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ADC Therapeutics Announces First Patient Dosed with Camidanlumab Tesirine (Cami) in Combination with Pembrolizumab in Ongoing Phase 1b Clinical Trial in Selected Solid Tumors

On November 3, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that the first patient has been dosed with camidanlumab tesirine (Cami, formerly ADCT-301) in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b clinical trial in patients with selected advanced solid tumors (Press release, ADC Therapeutics, NOV 3, 2020, View Source [SID1234569753]).

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"We are pleased to have dosed our first patient in an additional arm of our Phase 1b trial of Cami in solid tumors, which is intended to identify an appropriate dosing regimen for Cami in combination with pembrolizumab and detect signals of clinical activity in expansion cohorts using the identified dosing regimen," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "The preliminary pharmacokinetic and biomarker data from the Phase 1b trial that we presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, as well as a preclinical study recently published in the Journal for ImmunoTherapy of Cancer, support the evaluation of Cami in combination with other immune-modulating therapies. We look forward to the continued evaluation of our CD25-targeted ADC, as monotherapy and in combination with a checkpoint inhibitor, as a novel immuno-oncology approach for the treatment of solid tumor cancers."

Cami targets CD25, which is expressed on regulatory T cells (Tregs) that infiltrate the local tumor microenvironment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both as monotherapy and in combination with a checkpoint inhibitor.

The ongoing, multicenter, open-label, dose-escalation and dose-expansion Phase 1b trial is evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami as monotherapy or in combination with pembrolizumab in patients with selected advanced solid tumors. Approximately 95 patients will be enrolled in the trial. For more information about the Company’s Phase 1b clinical trial of Cami in solid tumors, please visit www.clinicaltrials.gov (identifier NCT03621982).

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells. PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL) and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

Oasmia to present at Investival Showcase November 11-16

On November 3, 2020 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at the Investival Showcase’s digital conference November 11-16, 2020 (Press release, Oasmia, NOV 3, 2020, View Source [SID1234569752]). The presentation will be made available on demand on the Investival Showcase website and accessible to attendees registered for the event. The presentation will also be uploaded onto Oasmia’s website following the event.

McKesson Reports Fiscal 2021 Second-Quarter Results

On November 3, 2020 McKesson Corporation (NYSE:MCK) reported results for the second quarter ended September 30, 2020 (Press release, McKesson, NOV 3, 2020, View Source [SID1234569751]).

Fiscal 2021 Second-Quarter Result Summary

"The dedication and execution of our teams continue to deliver outstanding results, responding to the evolving needs of our customers," said Brian Tyler, chief executive officer. "Our strong second-quarter earnings results reflect the breadth of McKesson’s differentiated portfolio and further improvement in volumes across the business. At the same time, we continue to invest into the business to support our long-term growth strategies. Based on our year-to-date performance, we are raising our guidance range for fiscal 2021 and now expect Adjusted Earnings per diluted share of $16.00 to $16.50. With our steadfast commitment to our communities and those in need, we will continue to play a critical role in the fight against the global COVID-19 pandemic."

Second-quarter revenues were $60.8 billion, up 6% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher volumes from retail national account customers, partially offset by branded to generic conversions.

Second-quarter Earnings per diluted share of $3.54 included a GAAP-only pre- and post-tax goodwill impairment charge of $69 million recorded in connection with the segment realignment and a GAAP-only after-tax charge of $37 million for an estimated liability related to the New York State Opioid Stewardship Act. Second-quarter Adjusted Earnings per diluted share does not include these charges.

Second-quarter Adjusted Earnings per diluted share was $4.80 compared to $3.60 a year ago, an increase of 33%, driven by a lower share count, a lower tax rate and growth in the Medical-Surgical Solutions segment, partially offset by the lapping of the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Second-quarter Adjusted Earnings per diluted share also includes pre-tax net gains of approximately $49 million, or $0.22 per diluted share, associated with McKesson Ventures’ equity investments.

For the first six months of the fiscal year, McKesson returned $388 million of cash to shareholders via $248 million of common stock repurchases and $140 million of dividend payments. During the first six months of the fiscal year, McKesson used cash from operations of $41 million, and invested $265 million internally, resulting in negative Free Cash Flow of $306 million.

U.S. Pharmaceutical Segment

Second-quarter revenues were $48.1 billion, up 5%, driven by market growth and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $623 million and operating margin was 1.30%, and included a GAAP-only pre-tax charge of $50 million for an estimated liability related to the New York State Opioid Stewardship Act. Adjusted Segment Operating Profit was $658 million, up 3% from a year ago, driven by growth in specialty, partially offset by higher operating expenses in support of the company’s strategic growth initiatives. Adjusted operating margin was 1.37%, down 3 basis points.
International Segment

Second-quarter revenues were $9.5 billion, up 2% on a reported basis and down 1% on an FX-Adjusted basis, primarily driven by lower volumes in the Canadian pharmaceutical distribution business due to the exit of an unprofitable customer at the onset of fiscal 2021, partially offset by higher volumes in the European business.
Second-quarter Segment Operating Loss was ($45) million and operating margin was (0.47%), driven by a GAAP-only goodwill impairment charge of $69 million recorded in connection with the segment realignment that commenced in the second quarter of fiscal 2021. Adjusted Segment Operating Profit was $116 million, up 20%. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $115 million, up 19%, driven by lower operating expenses in the European business. Adjusted operating margin was 1.22%, up 18 basis points. On an FX-Adjusted basis, adjusted operating margin was 1.24%, up 20 basis points.
Medical-Surgical Solutions Segment

Second-quarter revenues were $2.5 billion, up 23%, driven by demand for COVID-19 tests and personal protective equipment in the Primary Care and Extended Care businesses.
Second-quarter Segment Operating Profit was $187 million and operating margin was 7.38%. Adjusted Segment Operating Profit was $210 million, up 27%, driven by demand for COVID-19 tests and organic growth in the segment. Adjusted operating margin was 8.29%, up 22 basis points.
Prescription Technology Solutions Segment

Second-quarter revenues were $668 million, up 7%, driven by new brand support programs, partially offset by the impact of lower prescription volume trends.
Second-quarter Segment Operating Profit was $88 million and operating margin was 13.17%. Adjusted Segment Operating Profit was $104 million, down 10%, driven by higher operating expenses in support of the company’s strategic growth initiatives. Adjusted operating margin was 15.57%, down from 18.37% in the prior year.
Other remaining businesses

As a result of the segment realignment effective in the second quarter of fiscal 2021, Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of 2020. Operating loss for the second quarter of fiscal 2020 included GAAP-only pre-tax charges of approximately $1.4 billion, primarily related to an impairment in connection with this planned exit.
Company Updates

On August 14, 2020, McKesson announced the expansion of its existing partnership with the Centers for Disease Control to support the U.S. government’s Operation Warp Speed team as a centralized distributor of future COVID-19 vaccines and ancillary supplies needed to administer vaccinations. McKesson will leverage the strength of its experience, expertise, and commitment to health care delivery and access to make a difference in the fight against the COVID-19 pandemic.
Linda Mantia joined McKesson’s Board of Directors as a new independent director effective
October 19, 2020.
On November 1, 2020, McKesson completed the contribution of its German wholesale business to a joint venture with Walgreens Boots Alliance (WBA). WBA holds a 70% controlling equity interest in the joint venture and McKesson holds the remaining 30%.
McKesson was named to the Diversity Best Practices (DBP) fourth annual Inclusion Index. McKesson was among the 98 organizations that earned a top score.
Fiscal 2021 Outlook

McKesson raised fiscal 2021 Adjusted Earnings per diluted share guidance to $16.00 to $16.50 from the previous range of $14.70 to $15.50 to reflect strong execution and earlier improvement in volumes relative to expectations through the first half of fiscal 2021. Fiscal 2021 guidance assumes approximately $0.15 to $0.20 of Adjusted Earnings per diluted share related to the kitting and storage of ancillary supplies for future COVID-19 vaccines.

Fiscal 2021 guidance assumes that a full recovery of pharmaceutical prescription volumes and patient visits is not likely to occur this fiscal year.

Conference Call Details

The company has scheduled a conference call for today, Tuesday, November 3rd at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

2nd Annual Wolfe Research Virtual Healthcare Conference, November 18, 2020
39th Annual J.P. Morgan Healthcare Conference, January 11-14, 2021
Webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Equity Income from Change Healthcare, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

Cautionary Statements

Except for historical information contained in this press release, matters discussed may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that involve risks and uncertainties that could cause actual results to differ materially from those in those statements. It is not possible to identify all such risks and uncertainties. The reader should not place undue reliance on forward-looking statements, such as financial performance forecasts, which speak only as of the date they are first made. Except to the extent required by law, the company undertakes no obligation to publicly update forward-looking statements. Forward-looking statements may be identified by their use of terminology such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "plans", "estimates" or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans, assumptions or intentions may also include forward-looking statements. We encourage investors to read the important risk factors described in the company’s Form 10-K, Form 10-Q and Form 8-K reports filed with the Securities and Exchange Commission.

These risk factors include, but are not limited to: we experience costly and disruptive legal disputes, including regarding our role in distributing controlled substances such as opioids; we might experience losses not covered by insurance; we might record significant charges from impairment to goodwill, intangibles and other assets or investments; we may be unsuccessful in retail pharmacy profitability; we might be harmed by large customer purchase reductions, payment defaults or contract non-renewal; our contracts with government entities involve future funding and compliance risks; we might be harmed by changes in our relationships or contracts with suppliers; we might be adversely impacted by healthcare reform such as changes in pricing and reimbursement models; we might be adversely impacted by changes or disruptions in product supply and we have experienced and may experience difficulties in sourcing products due to the effects of the COVID-19 pandemic on supply chains; we might be adversely impacted as a result of our distribution of generic pharmaceuticals; we might be adversely impacted by an economic slowdown (including the effects we have experienced from the COVID-19 pandemic) or recession and by disruption in capital and credit markets that might impede our access credit, increase our borrowing costs and impair the financial soundness of our customers and suppliers; we might be adversely impacted by fluctuations in foreign currency exchange rates; we might be adversely impacted by events outside of our control, such as widespread public health issues (including the effects we have experienced from the COVID-19 pandemic), natural disasters, political events and other catastrophic events; and we face uncertainties and risks related to vaccination distribution programs.

BAUSCH HEALTH COMPANIES INC. ANNOUNCES THIRD-QUARTER 2020 RESULTS

On November 3, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its third-quarter 2020 financial results (Press release, Bausch Health, NOV 3, 2020, View Source [SID1234569748]).

"Bausch Health’s third-quarter 2020 results clearly demonstrate our recovery from the COVID-19 pandemic is in progress. In the third quarter, total company reported revenue grew 28% sequentially from the second quarter. Many of our durable brands are well-positioned to grow market share and return to growth, however, some of our prescription products are taking longer to return to pre-pandemic levels," said Joseph C. Papa, chairman and CEO, Bausch Health. "Throughout the pandemic, we have carefully managed our expenses, have prioritized our resources strategically, such as enhancing our e-commerce capabilities, and have maintained ample supply of our health care products for our customers and patients, and we will continue to do what’s right for all our stakeholders."

"We are also making good progress on our intention to separate our eye health business into an independent public company. As we look toward the future, we are excited about several new pipeline opportunities we are pursuing in areas of critical unmet medical need within eye health, including myopia, dry eye disease and age-related macular degeneration," continued Mr. Papa.

Executing on Core Businesses and Advancing Pipeline
•The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in the third quarter of 2020
◦Reported revenue in the Bausch + Lomb/International segment decreased 1% compared to the third quarter of 2019; revenue in this segment was flat organically1,2 compared to the third quarter of 2019
◦Launched Bausch + Lomb INFUSE silicone hydrogel (SiHy) daily disposable contact lenses in the United States

◦Received approvals from Health Canada and the Australian Therapeutic Goods Administration for BAUSCH + LOMB ULTRA ONE DAY silicone hydrogel (SiHy) daily disposable contact lenses
◦Received approval from the U.S. Food and Drug Administration (FDA) for Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100)
◦Entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro Ophthalmics, LLC, including global rights for risuteganib (Luminate)3
◦Acquired an exclusive license from Eyenovia, Inc. in the United States and Canada for the development and commercialization of an investigational microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of pediatric myopia progression in children ages 3-12
◦Acquired an exclusive global license from BHVI for a myopia control contact lens design
•The Salix segment comprised approximately 23% of the Company’s reported revenue in the third quarter of 2020
◦Reported and organic1,2 revenue in the Salix segment decreased by 10% compared to the third quarter of 2019
◦Reported revenue for TRULANCE (plecanatide) increased by 57% compared to the third quarter of 2019
◦The FDA granted Orphan Drug Designation to rifaximin for the treatment of sickle cell disease
•The Ortho Dermatologics segment comprised approximately 7% of the Company’s reported revenue in the third quarter of 2020
◦Reported revenue in the Ortho Dermatologics segment decreased by 2% compared to the third quarter of 2019; revenue in this segment decreased organically1,2 by 3% compared to the third quarter of 2019
◦Reported revenue for the Thermage franchise increased by 77% compared to the third quarter of 2019
•Released both Bausch Foundation Inaugural Activity Report and the Company’s annual Corporate Social Responsibility report in September 2020

Debt Management
•Repaid debt by approximately $100 million in the third quarter of 2020 for a total of approximately $420 million to date in 2020 with cash generated from operations
•Bausch Health has no debt maturities or mandatory amortization payments until 2023

Resolving Legal Matters
•Resolved outstanding intellectual property disputes with Sun Pharmaceutical Industries Ltd. regarding XIFAXAN (rifaximin) 200 mg and 550 mg tablets. Salix will maintain market exclusivity for XIFAXAN until 20284

Third-Quarter 2020 Revenue Performance
Total reported revenues were $2.138 billion for the third quarter of 2020, as compared to $2.209 billion in the third quarter of 2019, a decrease of $71 million, or 3%. Revenue was negatively impacted by approximately $150 million in the third quarter of 2020 due to the impact of the COVID-19 pandemic.
Excluding the unfavorable impact of foreign exchange of $6 million and the impact of divestitures and discontinuations of $4 million, revenue declined 3% organically1,2 compared to the third quarter of 2019.
Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.169 billion for the third quarter of 2020, as compared to $1.175 billion for the third quarter of 2019, a decrease of $6 million, or 1%. Excluding the unfavorable impact of foreign exchange of $7 million and the impact of divestitures and discontinuations of $3 million, the Bausch + Lomb/International segment was flat organically1,2 compared to the third quarter of 2019 primarily due to the impact of the COVID-19 pandemic.

Salix Segment
Salix segment revenues were $496 million for the third quarter of 2020, as compared to $551 million for the third quarter of 2019, a decrease of $55 million, or 10%. The decrease was primarily driven by the loss of exclusivity of products in the segment, primarily APRISO (mesalamine), which negatively impacted revenues by approximately $25 million; by an expected decline for GLUMETZA (metformin hydrochloride), whose revenue declined by $21 million due to reduced net selling prices; and by the impact of the COVID-19 pandemic, including the impact to sales of XIFAXAN, which declined by 3% compared to the third quarter of 2019.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $144 million for the third quarter of 2020, as compared to $147 million for the third quarter of 2019, a decrease of $3 million, or 2%. Excluding the favorable impact of foreign exchange of $1 million, the Ortho Dermatologics segment declined organically1,2 by approximately 3% compared to the third quarter of 2019 primarily driven by the loss of exclusivity of products in the segment, primarily ELIDEL (pimecroliumus) Cream, 1%, which negatively impacted revenues by approximately $15 million.

Diversified Products Segment
Diversified Products segment revenues were $329 million for the third quarter of 2020, as compared to $336 million for the third quarter of 2019, a decrease of $7 million, or 2%. The decrease was primarily attributable to the previously reported loss of exclusivity for a basket of products and the impact of the COVID-19 pandemic.
Operating Results
Operating income was $460 million for the third quarter of 2020, as compared to operating income of $329 million for the third quarter of 2019, an increase of $131 million. The increase in operating results was primarily due to decreases in amortization of intangible assets, selling, general and administrative expenses, asset impairments and R&D expenses partially offset by decreases in revenues and gross margins primarily due to the impact of the COVID-19 pandemic, as discussed above.

Net Income
Net income was $71 million for the third quarter of 2020, as compared to net loss of $49 million for the third quarter of 2019, a favorable change of $120 million. The change was primarily driven by the increase in operating results discussed above and lower interest expense partially offset by an increase in our provision for income taxes.

Adjusted net income (non-GAAP)1 for the third quarter of 2020 was $469 million, as compared to $425 million for the third quarter of 2019, an increase of $44 million, or 10%.

Cash Generated from Operations
The Company generated $256 million of cash from operations in the third quarter of 2020, as compared to $515 million in the third quarter of 2019, a decrease of $259 million. The decrease in cash from operations was primarily attributed to lower volumes and the timing of cash receipts as a result of the COVID-19 pandemic and also includes a payment of $45 million for the resolution of the legacy investigation by the U.S. Securities and Exchange Commission.

EPS
GAAP Earnings Per Share (EPS) Diluted for the third quarter of 2020 was $0.20, as compared to ($0.14) for the third quarter of 2019.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $948 million for the third quarter of 2020, as compared to $942 million for the third quarter of 2019, an increase of $6 million, or 1%. The increase was primarily due to decreases in selling, general and administrative expenses partially offset by decreases in revenues and gross margins primarily due to the impact of the COVID-19 pandemic, as discussed above.

2020 Financial Outlook
Bausch Health reaffirmed its revenue and Adjusted EBITDA (non-GAAP) guidance ranges for the full year of 2020, reflecting management’s current expectations. This assumes there are no material restrictions on access to health care products and services resulting from a possible resurgence of the virus on a global basis in the fourth quarter of 2020; the strict social restrictions seen earlier this year will not be materially re-enacted in the event of a material resurgence of the virus; rates of recovery will vary by geography and business unit; and an ongoing gradual global recovery as the macroeconomic and health care impacts of the COVID-19 pandemic run their course. Bausch Health’s guidance ranges are as follows:
•Full-year revenue range of $7.80 – $8.00 billion
•Full-year Adjusted EBITDA (non-GAAP) range of $3.15 – $3.30 billion

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are
not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The full-year guidance ranges have been lowered primarily due to the actual and anticipated impacts of the COVID-19 pandemic. These impacts have affected the Company’s assumptions regarding base performance and growth rates. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

Additional Highlights
•Bausch Health’s cash, cash equivalents and restricted cash were $1.988 billion6 at Sept. 30, 2020
•The Company’s availability under the Revolving Credit Facility was $1.118 billion at Sept. 30, 2020
•Basic weighted average shares outstanding for the quarter were 355.6 million shares. Diluted weighted average shares outstanding for the quarter were 357.8 million shares

Patient treatments commence with Clarity’s copper-64/copper-67 SARTATEin neuroblastoma clinical trial

On November 3, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that treatment has commenced in a 64/67Cu-SARTATETM theranostic trial of paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City (Press release, Clarity Pharmaceuticals, NOV 3, 2020, View Source [SID1234569699]).

The first patient was treated with 67Cu-SARTATE therapy following a positive diagnostic scan with 64Cu-SARTATE and is progressing through the study assessments as planned. Patient recruitment continues at MSK and will be expanding to other clinical sites across the United States (U.S.) in the coming months (ClinicalTrials.gov Identifier: NCT04023331)1.

"We are very excited to commence the treatment of neuroblastoma patients with SARTATE, especially given the great promise of both the diagnostic and therapeutic products in changing the treatment outcomes in these children," commented Dr Alan Taylor, Clarity’s Executive Chairman. "We are looking forward to building more data as we expand the trial to include additional clinical sites and recruit more patients with high-risk neuroblastoma into the study. We are very hopeful that 64/67Cu-SARTATE will save and improve lives of children with this insidious disease."

The SARTATE neuroblastoma trial uses the next-generation radiopharmaceutical pair of 64Cu-SARTATE and 67Cu-SARTATE to assess and treat paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial being conducted in the U.S. Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor continued: "Our team is pleased to have received very strong support from our numerous collaborators in the clinical development of 64/67Cu-SARTATE in neuroblastoma. We have also recently been granted Orphan Drug Designation as well as two Rare Paediatric Disease Designations for the diagnostic and therapeutic application of SARTATE in neuroblastoma by the U.S. Food and Drug Administration (FDA). These regulatory milestones will enable us to progress SARTATE through clinical development in a swift and cost-effective manner and make Clarity eligible for two Priority Review Vouchers (PRV) upon FDA marketing approval of the diagnostic and therapeutic products. PRVs, which allow for the faster processing of new drug applications through the FDA, are tradable and currently have a market value of approximately USD100 million each. The awarding of these two PRVs will underpin our extensive theranostic development pipeline as we look to progress treatments in other cancers including prostate and breast, as well as neuroendocrine tumours.

"From all the support and positive feedback from the industry that we have received to date, it is clear that the development of next-generation diagnostic and therapeutic tools as well as novel treatment strategies are imperative to improving treatment outcomes for children with high risk neuroblastoma who currently have very poor prognosis and few treatment options. Clarity and our collaborators remain focused on the important goal of developing better treatments for children with cancer and we look forward to further progressing the development of SARTATE together," Dr Taylor said.