On November 12, 2021 xCures reported their poster presentation at the 26th Annual Meeting of the Society for Neuro-Oncology, held from the 18th to the 21st of November (Press release, xCures, NOV 12, 2021, View Source [SID1234595513]). The Society for Neuro-Oncology (SNO) is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

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xCures poster presentation, entitled XCELSIOR: A real-time, real-world learning platform for patients with advanced cancer, will show clinical outcomes of real-world datasets from over 400 CNS cancer patients and approximately 250 glioblastoma patients. XCELSIOR is a direct-to-patient evidence-based platform leveraging a nationwide observational research protocol. The platform allows for continuous learning towards informing treatment decisions by aggregating, normalizing, and analyzing N-of-1 clinical outcomes from anywhere in the country.

At the conference, xCures will discuss their real-time learning infrastructure and present results of clinical case studies for pharma and non-profit groups, including more than 100 reported virtual tumor boards. Outcomes shown will be from real-world evidence generated from hundreds of patients with CNS cancers that xCures have helped in partnership with Cancer Commons and the Musella Foundation.

"I look forward to connecting with colleagues and presenting our first analysis of real-world clinical outcomes of CNS cancer patients from our observational registry, including a preliminary analysis of patients that received immune checkpoint inhibitors," stated Tim Stuhlmiller, VP of Scientific and Medical Affairs at xCures. "It is inspiring to see our approach to gather and analyze real-world data in real-time via patient participation in a nationwide observational research protocol yield evidence-based insights."

Al Musella, President of the Musella Foundation said, "With the launch of their provider portal xDECIDE, the xCures platform offers a major opportunity for oncologists all over the country to collaborate on observational research without the burden of data entry. The CNS dataset presented at the conference provides a foundation for ongoing clinical research to identify the most promising new combinations of therapies in glioblastoma."

"Cancer Commons’ close partnership with xCures, the Musella Foundation, and the expert physician advisers that serve on our virtual tumor boards has helped inform brain cancer patients across the U.S. about treatment options specific to their case. The data presented here demonstrates our first steps towards building a ‘learning health system’ that we hope will change the care for brain cancer patients, tightly integrate clinical care and research, and help us learn from each individual’s experience." said Matt Warner, Scientist at Cancer Commons.

For more information, visit the poster session on Friday, November 19th from 7:30-9:30 pm EST in Exhibit Hall D, or attend the live presentation of the xCures platform and preliminary RWD on CNS cancers on Saturday, November 20th at 1 pm EST in Room 309 in the Hynes convention center.

On November 12, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, NOV 12, 2021, View Source [SID1234595512])

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1. Financial Highlights for the First Quarter of FY2021 (for the six-month period ended September 30, 2021)

(1） Consolidated Operating Results
(2) Consolidated Financial Position

2. Cash Dividends

On November 12, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, NOV 12, 2021, View Source [SID1234595511])

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Japan: Despite the impact of the NHI drug price revision, both sales and core operating income exceeded the same period of the previous fiscal year due to increased sales of products launched in FY2020 and increased demand for Sawai Pharmaceutical products due to the supply stoppages etc. of products from other generics companies.

 United States: Both sales and core operating income decreased from the same period last year, due to the impact of competitor entries into key USL generic product markets

 Sales declined significantly, due to the impact of competitor entries into key USL generic product markets.
 Steady progress in brand products.
 Three products have launched in the first half of FY2021.

Combined performance for Zembrace and Tosymra is ahead of expectations for FY21; Tosymra volumes are in line with plan while Revenue is slightly behind plan due to lower than planned average selling price (ASP)

▍Key Actions to Accelerate Tosymra Growth
Drive improved Average Selling Price (ASP) through improved Prior Authorization (PA) performance (both submission rates and success rates for submitted PAs) and new Platinum Pass business rules

Drive new prescription growth via new Direct-to-Consumer channel partnerships with Cove, an online migraine telemedicine company, and two regional pharmacies to conduct patient consultations on non-oral migraine solutions
(Tosymra)

Engage new managed care partner, Eversana, and leverage real world economic data to influence better coverage from managed care

Continue to drive first fill success through specialty pharmacy channel with Blink Pharmacy

 The business in Japan grew steadily, while the sales in the US fell short of the initial forecast due to a sharp decline
in sales of main generics products.
 On a consolidated basis, both net sales and core operating income slightly exceeded the FY2021 first half forecast.
 Our full-year forecast remains unchanged as the circumstances surrounding the business environment are unclear,
considering shipment adjustments due to the supply stoppages of products from other generics companies etc

On November 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, NOV 12, 2021, View Source [SID1234595510]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week," commented Bill Enright, Vaccitech’s CEO. "As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility."

Third Quarter and Recent Corporate Developments

Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.
Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.
Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
Upcoming Milestones

At the virtual AASLD’s The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.
At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.
In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.
In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.
Third Quarter 2021 Financial Highlights:

Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the prior period and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.

On November 12, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the peer-reviewed publication of significant results from a pivotal study of abivertinib on 227 heavily pretreated NSCLC patients in the journal Clinical Cancer Research, authored by Dr. Yi-Long Wu, distinguished professor of Guangdong Lung Cancer Institute, awardee of the prestigious "International Association for the Study of Lung Cancer (IASLC) Scientific Award" in 2017, and the principal investigator of the study (Press release, Sorrento Therapeutics, NOV 12, 2021, View Source [SID1234595509]).

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The full manuscript is available at: View Source

Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR/BTK inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold potency as compared with wild-type EGFR. The 300 mg BID abivertinib dose was based upon the pharmacokinetics, efficacy and safety profiles characterized in prior studies. In the pivotal study, 227 patients received this dose for a median treatment duration of 24.6 weeks (0.43-129). Among 209 response evaluable patients, confirmed ORR was 52.2% (109/209; 95% CI: 45.2%, 59.1%) and the DCR was 88.0% (184/209, 95% CI: 82.9%, 92.1%). The median DoR and PFS were 8.5 months (95% CI: 6.1, 9.2) and 7.5 months (95% CI: 6.0, 8.8), respectively. The median OS was 24.9 months (95% CI: 22.4, NR). All patients (N=227) reported at least 1 AE, with 96.9% (220/227) reporting treatment-related AEs. Treatment-related serious AEs were reported in 13.7% (31/227) of patients. Death was reported in 4.4% (10/227) of patients, and none was deemed related to abivertinib.

With the ORR of 52.2%, and OS of 24.9 months, comparable to approved 3rd generation EGFR inhibitors, abivertinib demonstrated significantly efficacious effects in overcoming resistant mutation in NSCLC. Based on these results, Sorrento is conducting an independent review process with long-term follow up data and intends to request a pre-NDA meeting with FDA. "We are very encouraged by the publication of these significant positive results of abivertinib on the treatment of advanced and heavily pretreated NSCLC lung cancer in Clinical Cancer Research and look forward to bringing abivertinib into the armamentarium of this multi-billion dollar indication," said Dr. Henry Ji, Chairman and CEO of Sorrento.