On September 11, 2018 Provectus (OTCQB: PVCT) reported that data from two ongoing clinical trials, single agent PV-10 and PV-10 in combination with checkpoint inhibition for the treatment of uveal melanoma metastatic to the liver (an expansion cohort of NCT00986661) and PV-10 in combination with checkpoint inhibition for the treatment of metastatic melanoma (NCT02557321), will be presented in poster presentations at the SMR 2018 Congress (the Society for Melanoma Research annual meeting), held in Manchester, England from October 24-27, 2018 (Press release, Provectus Biopharmaceuticals, SEPT 11, 2018, View Source [SID1234529387]).

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The accepted abstracts are entitled:

"Percutaneous Oncolytic Rose Bengal Disodium for Metastatic Uveal Melanoma Patients with Hepatic Metastases," and

"Interim Results of a Phase 1b/2 Study of PV-10 and Anti-PD-1 in Advanced Melanoma."
Presentation details will be announced closer to the SMR 2018 Congress.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.1,2 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with the liver as the first site of disease involvement.1,2,3 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.4

About our Phase 1 Study of PV-10 for Cancers Metastatic to the Liver

Provectus’ ongoing, open-label, Phase 1 study is evaluating the safety, tolerability, and preliminary efficacy of PV-10 in patients with solid tumors metastatic to the liver. A single percutaneous injection of PV-10 is administered to a designated hepatic tumor. Response assessments are performed at Day 28, and then every three months. Patients with multiple injectable tumors may receive additional PV-10 after Day 28.

This study also includes a single-center cohort of 10 uveal melanoma patients with hepatic metastases. This site is MD Anderson Cancer Center in Houston, Texas, and the principal investigator for the basket study’s new cohort is Sapna Patel, MD. Eligible patients may also receive standard of care checkpoint blockade immunotherapy during treatment with PV-10.

About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Metastatic Melanoma

Patients with metastatic melanoma having at least one injectable cutaneous or soft tissue lesion were eligible for participation in the Phase 1b portion of the study and received the combination of IL PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability. Objective response rate and progression-free survival are key secondary endpoints; both are assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter.

Preliminary results were presented at the Society for Melanoma Research 2017 Congress in October 2017. Enrollment in the Phase 1b portion of this study was completed in May 2018.

About PV-10

Provectus’ lead investigational oncology drug product, 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 September 11, 2018 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Morgan Stanley Healthcare Conference onFriday, September 14, 2018 at 12:15 p.m. ET (Press release, Vertex Pharmaceuticals, SEPT 11, 2018, View Source [SID1234529388]).

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The audio portion of management’s remarks will be available live through Vertex’s website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On September 11, 2018 OncoResponse, an immunotherapy company developing a portfolio of novel antibodies to high-value targets for the treatment of cancer, reported the completion of a $40 million series B equity financing (Press release, OncoResponse, SEPT 11, 2018, View Source [SID1234529389]). Participants in the round, which was led by RiverVest Venture Partners, included new investors Qatar Investment Authority (QIA) and Redmile Group, and existing investors Alexandria Venture Investments, ARCH Venture Partners, HT Family Office, Canaan Partners, Helsinn Investment Fund and William Marsh Rice University. The proceeds will be used to advance the company’s five drug candidates into preclinical and clinical development. All drug candidates were derived from OncoResponse’s discovery platform, which mines the immune systems of patients who have responded exceptionally well to cancer immunotherapies.

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"We are very pleased to add RiverVest, QIA and Redmile to our already strong syndicate of investors as we transition our company’s efforts from identifying drug candidates to developing them for patients," said Clifford J. Stocks, CEO of OncoResponse. "We now have several antibodies from our cancer patient-derived platform that are directed at modulating immunosuppression of the tumor microenvironment. This new capital will allow us to advance our programs through pre-clinical development and enable us to move our lead programs into clinical studies."

"Since its inception in October 2015, OncoResponse has done an excellent job leveraging its platform to rapidly screen and discover therapeutically relevant antibodies from patients with elite response to immunotherapy," said John McKearn, Ph.D., Managing Director of RiverVest Venture Partners. "We believe that their portfolio of unique drug candidates has the potential to help cancer patients, expanding the promise of immunotherapy."

On September 10, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported business highlights and financial results for the fiscal year 2018 third quarter, ended July 31, 2018 (Press release, Advaxis, SEPT 10, 2018, View Source [SID1234529374]).

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Recent key accomplishments include:

Dosing of the first patient in the Company’s Phase 1 trial with ADXS-NEO, a personalized immunotherapy approach targeting neoantigens identified by sequencing a patient’s own cancer cells, partnered with Amgen.
U.S. Food and Drug Administration (FDA) allowance of the Company’s Investigational New Drug (IND) application for its first ADXS-HOT drug candidate, ADXS-503, for non-small cell lung cancer. ADXS-HOT is an off-the-shelf cancer-type specific immunotherapy approach that leverages the Company’s proprietary Lm technology platform to target hotspot mutations and other tumor-associated antigens that commonly occur in specific cancer types.
Selecting prostate and bladder cancers as the second and third ADXS-HOT drug candidates to take into the clinic.
Granting of a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma, a rare and aggressive tumor that forms in the bone.
Pricing of its public offering of common stock and warrants. The planned underwritten public offering is expected to result in gross proceeds of approximately $20 million and close on or around September 11, 2018.
Management Commentary

"We are encouraged by the momentum achieved with both of our neoantigen-focused programs during our third fiscal quarter and continue on our path of achieving our goal of having five neoantigen-based product candidates in clinical evaluation by the end of 2019," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We believe in the powerful impact neoantigens may have on the cancer treatment paradigm. Several of the unique attributes of our Lm platform including the capacity of our vector to contain a large number of neoantigens in each single drug construct, as well as the vector’s ability to generate strong T-cell responses to neoantigens as demonstrated in previously reported studies, provide us with an opportunity to lead in this potentially revolutionary field of cancer treatment.

"ADXS-NEO, partnered with Amgen, takes a personalized approach to therapy and has the potential to make an important contribution among underserved cancer patient populations with few or no treatment options," he added. "Similarly, the IND allowance by the FDA of our ADXS-HOT drug candidate for non-small cell lung cancer enables us to finalize our Phase 1 trial design and dose our first patient by the end of the year. The ADXS-HOT program, in general, is focused on shared hotspot mutations and other cancer antigens commonly found in cancers with large patient populations such as non-small cell lung cancer and prostate cancer."

"We are also excited about the licensing transaction executed with OS Therapies to evaluate our HER-2 therapy for the treatment of human osteosarcoma. This is a product candidate we believe in, although it falls outside our neoantigen focus. The transaction supports continued clinical development by a team of experts exclusively focused on finding new treatments for osteosarcoma and allows us to remain dedicated to our corporate strategy," he added.

Financial Results for Third Quarter Fiscal Year 2018

The net loss for the third quarter ended July 31, 2018 was $14.0 million or $0.27 per share. This compares with a net loss for the third quarter of fiscal year 2017 of $32.6 million or $0.80 per share. The $18.6 million reduction in the net loss compared to prior year was primarily a result of the significant reduction in spending in research, development and administrative areas.

Research and development expenses for the third quarter of fiscal year 2018 were $10.8 million, compared with $17.8 million for the third quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies supporting the MAA, which we withdrew in July 2018.

General and administrative expenses for the third quarter of fiscal year 2018 were $4.5 million, compared with $18.0 million for the third quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in stock-based compensation of approximately $11.4 million related to the resignation of the Company’s Chief Financial Officer and Chief Executive Officer in April 2018 and July 2017, respectively, two Board members who did not seek re-election in March 2018, a reduction in headcount and the elimination of stock-based compensation paid to consultants.

Balance Sheet Highlights

As of July 31, 2018, the Company had approximately $40.4 million in cash, restricted cash and cash equivalents on its balance sheet. The Company is anticipating closing on an underwritten public offering of its common stock and warrants on or around September 11, 2018 which is expected to result in gross proceeds of approximately $20 million to the Company.

On September 10, 2018 Glythera Limited (Glythera), the next-generation Antibody Drug Conjugate (ADC) development company, reported that it has changed its name to Iksuda Therapeutics (Iksuda) and unveiled a new corporate brand (Press release, Glythera, SEPT 10, 2018, View Source [SID1234529375]). The new identity signifies the Company’s transition from technology licensing to drug development, focusing on cancer therapeutics and the treatment of solid tumours. To coincide with the rebranding, Iksuda Therapeutics has launched a new website: www.iksuda.com.

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Iksuda’s primary focus will be on the development of superior ADCs for treatment of difficult-to-treat cancers, but the Company will continue to support its partners’ portfolios with its advanced conjugation platform, PermaLink, and novel toxin payloads.

Iksuda anticipates that it will nominate two ADCs for clinical progression in Q4 2018, with first indications expected to be ovarian and lung cancers. To support its pre-clinical and clinical activities, the Company has significantly expanded its team over the past 12 months, including the appointment of Dr Robert Lutz’s as CSO in January 2018.

Dr Dave Simpson, Chief Executive Officer, Iksuda, said: "The name Iksuda is derived from the Sumerian word for ‘all conquering’ and was chosen to reflect our ambition of overcoming the issue of ADC instability to create a new generation of stable, effective ADCs for treating the most severe cancers and improving patient lives."