On May 26, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported the presentation of the design and rationale of a Phase 1 trial-in-progress (KIN-4802, NCT05242822) evaluating the Company’s pan-FGFR inhibitor product candidate, KIN-3248 (Press release, Kinnate Biopharma, MAY 26, 2022, View Source [SID1234615091]). The details will be presented during a poster session on June 6, 2022, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place in Chicago, IL, June 3-7.

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"A major limitation of approved and clinical-stage FGFR treatments is the emergence of secondary, on-target resistance mutations that reduce duration of response, highlighting the urgency to further research and develop more efficacious next-generation therapies for these patients," said the trial’s co-investigator and presenter Lipika Goyal, MD, a faculty member in Gastrointestinal Medical Oncology at Mass General Cancer Center. "We are pleased to share additional details of this two-part Phase 1 trial-in-progress evaluating KIN-3248 at this year’s ASCO (Free ASCO Whitepaper) conference."

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other selected adult solid tumors. This trial is currently enrolling across multiple sites in the United States.

"Unfortunately, acquired resistance to FGFR inhibitors frequently emerges during therapy for patients with FGFR-driven cancers, creating an urgent need to develop more effective and durable targeted therapies for these patients," said Richard Williams, MBBS, Ph.D., Chief Medical Officer of Kinnate. "We are pleased with the recent initiation of this first-in-human trial of KIN-3248, in collaboration with Mass General Cancer Center and other participating sites, and are grateful to the patients and physicians involved, without whom this research would not be possible."

In addition, in an abstract published in the ASCO (Free ASCO Whitepaper) meeting proceedings, the Company also shared updates from its preclinical in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib. In these studies, KIN-2787 demonstrated significant combination benefit in NRAS-mutant melanoma models. Taken together with its unique selectively, these data support the use of KIN-2787 in combination therapy in this patient segment. Melanoma tumor cell lines bearing NRAS Q61 alterations demonstrated synergistic benefit with KIN-2787 combined with binimetinib. Daily KIN-2787 plus binimetinib treatment in NRAS-altered melanoma xenograft models resulted in significant tumor growth inhibition benefit relative to either agent alone and was associated with added MAPK pathway biomarker suppression. A Phase 1/1b dose escalation and expansion clinical trial evaluating the safety and efficacy of KIN-2787 is ongoing (NCT04913285).

Abstracts accepted for the ASCO (Free ASCO Whitepaper) Annual Meeting include:

For additional information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting webpage: View Source

Kinnate will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 3047.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in two upcoming investor conferences (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615107]). Veracyte will present at the William Blair 42nd Annual Growth Stock Conference on Wednesday, June 8, and will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 .

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Event: William Blair 42nd Annual Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 10:40 a.m. PT / 1:40 p.m. ET

Event: Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Monday, June 13, 2022
Time: 2:40 p.m. PT / 5:40 p.m. ET

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 26, 2022 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that interim safety data from its ongoing Phase 1 RAD-18-002 clinical trial assessing the dose, safety, and tolerability of Radspherin, in patients with peritoneal carcinomatosis from colorectal carcinoma will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place in Chicago, IL (both in-person and virtually) from June 3 to 7, 2022 (Press release, Oncoinvent, MAY 26, 2022, View Source [SID1234615123]). The poster, titled "First experience with 224Radium-labelled microparticles (Radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study)" will be presented by Principle Investigator Stein Gunnar Larsen, MD during the "Gastrointestinal Cancer – Colorectal and Anal" session at 9:00 a.m. EDT on June 4, 2022.

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"We are excited to share these compelling and important interim safety data at ASCO (Free ASCO Whitepaper), which continues to demonstrate that all dose levels of Radspherin are well tolerated with no dose limiting toxicities due to the Radspherin treatment observed to date," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "The data to be presented provides strong support as we progress Radspherin through clinical development. In particular, the observed biodistribution of Radspherin in this study is highly encouraging. We look forward to reporting longer-term safety, dosimetry, and first efficacy results of Radspherin later this year."

Details of the poster presentation are as follows:

Poster Presentation Title: First experience with 224Radium-labelled microparticles (radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study).
Session Title: Gastrointestinal Cancer – Colorectal and Anal
Date/Time: June 4, 2022 at 9:00 a.m. EDT
Presenting Author: Stein G Larsen
Abstract Number: 3599

This first-in-human Phase 1 study is designed to evaluate the safety and tolerability of Radspherin after dose escalation at increasing levels of 1-2-4-7 MBq and explore the highest tolerated dose and biodistribution. In this planned safety interim analysis, conducted 21 days following administration at two specialized cytoreductive surgery-hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) centers (Norwegian Radium Hospital and Uppsala University Hospital), a total of 23 patients were enrolled; 14 in the dose escalation cohort, 3 in the repeated cohort, and 6 in an expansion cohort. Radspherin was injected in the abdominal cavity through an in-dwelling catheter 2 days after completion of CRS-HIPEC. The maximal tolerated dose and biodistribution were evaluated by single photo-emission computed tomography and computed tomography (SPECT/CT) imaging.

Key results:

The biodistribution of Radspherin showed a relatively even peritoneal distribution, and no patients had compartments of the abdominal cavity without radioactivity, and the number of hot spots were low.
No serious adverse events were observed related to treatment with Radspherin.
The 7Mbq dose was selected as recommended dose as no dose limiting toxicity (DLT) was observed at this level.
Radspherin is also being evaluated at the 7Mbq dose in a Phase 1 open-label, dose-escalation clinical trial in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery.

About the RAD-18-002 Study

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety, and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

On May 26, 2022 Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, reported that its abstract highlighting supportive preclinical data for its lead asset BTX-1188, a potentially first-in-class, dual protein degrader of GSPT1 and IKZF1/3, will be presented in a poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois and virtually (Press release, BioTheryX, MAY 26, 2022, View Source [SID1234615139]).

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"Our distinctive PRODEGY platform is designed to enable the discovery and development of a broad range of targeted protein degrader molecules and BTX-1188 is the first of our pipeline to enter the clinic," said Leah Fung, Ph.D., Chief Scientific Officer of Biotheryx. "BTX-1188 is a molecular glue that was rationally designed to degrade GSPT1 and IKZF1/3. The data being presented at ASCO (Free ASCO Whitepaper) 2022 support the ongoing Phase 1 clinical trial evaluating BTX-1188 in patients with hematologic and solid tumor cancers and demonstrate what we believe to be our ability to design first-in-class molecular glues with the potential to improve clinical outcomes for patients with cancer and other serious diseases."

"We are leveraging our deep expertise with the modulation of Cereblon, the only clinically and commercially validated E3 ligase, to design innovative targeted protein degraders with the potential to address significant unmet medical need," said Philippe Drouet, President and Chief Executive Officer of Biotheryx. "We look forward to presenting these pre-clinical data from our lead program, BTX-1188, at ASCO (Free ASCO Whitepaper) 2022."

Key Highlights from BTX-1188 Preclinical Results

BTX-1188 has shown deep and durable degradation of GSPT1 and IKZF1/3 and inhibition of MYC in several types of hematologic and solid tumor cell lines, including lymphoma, diffuse large B-cell lymphoma, non-small cell lung cancer and glioma.
BTX-1188 has shown inhibition of pro-inflammatory cytokines and enhancement of immune stimulatory cytokines, owing to IKZF1/3 degradation, which may prevent the known systemic inflammatory dose-limiting toxicities associated with pure GSPT1 degradation (Uy 2019)[1].
BTX-1188 potently inhibits tumor cell proliferation and tumor growth in ex vivo and in vivo models of acute myeloid leukemia (AML) and in in vitro and in vivo models of lung, breast and ovarian cancer.
These preclinical results support the ongoing Phase 1 clinical evaluation of BTX-1188 in patients with AML and certain solid tumors, especially in MYC-dependent cancers.
Details for the BTX-1188 ASCO (Free ASCO Whitepaper) 2022 poster presentation are as follows:

Title: BTX-1188, a first-in-class dual degrader of GSPT1 and IKZF1/3, for treatment of acute myeloid leukemia (AML) and solid tumors
Presenter: Aparajita Hoskote Chourasia, Ph.D.
Abstract Number: 7025
Poster Number: 256
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: Saturday, June 4, 2022 at 9:00 a.m. CT (10:00 a.m. ET)

This poster presentation will be available on the ASCO (Free ASCO Whitepaper) Meeting website. Following the presentation at the meeting, a PDF copy of the poster will be available in the "Publications and Presentations" section of Biotheryx’s website.

About BTX-1188

Biotheryx’s lead molecular glue drug candidate BTX-1188 is a dual protein degrader which was designed to degrade GSPT1, a promising cancer target, and IKZF1/3 (also known as Ikaros/Aiolos), both clinically validated anti-inflammatory and immunomodulatory targets. Prior literature has demonstrated that degradation of GSPT1 can result in antitumor activity in difficult-to-treat tumors such as acute myeloid leukemia (AML) and in solid tumors, including those that overexpress oncogenic transcription factors, such as MYC, however, prior clinical research by others has shown that administration of a GSPT1-only degrader was associated with dose-limiting toxicities related to the release of pro-inflammatory cytokines. BTX-1188 was specifically designed as a potent degrader of GSPT1 that can also directly block inflammation by degrading IKZF1/3. In preclinical studies conducted by Biotheryx, administration of BTX-1188 led to complete eradication of tumors and extended survival in xenograft models of AML. BTX-1188 also led to potent cell killing in a number of cell lines derived from solid tumors. BTX-1188 is currently being evaluated in a Phase 1 dose-escalation trial in patients with hematologic and solid tumor malignancies.

On May 26, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the publication of updated results from the clinical trial of the lead asset from its ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program (Press release, Advaxis, MAY 26, 2022, View Source [SID1234615156]).

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These results from the clinical study ADXS-503-101 evaluating the ADXS-503 construct, which is designed to target certain cancers’ commonly occurring hotspot mutations and other tumor-associated antigens, will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting to be held on June 4-7, 2022, along with the trial design of the study of the second construct from the ADXS-HOT program, ADXS-504.

The goals of this Phase 1/2 open-label trial are to evaluate safety, tolerability, antitumor activity and immune-correlative data of ADXS-503 administered in combination with KEYTRUDA in patients with metastatic NSCLC. In Part B of this study, ADXS-503 is added-on to KEYTRUDA within 12 weeks of the first scan showing disease progression following treatment with KEYTRUDA. In Part C, both drugs are administered to previously untreated patients. The study design of the Phase 1 investigator-sponsor study of ADXS-504 for patients with biochemically recurrent prostate cancer at Columbia University, Herbert Irving Comprehensive Cancer Center NYC, will also be presented.

Key presentation highlights:

Poster Title: "A phase 2 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in patients with metastatic non-small-cell lung cancer either progressing on prior pembrolizumab or in the first-line setting"
Presenter: Gregory J. Gerstner, M.D., Illinois Cancer Care
Session Type: Poster Session – Hall A
Session Title: "Lung Cancer—Non-Small Cell Metastatic"
Date and Time: June 6, 2022, 8-11 AM (CDT)

Key study characteristics and takeaways:

Part B: 14 patients failing pembrolizumab as last therapy have been treated with ADXS-503 + pembrolizumab (Dose Level 1) with all patients evaluable for safety and efficacy
Overall response rate (ORR) was 14% (2/14) and Disease Control Rate (DCR) was 36% (5/14)
Two durable partial responses (PR) sustained for over 9 months and 21 months, respectively
Three durable cases of stable disease (SD) lasting for over 3, 5 and 14 months, respectively
Patients who seem to achieve clinical benefit in Part B of the study include those with PD-L1 expression ≥ 50% and those with prior pembrolizumab monotherapy exposure ≥ 12 months and/or with DCR > 6 months
Part C: 3 patients have received ADXS-503 + pembrolizumab in the 1st-line metastatic setting with all patients evaluable for safety and efficacy
Data continue to show a DCR of 67% (2/3) in the first three evaluable patients in Part C
Poster Title: "Immunogenicity and disease control induced by a multi-neoantigen vaccine (ADXS-503) in patients with metastatic non-small-cell lung cancer who have progressed on pembrolizumab"

Presenter: Dr. Aaron E. Lisberg, M.D., UCLA
Session Type: Poster Session – Hall A
Session Title: "Lung Cancer—Non-Small Cell Metastatic"
Date and Time: June 6, 2022, 8-11 AM (CDT)

Key takeaways: Long-term follow up of immune correlative markers suggest that ADXS-503 leads to durable clinical benefit in select patients through:

the production of cytokines with periodic pro-inflammatory and anti-tumoral effects supporting innate and adaptive immunity
the activation of Natural Killer (NK) cells in tumor control
the induction of proliferation and activation of previously exhausted CD8+ T-cells facilitating reaction to hotspot mutation antigens, tumor associated antigens (TAAs), and antigen spreading.
The activation of various subsets of memory CD8+ T cells
Poster Title: "A phase I study of ADXS-504, a cancer type specific immunotherapy, for patients with biochemically recurrent prostate cancer"

Presenter: Karie Runcie, M.D., Columbia University
Session Type: Poster Session – Hall A
Session Title: "Trials in Progress"
Abstract Number: TPS5115
Date and Time: June 6, 2022, 1:15-4:15 CDT (CDT)

"The correlation of durable clinical benefit with long-term immunological surveillance data from Part B of the ADXS-503 study is extremely encouraging," said Ken Berlin, President and CEO of Advaxis. "We not only observe a competitive ORR by adding-on ADXS-503 in patients failing pembrolizumab, but we also now better understand how ADXS-503 may reverse the exhaustion or enhance the activity of pembrolizumab in these cases," he concluded. "The immunogenicity studies tend to demonstrate that ADXS-503 does more than just activate antigen-specific T cells as part of the adaptive response in Part B patients. The clinical benefit may also be derived from the serial elevation of certain serum cytokines throughout the course of therapy as well as from the activation of NK and induction of memory T cells. These pleotropic effects of Lm vectors, which had been documented in preclinical models and now shown in the ADXS-503 trial, help to differentiate ADXS-503 from other vaccine platforms," added Andres Gutierrez, EVP and Chief Medical Officer of Advaxis. "Importantly, those effects are induced safely and without the use of adjuvant agents," he concluded.

Enrollment in Part B will continue up to a total of 18 patients to further evaluate if ADXS-503 is able to achieve ORR of ≥20% in patients progressing on pembrolizumab therapy, while Part C may enroll up to 25 patients.