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 26, 2018 AVEO Oncology (NASDAQ:AVEO) reported that Michael Bailey, president and chief executive officer, will present at the following investor conferences (Press release, AVEO, MAR 26, 2018, View Source;p=RssLanding&cat=news&id=2339739 [SID1234524989]):

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Needham & Company’s 17th Annual Healthcare Conference on Wednesday, March 28, 2018 at 8:00 a.m. Eastern Time. The conference is being held at the Westin Grand Central Hotel in New York, New York.
H.C. Wainwright Global Life Sciences Conference on Tuesday, April 10, 2018 at 10:40 a.m. Central European Summer Time. The conference is being held at the Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco.
A live webcast of the presentations can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On March 26, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company announced the presentation of maturing data from the TOPACIO trial of niraparib in combination with an anti-PD-1 monoclonal antibody, KEYTRUDA during a plenary session today at the 2018 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in New Orleans, Louisiana. In addition, retrospective data analyses of the Phase 3 ENGOT-OV16/NOVA study that could potentially reduce Grade 3/4 thrombocytopenia in niraparib treated patients was presented in the plenary session on Sunday, March 25 (Press release, TESARO, MAR 26, 2018, View Source [SID1234525015]).

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"Patients with platinum-resistant or platinum-refractory ovarian cancer have limited treatment options available to them. Approximately 10,000 women in each of the US and EU begin treatment for platinum-resistant or refractory ovarian cancer each year," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Preliminary results from TOPACIO suggest the combination of niraparib and an anti-PD-1 antibody could provide meaningful clinical benefit to these patients, regardless of biomarker status. Planning of a registration study is underway to support approval of ZEJULA and TSR-042 combination therapy for these patients. TSR-042 is TESARO’s anti-PD-1 antibody, which is currently in a registration study for MSI-H tumors."

"These data provide a compelling initial step in our ovarian cancer development strategy which is progressing from monotherapy ZEJULA utilized in PRIMA, NOVA and QUADRA to doublet and triplet combination approaches with anti-PD-1 antibodies and bevacizumab," said Marty Huber, M.D., Senior Vice President and Chief Medical Officer of TESARO. "Our ultimate goal is to maximize the benefit to women across the full spectrum of ovarian cancer"

Phase 2 TOPACIO Data Demonstrate Activity in Platinum-Resistant and Platinum-Refractory Ovarian Cancer Patients, Regardless of Biomarker Status
TOPACIO is a Phase 1/2 clinical trial designed to evaluate the safety and efficacy of niraparib plus KEYTRUDA (pembrolizumab) in patients with recurrent, platinum-resistant ovarian cancer or triple negative breast cancer. Niraparib administered orally, once-daily, at a dose of 200 milligrams is being evaluated in combination with 200 milligrams of pembrolizumab administered intravenously on day one of each 21-day treatment cycle in two patient cohorts; platinum-resistant/refractory ovarian cancer and triple-negative breast cancer. Endpoints include RECIST response rate, duration of response, disease control rate, progression-free survival and overall survival. Data presented at SGO were from the group of patients with ovarian cancer.

At the time of data cutoff, of the 62 patients enrolled, 60 were evaluable; 45% had been treated with 3 or more prior lines of chemotherapy, 97% with prior taxane, 63% received prior bevacizumab, and 29% were platinum refractory. The majority (73%) did not have a BRCA mutation. Data indicate an overall response rate (ORR; including CR and PR) of 25% and a disease control rate (DCR; CR+PR+SD) of 68%; ORR was 24% in the platinum refractory population. Response rates were not dependent on biomarker status; ORR was 26% (9/34) in patients without a tumor BRCA mutation (tBRCAwt), and 29% (7/24) in patients with HRD-negative tumors. Duration of response was immature, with 9 of 15 (60%) of responders remaining on treatment, and over one-half of patients with disease control continuing on treatment or having already received treatment for over 6 months.

For patients with platinum-resistant ovarian cancer, response to chemotherapy is 5-18%, including the most commonly prescribed regimen in the U.S., bevacizumab plus pegylated liposomal doxorubicin1. Platinum refractory patients typically have even lower response rates and NCCN treatment guidelines recommend clinical trials for these patients2. Historical response to PARP inhibitors is 5-10% in patients without BRCA mutations who have platinum resistant disease3 and 0-14% in those with BRCA mutations and platinum refractory disease4. Response rates of 10-15% have been reported with anti-PD-1 antibodies in this ovarian cancer population5.

The combination of niraparib with pembrolizumab was well tolerated with an incidence of Grade 3/4 thrombocytopenia of 9%. In addition to thrombocytopenia, the other most commonly observed Grade ≥3 adverse events included anemia (19%) and neutropenia (6%).

Abstracts containing additional data from the TOPACIO trial, including results from patients with platinum-resistant ovarian cancer and patients with triple-negative breast cancer, have been submitted to the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

A Retrospective Analysis of Phase 3 ENGOT-OV16/NOVA Trial Identified Predictors of Early Dose Modification for Niraparib
A retrospective analysis of the Phase 3 NOVA trial identified two baseline characteristics, patient body weight less than 170 pounds (77 kilograms) or platelet count of <150,000/µL to be significant factors for Grade 3 or 4 thrombocytopenia. The incidence of thrombocytopenia in the first month in this population was 35% in the NOVA study vs 12% in those with higher weight and platelet counts. By month 4, of the patients who remained on treatment, 83% with body weight < 170lbs or platelet count of <150,000/µL at baseline were receiving a dose of niraparib <300 milligrams. With dose interruptions, this group’s average daily dose was 207 milligrams in the first two months of niraparib therapy in NOVA. Regardless, efficacy was uncompromised (HR: 1.01 (95%CI: 0.69, 1.48)) in patients receiving a 200 milligram versus 300 milligram dose of niraparib. Of note, in TOPACIO, where starting dose is 200 milligrams, a 9% incidence of Grade 3 or 4 thrombocytopenia was reported.

"This analysis provides physicians with new information to help quickly identify the most appropriate dose for each of their patients," said Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator on the ENGOT-OV16/NOVA trial. "This information is particularly important as we move towards combination treatment approaches with niraparib, which are currently being studied in multiple ongoing clinical trials."

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

About TSR-042

TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

On March 26, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the use of AGI-134, a novel immunotherapy compound, for the treatment of solid cancer tumors (Press release, BioLineRx, MAR 26, 2018, View Source;p=RssLanding&cat=news&id=2339626 [SID1234525477]).

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This patent, when issued, will be valid until May 2035 with a possibility of up to five years patent term extension. Additional corresponding patent applications for AGI-134 are pending in Europe, Japan, China, Canada, Australia and Israel.

"We are extremely pleased at receiving this important notice of allowance from the USPTO for the patent application covering AGI-134, and believe this represents significant progress in the development of our second oncology asset," stated Philip A. Serlin, Chief Executive Officer of BioLineRx. "We have recently presented very encouraging preclinical data demonstrating complete tumor regression of primary tumors following intratumoral injection of AGI-134, and are looking forward to commencing a Phase 1/2a study for this compound in several solid tumor indications in mid-2018."

About AGI-134

AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating complete tumor regression of primary tumors following intratumoral injection, as well as robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.