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Major Cancer Journal Highlights Data From An Inovio-Sponsored Trial In Which A Patient Achieved Full Remission After Dosing With DNA Immunotherapy and Checkpoint Inhibitor

On October 2, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a paper published in a major cancer journal detailed results of a patient with head and neck cancer treated with MEDI0457 achieved a sustained complete response (full remission) on treatment with a subsequent PD-1 checkpoint inhibitor (Press release, Inovio, OCT 2, 2018, View Source [SID1234530271]). In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma the company reported 91% (20/22) showed T cell activity in the blood or tissue. MEDI0457 – formerly called INO-3112 – was in 2015 licensed to MedImmune, the global biologics research and development arm of AstraZeneca. These immune data as well as the financial terms of the license agreement have been previously reported by Inovio.

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We are buoyed by the study as it lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. Inovio is collaborating with MedImmune (w/ MEDI0457) as well as Genentech and Regeneron (w/ INO-5401) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates with data expected in 2019."

An article in the most recent edition of Clinical Cancer Research highlights data from an Inovio-sponsored trial that demonstrated that after a cancer progressed a patient was subsequently given a PD-1 checkpoint inhibitor. The patient achieved a complete response, which has sustained for over two years and counting. Increasing evidence suggests that response rates from checkpoint inhibitors can be enhanced when used in combination with cancer vaccines like MEDI0457 that generate tumor-specific T cells. Interim data from a MEDI0457 monotherapy study of head and neck cancer patients demonstrated that MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples.

Charu Aggarwal, MD, MPH, the study’s principal investigator and an assistant professor of Hematology-Oncology at the University of Pennsylvania’s Perelman School of Medicine, said, "We wanted to know if this vaccine (MEDI0457) can boost the immune systems of patients with HPV-related head and neck cancer, potentially opening the door for better response rates to other existing therapies, and our findings show that we can."

The article notes that researchers administered four doses of MEDI0457 to 21 patients separated into two different groups. One group received a dose before surgery, followed by three doses after surgery. The second group received four doses following chemotherapy and radiation. Eighteen out of the 21 patients showed elevated T cell activity that lasted at least three months after the final vaccine dose, meaning the immune effect persisted for at least six months from the start of immunotherapy. Five tumors were biopsied both before and after one dose of the vaccine, and there was evidence of T cells infiltrating into tumors and expressing proteins associated with cell killing potential.

"We have not seen that kind of T cell infiltration with just one dose of a vaccine before," Dr. Aggarwal added. "These findings open the door for utilizing targeted immunotherapy approaches against specific cancer-causing targets like HPV."

Overall the characteristics of these immune response data mirrored those previously observed in a Phase 2b clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. VGX-3100, which is currently in global REVEAL 1 Phase 3 trial, is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2018 an estimated 48,330 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing.

Epigenomics AG: U.S. Congress supports CMS coverage of colorectal cancer screening blood tests

On October 2, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported that the U.S. Congress urges the Centers of Medicare & Medicaid Services (CMS) to consider coverage of colorectal cancer screening blood tests as part of the approved 2019 Health and Human Services (HHS) Appropriations Bill (Press release, Epigenomics, OCT 2, 2018, View Source [SID1234530237]).

According to the Appropriations report issued in concert with the Appropriations Bill signed into law on September 28, 2018 the U.S. Congress stated its intent by urging CMS to provide "…coverage of blood tests…(which) could serve to deter or immediately recommend the need for colonoscopy so as to increase the number of patients that go in for testing and decrease the amount of late-stage colon cancer diagnoses."

"We are very pleased that the U.S. Congress has urged CMS to cover FDA approved blood tests for colorectal cancer screening. We believe this is a positive step towards legislative approval," said Greg Hamilton, Chief Executive Officer of Epigenomics AG. "Colorectal cancer remains the second-leading cause of cancer death in the United States as still 1 in 3 or approximately 30 million Americans are not screened. CMS coverage of blood tests could help to increase screening participation rates and ultimately save lives."

In March 2018, Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM) introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ) in 2017. These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood tests.

About colorectal cancer (CRC)

The American Cancer Society projects there will be over 140,000 new diagnosed cases of colorectal cancer, and over 50,000 deaths, from colorectal cancer in 2018 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four- out-of-ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening.

About Epi proColon

Epi proColon is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Cellectar Announces Overall Survival Exceeding 19 Months in Phase 1b Trial with CLR 131 in Relapsed/Refractory Multiple Myeloma

On October 2, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported its updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Cellectar Biosciences, OCT 2, 2018, View Source [SID1234530173]).

The results to date show that OS is currently at 19.4 months. Cellectar continues to monitor these patients and intends to update OS results as data become available. All 15 patients from the Phase 1b, single-dose cohorts were heavily pretreated, receiving an average of 5 previous lines of multidrug therapy including anti CD38, immunomodulating drugs and proteasome inhibitors. All patients were relapsed or refractory to at least one proteasome inhibitor and IMiD. Most patients presented with advanced stage 2 or 3 disease and 67% had previously received at least 1 stem cell transplant.

"We are extremely pleased to announce that CLR 131 has achieved OS of 19.4 months in our Phase 1b trial in R/R MM. We view this outcome as impressive considering all patients were heavily pretreated and presented with high tumor burden," said James Caruso, president and chief executive officer of Cellectar Biosciences. "Most drugs currently approved for third-line or later R/R MM average approximately 12 months of survival, including several recent approvals. We believe extending OS to beyond 19 months with a more patient-friendly dosing regimen provides both a unique product profile and potential for beneficial patient outcomes."

The objective of this multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 administered as a single-dose, 30-minute infusion in patients with R/R MM. Patients received doses of 12.5 mCi/m2 up to 31.25 mCi/m2. All doses were deemed safe and well tolerated by an independent data monitoring committee.

Data from a fifth cohort, released in August, evaluated a split or fractionated dose of 31.25 mCi/m2 for tolerability and safety. The dosing schedule provided higher average drug exposure but lower peak serum levels than non-fractionated dosing potentially reducing adverse events and improving efficacy. The independent Data Monitoring Committee (DMC) determined the fractionated dose used in Cohort 5 to be safe and well tolerated and recommended advancement to a higher dose cohort.

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2. All study doses have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

LSKB Announces MFDS Approval to Initiate a Phase I/IIa Combination Study of Rivoceranib and Paclitaxel at Asan Medical Center (South Korea)

On October 2, 2018 LSK BioPharma (LSKB, Company) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a Phase I/IIa study protocol to investigate the combination of rivoceranib and paclitaxel, "A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer" (Press release, LSK BioPharma, OCT 2, 2018, View Source [SID1234530136]). The study will take place at Asan Medical Center in South Korea under the direction of Dr. Yoon-Koo Kang.

"Asan Medical Center has been a key site in our pivotal Phase 3 gastric cancer trial for advanced and metastatic patients. We are excited to add this combination therapy trial at the same center with Professor Kang to investigate the use of rivoceranib in earlier stage patients," said Dr. Sung Chul Kim, LSKB President.

The study is expected to enroll its first patients in October 2018.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

IMMUNOPRECISE ANTIBODIES’ Q1 REVENUES INCREASE 386% OVER Q1 2017

On October 2, 2018 IMMUNOPRECISE ANTIBODIES LTD. ("ImmunoPrecise") (TSX Venture: IPA, Pink Sheets: IPATF) reported its financial results for Q1 ended July 31, 2018 (Press release, ModiQuest Therapeutics, OCT 2, 2018, View Source [SID1234530114]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

Financial Highlights:

Revenue.During the three months ended July 31, 2018, the Company increased revenues to $2,872,785 from $591,058 in 2017. This represents a 386% increase in revenue, in part, from the acquisitions of U-Protein Express and ModiQuest Research, the Company’s ability to grow its capacity in its core business and expand its market share in Europe, as well as growth in higher revenue services.
Gross Margin. During the three months ended July 31, 2018, the Company increased its gross margin to $1,567,826 from $46,658 in 2017. In percentage terms, the Company’s gross margin increased to 55% from 8% in 2017. The lower gross margin in 2017 was mostly attributable to the fact that the Company increased its staffing levels, made salary adjustments and incurred higher lab operating costs to accommodate greater levels of activity in 2017, which drove down the gross margin.
Net Loss. The Company recorded a net loss of $1,102,362 during the three months ended July 31, 2018, compared to net loss of $857,832 for three months ended July 31, 2017. The net loss increased in 2018, primarily as a result of the acquisitions of U-Protein and ModiQuest, which required higher expenses in all facets of the business in order to manage a global landscape. The Company continues to invest in research and development as it broadens the breadth and value of its intellectual property assets.
Growth Initiatives in Fiscal 2018:

European Acquisitions. ImmunoPrecise acquired two profitable companies within the EU during the Fiscal year of 2018, U-Protein Express (August, 2017) and ModiQuest Research (April, 2018). These acquisitions will enhance ImmunoPrecise’s position as a leading, full-service antibody CRO, by strengthening its ability to partner with clients across the entire antibody discovery, manufacturing, and engineering continuum.These acquisitions also enhance ImmunoPrecise’s ability to achieve its longer-term goals by scaling to meet demand, and by expanding our global biotechnology and pharmaceutical client base.
Full-Service B-Cell Facility. During the Fiscal year of 2018, ImmunoPrecise expanded its B-cell offerings in both North America and Europe. This expansion will enable the ImmunoPrecise family of companies to increase its capacity for B-cell services supporting therapeutic antibody development, provide a client-centric focus with worldwide production centers, and help to bring leading antibody discovery services to more pharmaceutical and biotech companies around the world.
"We believe our strong revenue growth reflects our progress toward the goal of aligning our Companies’ unique continuum of services, supporting clients from target selection through pre-clinical studies, with an ever-strong and growing, global market. There has been an impressive increase in the scale of services requested by prospects and clients, further confirming the value of investing in our global presence to emerge as a leader in the full-service, antibody discovery and development sector," stated CEO and President, Dr. Jennifer Bath. "We are happy with our second-quarter performance, the integration of our new production sites, and we are optimistic about continued growth in revenue and shareholder value."