On January 29, 2019 Triphase Accelerator, together with its majority shareholder FACIT, reported a new strategic collaboration with Celgene for a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers including leukemia (Press release, Celgene, JAN 29, 2019, View Source [SID1234536469]). Triphase is a drug development company advancing novel compounds through Phase 2 proof-of-concept, including the WDR5 program.

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Under the terms of the agreement, Celgene has the option to acquire TRPH-395 from Triphase Accelerator. Celgene will pay an upfront of US$40M and upon exercise of the option, Celgene will pay up to US$940M in contingent development, regulatory and sales milestones. Additional payments for sales-based royalties are also possible.

"As with our previously announced spin outs, the Drug Discovery team at Ontario Institute for Cancer Research (OICR), led by Dr. Rima Al Awar, has yet again produced a world-class asset for patients with cancer," remarked Dr. David O’Neill, President of FACIT. FACIT seed financed Propellon Therapeutics to commercialize the preclinical asset and ran a competitive global business development process to identify strategic partners. Multiple formal offers were received from the US, Europe and Japan, reflecting the high quality of science in the program.

Dr. O’Neill continued "The quality of the team and commitment by Triphase Accelerator to engage Ontario researchers and clinical sites in its high content studies, combined with its long-standing relationship with Celgene made this partnership the most compelling path to impact patients and the local economy." While additional payments to the program are largely contingent on clinical success, the significant financial commitment will enable re-investable returns by FACIT in the Ontario innovation economy.

The WDR5 protein is critical for the formation and activities of certain protein complexes that are associated with DNA and indirectly modify genes. These processes represent an exciting new therapeutic field, referred to as epigenetics. Blood cancers like leukemia can result when WDR5-associated protein complexes are not appropriately regulated in the body. Drug compounds that can disrupt these cancer-causing cellular activities represent a novel therapeutic approach, which may also improve clinical outcomes in patients with solid tumours.

"This transaction represents a significant milestone for Triphase Accelerator as it brings together our long-standing collaboration with Celgene and a first-in-class asset from Ontario" said Dr. Ilse Treurnicht, Executive Chairperson at Triphase Accelerator. "We are excited that this transaction is another step forward to realizing the vision of the founding partners – OICR, MaRS Innovation and MaRS – and will allow Triphase to apply its unique science based, rapid, and cost-effective approach to advancing this Ontario based program toward clinical proof of concept."

"Our investment in Propellon’s technology reflects our commitment to developing first-in-class epigenetic therapies for patients with hematological cancers," remarked Dr. Jorge DiMartino, Vice President of Translational Development at Celgene. "The teams at OICR Drug Discovery, FACIT and Triphase Accelerator have together created an optimal pathway for oncology innovation and help make Ontario a strong collaborator and destination for our investment."

"This is a great day for cancer research in Ontario. Congratulations to FACIT, OICR and Triphase Accelerator," said Todd Smith, Minister of Economic Development, Job Creation and Trade. "This discovery and investment will benefit Ontario cancer patients and support industry jobs in the province. Ontario is open for business, and we welcome more innovative cancer research and trials."

"This is an exciting development for cancer research and innovation in Ontario, and I congratulate FACIT, OICR and Triphase Accelerator on their important collaboration," said Christine Elliott, Deputy Premier and Minister of Health and Long-Term Care. "It’s partnerships like these that keep Ontario open for business and are invaluable as we work toward developing a long-term transformational health care strategy guided by innovation, integration and the better use of technology."

On January 29, 2019 Provectus (OTCQB: PVCT) reported that the Journal of Surgical Oncology (JSO) has published results from an investigator-conceived and led, single-center study of in-transit melanoma (ITM) patients receiving either regionally-administered isolated limb infusion (ILI) or intratumoral (aka intralesional) PV-10 to assess and compare the effect of these treatments on survival (Press release, Provectus Biopharmaceuticals, JAN 29, 2019, View Source [SID1234532943]). The JSO article detailed the work of investigators at the Princess Alexandra Hospital (PAH) in Brisbane, Australia, where ILI represents the historical standard of care for ITM and PV-10 was used to treat ITM under expanded access. Intratumoral injection of PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1,2,3,4

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This article, entitled "Patients with in-transit melanoma metastases have comparable survival outcomes following isolated limb infusion or intralesional PV-10 – A propensity score matched, single center study," may be accessed via the JSO’s website at View Source

Key Results from the JSO Article:

Baseline and disease characteristics:

Patients matched for key covariates: age, gender, primary disease site, and Breslow thickness
ILI: 36 patients; 56% men; median age of 76.5 years (interquartile range 69-83); 100% Stage IIIB/IIIC
PV-10: 36 patients; 56% men; median age of 74.5 years (65-81); 89% Stage IIIB/IIIC (11% Stage IV)

Treatment response (patient-level best overall response):

ILI: 22% complete response and 50% overall response rate
PV-10: 25% complete response and 83% overall response rate

Survival outcomes:

ILI
progression-free survival (PFS): median of 5.0 months (interquartile range 2.7-10.7)
disease-free survival (DFS): median of 16.5 months (8.9-48.4)
overall survival (OS): median of 29.7 months (12.3-88.5)
melanoma-specific survival (MSS): median of 74.4 months (24.3-NA); 12‐, 24‐, 36‐, and 60‐month MSS rates of 85%, 75%, 60%, and 60%, respectively
PV-10
PFS: median of 3.9 months (9.6-47.9)
DFS: median of 14.1 months (4.5-20.9)
OS: median of 27.1 months (14.3-48.6)
MSS: median of 36.4 months (16.6-65.3); 12‐, 24‐, 36‐, and 60‐month MSS rates of 83%, 70%, 54%, and 36%, respectively
Differences in PFS, DFS, and MSS comparing ILI with PV‐10 were not statistically significant
Among the authors’ conclusions:

"Overall these results demonstrate that demographically similar patients with in-transit melanoma metastases treated with ILI or PV-10 have comparable long-term survival rates,"

"Propensity score matching is a useful statistical technique for examining relative treatment effects within complex patient groups, particularly when larger randomized controlled studies are impractical,"

"A complete response to either treatment was the only independent factor identified that significantly predicted long-term survival,"

"These findings suggest that both ILI and PV‐10 can be considered as a suitable standard of care," and

"These treatments are relevant and likely to remain of value in the near future, particularly for the treatment of symptomatic or refractory metastases following the discontinuation of systemic therapies due to serious drug-related side-effects or exhaustion of other systemic options."
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Despite the advances made by targeted therapies and checkpoint inhibitors, these comparative survival data highlight the important role that investigational PV-10 may have for the treatment of advanced melanoma. The Australian investigators place PV-10’s role in the context of relatively more expensive systemic agents that have substantial toxicity profiles and similar response rates."

Mr. Rodrigues added, "Furthermore, these comparative survival data substantiate the Company’s historical work in melanoma and provide more validation of PV-10 in a single-agent setting for a challenging patient population. The key focus of Provectus’ drug development program now is to demonstrate PV-10 activity in both single-agent and combination therapy settings for the treatment of both hot and cold tumor types."

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On January 29, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported updates on its clinical program for its lead investigational treatment, DPX-Survivac, as a potential monotherapy in advanced recurrent ovarian cancer (Press release, IMV, JAN 29, 2019, View Source [SID1234534098]). In December 2018, IMV met with the U.S. Food and Drug Administration (FDA) in a Type B meeting to discuss the results-to-date of its DECIDE1 clinical trial and ongoing development plan, as well as to obtain agency guidance on a potential accelerated regulatory pathway for DPX-Survivac as a T cell immunotherapy for the treatment of advanced ovarian cancer in patients with progressing disease.

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"This FDA meeting was an important milestone for the DPX-Survivac program, and we are very pleased to be aligned with the agency on key aspects of our clinical development plan," said Frederic Ors, Chief Executive Officer at IMV. "We believe that, with no currently approved immunotherapy options available, ovarian cancer remains a serious unmet medical need. We look forward to advancing our ongoing phase 2 DECIDE study in order to potentially expedite DPX-Survivac development as a possible first-in-class T cell immunotherapy treatment for patients with advanced ovarian cancer."

FDA Meeting Highlights

The purpose of IMV’s Type B meeting with the FDA was to request feedback on the design of the clinical program for DPX-Survivac. This program includes the ongoing DECIDE phase 2 clinical study and a potential future registration trial for accelerated approval in a subset of ovarian cancer patients.

The FDA reviewed the Company’s proposed clinical development plan and acknowledged the potential for accelerated approvals in advanced ovarian cancer based on objective response rate (ORR) according to RECIST 1.1 criteria with reported median duration of response (DOR). In addition, the FDA provided important guidance on clinical design considerations for different lines of therapy and platinum-sensitive and -resistant patient populations.

In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial, and further discussed those details with the FDA during the Type B meeting. The phase 2 primary endpoint, based on objective response rate (ORR) per RECIST 1.1 criteria, is intended to confirm the high response rate and duration of clinical benefits observed in previously announced results in a patient population defined by a clinical biomarker based on baseline tumor burden (BTB).

Multiple clinical sites are now open for enrollment in the DECIDE phase 2 trial. Subject to phase 2 results, IMV plans to schedule a follow-up meeting with FDA to finalize the design of a potential pivotal trial based on ORR and DOR.

About the DECIDE Phase 2 Trial Cohort

The DECIDE (DPX-Survivac with low dose intermittent cyclophosphamide) phase 2 study is an open label safety and efficacy study for individuals with advanced platinum-sensitive and -resistant ovarian cancer with sum of base line target lesions per RECIST criteria less than 5 cm. Primary and secondary endpoints include:

Safety profile,

ORR and DOR using RECIST 1.1 criteria,

Induction of systemic survivin-specific T cells in the blood, and

Induction of T cell infiltration into tumors.

On January 29, 2019 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a clinical stage biopharmaceutical company focused on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that its Chief Executive Officer, James Nathanielsz, will be presenting at the 2019 BIO CEO & Investor Conference on Tuesday, February 12, 2019, at 9:45 am EST (Press release, Propanc, JAN 29, 2019, View Source [SID1234532944]). The conference will be held at the New York Marriott Marquis.

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"The BIO CEO & Investor Conference is one of the largest investor conferences, focused on established and emerging publicly traded and select private biotech companies, and I am honored to be selected to present at this year’s conference. As we prepare to transition our lead technology into human trials, this is a great opportunity for us to meet with investors and potential partners to provide a company update for 2019, focusing on the advancement of our lead product, PRP," said James Nathanielsz, CEO and Executive Chairman of Propanc. "PRP is a solution for intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Progressing towards a first-in-human study, PRP seeks to prevent recurrence and metastasis from solid tumors by targeting and eradicating cancer stem cells."

Investors and potential partners attending the conference who wish to meet with Propanc’s management can reach out through the BIO One-on-One Partnering system to request a meeting. For those not planning to attend the meeting, please contact Lisa DeScenza to set up a call with Mr. Nathanielsz to learn more about Propanc.

A live audio webcast of Mr. Nathanielsz’s presentation will be accessible within the Investor Relations section of Propanc’s website at View Source An archived version of this webcast will be available for 90 days following the conclusion of the live presentation.

On January 29, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that its fourth quarter and full year 2018 financial results will be released on Tuesday, February 12, 2019 after the markets close (Press release, Exelixis, JAN 29, 2019, View Source;p=irol-newsArticle&ID=2385255 [SID1234532962]). At 5:00 p.m. EST / 2:00 p.m. PST, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6681209 to join by phone.

A telephone replay will be available until 8:00 p.m. EST on February 14, 2019. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6681209. A webcast replay will also be archived on www.exelixis.com for one year.