On August 9, 2022 Daiichi Sankyo reported that Initial results from the TROPION-Lung02 phase 1b trial showed that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy demonstrated promising clinical activity and a tolerable safety profile in patients with previously untreated or pretreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. Results were presented today during a late-breaking mini-oral presentation (#MA13.07) at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC22) (Press release, Daiichi Sankyo, AUG 9, 2022, View Source [SID1234617899]).

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Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

NSCLC is diagnosed at an advanced stage in nearly 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.1,2,3 While first-line treatment consisting of immunotherapy with or without chemotherapy has improved outcomes in patients with NSCLC without actionable genomic alterations, disease progression still occurs in the majority of patients and additional treatment strategies in this setting are needed.4,5

An interim analysis of the ongoing TROPION-Lung02 trial in patients with previously untreated or pretreated advanced or metastatic NSCLC without actionable genomic alterations demonstrated a promising overall response rate (ORR) in the overall population of 37% (median follow-up of 6.5 months) of 38 patients receiving datopotamab deruxtecan in combination with pembrolizumab (doublet therapy) and an ORR of 41% (median follow-up of 4.4 months) of 37 patients receiving datopotamab deruxtecan in combination with pembrolizumab and platinum chemotherapy (triplet therapy). A disease control rate (DCR) of 84% was seen with both the doublet and triplet combination therapy in the overall population that comprised both first-line and second-line settings.

In previously untreated patients, ORRs of 62% (eight of the 13 patients receiving doublet therapy) and 50% (10 of 20 patients receiving triplet therapy) were observed. Eight partial responses (PRs) were seen in patients receiving doublet therapy and 10 PRs (three pending confirmation) were seen in patients receiving triplet therapy. A DCR of 100% was observed with doublet therapy and a DCR of 90% was observed with triplet therapy.

"Many patients with advanced non-small cell lung cancer still experience disease progression following initial treatment, underscoring the need for new therapeutic approaches," said Benjamin Philip Levy, MD, Clinical Director of Medical Oncology, Johns Hopkins Sidney Kimmel Cancer Center, at Sibley Memorial Hospital and Associate Professor of Oncology at Johns Hopkins University School of Medicine. "The initial results from the TROPION-Lung02 trial show encouraging safety and efficacy results when combining datopotamab deruxtecan and pembrolizumab with or without platinum chemotherapy and warrant further study in the first-line metastatic setting."

Combinations with datopotamab deruxtecan demonstrated a tolerable safety profile, which supports further evaluation in ongoing studies. Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 40% and 60% of patients in the doublet and triplet cohorts, respectively. The most frequent TEAEs of any grade in the doublet and triplet cohorts respectively were stomatitis (56% and 29%), nausea (41% and 48%), decreased appetite (28% and 38%), fatigue (25% and 36%) and anemia (16% and 36%). There were four interstitial lung disease (ILD) events determined as drug-related by an independent adjudication committee across both cohorts; two were adjudicated as grade 1/2 and two were adjudicated as grade 3. No grade 4 or grade 5 ILD events were adjudicated as drug-related. At the time of the data cut-off, there were three potential ILD events pending adjudication. Three deaths occurred (two within the doublet cohort, one in the triplet cohort), none of which were determined as drug-related. Treatment discontinuations due to adverse events occurred in less than 21% of patients and datopotamab deruxtecan dose discontinuation occurred in 13% of patients.

"These early findings from TROPION-Lung02 are promising and represent the first lung cancer trial to report results combining a TROP2 directed antibody drug conjugate with an immune checkpoint inhibitor with or without platinum chemotherapy in patients with advanced or metastatic non-small cell lung cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "These data support the initiation of the TROPION-Lung08 phase 3 trial to further evaluate datopotamab deruxtecan in combination with pembrolizumab as a first-line combination treatment in patients with advanced non-small cell lung cancer without actionable genomic alterations."

"Building on preliminary findings of datopotamab deruxtecan combination therapy in triple negative breast cancer shared earlier this year, these initial results from TROPION-Lung02 reflect the broader promise of combining existing treatments with antibody drug conjugates," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "We look forward to continuing this important research with the goal of providing a new treatment option for patients with advanced non-small cell lung cancer."

Patients in TROPION-Lung02 receiving doublet therapy were previously-treated with one median line of therapy, including platinum chemotherapy (60%) and immunotherapy (30%). In the triplet cohort, patients previously received platinum chemotherapy (35%) and immunotherapy (38%). Datopotamab deruxtecan-based combination as first-line therapy accounted for 33% and 63% of patients in doublet and triplet cohorts, respectively. As of the May 2, 2022 data cut-off, 53% and 77% of patients remained on the doublet and triplet therapy, respectively.

Summary of TROPION-Lung02 Results
About TROPION-Lung02
TROPION-Lung02 is an ongoing global, open-label, six-cohort phase 1b trial evaluating the safety and efficacy of datopotamab deruxtecan at two dose levels (4 mg/kg and 6 mg/kg) in combination with pembrolizumab (200 mg) with or without four cycles of platinum chemotherapy (carboplatin or cisplatin) in both previously untreated and pretreated patients with advanced or metastatic NSCLC without actionable genomic alterations (e.g., EGFR, ALK, ROS1, NTRK, BRAF, RET, MET or other known actionable alterations).

The primary endpoints of TROPION-Lung02 are dose-limiting toxicities (DLTs) and TEAEs. Secondary endpoints include ORR, duration of response, progression-free survival, overall survival, pharmacokinetics and anti-drug antibodies for datopotamab deruxtecan and pembrolizumab.

TROPION-Lung02 is one of two clinical trial collaborations with Merck & Co., Inc., Rahway, NJ., USA (known as MSD outside of the United States and Canada) evaluating datopotamab deruxtecan in combination with pembrolizumab with or without platinum chemotherapy. The second clinical trial collaboration for the TROPION-Lung08 phase 3 trial is currently enrolling previously untreated patients with PD-L1 high (tumor proportion score ≥ 50%) advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations to evaluate the safety and efficacy of datopotamab deruxtecan in combination with pembrolizumab compared to pembrolizumab alone.

About Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide.6 NSCLC is diagnosed at an advanced stage in nearly 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.1,2,3

While the introduction of targeted therapies and checkpoint inhibitors in recent years have improved outcomes for patients with advanced NSCLC, the majority of tumors do not have known actionable genomic alterations.7,8,9,10 Current standard of care in the first-line treatment of patients with advanced NSCLC without actionable genomic alterations is immunotherapy with or without platinum-based chemotherapy, based upon PD-L1 expression. While these therapies may improve survival, at least 40 to 60% of tumors do not respond to initial treatment and disease progression occurs, underscoring the need for new therapeutic approaches and options.11,12,13,14

About TROP2 in Non-Small Cell Lung Cancer
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is widely expressed in several types of solid tumors, including NSCLC.15,16,17,18 TROP2 is expressed across all lung cancer subtypes, with the highest expression seen in the majority of adenocarcinoma and squamous cell carcinoma (the most common forms of NSCLC).17,19 No TROP2 directed therapies are currently approved for the treatment of patients with NSCLC.14,20,21

About Datopotamab Deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three leading ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including triple negative breast cancer, HR positive/HER2 negative breast cancer, NSCLC, small cell lung cancer, urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

On August 9, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the second quarter ended June 30, 2022 (Press release, Invitae, AUG 9, 2022, View Source [SID1234617915]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"In the second quarter, we are pleased with our progress towards achieving operational excellence, as demonstrated by the improvements in several key metrics focusing on non-GAAP gross margin, operating expense, and cash burn trajectory, both on a year-over-year and quarter-over-quarter basis. These numbers reflected positive results based on the initiatives that we have been implementing," said Ken Knight, president and chief executive officer of Invitae. "We recently announced our strategic realignment plan, as we step into our company’s next chapter. The planned changes are broad and necessary to continue driving us toward our goal of using our industry leading genetic testing, and advanced technologies, to transform healthcare for today and tomorrow. We have the roadmap and the pieces in place, and execution of our plan is top of mind as we fuel our testing business and make focused investment in delivering the future of personalized, genetically-driven healthcare."

Second Quarter 2022 Highlights

Generated revenue of $136.6 million in the quarter, a 17.5% increase compared to $116.3 million in the second quarter of 2021.
GAAP gross profit was $26.3 million, and non-GAAP gross profit was $54.7 million in the second quarter of this year.
GAAP gross margin was 19.2%. Non-GAAP gross margin was 40.1% as compared with 36.6% in the first quarter of 2022 and 35.4% in the second quarter of 2021.
Cash, cash equivalents, restricted cash and marketable securities were $737 million as of June 30, 2022. Cash burn was $147 million, achieving a $22 million reduction from the first quarter of 2022.
Total active healthcare provider accounts in the second quarter of 2022 totaled 20,217, roughly 25% growth over the second quarter of 2021.
Active pharma and commercial partnerships grew to 232, an increase of approximately 52% over the second quarter of 2021, driving continued revenue growth from Invitae’s lab services, data and data services platform to pharma, health system and software and services partners.
Total patient population is more than 3.1 million with nearly 62% available for data sharing.
Total operating expense, which excludes cost of revenue, for the second quarter of 2022 was $2.5 billion, which included an asset impairment. As a result, GAAP operating expense as a percentage of revenue was 1,864%. Non-GAAP operating expense was $200.1 million for the second quarter of 2022. Non-GAAP operating expense as a percentage of revenue was 146%, which consistently improved as compared with 169% in the first quarter of 2022 and 170% in the second quarter of 2021.

Net loss for this year’s second quarter was $2.5 billion, or a $10.87 net loss per share, compared to net income of $133.8 million, or net income per share of $0.66, for the second quarter of 2021. Our second quarter 2022 net loss included a complete writedown of goodwill of $2.3 billion, which was a result of a significant, sustained decline in the stock price and related market capitalization and a lower than expected financial performance. It also included indefinite-lived intangible and asset impairments of $34.8 million. Net income for the second quarter in 2021 was a result of the change in fair value of contingent consideration. Non-GAAP net loss for the second quarter of 2022 was $158.5 million, or a $0.68 non-GAAP net loss per share, compared to a net loss of $171.5 million, or an $0.84 non-GAAP net loss per share, for the second quarter of 2021.

At June 30, 2022, cash, cash equivalents, restricted cash and marketable securities totaled $737 million as compared with $885 million as of March 31, 2022. Cash burn in this year’s second quarter, including cash paid for acquisition related activities, was $147 million, a decrease of $22 million or 13.2% from the first quarter of 2022 and approximately $50 million from the fourth quarter of 2021.

Financial Guidance

Invitae is reiterating its financial guidance. The company expects a low double-digit growth rate for its full year 2022 revenue over 2021. Longer term revenue growth rate is expected to return to between 15% and 25% beyond 2023.

Invitae is maintaining its 2022 cash burn guidance of $600-650 million, which includes up to an estimated $75 million cash to be used for realignment activities and severance. The company also continues to anticipate its cash burn to be in the range of $225-275 million in 2023, which includes up to an estimated $25 million cash to be used for realignment activities and severance.

2022 non-GAAP gross margins are expected to continue to increase for the rest of the year, based on ongoing margin improvement efforts and the current realignment initiatives, to the range of 42-43% for full year 2022.

Additional non-cash related charges are expected to be recorded in the third quarter of 2022 and in following quarters.

Webcast and Conference Call Details

Management will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss financial results and recent developments. To access the conference call, please register at the link below:

View Source

Upon registering, each participant will be provided with call details and a conference ID.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

On August 9, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $10.3 million during the second quarter of 2022 – a 14% increase over the prior year period (Press release, Cumberland Pharmaceuticals, AUG 9, 2022, View Source [SID1234617931]). Cumberland also reports a 10% increase in net revenues for the first half of the year compared to the same period in 2021.

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Year-to-date cash flow from operations were $2.2 million. The Company’s financial position included $93 million in total assets, $53 million in total liabilities and $40 million of shareholders’ equity at the end of the quarter.

"We have had a strong first half of the year, especially following our exciting and significant acquisition of the oncology-supportive care medicine Sancuso," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We look forward to building on this success throughout the remainder of the year, as we continue to fulfill our mission of providing innovative products to improve the quality of care for patients."

Cumberland will report its full second quarter 2022 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.

Earnings Call Participation
To join, please register at https://register.vevent.com/register/BIcc5e9791aa7343d9927dca16dc4cf493. Once registered, participants can dial in from their phone using a dial-in and PIN number that will be provided. Alternatively, there is a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source

Among the updates the company will share during today’s conference call are:
Sancuso Promotion
Following its January 2022 acquisition of oncology-supportive care medicine Sancuso, Cumberland entered into an agreement with Verity Pharmaceuticals International Limited for the national co-promotion of the product. A specialty pharmaceutical company, Verity will utilize its established oncology commercial organization and customer network to co-promote Sancuso throughout the United States. Verity launched its national co-promotion efforts in July 2022.

2021 Sustainability Report
In early August 2022, Cumberland announced the results of its 2021 Sustainability Report, outlining the company’s activities pertaining to environmental, social and governance matters.

Highlights from the report include:

• Cumberland provided 2.43 million doses of its products for patients in 2021.
• Cumberland also safely disposed of over 6,200 pounds of expired or damaged products in 2021.
• During 2021, Cumberland had:
* no products recalled,
* no company brands listed on FDA’s MedWatch Safety Alerts for Human Medical Products,
* no company product issues identified by FDA from their Adverse Event Reporting System,
* no clinical trials terminated due to failure to practice good clinical standards.

The 2021 Sustainability Report also highlights Cumberland’s investment in its employees through its continuing education programs, employee development initiatives and employee recognition awards. Cumberland’s workforce is 44% women, and 15% of its employees are minorities.

New Board Member
In July 2022, Cumberland welcomed Martin Brown Jr. to its board of directors. Brown’s experience includes 10 years on the board of directors of Brown-Forman Corporation, a large American spirits and wine company whose shares are listed on the New York Stock Exchange. Additionally, he has served since 2018 on the board of directors of the parent company of Aegis Sciences Corporation, a federally certified health care laboratory headquartered in Nashville.

Brown is an attorney at Adams and Reese LLP. He has nearly 30 years of legal experience representing privately held businesses, counseling owners in complex business transactions, intellectual property licensing, international commerce, mergers and acquisitions, and estate planning. He has been listed since 2009 in the corporate law category of Best Lawyers.

Additionally, Brown has been an active board member for many community organizations, including the Land Trust for Tennessee, Nashville Public Radio, Montgomery Bell Academy, Nashville Public Television, Centerstone Mental Health Center, Cheekwood Estate and Gardens, and Tennessee chapter of the Nature Conservancy.

RediTrex Arrangements with Nordic Pharma
On July 12, 2022, Cumberland and Nordic Pharma entered into an amendment to their agreement, addressing the responsibilities and financial arrangements regarding Cumberland’s license to Nordic’s methotrexate line of products for the U.S., which is marketed under the brand name RediTrex.

Based on the amendment, Cumberland has provided Nordic the opportunity to assume responsibility for commercializing the methotrexate products in the U.S. after March 31, 2023. Until then, Cumberland will continue to distribute and support the RediTrex product line. Following the return of the license, Nordic will provide Cumberland with a royalty on their future sales of the product through April 2035. The two companies will continue to collaborate on any transition and ongoing commercialization of the product line.

Ifetroban Clinical Studies
Cumberland is currently sponsoring three Phase II clinical programs to evaluate its ifetroban product candidate in 1) Aspirin-Exacerbated Respiratory Disease (AERD), a severe form of asthma; 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and 3) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, a genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles. Cumberland is awaiting results from the studies underway before deciding on the best development path for the registration of ifetroban.

The company is also designing a fourth Phase II program to evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases and is currently preparing an application to the FDA to support the new program.

In addition to these Cumberland-sponsored studies, Harvard clinical investigators have led a Phase II trial in patients with AERD. Their study is designed to understand the mechanism of ifetroban in those patients and therefore complements the work Cumberland has underway. Their work has been supported by a $5 million grant from the NIH. Patient enrollment in the study is now closed, and the data analysis is underway.

New Ifetroban Publication
In June 2022, the American Journal of Respiratory and Critical Care Medicine published preclinical studies that support the use of ifetroban as a promising therapeutic for patients with pulmonary fibrosis associated with lung disease.

Specifically, the researchers reported that ifetroban was used to block thromboxane receptor signaling in three preclinical models of lung fibrosis: bleomycin-induced lung fibrosis, Hermansky-Pudlak Syndrome mice and radiation-induced lung fibrosis. Ifetroban reduced pro-fibrotic signaling in the lungs and prevented lung fibrosis due to multiple causes (bleomycin, genetic and radiation).

FINANCIAL RESULTS:
Net Revenue: For the three months ended June 30, 2022, net revenues from continuing operations were $10.3 million.

Net revenue by product for the second quarter of 2022, included $3.6 million for Kristalose, $3.4 million for Sancuso, $1.6 million for Vibativ and $1.2 million for Caldolor.

Year-to-date 2022 net revenues were $21.5 million, compared to $19.6 million for the prior year period.

Year-to-date net revenues by product were $7.5 million for Kristalose, $6.8 million for Sancuso, $4.1 million for Vibativ and $2.2 million for Caldolor.

Operating Expenses: Total operating expenses for the second quarter were $12.1 million, compared to $10.5 million for the prior year period.

Year-to-date 2022 operating expenses were $24.6 million, compared to $21.4 million for 2021.

Adjusted Earnings: Adjusted earnings for the second quarter of 2022 were $(0.3) million, or $(0.01) per share.

The adjusted earnings calculation does not include the benefit of the $0.3 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.4 million of Sancuso cost of goods, which were received with that product’s acquisition.

Cash Flow: Year-to-date cash flow from operations was $2.2 million.

Balance Sheet: At June 30, 2022, Cumberland had $93 million in total assets including $18 million in cash and cash equivalents. Total liabilities were $53 million, including $19 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $40 million.

ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in the Mid-South and is focused on the delivery of high-quality, prescription brands designed to improve patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology, rheumatology and oncology market segments.

The Company’s portfolio of FDA-approved brands includes:

• Acetadote (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor (ibuprofen) injection, for the treatment of pain and fever;
• Kristalose (lactulose) oral, a prescription laxative, for the treatment of constipation;
• Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
• RediTrex (methotrexate) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
• Sancuso (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
• Vaprisol (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
• Vibativ (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections;

The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Aspirin-Exacerbated Respiratory Disease.

For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website www.cumberlandpharma.com.

About Acetadote (acetylcysteine) Injection
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com.

About Caldolor (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.

About Kristalose (lactulose) Oral Solution
Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com

About Omeclamox-Pak (omeprazole, clarithromycin, amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. For full prescribing and safety information, visit www.omeclamox.com.

About RediTrex (methotrexate) Injection
RediTrex is a single-dose prefilled syringe containing prescription methotrexate. RediTrex is used to treat adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis, after treatment with other medicines including non-steroidal anti-inflammatory drugs (NSAIDS) have been used and did not work well. Methotrexate can control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have failed. For full prescribing and safety information, visit www.reditrex.com

About Sancuso (granisetron) Transdermal System
Sancuso is the only skin patch approved by the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the SANCUSO patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient’s bloodstream. It can be worn for up to seven days in a row for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com.

About Vaprisol (conivaptan hydrochloride) Injection
Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.

About Vibativ (telavancin) for Injection
Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information please visit www.vibativ.com.

On August 9, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported results from preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines (Press release, Sellas Life Sciences, AUG 9, 2022, View Source [SID1234617948]). The data shows that GFH009 demonstrated significant anti-tumor effects in all four selected cell lines. In three out of the four cell lines, GFH009 inhibited cancer cell growth by 90 to 100 percent.

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The in vitro studies were conducted at an independent, third-party contract research organization, Translational Drug Development (TD2), and the following cell lines were selected for the studies based on their unique characteristics, combined with GFH009’s mechanism of action:

RH30: a pediatric soft tissue sarcoma cell line that is a model for studying high-risk pediatric rhabdomyosarcoma, an indication for which currently available treatments are limited to high-dose chemotherapy with unsatisfactory results. RH30 cells are driven by PAX3-FOXO1, a transcription factor whose expression is strictly needed for tumor cell survival. RH30 is also dependent on MYCN, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.

NCI-H209: a small cell lung cancer cell line characterized by the loss of function of two major tumor suppressor genes, RB1 and TP53. This cell line also expresses MCL-1, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at highest dose levels.

SKOV-3: an ovarian cancer cell line containing the wild type BRCA1 gene and highly expresses CDK9. Treatment with GFH009 resulted in more than 50 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial.

OCI-AML-2: an AML cell line that develops resistance to the chemotherapy venetoclax on exposure. Treatment with GFH009 resulted in 90 to 100 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.
"The data from preclinical studies that we are reporting today demonstrates that certain cancer cell lines, whose survival depends on specific changes in the cell, can be identified and treated with GFH009," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "Through identifying specific genes in cancer cells, GFH009 has shown in these preclinical studies the ability to stop the transcription and expression from gene to protein, inhibiting cancer cell growth altogether. We will utilize this important information as we design our clinical development program for GFH009 in adult and pediatric tumor types."

About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

On August 9, 2022 BioMarker Strategies reported that the journal CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS has published a manuscript by the Company’s scientists entitled "Functional Profiling of Head and Neck/Esophageal Squamous Cell Carcinoma to Predict Cetuximab Response" (Press release, BioMarker Strategies, AUG 9, 2022, View Source [SID1234617963]). The manuscript describes the company’s progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma (SCC) who may benefit from treatment with cetuximab (Erbitux) and biosimilars.

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Cetuximab is an antibody that targets an epidermal growth factor receptor (EGFR), and remains the only targeted therapy approved by the U.S. Food and Drug Administration (FDA) for SCC of head and neck/esophagus. For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.

The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial. The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately $100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC. Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.

SCC is the world’s sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year. In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.

"To minimize risk and maximize the therapeutic benefit of cetuximab, predictive tests to better identify patients likely to be responsive to cetuximab therapy are clearly an important need," said Jerry Parrott, President and CEO of BioMarker Strategies. "From my perspective, based on the results reported here, I would agree with the authors that further studies are warranted to test in more complex samples, including patient-derived tumor tissues."

The research described in the manuscript discussed here was supported by a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).