On March 26, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel (Press release, Hoffmann-La Roche, MAR 26, 2018, View Source [SID1234525397]). A survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression. Safety for the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combinations. These data will be presented at an upcoming oncology congress.

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"We are pleased that the IMpower150 study demonstrated a clinically meaningful survival benefit for people receiving their initial treatment for this type of advanced lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These results add to the growing body of evidence supporting the role of combining TECENTRIQ with Avastin. We will submit these additional data to global health authorities and hope to bring this potential treatment option to patients as soon as possible."

At this interim analysis, the study found that substituting Avastin with TECENTRIQ in the combination with carboplatin and paclitaxel did not show a statistically significant OS benefit in people with advanced NSCLC compared to a combination of Avastin plus carboplatin and paclitaxel. The study will continue as planned to the final analysis. Safety in the TECENTRIQ plus carboplatin and paclitaxel arm appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
Previously reported results from the IMpower150 study showed that the combination of TECENTRIQ and Avastin plus carboplatin and paclitaxel reduced the risk of disease worsening or death (progression-free survival; PFS), a co-primary endpoint, by 38 percent (HR=0.62; p<0.0001, 95 percent CI: 0.52-0.74) compared to Avastin plus carboplatin and paclitaxel in the first-line treatment of people with advanced non-squamous NSCLC. This PFS benefit was observed across key subgroups, including those with varying levels of PD-L1 expression.
IMpower150 is one of eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines. Following the positive IMpower150 and IMpower131 studies, three more Phase III lung cancer studies are expected to report this year.

About the IMpower150 study
IMpower150 is a multicenter, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and paclitaxel with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of which those with ALK and EGFR mutations were excluded from the primary intention-to-treat (ITT) analysis. People were randomised (1:1:1) to receive:
TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm)

During the treatment-induction phase, people in Arm A received TECENTRIQ administered intravenously at 1200 mg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. Following the induction phase, people received maintenance treatment with TECENTRIQ (1200 mg every 3 weeks) until loss of clinical benefit or disease progression.
People in Arm B received induction treatment with TECENTRIQ (1200 mg) and Avastin administered intravenously at 15 mg/kg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. People then received maintenance treatment with the TECENTRIQ and Avastin regimen until disease progression (Avastin) or loss of clinical benefit/disease progression (TECENTRIQ).
People in Arm C received induction treatment with Avastin administered intravenously at 15 mg/kg plus intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. This was followed by maintenance treatment with Avastin alone until disease progression.
The co-primary endpoints were PFS and OS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The co-primary OS endpoint in IMpower150 was assessed in all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed PFS and OS, safety in the ITT population and in EGFR and ALK mutation subgroups.
The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression ). IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed.

About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.
About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.
About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.
About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

On March 26, 2018 Polaris Group reported that its lead product ADI‑PEG 20 modulates PD-L1 expression via stimulating the release of IFN-α and -ß in several tumor cell lines and the combination of ADI‑PEG 20 and PD-1/PD-L1 blockade abrogated tumorigenesis in a murine model according to research presented by a group from Barts Cancer Institute, London at the 2018 Cancer Immunotherapy Keystone Symposia held in Montreal, Canada (Press release, Polaris Pharmaceuticals, MAR 26, 2018, View Source [SID1234526245]). These findings suggest that ADI‑PEG 20 could potentially enhance the anti-tumor activity of checkpoint inhibitors.

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Anti-PD1/anti-PD-L1 agents belong to a group of drugs called checkpoint inhibitors and work by disrupting the interaction between PD-1 on immune cells and PD-L1 on cancer cells, thereby unleashing the body’s own immune system to fight cancers. ADI‑PEG 20 converts the amino acid arginine in body’s circulation to citrulline and ammonia. Normal cells are able to synthesize arginine through the urea cycle. Certain cancer cells are deficient in argininosuccinate synthetase (ASS1), a key enzyme in the urea cycle, thereby rendered entirely dependent on arginine in the circulation for their survival and growth. These ASS1-deficient cancer cells are more sensitive to arginine depletion by ADI‑PEG 20.

In several mesothelioma and uveal melanoma cell lines, overexpression of ASS1 by transfection or prolonged treatment with ADI-PEG 20 was found to induce type I interferon genes and PD-L1 gene expression. In addition, the researchers also noted a statistically significant correlation between constitutive expressions of ASS1 and PD-L1 genes in primary mesothelioma and uveal melanoma tumor samples. Finally the combination of PD-1/PD-L1 blockade with ADI‑PEG 20 abrogated tumorigenesis in an immunocompetent ASS1 negative and PD-L1 negative fibrosarcoma murine model in which PD-1/PD-L1 inhibition alone had limited efficacy.

"The immunometabolic link between ADI‑PEG 20 and PD-1/PD-L1 is very intriguing," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "To explore this in the clinic, we are currently conducting a clinical study combining ADI‑PEG 20 with Pembrolizumab, a PD-1 inhibitor, in solid tumors to investigate the potential of combining ADI‑PEG 20 with checkpoint inhibitors."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

On March 26, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform today reported its financial results for the fourth quarter and year ended December 31, 2017, and provided a business update (Press release, RXi Pharmaceuticals, MAR 26, 2018, View Source [SID1234525014]).

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"In early 2018, RXi announced a strategic decision to solely focus its development efforts on novel immuno-oncology treatments based on its self-delivering RNAi platform. We have made good progress by entering in development collaborations with some major cancer research centers in Europe and in the US. The first results from these collaborations are promising and support our goals to enter into clinical testing in the coming 12 to 18 months," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "RXi is well-positioned for success with the potential to match and possibly surpass current antibody treatments by exploiting the self-delivering attributes of our therapeutic compounds for immuno-oncology using an adoptive cell transfer approach. As outlined in January of this year, RXi is seeking to monetize our dermatology and ophthalmology assets through out-licensing or partnerships for which we have achieved proof of concept in clinical trials, as such demonstrating the significant therapeutic potential of our self-delivering RNAi platform. The success of this initiative should provide additional non-dilutive means to advance our ongoing internal programs and external collaborations for our immuno-oncology pipeline and prepare for entering the clinic in 2019."

The Company will host a conference call today at 5:00 p.m. EST to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States: +1 (844) 376-4678. International participants may access the event by dialing: +1 (209) 905-5958. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Fourth Quarter and Fiscal 2017 Financial Highlights

Cash

At December 31, 2017, the Company had cash of $3.6 million as compared with $12.9 million at December 31, 2016.

On August 8, 2017, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $15 million in shares of the Company’s common stock, subject to certain limitations and conditions set forth therein, over the 30-month term of the purchase agreement. To date, the Company has sold a total of 285,000 shares of common stock to LPC for net proceeds of approximately $1.2 million.

Revenues

In September 2017, the Company’s collaborative partner BioAxone Biosciences, Inc. received a grant award from the National Institute of Neurological Disorders and Stroke. BioAxone has been awarded a total of $1,794,895 to fund the collaborative project over 24 months. For our contribution, RXi will receive approximately $129,000 in the first year with the potential to receive an additional $118,800 in the second year after achieving certain milestones. The two-year grant provides funding for further development of BioAxone’s preclinical candidate BA-434, a novel sd-rxRNA compound that targets PTEN for the treatment of spinal cord injury.

Revenues for the quarter ended December 31, 2017 were $15,000. The Company had no revenue during the quarter ended December 31, 2016. Revenues for the year ended December 31, 2017 were $15,000, as compared with $19,000 for the year ended December 31, 2016. Revenues for the quarter and year ended December 31, 2017 were due to the work performed by the Company under the grant with BioAxone. Revenues for the year ended December 31, 2016 were due to the Company’s exclusive out-licensing agreements with MirImmune, prior to its acquisition by the Company, and Thera Neuropharma, Inc.

Research and Development Expenses

Research and development expense for the quarter ended December 31, 2017 was $1.2 million, as compared with $1.3 million for the quarter ended December 31, 2016. The decrease was due to lower spending on clinical trial-related expenses as subject visits in each of the Company’s ongoing clinical trials came to an end.

Research and development expense for the year ended December 31, 2017 was $5.4 million, as compared with $5.4 million for the year ended December 31, 2016. Overall, expenses were consistent year over year despite an increase in direct research and development expenses due to the addition of the immuno-oncology program to the Company’s development pipeline in the first quarter of 2017 with the acquisition of MirImmune, which was offset by a decrease in non-cash stock-based compensation expense.

Acquired In-process Research and Development

In January 2017, the Company acquired all of the issued and outstanding capital stock of MirImmune Inc., a privately-held biotechnology company that was engaged in the development of cancer immunotherapies, in exchange for securities of the Company. The aggregate fair value of the consideration given, which includes transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the acquisition was recorded as in-process research and development expense.

Acquired in-process research and development expense related to the acquisition of MirImmune was $5.0 million for the year ended December 31, 2017. The Company did not have acquired in-process research and development expense for the three months ended December 31, 2017 and 2016 and the year ended December 31, 2016.

General and Administrative Expenses

General and administrative expense for the quarter ended December 31, 2017 was $0.8 million, as compared with $1.0 million for the quarter ended December 31, 2016. The decrease was due to a reduction in mailing and printing-related fees for the Company’s annual meeting, which last year was held in the December time-frame, as well as a reduction in professional fees for legal services and employee-related expenses as compared to the prior year quarter.

General and administrative expense for the year ended December 31, 2017 was $4.0 million, as compared with $3.6 million for the year ended December 31, 2016. The increase was primarily due to payroll-related expenses, including severance benefits, related to the Company’s former Chief Business Officer and professional fees for legal-related services.

Income Tax

The Company recognized an income tax benefit of $1.6 million for the year ended December 31, 2017 due to the tax-related impact of the Company’s acquisition of MirImmune Inc. The Company did not have income tax expense or benefit for the three months ended December 31, 2017 and 2016 and the year ended December 31, 2016.

Net Loss Applicable to Common Stockholders

Net loss applicable to common stockholders for the quarter ended December 31, 2017 was $2.0 million, compared with $4.4 million for the quarter ended December 31, 2016. The decrease was due to the one-time charge related to the beneficial conversion feature of the Company’s Series B Convertible Preferred Stock in 2016.

Net loss applicable to common stockholders for the year ended December 31, 2017 was $12.5 million, compared with $11.1 million for the year ended December 31, 2016. The increase was primarily driven by acquired in-process research and development expense incurred for the acquisition of MirImmune, offset by the one-time charge related to the beneficial conversion feature of the Company’s Series B Convertible Preferred Stock in 2016.

Nasdaq Compliance

On January 23, 2018, the Company received written notice from the Nasdaq Stock Market, LLC notifying the Company that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The written notice was sent following the implementation of the Company’s 1-for-10 reverse split of the Company’s common stock, which became effective on January 8, 2018. At the effective time of the reverse stock split, every ten shares of RXi common stock was combined into one share of common stock, reducing the Company’s issued and outstanding common stock from 24.3 million shares to 2.4 million shares.

Select Fourth Quarter 2017 and Recent Corporate Highlights

Select Business and Corporate Highlights

Immuno-Oncology

RXi Pharmaceuticals developed a robust self-delivering RNAi-based technology platform, termed sd-rxRNA, a key value driver unique to RXi. The robust technology platform provides a strong foundation that we have leveraged to build a leading Immuno-oncology company, with a short-term focus using Adoptive Cell Transfer (ACT). sd-rxRNA offers unprecedented flexibility in targeting immunosuppressive pathways with the potential to modulate multiple checkpoint genes in a single therapeutic treatment. The built-in delivery and therapeutic properties of sd-rxRNA lend themselves well for local therapeutic applications, such as ex vivo treatment of the immune cells. The ex vivo use of sd-rxRNA to pre-treat immune cells prior to infusion may prove advantageous as an immuno-therapeutic in that there is the potential to simultaneously reduce multiple checkpoints or targets, including both intracellular and extracellular targets, with little change to current protocols.

During 2017, the Company advanced its development strategy by selecting a lead preclinical compound and commencing cGMP manufacturing to prepare for the initiation of a clinical trial in 2019. In addition, the Company entered into a number of partnerships across the globe to expand its pipeline, which include:

1. PCI Biotech: A collaboration is underway with this biopharmaceutical company located in Norway, to evaluate technology compatibilities and synergies between our respective technology platforms for the potential applicability of combination therapy in immuno-oncology.

2. Gustave Roussy: This leading Comprehensive Cancer Centre in Europe is evaluating the potential of RXi’s novel sd-rxRNA technology platform for use in cancer treatments.

3. Center for Cancer Immune Therapy (CCIT) at Herlev Hospital: Based in Denmark, CCIT is a leading European center evaluating the potential of the sd-rxRNA technology platform in TILs for the use in treatment for a number of cancer types, including melanoma and ovarian cancer.
4. Medigene AG: A German based biotechnology company is exploring potential synergies of using sd-rxRNA in combination with Medigene’s recombinant TCRs to develop modified T cells with enhanced efficacy and/or safety.
To further support these efforts, RXi appointed two leading oncology experts to its Scientific Advisory Board (SAB). RXi’s new SAB members are Dr. Rolf Kiessling, Professor in Experimental Oncology at Karolinska Institutet and Senior Chief Physician of Radiumhemmet at Karolinska Hospital as well as medical oncology expert Dr. James D. Griffin, Chairman, Department of Medical Oncology, Dana-Farber Cancer Institute. Dr. Griffin also serves as Professor, Medicine, Harvard Medical School and Director, Medical Oncology, Brigham and Women’s Hospital.

The Company also added additional strategic business development and immuno-oncology expertise to its Board of Directors through the appointment of Dr. Jonathan Freeman. Dr. Freeman is an established leader with positions spanning from Senior Vice President, Head of Strategy Development and Portfolio Management at Merck KGaA to a number of senior positions at Baxter and Serono, in M&A and, Corporate and Business Development, respectively.

In addition to the expansion of our SAB and Board of Directors, Dr. Gerrit Dispersyn, Dr. Med. Sc. joined RXi as its Chief Development Officer in May 2017. Dr. Dispersyn is an accomplished leader and brings a wealth of experience in clinical, product and business development. He has held a number of senior leadership positions at Integra LifeSciences Corporation and Barrier Therapeutics.

Business Development Opportunities

RXi has developed two robust therapeutic Franchises in Dermatology and Ophthalmology that are comprised of advanced clinical programs, robust discovery assets and substantial Intellectual Property rights. RXi added to its broad patent estate with the granting of a patent from the Japan Patent Office (JPO) in Q1 207 for the composition of matter of sd-rxRNAs targeting connective tissue growth factor (CTGF) for the treatment or prevention of fibrotic disorders, including but not limited to skin fibrosis and proliferative retinopathy (Japanese Patent #: 6060071), which includes RXI-109.

The Company has an active process underway to monetize these assets which will support a return on investment for stockholders and accelerated growth in the immuno-oncology focus area.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "should," "potential," "designed to," "will" and similar references, although not all forward-looking statements contain these words. Forward-looking statements are neither historical facts

nor assurances of future performance. These statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including those identified in our most recent Annual Report on Form 10-K under the caption "Risk Factors" And in other filings the Company periodically makes with the Securities and Exchange Commission. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.

On March 24, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported encouraging efficacy and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (EOC) (Press release, ImmunoGen, MAR 24, 2018, View Source [SID1234525455]). These data are being presented at the Society of Gynecologic Oncology (SGO) Annual Meeting, March 24-27, 2018 in New Orleans, LA.

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Key findings in 14 heavily pre-treated patients are as follows:

In the subset of 8 patients with medium or high folate receptor alpha (FRα) expression levels, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median progression-free survival (PFS) of 8.6 months (95% CI 1.6, upper bound not yet reached).
For all patients, the confirmed ORR was 43 percent (95% CI 18, 71), with a median PFS of 5.2 months (95% CI 1.6, 9.5); patients in this cohort had received a median of 4.5 prior lines of systemic therapy, with 64% of patients receiving 4 or more prior lines.
As previously reported, at full dosing, the combination of mirvetuximab (6 mg/kg) and pembrolizumab (200 mg, supplied by Merck) demonstrates favorable tolerability, consistent with the known safety profiles of each agent, with primarily mild to moderate (≤ grade 2) adverse events observed.
Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study.

"We are encouraged by the early evidence of anti-tumor activity with durable responses and the tolerability profile of mirvetuximab in combination with pembrolizumab, particularly among the subset of patients with medium or high folate receptor alpha expression where we saw the greatest benefit," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "Across multiple combinations, we’ve demonstrated that our Phase 3 single agent dose level for mirvetuximab combines readily with other therapies. The consistency of these findings further underscore the potential of mirvetuximab for ovarian cancer – both as monotherapy, and in combination with other therapies in earlier lines of treatment."

Featured Poster Presentation Details

Title: "Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer (EOC) patients" (abstract #74)

Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

The findings will be presented during featured poster presentation discussion sessions:

Sunday, March 25 at 3:30pm CT
Monday, March 26 at 3:30pm CT
Additional information can be found at www.sgo.org

About FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), pegylated liposomal doxorubicin, or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant EOC, primary peritoneal, or fallopian tube tumors, as well as a doublet combination of mirvetuximab with carboplatin and a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On March 24, 2018 Barricade Therapeutics reported a study conducted at The Wistar Institute in collaboration with The University of Texas Southwestern Medical Center which has demonstrated the efficacy of targeting aberrantly active telomerase to treat therapy-resistant melanoma (Press release, Barricade Therapeutics, MAR 24, 2018, View Source [SID1234524977]).

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A hallmark of several cancer types, including melanoma, is increased telomerase activation. Telomerase is an enzyme responsible for elongating telomeres which protect the integrity of chromosome ends during cell replication. While absent in most normal cells, telomerase is highly active in cancer cells, driving continuous cell divisions.

"Telomerase is an almost universal oncology target. In the present study, we provide a scientific rationale for the development of new clinical cancer treatments based on targeting telomeres in cancer cells," said Jerry W. Shay, co-author of the study, and professor of Cell Biology at UT Southwestern Medical Center.

Meenhard Herlyn, D.V.M., D.Sc., Caspar Wistar Professor in Melanoma Research and director of The Wistar Institute Melanoma Research Center, and his collaborators used a modified telomerase substrate they had previously described, 6-thio-2’-deoxyguanosine or 6-thio-dG (THIO), to utilize telomerase to induce telomere dysfunction. They demonstrated that THIO induced cell death in melanoma cells harboring BRAF gene mutations and impaired tumor growth in several BRAF-mutant mouse melanoma models without affecting the viability of normal skin cells.

The team also studied the ability of THIO treatment to stop proliferation and tumor growth of therapy-resistant melanoma cells. They created a large panel of human melanoma cell lines with acquired resistance to targeted therapy and immunotherapy and showed a general sensitivity of these cells to THIO both in vitro and in vivo.

"These exciting results add to a substantial amount of scientific data on THIO supporting our development program," said Frank Perabo, CEO of Barricade Therapeutics. "The data suggest that THIO could be studied in future clinical trials in a first- and second-line therapy setting, or in combination with other agents to overcome intrinsic resistance."

This work was supported by grants from NIH, DoD, Dr. Miriam and Sheldon G. Adelson Medical Research Foundation and the Melanoma Research Foundation