On June 11, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that the Company will host a conference call and live webcast on Tuesday, June 25, 2019, at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time to provide a mid-year update on its clinical and preclinical programs (Press release, Arcus Biosciences, JUN 11, 2019, View Source [SID1234537003]).

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Investors interested in listening to the conference call may do so by dialing (866) 211-3164 in the U.S. or (647) 689-6573 internationally, using Conference ID: 7163128.

To access the live webcast and accompanying slide presentation, please visit the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for approximately 30 days.

On June 11, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported it has entered into an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s proprietary HexaBody technology (Press release, Genmab, JUN 11, 2019, View Source [SID1234536987]). Under the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development activities until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma. Based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38. Should this occur, Janssen will pay Genmab a USD 150 million option exercise fee and up to USD 125 million in development milestones, as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13-20% tiered royalties on sales thereafter. Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialize HexaBody-CD38 for DARZALEX-resistant patients, and in all other indications except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed.

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The agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma and leukemia models.

"With this agreement, we hope to build upon the successful and productive relationship that we have established with Janssen. As a result of our collaboration, DARZALEX has dramatically improved outcomes for patients with multiple myeloma, yet there are still unmet needs for patients. We are excited that Genmab’s world-class antibody expertise and passion for innovation has led to the novel HexaBody-CD38 product concept. Encouraging pre-clinical data suggest that HexaBody-CD38 could be superior to daratumumab for certain tumor cell types and may expand and extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukemia, and potentially beyond," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Additional details of the collaboration are not being disclosed and this news does not materially impact Genmab’s 2019 Financial Guidance.

On June 11, 2019 MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, reported that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme (Press release, MetVital, JUN 11, 2019, View Source [SID1234537004]). The notice to proceed was received following MetVital’s submission of an investigational new drug (IND) application for this program. FDA has approved a Phase 2A "Proof of Concept" trial to advance.

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AEO, a patented metabolite, is MetVital’s lead clinical development candidate for Glioblastoma Multiforme, a malicious type of brain cancer. Measured endpoints in the trial include Overall Survival (OS), Progression Free Survival at 6 months (PFS-6) and Seizure amelioration.

"The FDA’s acceptance of this commercial IND application is an important milestone for MetVital, as it allows us to immediately go into Phase 2A testing," said Alan Cash, president and chief executive officer of MetVital, Inc. "We are excited about the potential of modulating the excess glutamate levels in the central nervous system for patients with brain cancer, and the potential of the drug for a wide variety of other diseases." AEO is also being examined in Investigator lead clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease.

Anhydrous Enol-Oxaloacetate is a metabolite that has demonstrated efficacy in animal models with human Glioblastoma Multiforme tissue implants, in animal models of ALS, and in animal models of Alzheimer’s disease. US FDA Orphan Drug Designations for oxaloacetate have been received for Gliomas, ALS and Hepatocellular Carcinoma.

Glioblastoma Multiforme is the most aggressive of the gliomas. It is often referred to as a grade IV astrocytoma, and is the most common type of brain cancer.

On June 11, 2019 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported its financial results for its fiscal third quarter ended April 30, 2019 (Press release, Helix BioPharma, JUN 11, 2019, View Source [SID1234537432]).

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FINANCIAL REVIEW

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively. For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share).

Research and development

Research and development costs for the three and nine-month periods ended April 30, 2019 totalled $1,351,000 and $3,695,000, respectively ($1,435,000 and $5,095,000 respectively for the three and nine-month periods ended April 30, 2018).

L-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $1,054,000 and $2,703,000, respectively ($1,029,000 and $4,039,000 respectively for the three and nine-month periods ended April 30, 2018). L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., and LDOS003 Phase II clinical study in Poland, Ukraine and Hungary.

The Company’s LDOS001 clinical study continues to face patient enrolment challenges. An accelerated dosing protocol has been approved to help accelerate the LDOS001 clinical study. The Company continues to be committed to the LDOS001 study and has re-allocated limited resources to improve patient enrollment. Enrolment in the Company’s LDOS002 clinical study was previously halted at the end of stage 1 of a two-stage phase II study as the intensified schedule did not result in improving patient benefits compared to that observed in the Phase I portion of the study. The Company’s LDOS003 clinical study recently dosed its third patient and commenced second cohort enrollment. The Company is very close to finalizing a clinical study protocol for a Phase I/II study with L-DOS47 to be given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. The Company expects to file an investigational new drug application with the U.S. Food and Drug Administration for a study by the end of the month.

The Company’s Polish subsidiary continues to focus its activities on the V-DOS47 pre-clinical program. V-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $137,000 and $369,000, respectively ($133,000 and $310,000 respectively for the three and nine-month periods ended April 30, 2018). For the three and nine-month periods ended April 30, 2019 the Company’s Polish subsidiary received grant funding of $130,000 and $352,000, respectively ($144,000 and $344,000 respectively for the three and nine-month periods ended April 30, 2018). Grant funding for the V-DOS4 program is the result of an agreement entered into with the Polish National Centre for Research and Development ("PNCRD"). The Agreement may be terminated by either party upon one month’s written notice and must also state the grounds for which the Agreement is being terminated. In certain cases of termination, the Company’s Polish subsidiary may be obligated to return the received financial support in full within fourteen days of the day notice is served, with interest. As at April 30, 2019 that Company’s Polish subsidiary has received grant funds of approximately PLN3,634,609 or 28% of the entire grant funding amount approved by the PNCRD.

CAR-T research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $nil and $333,000 respectively ($192,000 and $317,000 respectively for the three and nine-month periods ended April 30, 2018). The Company commenced development of novel CAR-T therapeutics and new antibody-based technologies for cell-based therapies. The Company’s CAR-T expenditures relate primarily to collaborative research activities with ProMab Biotechnologies Inc.

Trademark and patent related expenses for the three and nine-month periods ended April 30, 2019 totalled $109,000 and $177,000, respectively ($70,000 and $308,000 respectively for the three and nine-month periods ended April 30, 2019). The Company continues to ensure it adequately protects its intellectual property.

Operating, general and administration

Operating, general and administration expenses for the three and nine-month periods ended April 30, 2019 and 2018 totalled $699,000 and $1,605,000, respectively ($686,000 and $1,856,000 respectively for the three and nine-month periods ended April 30, 2018). The decrease in operating, general and administration expenses mainly reflects the normalization of expenditures after companywide cost cutting initiatives.

The following table outlines operating, general and administration costs expensed for the following periods:

LIQUIDITY AND CAPITAL RESOURCES

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively. For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share), respectively.

As at April 30, 2019 the Company had a working capital deficiency of $2,203,000, shareholders’ deficiency of $1,920,000 and a deficit of $169,363,000. As at July 31, 2018 the Company had a working capital deficiency of $1,901,000, shareholders’ deficiency of $1,527,000 and a deficit of $164,005,000.

The Company continues to work with vendors to manage its cash position while ensuring vendors continue providing services while being paid, albeit over a longer period of time than previously agreed terms. Some vendors have placed the Company on hold (cash in advance) and is impacting the Company’s clinical development program. The Company has raised gross proceeds of approximately $8,518,000 from private placement financings during fiscal 2018 and an additional $6,014,000 during the nine-month period ended April 30, 2019. Subsequent to the April 30, 2019 quarter end, the Company announced the closing of a private placement on May 29th, 2019 for gross proceeds of $507,960. Nevertheless, the Company’s cash reserves of $938,000 as at April 30, 2019 continue to be insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current or any planned research and development initiatives through to completion. Though the funds raised have somewhat assisted the Company in dealing with its working capital deficiency and attempts to make vendors current, additional funds are required to advance the various clinical and preclinical programs, pay for the Company’s overhead costs and its past due vendors. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs.

Additional information can be found about the Company’s liquidity and capital resources in the Company’s Management Discussion and Analysis.

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and nine-month periods ending April 30, 2019 and 2018 and the condensed unaudited interim consolidated statement of cash flows for the nine-month periods ending April 30, 2019 and 2018 are summarized below:

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On June 11, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies (Press release, Hoffmann-La Roche, JUN 11, 2019, View Source [SID1234536990]). Accelerated approval was granted for this indication based on complete response rates observed in a randomised, controlled clinical trial. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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"Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease."

The accelerated approval of Polivy was based on the results from the phase Ib/II GO29365 study. This is the first and only randomised pivotal clinical trial to show higher response rates over BR, a commonly used regimen, in people with R/R DLBCL who are ineligible for a haematopoietic stem cell transplant. Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response (n=16/40; 95% CI: 25-57), meaning no cancer could be detected at the time of assessment, compared to 18% with BR alone (n=7/40; 95% CI: 7-33). Complete response rates were assessed by independent review committee. The study also showed that 45% of people on Polivy plus BR achieved an objective response at the end of treatment (n=18/40; 95% CI: 29-62), compared to 18% of people treated with BR alone (n=7/40; 95% CI: 7-33). Of the people treated with Polivy plus BR who achieved a complete or partial response, 64% (n=16/25) had a duration of response (DOR) lasting at least six months as compared to 30% (n=3/10) of people treated with BR alone. Additionally, 48% (n=12/25) of people treated with Polivy plus BR had a DOR lasting at least a year as compared to 20% (n=2/10) of people treated with BR alone. Adverse reactions occurring in at least 20% of patients, and at least 5% more frequently in patients treated with Polivy plus BR compared to BR alone, included low white blood cell count, low platelet levels, low red blood cell count, numbness, tingling or pain in the hands and feet, diarrhoea, fever, decreased appetite and pneumonia.

The US FDA granted Priority Review for the company’s Biologics License Application for Polivy in February 2019. Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. In addition, Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies.

About the GO29365 study
GO29365 is a global, phase Ib/II randomised study evaluating the safety, tolerability and activity of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and Rituxan (rituximab) (BR) or Gazyva (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). Eligible patients were not candidates for haematopoietic stem cell transplant at study entry. The phase II part of the study randomised 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the Polivy arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee (IRC). Secondary endpoints included overall response rate (ORR; CR and partial response) by investigator assessment and best ORR at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival, event-free survival and overall survival.

About Polivy (polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells (an immune cell impacted in some types of non-Hodgkin lymphoma (NHL)), making it a promising target for the development of new therapies.1,2 Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.3,4 Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of several types of NHL.

About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.5 DLBCL is an aggressive (fast-growing) type of NHL, which is generally responsive to treatment in the frontline.6 However, as many as 40% of patients will relapse, at which time salvage therapy options are limited and survival is short.1,4 Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.7

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin-piiq), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, and Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.