On December 2, 2019 Provectus (OTCQB: PVCT) reported that data from an ongoing clinical trial of lysosomal-targeting cancer immunotherapy PV-10 (rose bengal disodium) as a single-agent for the treatment of primary or metastatic tumors of the liver (NCT00986661) will be presented at the upcoming Society of Interventional Radiology (SIR) 2020 Annual Scientific Meeting, to be held March 28-April 2, 2020, in Seattle, Washington (Press release, Provectus Biopharmaceuticals, DEC 2, 2019, View Source [SID1234551832]). The accepted abstract is:

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"Oncolytic immunotherapy of hepatic tumors with intralesional rose bengal disodium."
PV-10 is administered percutaneously when targeting primary or metastatic tumors of the liver, such as hepatocellular carcinoma, metastatic colorectal cancer, metastatic neuroendocrine tumors, and metastatic uveal melanoma. Intralesional (aka intratumoral) injection with PV-10 can yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells.1-4

About PV-10

Provectus has shown that PV-10 selectively accumulates in the lysosomes of only cancer cells upon contact, disrupts them, and causes the cancer cells to die.1,5 This lysosomal targeting and destruction mechanism has been reproduced by external collaborators.6 Provectus, external collaborators, and independent researchers have further shown that PV-10 treatment (RB application) can trigger each of the three primary lysosomal cell death pathways of apoptosis, autophagy, and necrosis, and do so in a disease-dependent manner.2,3,6-9

PV-10 causes acute oncolytic destruction of injected tumors (i.e., cell death), mediating several identified immune signaling pathways to date, such as the release of danger-associated molecular patterns (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Other mediated immune signaling pathways that have been identified include poly-ADP ribose polymerase (PARP) cleavage, and a third pathway currently being investigated that plays an important role in innate immunity. PV-10 is the first cancer drug that may facilitate multiple, temporally-distinct, immune system signaling pathways.10

PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver (including metastatic neuroendocrine tumors and metastatic uveal melanoma), and preclinical study for pediatric solid tumor cancers (like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma) and pediatric blood cancers (like leukemia).

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10 is an injectable formulation of rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), which is a small molecule halogenated xanthene and PV-10’s active pharmaceutical ingredient. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property (IP) includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to control these impurities is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international patents that protect the combination of PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035.

On December 2, 2019 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported that the Company will present an overview of the company at the Piper Jaffray 31st Annual Healthcare Conference on Thursday, December 5, 2019 in New York, NY, and meet with investors in 1×1 meetings throughout the day (Press release, Cytosorbents, DEC 2, 2019, View Source [SID1234551848]).

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Piper Jaffray 31st Annual Healthcare Conference
Where: Lotte New York Palace, 455 Madison Ave, New York, NY
When: Thursday, December 5, 2019 from 11:50AM-12:10PM EST
Webcast: Piper Jaffray 31st Annual Healthcare Conference Webcast Link

A live webcast of the presentation will be available at the above webcast link. An archived replay of the webcast will be available for 90 days following the event.

On December 2, 2019 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility (Press release, Mylan, DEC 2, 2019, View Source [SID1234565290]). Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

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Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila, a biosimilar to Neulasta. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products.

Mylan President Rajiv Malik commented: "As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, biosimilar trastuzumab, in both the 420mg and 150mg strengths and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With regulatory approval for our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the U.S. and look forward to continuing our work with all stakeholders in the healthcare system to reduce costs, improve access and advance care. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients.

Malik continued, "Today’s launch has been achieved through years of hard work as a result of our successful collaboration with Biocon. Our early settlement and license with Roche to bring this product to market allows us to launch Ogivri without legal risk."

Dr. Christiane Hamacher, CEO, Biocon Biologics, said: "The U.S. launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. As a global frontrunner in biosimilars, Biocon Biologics is committed to fulfil unmet patient needs by providing greater affordability for enhanced patient access. We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$ 1bn by FY22.

"Ogivri is the second biosimilar from our partnered portfolio being commercialized by Mylan in the U.S. Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar pegfilgrastim," she added.

FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. Long-term results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Dr. Hope S. Rugo, professor of medicine at the University of California, San Francisco, and lead author of the HERITAGE study commented: "Trastuzumab-dkst (Ogivri) has many firsts to its credit. It was one of the first biosimilar oncology products to get a unanimous approval vote at an ODAC meeting, and it was the first biosimilar study to be published in the Journal of the American Medical Association. In this context, the HERITAGE study had a unique trial design that not only evaluated objective response rate at week 24 as its primary endpoint but also assessed key endpoints including progression-free survival rate and overall survival at 36 months. The concordant efficacy data across all three endpoints conclusively demonstrated that Ogivri was similar to Herceptin, and patients without progression now continue on Ogivri as maintenance therapy. We are pleased that patients with HER2-positive cancers now have an additional treatment option backed by robust safety and efficacy data, including long-term 36-month data. The worldwide introduction of this agent has already improved access to trastuzumab."

Ogivri is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in the U.S. and the second FDA-approved biosimilar through this collaboration to support cancer patients. Mylan and Biocon launched the world’s first biosimilar trastuzumab in India in 2014. Today, Mylan has one of the largest and most diverse biosimilars portfolios, with 20 biosimilar and insulin analog products in development or on the market.

A full suite of patient services for Ogivri will be offered through the Mylan Advocate program.

About the HERITAGE Study

HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as MYL-1401O) versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either trastuzumab-dkst or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival, and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for trastuzumab-dkst versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).The primary endpoint has previously been reported: the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA. 2017;317:37-47).

Bringing Access to Biologics

Biologic drugs, like Herceptin, represent a large and increasing portion of the overall prescription drug market. They are important in the treatment of many chronic and acute diseases, including cancer. However, these drugs can cost far more than traditional prescription drugs, and their cost can prohibit access. One study found that nearly 40% of women were at least somewhat worried about finances because of their breast cancer treatment. Biologics now account for about 40% of all U.S. drug spending and 70% of spending growth from 2010 to 2015.

Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It’s estimated that the introduction of biosimilars in the U.S. could save the nation’s healthcare system up to $150 billion between 2017 and 2027.

Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients.

About the Biocon and Mylan Partnership

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar trastuzumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

On December 2, 2019 LIDDS AB reported An interview with Professor Laurence Klotz, one of the LPC-004 study investigators was done in connection to the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19 in which he summarizes the study results. At the conference, the Phase IIb clinical data from the LIDDS study LPC-004 prostate cancer study on Liproca Depot was presented by Professor Klotz in an oral session at EMUC19 as "Late Breaking News" on November 16, 2019.

Professor Laurence Klotz is a world leading expert in Active Surveillance of prostate cancer patients and a Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada.

-The appealing aspect of this LIDDS Liproca Depot is that it is quite easy to administer, it has little or no effect on erectile function, on voiding, really virtual free of long-term side effects and is therefore a very appealing approach for patients under Active Surveillance, concludes Laurence Klotz in the video.

The interview is available on https://bit.ly/2Dzb55d

About the Phase IIb Liproca Depot clinical trial
The single blind, two-part dose finding study aimed to determine the highest tolerable dose of Liproca Depot in part I and to determine the level of PSA reduction for part II patients at month 5. The study was conducted at eight specialist urology clinics in Canada; Lithuania and Finland. The study involved 61 patients diagnosed with localized non-aggressive prostate cancer who were on Active Surveillance. Patients were followed for six months to assess response and tolerability. Three previous clinical trials (LPC-001, LPC-002 and LPC-003) involved a total of 57 patients and showed promising results for tolerability and effect on tumor tissue, prostate volume and the PSA biomarker.

About prostate cancer and the market
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.
According to market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca Depot’s target group is an untapped market potentially exceeding USD 3 billion per year.

About Liproca Depot and NanoZolid
NanoZolid is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid forms a solid depot releasing the active drug over periods of potentially more than six months. As it releases its drug load, the NanoZolid depot dissolves and is absorbed harmlessly into the body.
Liproca Depot combines NanoZolid and 2-HOF (2-hydroxyflutamide), a well-established antiprostate cancer drug. Liproca Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression.

On December 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government (Press release, Puma Biotechnology, DEC 2, 2019, View Source [SID1234551817]). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

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STA Chief Executive Officer Carlo Montagner said, "The approval in Singapore is a key milestone for the company as NERLYNX is the first drug in our portfolio to be approved by the HSA for commercialization in Singapore. We look forward to extending the reach of this medicine, with regulatory dossiers also submitted in Malaysia, Brunei and the Philippines."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We have been extremely pleased with the strong commercial strategy implemented by Specialised Therapeutics in Australia and we look forward to their continued success throughout South East Asia. We are committed to expanding access to NERLYNX to breast cancer patients around the world."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.