On July 28, 2021 Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported a new peer-reviewed paper published in Gastroenterology validating its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, in resected esophageal adenocarcinoma (EAC) (Press release, Natera, JUL 28, 2021, View Source [SID1234585334]). The paper can be found here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study represents the first published data on the use of Signatera in EAC and demonstrates the potential of the Signatera technology in esophageal cancer, which sees around 20,000 new cases per year in the U.S.1

Key findings from this retrospective study of 20 EAC patients after resection:

Signatera detected recurrence with a sensitivity of 80% (4/5). The only missed recurrence had the last sample drawn two years before recurrence. The specificity was 100% (12/12) and the PPV was 100%.
Signatera detected recurrence with a median lead time of almost one year before clinical or radiological recurrence.
Postsurgical MRD-positive patients had disease-free survival of 14.2 months, compared to 51.2 months in MRD-negative patients, indicating prognostic value in this setting.
Patients who were MRD-positive preoperatively and became MRD-negative after surgery had a good prognosis, indicating that Signatera can potentially be used to risk-stratify patients for adjuvant therapy.
"The incidence of esophageal cancer is on the rise globally and more than half of these patients experience recurrence after surgery or treatment with curative intent,"2,3 said Alexey Aleshin, M.D., M.B.A., vice president of medical affairs, oncology at Natera. "For these patients, a sensitive prognostic biomarker, such as Signatera status, could have significant clinical utility in predicting relapse and guiding adjuvant treatment decisions."

This study comes on the heels of another peer-reviewed study recently published in JCO Precision Oncology validating Signatera in oligometastatic cancer, adding to the growing body of evidence behind Signatera in gastrointestinal cancers. To date, Signatera has been published in 14 peer-reviewed publications, in a wide range of cancer types, including colorectal, breast, lung, bladder, pancreatic and more.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On July 28, 2021 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported the completion of a $90 million Series C financing, bringing the company’s total financing to over $130 million since the company’s inception (Press release, Strata Oncology, JUL 28, 2021, View Source [SID1234585333]). The proceeds will be used to accelerate the development of Strata Oncology’s personalized minimal residual disease (MRD) assay for early-stage cancers and advance its pipeline of novel RNA-based treatment selection tests for solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Wellington Management led the financing and was joined by other new investors including Cormorant Asset Management, Monashee Investment Management and Highside Capital Management. Strata Oncology’s existing investors, including Pfizer Ventures, Merck Global Health Innovation Fund, Arboretum Ventures, Deerfield Management, Baird Capital and Renaissance Venture Capital Fund also participated in the financing. J.P. Morgan served as sole placement agent to Strata Oncology on the financing.

"We are grateful to our new and existing investors for their commitment to our bold mission of delivering the best possible treatment for each patient, as early as possible," said Dan Rhodes, Ph.D., co-founder and Chief Executive Officer, Strata Oncology. "This financing will enable us to increase our investment in our platform, programs, and team, as we combine highly sensitive MRD testing with DNA and quantitative RNA-informed treatment selection testing."

The financing supports Strata Oncology’s efforts to expand its comprehensive genomic and transcriptomic profiling platform to deliver a portfolio of industry-leading treatment selection tests for solid tumors. The company’s platform, which integrates comprehensive genomic profiling and highly quantitative RNA expression profiling, enables comprehensive molecular insights from a single, minute tumor tissue specimen. In a recent study shared at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Strata Oncology demonstrated the potential of its platform, identifying a new multifactorial biomarker that can predict immune checkpoint inhibitor benefit.

On July 28, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the second quarter ended June 30, 2021 (Press release, Vanda Pharmaceuticals, JUL 28, 2021, View Source [SID1234585332]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Vanda had another outstanding quarter of commercial revenue growth as we resumed activity across a number of our clinical programs. Our tradipitant in gastroparesis program is nearing completion, bringing us closer to a much-needed new treatment option for patients with gastroparesis and a potentially transformational commercial opportunity for Vanda," said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board.

Financial Highlights

Second Quarter of 2021

Total net product sales from HETLIOZ and Fanapt were $67.9 million in the second quarter of 2021, a 9% increase compared to $62.2 million in the second quarter of 2020.
HETLIOZ net product sales were $44.5 million in the second quarter of 2021, a 7% increase compared to $41.6 million in the second quarter of 2020.
Fanapt net product sales were $23.4 million in the second quarter of 2021, a 13% increase compared to $20.6 million in the second quarter of 2020.
Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020.
First Six Months of 2021

Total net product sales from HETLIOZ and Fanapt were $130.6 million in the first six months of 2021, a 9% increase compared to $120.2 million in the first six months of 2020.
HETLIOZ net product sales were $83.9 million in the first six months of 2021, a 9% increase compared to $76.9 million in the first six months of 2020.
Fanapt net product sales were $46.7 million in the first six months of 2021, an 8% increase compared to $43.3 million in the first six months of 2020.
Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020.
Cash, cash equivalents and marketable securities (Cash) was $396.5 million as of June 30, 2021, representing an increase to Cash of $56.6 million compared to June 30, 2020.
Key Operational Highlights

Tradipitant

The Phase III clinical study of tradipitant in gastroparesis is nearing completion with 95% of the target 200 patients already enrolled. Results are expected by the end of 2021.
HETLIOZ (tasimelteon)

A Phase III clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) is currently enrolling patients.
Fanapt (iloperidone)

A Phase III clinical study of Fanapt in bipolar disorder is currently enrolling patients.
A clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt is ongoing.
Key Publications

The article "Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension" was published in July 2021 in Genetics in Medicine.1
GAAP Financial Results

Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020. Net income was $9.7 million in the second quarter of 2021 compared to net income of $8.7 million in the second quarter of 2020. Diluted net income per share was $0.17 in the second quarter of 2021 compared to diluted net income per share of $0.16 in the second quarter of 2020.

Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020. Net income was $18.3 million in the first six months of 2021 compared to net income of $9.2 million in the first six months of 2020. Diluted net income per share was $0.32 in the first six months of 2021 compared to diluted net income per share of $0.17 in the first six months of 2020.

2021 Financial Guidance

Vanda expects to achieve the following financial objectives in 2021:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, July 28, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5298904. A replay of the call will be available on Wednesday, July 28, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, August 4, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5298904.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

References

Polymeropoulos, C.M., Brooks, J., Czeisler, E.L., Fisher, M.A., Gibson, M.M., Kite, K., Smieszek, S.P., Xiao, C., Elsea, S.H., Birznieks, G., Polymeropoulos, M.H. (2021). Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension. Genetics in Medicine. View Source

On July 28, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") reported its entry into an amended collaboration agreement (the "Restated Agreement") with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates (Press release, Protagonist, JUL 28, 2021, View Source [SID1234585331]). The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn’s disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232 and PN-235 are currently in Phase 1 clinical development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications. As such, certain development milestones have been reconfigured based on multiple drug candidates advancing in parallel. Protagonist remains eligible to potentially receive approximately $900 million in future development and sales milestones, in addition to the $80 million in payments already received under the original agreement. Royalty rates remain unchanged. Janssen will have the right to continue research on IL-23 receptor antagonists developed during the collaboration for three years from the closing of the Restated Agreement.

Under the terms of the Restated Agreement, Janssen will conduct all future studies beyond those that are currently ongoing with PTG-200, PN-232 and PN-235 and will be solely financially responsible for any such studies. Accordingly, Protagonist’s development and expense obligations will be limited to its relative share of the currently ongoing studies with these candidates. With this revised agreement, Janssen will continue to deploy the breadth of its established global capabilities and proven experience toward further clinical development of these assets.

"We are very pleased with this amendment to our agreement, which reflects the successful trajectory of the collaboration to date, giving rise to the parallel development of multiple oral IL-23 receptor antagonists," said Dinesh Patel, PhD, President and Chief Executive Officer of Protagonist. "The progress from de novo discovery to development validates our innovative technology platform and its potential to develop oral peptide drugs for diverse clinical indications. We look forward to supporting our Janssen counterparts in their parallel development efforts for PTG-200, PN-232, and PN-235 in multiple indications, which may ultimately provide significant benefit to patients."

Janssen retains exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from the research collaboration conducted under the Original Agreement, or Janssen’s further research under the Restated Agreement. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis (UC) and CD in the U.S. market.

Further details related to the Restated Agreement are available on the Company’s Form 8-K as submitted to the U.S. Securities and Exchange Commission.

Conference Call and Webcast Information

Protagonist management will host a conference call and webcast today at 5:00 p.m. ET to provide a brief overview of the amended collaboration agreement. To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On July 28, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967) (Press release, Fusion Pharmaceuticals, JUL 28, 2021, View Source [SID1234585330]). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab to actinium-225.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Leveraging Fusion’s platform and expertise developing targeted alpha therapies, we are excited to begin our second clinical program," said Chief Executive Officer John Valliant, Ph.D. "FGFR3 is an established and validated cancer target which is found in multiple tumor types with substantial unmet need, notably head and neck and bladder cancers. We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm. While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only over-expression of FGFR3. If successful, this could provide an opportunity to treat a larger population of patients."

Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise four sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake. As part of the screening process, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-1966.

About FPI-1966
[225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.