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Gossamer Bio Announces First Quarter 2022 Financial Results and Provides Business Update

On May 10, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Gossamer Bio, MAY 10, 2022, View Source [SID1234614070]).

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"We are looking forward to the fourth quarter release of topline data from the ongoing Phase 2 TORREY Study, which has now completed enrollment," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.

"Additionally, through a recent internal reprioritization and the implementation of certain cost containment measures, we are pleased to see Gossamer’s expected capital runway further extended into the first half of 2024. As part of this reprioritization, we now anticipate moving GB7208 into the clinic in the first half of 2023, pending the TORREY Study results."

Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment has completed in the ongoing TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
Topline data from the TORREY Study are expected in the fourth quarter of 2022.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies

We expect to initiate the Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies in the second quarter of 2022.
GB7208: Oral, CNS-Penetrant BTK Inhibitor for Neuroinflammatory Diseases

Pending the outcomes of ongoing preclinical studies and the seralutinib Phase 2 TORREY Study topline results, we expect to initiate a Phase 1 clinical trial in healthy volunteers in the first half of 2023.
Financial Results for Quarter Ended March 31, 2022

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2022, were $271.6 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into 2024.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2022, R&D expenses were $42.3 million, compared to R&D expenses of $41.8 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2022, G&A expenses were $12.0 million, compared to $11.3 million for the same period in 2021.
Net Loss: Net loss for the quarter ended March 31, 2022, was $57.8 million, or $0.76 per share, compared to a net loss of $57.6 million, or $0.78 per share, for the same period in 2021.

Presentation About Phase 3 Trial of DCVax®-L for Glioblastoma

On May 10, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that, as previously announced, a presentation entitled "Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma" will be made today at 11:10 a.m., at the Frontiers of Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, MAY 10, 2022, View Source [SID1234614069]). The presentation will be made by Dr. Paul Mulholland of University College Hospital.

This presentation can be viewed virtually by registering online at the Academy’s website at: View Source

Additionally, the slides used in the presentation will be posted online concurrently with or promptly following the presentation at Virtualtrials.org/Dcvax. The slides will not be posted on the Company’s website.

TriSalus Life Sciences Enrolls First Patient in PERIO-02 Clinical Trial, Studying the Delivery of SD-101 via Pressure-Enabled Drug Delivery in Adults with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

On May 10, 2022 TriSalus Life Sciences, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, reported the enrollment of the first patient in its Pressure-Enabled Regional Immuno-Oncology (PERIO-02) clinical study (Press release, TriSalus Life Sciences, MAY 10, 2022, View Source [SID1234614068]).

The trial is evaluating SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). SD-101 will be administered using the Pressure-Enabled Drug Delivery (PEDD) method in combination with systemic checkpoint inhibitors.

Initiated at The University of Texas MD Anderson Cancer Center, with additional sites anticipated, the study is the second in a series of clinical trials assessing TriSalus’ immunotherapy platform across multiple indications. The platform integrates an immunotherapeutic and proprietary drug delivery technology to address the unique challenges facing patients with tumors in the liver. The PERIO-02 clinical trial will first evaluate the safety of SD-101 delivered by PEDD in varying doses and with checkpoint inhibitors in patients with HCC or ICC. Efficacy will be evaluated based on the tumor response.

The initial trial using this platform, the PERIO-01 study, is actively enrolling and is evaluating the safety of SD-101 administered by PEDD in combination with checkpoint inhibitors in patients with uveal melanoma with liver metastases. The PERIO-01 study has provided initial safety validation for the platform, and early data indicate the ability of SD-101 to favorably reprogram the tumor microenvironment of liver tumors.

"Patients with advanced HCC or ICC often have limited options when seeking treatment, as checkpoint inhibitors have had some success in these indications but results are not what we want them to be in most cases," said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. "The PERIO-02 clinical trial has potential to advance the scientific foundation required to help address this unmet need, deliver new therapies to improve clinical outcomes, and ultimately, give patients a better chance to respond more reliably to different forms of immunotherapy."

While immunotherapy has yielded significant advances in cancer treatment, unique properties of liver tumors, including immune response suppression and high intratumoral pressure, can prevent optimal delivery and performance of therapeutics and limit the overall effectiveness of immunotherapy for patients with liver cancers.|[1]-4|

TriSalus’ platform is designed to address these treatment challenges. The platform consists of an investigational immunotherapy, SD-101, that aims to reactivate the immune system within the liver, and a proprietary drug delivery method, PEDD, that modulates pressure and flow within blood vessels to improve therapy uptake and tumor response.

"With the PERIO-02 trial, we’re striving to enable immunotherapy for the most common primary liver tumors," said Dr. Katz. "The study is implementing a multifaceted approach by testing the integration of an immunotherapeutic, SD-101, with an FDA-cleared delivery device, to hopefully induce the type of immune response that we’re so eager to see for patients with HCC and ICC."

As the second of three Pressure-Enabled Regional Immuno-Oncology studies planned, PERIO-02 builds upon TriSalus’ collaboration with leading cancer research centers to further develop the company’s organ-specific platform and rapidly bring new treatments to patients. The phase 1b/2 study will enroll up to 89 patients with HCC or ICC, while future studies will seek to validate this platform in additional liver and pancreatic tumor types.

Milind Javle, MD, professor in the Department of Gastrointestinal Medical Oncology at MD Anderson, will serve as principal investigator on the PERIO-02 trial.

Catalyst Clinical Research Earns Recognition from Inc. Magazine as one of its Best Places to Work for 2022

On May 10, 2022 Catalyst Clinical Research, a market-leading provider of clinical research services, reported its selection into Inc. Magazine’s Best Places to Work (Press release, Catalyst Clinical Research, MAY 10, 2022, View Source [SID1234614067]). Catalyst was identified as an organization with Established Excellence for companies in the 5-14 years category for business. This is Catalyst’s first year being named to the list and Inc.’s most competitive selection process; only a small fraction of the thousands of applicants are featured.

"At Catalyst, our people remain our greatest differentiator and we champion them every day. This honor provides strong evidence of Catalyst’s commitment to a people-first culture and reinforces that the work we are doing to create an intentional, healthy culture is truly making an impact," said Marshall Skelton, Senior Vice President of People and Culture at Catalyst Clinical Research. A big thanks to each of our employees for the role they play in helping Catalyst achieve this honor."

Results were based on an employee-based survey. Some of the insights gleaned during the selection process included:

More than 98% of our team members were judged engaged advocates of Catalyst.
In the open-ended commentary, many of the team members commented on our people-first culture and how it’s truly an action and not just a phrase. Example: "Catalyst says they put people first, and they really do. I’ve worked at other large CROs who have said the same thing, but in actuality, you are just a cog in a machine, and the only way you would get noticed there is if you mess up. They don’t just care for you while you work. If you have an illness with you or your family, they will reach out to make sure everything is ok, and offer to helo. They offer unlimited PTO, and constantly urge us to take advantage of it. I don’t view the people at Catalyst as my co-workers. I view them as an extension of my family."
More than three-quarters of the company’s employees agreed that "they see professional growth and career development opportunities for themselves in the organization."
The word that best described our work environment from survey takers was "Flexible."
Catalyst was in the top 10% of all companies for senior leaders visibly valuing people as the most important asset of the company.
"This recognition is a huge accomplishment as we emerge from a two-year pandemic and associated challenges, and creates a great opportunity to continue building a differentiated culture as we expand internationally both organically and via the acquisition of Aptus Clinical," said Nick Dyer, CEO of Catalyst Clinical Research. "I am honored on behalf of all our employees and grateful to our entire management group who engage with our teams daily, creating the foundation to make Catalyst an attractive company to work at and to grow a sustained career."

Additional recent awards and recognitions given to Catalyst Clinical Research include: Triangle Business Journal’s Fast 50 (2017, 2020, 2021), Inc.’s 5000 Fastest-Growing Private Companies (2020, 2021), CRO Leadership Awards (2020) and Clearlyrated Best Staffing – Talent Satisfaction (2021).

GeneCentric to Present Initial Clinicogenomic Results from the GARNER High-Risk Non-Muscle Invasive Bladder Cancer Real-World Study

On May 10, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported an upcoming presentation of initial results from the GARNER (Genomic Analysis of high-Risk Non-muscle invasive bladder cancer) real-world study at the 2022 American Urological Association (AUA) Annual Meeting, which is being held in New Orleans, Louisiana, May 13-16, 2022 (Press release, GeneCentric Therapeutics, MAY 10, 2022, View Source [SID1234614066]). In this moderated poster presentation, the frequency of fibroblast growth factor receptor (FGFR) alterations in high-risk non-muscle invasive bladder cancer (HR-NMIBC) and the association with bacillus Calmette-Guérin (BCG) outcome will be discussed.

The GARNER Study is the largest HR-NMIBC real-world patient cohort ever assembled with both clinical and genomic detail and the first study of the broader GARNER Bladder Cancer Program. The study is a collaboration between the Department of Urology at Erasmus MC Cancer Institute (EMC), Janssen Research & Development, LLC (Janssen) and GeneCentric Therapeutics. The collaboration, led at EMC by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Erasmus MC Urothelial Cancer Research Group (EUCRG), involves retrospective longitudinal, genomic analysis of samples from a cohort of almost 600 NMIBC patients who underwent surgery and adjuvant BCG treatment.

"The initial results from the GARNER Study provide a comprehensive picture of FGFR alteration frequency and other findings and provides a deeper understanding of drivers of disease progression, as well as potential factors related to treatment response and failure or drug resistance," said Dr Zuiverloon. "We look forward to presenting the initial findings from the study with our collaborators at GeneCentric and Janssen as we continue to explore the complexities of FGFR in HR-NMIBC."

While topline clinicogenomic results from this study will be presented at AUA2022, further results will be presented as part of a subsequent publication.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Frequency of Fibroblast Growth Factor Receptor Alterations and Association with Bacillus Calmette-Guérin Outcomes in a Real-World Genomic Analysis of High-Risk Non-Muscle-Invasive Bladder Cancer (GARNER) Study

First Author: Tahlita C.M. Zuiverloon, MD, Department of Urology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands