On September 7, 2022 Hoag Memorial Hospital Presbyterian reported that it has been named a Radiopharmaceutical Therapy Center of Excellence (RTCoE) by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), a distinction held by only 17 centers in the U.S., including Stanford Health Care, Harvard Medical School and the University of California, San Francisco (Press release, Hoag Cancer Center, SEP 7, 2022, View Source [SID1234619209]).

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The designation is a recognition of Hoag’s leading advancements in the burgeoning field of nuclear medicine research and treatment, according to the SNMMI.

"Radiopharmaceutical therapy represents an exciting new tool in the diagnosis, prevention and treatment of cancer, and we are honored to be recognized for our pioneering work in this emerging field," said Hoag CEO and President Robert T. Braithwaite. "This distinction is both an accomplishment and a promise to our patients and community that Hoag will continue to conquer cancer."

As a Radiopharmaceutical Therapy Center of Excellence, Hoag will continue to lead the nation in testing and offering evidence-based therapies to improve patient care at Hoag and throughout the world, said Gary A. Ulaner, M.D., Ph.D., F.A.C.N.M, James & Pamela Muzzy Endowed Chair in Molecular Imaging and Therapy and director of Molecular Imaging and Therapy for the Hoag Family Cancer Institute.

"Over time, there will likely be improvements in second- and third-generation agents, which will make it important to develop more therapies," Dr. Ulaner said. "Here at Hoag, we are offering the same therapies that are being offered at Memorial Sloan Kettering and other leading cancer institutions worldwide. Patients are often relieved to learn that they have access to these therapies right here in Orange County."

The elite SNMMI designation comes on the heels of the publication of two important peer-reviewed studies coming out of Hoag about the potential for nuclear medicine to change the course of cancer care.

Dr. Ulaner recently published two papers that analyzed molecular imaging in prostate cancer, as well as a separate study studying the effectiveness of imaging in a new targeted breast cancer therapy. His studies appeared in the journals Radiology and Nature Communications, respectively.

"With philanthropic support from the community, Hoag has continuously prioritized providing the best patient care available. With these innovative research programs, Hoag is developing and delivering the future of patient care," said Dr. Ulaner.

Molecular medicine advanced earlier this year when the FDA approved the first targeted radioligand therapy for prostate cancer patients whose tumor cells contain a protein called prostate-specific membrane antigen (PSMA). The therapy, known commercially as Pluvicto, is the first FDA-approved PSMA-targeted radiotherapy for metastatic prostate cancer.

Hoag’s Molecular Imaging & Therapy program is the only program in Orange County to offer Pluvicto, as well as several similar radiotherapies that are currently in clinical trials for prostate and other cancers.

In addition to helping determine the effectiveness of Pluvicto, Dr. Ulaner explains that molecular medicine works like a lock and a key. Every cancer cell has a protein on its surface that can be thought of as a lock. Molecular agents designed to bind specifically to those locks are the key. Infused with radiation, those keys can either help detect or destroy the cancer cells wherever they are in the body, leaving neighboring healthy cells unharmed.

"This is a relatively new field," Ulaner said. "We are the only molecular imaging and therapy center in Orange County. We use molecular agents to help detect cancer and to treat cancer through radioactive molecules."

Hoag is offering ongoing clinical trials in molecular imaging and therapy for a number of cancer types. For more information, contact Hoag Family Cancer Institute at 949-7-CANCER.

On September 7, 2022 Novavax, Inc. ( Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported that it will participate in two upcoming investor conferences (Press release, Novavax, SEP 7, 2022, View Source [SID1234619208]). Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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H.C. Wainwright 24th Annual Global Investment Conference:

Recordings

All replays of the recorded fireside sessions will be available through the Events & presentations page of the Company’s website at ir.novavax.com for 90 days from the date of the conference.

On September 7, 2022 Poseida Therapeutics, Inc. ( Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the Company’s Chief Financial Officer, Johanna Mylet, will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference being held in New York, NY from September 12-14, 2022 (Press release, Poseida Therapeutics, SEP 7, 2022, https://www.prnewswire.com/news-releases/poseida-therapeutics-to-present-at-hc-wainwright-24th-annual-global-investment-conference-301619603.html [SID1234619207]). The on-demand session will become available at 7:00am ET on September 12, 2022.

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A webcast of the presentation will be available on the Investors & Media Section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for 30 days following the presentation.

On September 7, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported results from KRYSTAL-1, a multicohort Phase 1/2 study, evaluating adagrasib with or without cetuximab in patients with advanced CRC harboring a KRASG12C mutation (Press release, Mirati, SEP 7, 2022, View Source [SID1234619206]).

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"These exciting results further our understanding of the well-tolerated profile with robust and sustained responses that adagrasib provides as a monotherapy and in combination with cetuximab to patients with KRASG12C-mutated advanced colorectal cancer," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "We are pleased about the significant improvement these results demonstrate relative to the existing standard of care. We continue to explore the full potential of adagrasib in combination with cetuximab in late-line CRC in a potentially registration-enabling Phase 2 cohort of the KRYSTAL-1 study and in second line CRC in the ongoing Phase 3 KRYSTAL-10 study."

In this analysis, 44 patients received adagrasib monotherapy (600 mg twice daily) and 32 patients received the combination of adagrasib (600 mg twice daily) with full dose cetuximab, with a follow up of 20.1 months and 17.5 months, respectively.

Of the evaluable patients in the adagrasib monotherapy cohort (n=43), the investigator assessed confirmed objective response rate (ORR) was 19% (8/43) and the disease control rate (DCR) was 86% (37/43). The median duration of response was 4.3 months (95% CI, 2.3–8.3) and median progression-free survival (PFS) was 5.6 months (95% CI, 4.1–8.3).

Of the evaluable patients in the adagrasib plus cetuximab combination cohort (n=28), the investigator assessed confirmed ORR was 46% (13/28) and the DCR was 100% (28/28). The median DOR was 7.6 months (95% CI 5.7–NE) and median PFS was 6.9 months (95% CI, 5.4–8.1).

The prognosis for patients with CRC has historically been poor in later lines of therapy with response rates of approximately 1-2% and median PFS of approximately 2 months1,2,3 in patients with late-line CRC; patients with KRASG12C-mutated CRC tend to have even worse outcomes than the broader CRC patient population.

In the overall subset of patients with KRASG12C-mutated CRC evaluated in this study, adagrasib was found to be well-tolerated as a monotherapy and in combination with cetuximab. The majority of observed treatment-related adverse events (TRAEs) were grade 1–2 (59%); no grade 5 TRAEs were observed.

"These data illustrate the importance of durable KRAS inhibition in colorectal cancer and the added benefit that dual EGFR/KRAS blockade may provide for some patients in their regimen as evidenced by the more sustained responses from the adagrasib and cetuximab combination," commented Dr. Samuel J. Klempner of the Massachusetts General Cancer Center and study investigator. "Overall, it’s encouraging to see the emergence of KRAS inhibitors like adagrasib providing more targeted, efficacious, and safe treatment options for colorectal cancer and other solid tumors with KRAS mutations."

The data (Presentation #LBA24) will be presented in an oral presentation on Monday, September 12 at 4:15 am ET (10:15 am CET) during the Proffered Paper Session II at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

In addition, at the ESMO (Free ESMO Whitepaper) Congress 2022, the Company shared a poster presentation detailing additional practice-informing data on adverse event patterns and management for investigational adagrasib in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC). The presentation (Presentation #1133P) is available online via the ESMO (Free ESMO Whitepaper) website and will be available onsite in Poster Session 15, Hall 4 on September 12, 2022.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24–48 hours. Adagrasib is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small lung cancer, colorectal cancer, and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, including patients with treated or untreated CNS metastases, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

On September 7, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicates to developing innovative therapies targeting drug resistance and metastasis for hard-to-treat solid tumors, reported the dosing of the first patient in its Phase 2 pivotal study evaluating IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant recurrent ovarian cancer (PROC) (Press release, InxMed, SEP 7, 2022, View Source [SID1234619205]).

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The Phase 2 pivotal study is a randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of IN10018 in combination with PLD in patients with PROC. A total of 168 PROC patients will be enrolled and randomized in a 2: 1 ratio to receive IN10018 in combination with PLD or placebo of IN10018 in combination with PLD treatment in a double-blind manner.

Progression-free survival (PFS) as assessed by blinded independent central review (BICR) will be used as primary efficacy endpoint and overall survival (OS) will be used as key secondary efficacy endpoint. Objective remission rate (ORR), overall disease control rate (DCR), duration of remission (DOR), etc. as assessed by BICR and investigator will be other secondary efficacy endpoints.

InxMed previously reported results from its Phase Ib study of IN10018 in combination with PLD on ASCO (Free ASCO Whitepaper) 2022, demonstrated promising antitumor efficacy and a well-controlled safety profile in the treatment of patients with PROC.

The Phase 2 pivotal study was initiated in August 2022 and is expected to be completed in Q1 2024. The company also has completed a Type B Meeting discussion with U.S. Food and Drug Administration (FDA) and planned to submit US IND for a Phase 2 pivotal study evaluating IN10018 in combination with PLD for PROC in US by September this year.

InxMed set up a global clinical development program for IN10018. Clinical trials currently underway in the US, China and Australia are designed for platinum-resistant recurrent ovarian cancer, NRAS mutant metastatic melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer, and other solid tumors that are still lacking effective treatment. IN10018 received fast track designation from the US FDA in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) in April 2022 for the treatment of patients with platinum-resistant ovarian cancer.