate immune responses directed at the cancer. The GT-EPIC Platform is based on a DNA vaccine platform which Geneos exclusively licensed from Inovio Pharmaceuticals (NASDAQ:INO), and allows the company to develop exquisitely personalized therapies tailored to each patient’s unique tumor mutations. Geneos, along with its collaborators at The Wistar Institute, recently published preclinical, proof-of-concept animal model data in the prestigious journal, Cancer Immunology Research, demonstrating the functional advantages of the Geneos Platform.

For more information on the company, visit www.geneostx.com.

About Geneos Therapeutics’ GT-EPIC Neoantigen-Targeting Platform
Geneos Therapeutics’ GT-EPIC Neoantigen-Targeting Platform is based on a clinically-validated DNA vaccine platform exclusively licensed from Inovio Pharmaceuticals, Inc. (NASDAQ: INO) for use in developing personalized, neoantigen-targeting immunotherapies. The platform has been used extensively and safely by Inovio Pharmaceuticals in the clinical treatment of patients with over 2,000 patients treated and over 6,000 administrations. The GT-EPIC platform allows Geneos to develop exquisitely personalized DNA-based therapies tailored to each patient’s unique tumor mutations. The GT-EPIC platform is poised to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos believes that these are the three key differentiators that will drive the company, and the oncology space, into the next generation of immunotherapies.

On July 10, 2019 TARIS Bio reported the dosing of the first patient in a Phase 1b clinical trial evaluating the investigational product TAR-200 in combination with Opdivo (nivolumab), a programmed death-1 (PD-1) immune checkpoint inhibitor from Bristol-Myers Squibb (Press release, TARIS Biomedical, JUL 10, 2019, View Source [SID1234537470]). The combination will be assessed for safety, tolerability and preliminary efficacy in patients with muscle-invasive bladder cancer (MIBC). This trial is being conducted as part of a clinical collaboration between the companies; Bristol-Myers Squibb is also an equity investor in TARIS.

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Bladder cancer affects more than 2.7 million patients worldwide and is among one of the most expensive types of cancers to treat on a per-patient lifetime basis. MIBC is an aggressive and often lethal form of the disease, with the potential for rapid progression and metastasis. The preferred standard of care for MIBC is radical cystectomy (surgical removal of the bladder) with a neoadjuvant course of platinum-based chemotherapy. This neoadjuvant therapy has been shown to confer a survival benefit to patients versus cystectomy alone. Unfortunately, this therapy is utilized in less than 15% of patients scheduled for cystectomy, due primarily to concerns around patient frailty and potential delays to surgery. [i] A neoadjuvant regimen such as the combination of TAR-200 plus Opdivo, which has the potential to be used in the large majority of patients not receiving platinum-based therapy, would address a substantial unmet need.

"This clinical trial will be the first to evaluate the combination of the locally-administered TAR-200 system with a systemic PD-1 checkpoint inhibitor, approved for previously treated adults with advanced bladder cancer," said Christopher J. Cutie, M.D., Chief Medical Officer of TARIS. "We are eager to evaluate the potential antitumor and immunologic synergy of this product combination administered prior to surgery."

"We are excited to be working with BMS, an industry leader in oncology, on this clinical study," said Tony Kingsley, President and Chief Executive Officer of TARIS. "It illustrates TARIS’ commitment to advancing new therapies for this serious disease, and the potential of TAR-200 to improve outcomes for patients. In parallel, TARIS continues to study TAR-200 as a single agent for the treatment of MIBC patients not receiving surgery."

The open-label, multi-center, single group assignment Phase 1b clinical study will enroll up to 25 patients with MIBC who are scheduled for radical cystectomy. TAR-200 and Opdivo will each be administered on day one of four consecutive 21-day dosing cycles, for a total dosing period of 84 days prior to radical cystectomy. Information about the trial is available on ClinicalTrials.gov, identifier #NCT03518320.

About TAR-200
TARIS’ lead investigational product, TAR-200, is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks. TARIS believes that TAR-200 has the potential to harness gemcitabine’s both direct antitumor and immuno-oncologic activity without meaningful systemic drug exposure, yielding a powerful therapy and mitigating systemic side-effects. TAR-200 has been granted Fast Track status by the U.S. Food and Drug Administration for the potential treatment of MIBC patients unfit for curative-intent therapy.

On July 10, 2019 Biomarck Pharmaceuticals, Ltd reported that statistical significance (p=0.02) was achieved in improvement of Overall Response Rate (ORR) in the BIO-11006/SOC group compared to standard of care alone at 3 months in the Phase 2 study in NSCLC (Press release, BioMarck Pharmaceuticals, JUL 10, 2019, View Source [SID1234537469]). This study compares standard of care alone, (pemetrexed/carboplatin; SOC) to SOC plus BIO-11006 in 60 patients with stage 4, NSCLC.

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BIO-11006/SOC also showed less Disease Progression (DP) than SOC alone (7% to 17% respectively) and more Partial Response (PR) than SOC (40% to 30%).

BIO-11006 was well tolerated with cough, dyspnea and headache being most commonly (5%) related adverse events. This compares favorably to the myelosuppression, liver and renal toxicity of other commonly used agents.

In Vivo studies have shown BIO-11006 can inhibit NSCLC metastases and reduce tumor size in several animal species. Those treated with BIO-11006 also did not lose weight over the treatment period. This study is intended to give confirmation of these findings in a clinical setting.

About the Phase 2 study
This is a SOC controlled randomized, parallel group, clinical study evaluating BIO-11006 in addition to SOC in patients who have end stage NSCLC. The primary endpoint is progression free survival (PFS) at three months with secondary endpoints of response rate (RR), overall survival (OS) at 3 and 12 months. Body weight is also a clinical endpoint. For more information please visit View Source ID number NCT 03472053

On July 10, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, and I-Mab Biopharma (I-Mab), a China and U.S.-based clinical-stage biopharmaceutical company committed to the discovery and development of first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, reported that the companies have entered into an exclusive collaboration and license agreement to develop and commercialize enoblituzumab (Press release, MacroGenics, JUL 10, 2019, View Source [SID1234537468]). This investigational drug is an immune-optimized, anti-B7-H3 monoclonal antibody that incorporates MacroGenics’ proprietary Fc Optimization technology platform. Enoblituzumab represents one of the most advanced programs in development directed against B7-H3, a target for which no agent is currently approved. I-Mab obtains regional development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan.

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As part of the collaboration, I-Mab will both lead regional studies in its territories as well as participate in global studies conducted by MacroGenics. MacroGenics intends to initiate a Phase 2 study of enoblituzumab in combination with MGA012 (also known as INCMGA0012), an investigational anti-PD-1 antibody that MacroGenics licensed to Incyte Corporation, in first-line patients with head and neck cancer later this year.

"We are very pleased to be partnering with I-Mab to further accelerate and broaden the development of enoblituzumab and to support our mission of bringing innovative medicines to patients with high unmet medical needs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "We believe that I-Mab is an ideal partner given its track record of rapidly progressing innovative immuno-oncology programs and its ability to tap into the growing pharmaceutical market in this region."

"MacroGenics is recognized as a leader in the development of therapeutics targeting B7-H3 and we are committed to accelerating the development of enoblituzumab, a promising investigational drug which may represent a new treatment paradigm in immuno-oncology," said Jingwu Zang, M.D., Ph.D., Chief Executive Officer of I-Mab. "We believe that this program is an exciting addition to our innovative pipeline of clinical stage oncology assets."

MacroGenics expects to receive an upfront payment of $15 million in connection with the collaboration. MacroGenics will also be eligible to receive additional development and regulatory milestone payments of up to $135 million. In addition, I-Mab will pay tiered double-digit royalties (ranging from mid teens to twenty percent) based on annual net sales in the territories.

About Enoblituzumab Program

Enoblituzumab is an investigational Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of immune regulator proteins. B7-H3 is widely expressed by a number of different tumor types and may play a key role in regulating the immune response to various types of cancer. Encouraging data from the Phase 1 clinical study of enoblituzumab in combination with an anti-PD-1 antibody were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2018. Based on these data, MacroGenics is planning to initiate a Phase 2 study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) in the second half of 2019.

About MacroGenics’ Fc-Optimization Technology

MacroGenics’ Fc-Optimization platform is designed to modulate an antibody’s interaction with immune effector cells. The Fc region of certain antibodies binds activating and inhibitory receptors, referred to as FcγRs, on immune cells found within the innate immune system. Such interactions affect killing of cancer cells through antibody dependent cellular cytotoxicity (ADCC), among other Fc-dependent functions.

MacroGenics’ optimized Fc region binds with increased affinity to the activating CD16A FcγR and unique to MacroGenics’ technology, with reduced affinity to CD32B, the inhibitory FcγR. MacroGenics’ optimized Fc mediates improved effector functions, such as ADCC. To date, MacroGenics has successfully incorporated its proprietary Fc Optimization technology in enoblituzumab, as well as margetuximab, an investigational anti-HER2 monoclonal antibody currently in Phase 3 development.

On July 10, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the fourth quarter of fiscal year 2019, which ended May 31, 2019 (Press release, AngioDynamics, JUL 10, 2019, View Source [SID1234537467]).

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"Fiscal year 2019 was an exciting and transformative year for AngioDynamics. I am very pleased with our fourth quarter and full-year performance, as we achieved solid revenue growth and continued to implement meaningful operational improvements," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "During the quarter, we strengthened our balance sheet and made significant progress towards our long-term portfolio management goals through the sale of our NAMIC Fluid Management business, setting us on a path towards becoming a leaner, more innovation-focused company. We also made significant strides with our NanoKnife platform, enrolling the first patient in our DIRECT study for pancreatic cancer and receiving FDA approval to initiate a pilot study for the treatment of prostate cancer. I am extremely proud of all of the members of our AngioDynamics team for their hard work during the year, and I look forward to sustaining and growing this momentum throughout fiscal year 2020."

Fourth Quarter 2019 Financial Results

Net sales for the fourth quarter of fiscal 2019 were $96.3 million, an increase of 9.0%, compared to $88.3 million a year ago. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $15.3 million, an increase of 26.5% from $12.1 million a year ago. Strong sales of Solero, along with the recent BioSentry and RadiaDyne acquisitions, more than offset lower NanoKnife capital sales during the quarter.
Vascular Interventions and Therapies net sales were $56.2 million, an increase of 6.9%, compared to $52.6 million a year ago, as strong growth in AngioVac and our Core product line offerings was partially offset by a decline in the Venous Insufficiency business.
Vascular Access net sales were $24.8 million, an increase of 4.9% from $23.7 million a year ago, driven by higher sales of midlines, ports and dialysis.
U.S. net sales in the fourth quarter of fiscal 2019 were $73.4 million, an increase of 4.4% from $70.3 million a year ago, and International net sales were $22.9 million, an increase of 27.0% from $18.0 million a year ago.

Gross margin for the fourth quarter of fiscal 2019 was 53.6%, roughly flat compared to the year ago quarter as improvements in net productivity and higher volume were offset by negative impacts of price and product mix.

The Company recorded net income of $58.9 million, or $1.54 per share, in the fourth quarter of fiscal 2019. This compares to net income of approximately $2.1 million, or $0.06 per share, a year ago. Net income was favorably impacted in the fourth quarter of fiscal 2019 by the gain on the sale of the NAMIC fluid management business of $46.6 million.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the fourth quarter of fiscal 2019 was $9.6 million, or $0.25 per share, compared to adjusted net income of $7.7 million, or $0.20 per share, in the fourth quarter of fiscal 2018.

Adjusted EBITDAS in the fourth quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $17.6 million, compared to $15.6 million in the fourth quarter of fiscal 2018.

In the fourth quarter of fiscal 2019, the Company generated $25.0 million in operating cash flow and had capital expenditures of $0.9 million. As of May 31, 2019, the Company had $227.6 million in cash and cash equivalents and $132.5 million in debt, excluding the impact of deferred financing costs.

Full-Year 2019 Financial Results

For the twelve months ended May 31, 2019:

Net sales were $359.5 million, an increase of 4.4%, compared to $344.3 million for the same period a year ago.
The Company’s net income was $61.3 million, or $1.61 per share, compared to net income of $16.3 million, or $0.44 per share, a year ago.
Gross margin improved 200 basis points to 53.4% from 51.4% a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $31.6 million, or $0.83 per share, compared to adjusted net income of $27.6 million, or $0.74 per share, a year ago.
Adjusted EBITDAS, excluding the items shown in the reconciliation table below, was $61.5 million, compared to $57.0 million for the same period a year ago.
Pro Forma 2019 Performance

In addition to actual results, the tables accompanying this press release reflect pro forma results, which exclude the full-year impact of the NAMIC Fluid Management business that was divested on May 31, 2019.

Fiscal Year 2020 Financial Guidance

The Company expects its fiscal year 2020 net sales to be in the range of $280 to $286 million and adjusted earnings per share in the range of $0.25 to $0.30. Additionally, the Company expects gross margin to be in the range of 58% to 59%.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal fourth quarter and full-year 2019 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13691777.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Wednesday, July 10, 2019, until 11:59 p.m. ET on Wednesday, July 17, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13691777.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDAS, adjusted net income, adjusted earnings per share and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.