On November 10, 2021 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 financial results for the quarter ended September 30, 2021 (Press release, Kinnate Biopharma, NOV 10, 2021, View Source [SID1234595231]).

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"With the active recruitment of additional patients at multiple centers in the United States ongoing in the KN-8701 clinical trial, we are pleased with the continued advancement of the KIN-2787 program," said Nima Farzan, Chief Executive Officer of Kinnate. "We believe our recent collaboration with Guardant Health also presents a unique opportunity to assess real-world outcomes and further supports our work to improve the lives of cancer patients with limited treatment options. Unlike currently available treatments that target only Class I BRAF kinase alterations, KIN-2787 targets Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations."

Other Recent Business Highlights and Corporate Update:

Announced a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations. The study will also assess real-world clinical outcomes stratified by BRAF alteration class and by treatment line and type. Preliminary analyses conducted utilizing the GuardantINFORM platform suggest that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC) – approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class and by treatment, are planned for presentation at a future date.
Presented design and rationale details of a Phase 1 clinical trial (KN-8701: NCT04913285) evaluating KIN-2787 during the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). KN-8701 is a first-in-human, multicenter, non-randomized, open-label, Phase 1 clinical trial of KIN-2787 in adult patients with BRAF mutant advanced and metastatic solid tumors (AMST). KIN-2787 is given orally BID continuously in 28-day cycles until drug intolerance or disease progression. Planned sample size is approximately 115 patients in two parts: Part A is a trial of dose-escalation to maximum tolerated dose open to patients with AMST driven by BRAF Class I, Class II or Class III genomic alterations. Part B will evaluate a selected dose of KIN-2787 in three cohorts of patients with melanoma, NSCLC, or other AMST, each driven by BRAF Class II or Class III alterations. Standard Phase 1 enrollment criteria are required, and key exclusion criteria include known clinically active brain metastases from non-brain tumors, and prior receipt of BRAF-, MEK-, or MAPK-directed inhibitor therapy (except for cases in which these inhibitors were used in indications approved by the U.S. Food and Drug Administration (FDA)).
Announced results from preclinical studies evaluating Kinnate’s lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248 during a virtual poster session at the joint JCA-AACR Precision Cancer Medicine International Conference. The poster presentation highlighted data which show that in biochemical and cellular assays, KIN-3248 exhibited nanomolar potency against all four wild-type FGFR family members but not against other non-FGFR kinases. Importantly, KIN-3248 was active against mutations associated with resistance to FGFR inhibitors both in the clinic and in experimental models, including the FGFR2 and FGFR3 gatekeeper (V565X and V555M, respectively), molecular brake (N550X and N540X, respectively), and activation loop (L618V and K650M, respectively) mutations with less than a five-fold difference in IC50 values relative to corresponding wild-type receptors. In addition, dose-dependent inhibition of FGFR2- and FGFR3-driven human in vivo xenografts, including one with an acquired gatekeeper mutation, was attained with once-daily KIN-3248 treatment and was well tolerated. This efficacy was accompanied by both pharmacodynamic biomarker modulation and downstream pathway inhibition. Kinnate anticipates filling an Investigational New Drug application for KIN-3248 with the FDA in the first half of 2022.
Announced that on December 3, 2021 Eric Murphy, Ph.D. will transition from the company’s Chief Scientific Officer to a member of its Scientific Advisory Board.
Third Quarter 2021 Financial Results

Third quarter net loss for 2021 was $24.7 million, compared to $10.5 million for the same period in 2020.
Third quarter research and development expenses for 2021 were $18.7 million, compared to $8.5 million for the same period in 2020.
Third quarter general and administrative expenses for 2021 were $6.1 million, compared to $2.0 million for the same period in 2020.
As of September 30, 2021, the total of cash and cash equivalents and investments was $347.9 million, exclusive of the China joint venture’s cash.

On November 10, 2021 Odonate Therapeutics, Inc. (NASDAQ: ODT) reported financial results for the three and nine months ended September 30, 2021 (Press release, Odonate Therapeutics, NOV 10, 2021, View Source [SID1234595282]).

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As of September 30, 2021, Odonate had $95.0 million in cash compared to $157.3 million as of December 31, 2020. Odonate’s cash used in operating activities for the three and nine months ended September 30, 2021 was $15.1 million and $63.0 million, respectively.

Odonate’s net loss for the three and nine months ended September 30, 2021 was $14.0 million and $69.8 million, or $0.37 and $1.85 per share, respectively, compared to $30.5 million and $94.1 million, or $0.93 and $3.00 per share, respectively, for the same periods in 2020.

On November 10, 2021 CellPoint and Hypertrust Patient Data Care (HPDC) reported the launch of xCellit (Press release, CellPoint, NOV 10, 2021, https://cellpoint.bio/cellpoint-and-hypertrust-co-develop-xcellit-platform-for-cell-therapies-at-the-point-of-care/ [SID1234616306]). The xCellit system was co-developed to make autologous cell therapies available more rapidly and efficiently by facilitating the scheduling, monitoring and data capturing of cell treatment workflows. It is based on HPDC’s X-Chain Cell & Gene Therapy Orchestration solution and fully tailored to the CellPoint point-of-care manufacturing model.

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Using xCellit in combination with a closed and automated manufacturing device developed by Lonza (Cocoon), patient vein-to-vein times can be reduced to 6 days only, as compared to the industry standard of 4-6 weeks. This improvement is made possible as point-of-care manufacturing eliminates the need for complex, time-consuming and cost-intensive logistics.

"We are excited about our partnership with Hypertrust Patient Data Care. xCellit provides an end-to-end platform to digitize, streamline and secure our point-of-care supply chains for our CAR-T treatments. The convenient dashboards and notification triggers are critical in continuously involving and informing all stakeholders along the treatment workflow", says Tol Trimborn, CEO of CellPoint.

Andreas Göbel, Managing Director at Hypertrust Patient Data Care adds: "This is a great step to further advance Cell & Gene therapies. The collaboration with CellPoint shows that even in fully decentralized setups it is possible to provide the required level of trust between multiple parties so that personalized treatment data can be handled reliably and securely."

The point-of-care model brings a new, decentralized approach to autologous cell therapies. Currently available cell therapies involve numerous sequential steps: taking material from the patient, freezing, shipment by air freight, custom clearance, thawing, central factory manufacturing, quality control and release, transport back to the patient, and finally administering the product to the same patient. This current model struggles with limited manufacturing capacity and tremendous costs. In CellPoint’s point-of-care model, the production workflow is executed directly at the hospital where the patient is treated, circumventing many steps like cryopreservation and transport, driving down time and costs.

The xCellit platform provides a comprehensive set of features: a fully blown manufacturing execution system (MES) component including batch record QA/QC (quality assurance/quality control) and release in a remote environment. At its core, xCellit offers a highly trustworthy and customizable workflow process engine supporting the entire personalized medicine supply chain from patient treatment to recovery.

More information about point-of-care treatments and the xCellit platform is also available in the joint webinar by CellPoint, Dell and HPDC.

On November 10, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported an update on the upcoming Phase III clinical trial FLAMINGO-01 (Press release, Greenwich LifeSciences, NOV 10, 2021, View Source [SID1234595049]).

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CEO Snehal Patel commented, "Our objective is to make GLSI-100 available to as many patients as possible as soon as possible. This will include opening FLAMINGO-01 in many clinical sites that are geographically situated to maximize access for patients. We continue to hear from patients interested in participating in our GLSI-100 trial and expect to be able to refer them to participating sites as appropriate. We recommend that patients or their physicians contact a participating clinical trial site near them once these sites have been opened and we communicate the participating sites to the public. We have been pleasantly surprised by the level of interest in our trial by major teaching hospitals led by breast cancer KOLs. While these sites may lead to strong enrollment, they may also lead to additional collaboration designed to optimize treatment with GLSI-100 in subsequent trials. We will be meeting with these KOLs at the upcoming in-person San Antonio Breast Cancer Symposium in December 2021 and look forward to opening the first sites and the trial soon thereafter."

The trial is titled:

"A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)".

Vice President of Clinical and Regulatory Affairs, Dr. Jaye Thompson further commented, "The trial has been designed with an open label arm designed to provide a continual flow of data that can be publicly released, while preserving the blinding and randomization of the pivotal arms of the trial. Thus, we plan to continue to publish Phase IIb and Phase III trial data at conferences throughout the conduct of the Phase III study. The projected timeline to report the interim analysis data will depend on the rate of recurrences in both arms of the trial, but is estimated to be approximately 3 years from the time of first patient treatment. We are also making a major investment in commercial manufacturing now, which may allow for submission of a Biologics Licensing Application (BLA) to the FDA for conditional marketing approval of GLSI-100 based on the results of the interim analysis."

Design features of the FLAMINGO-01 Phase III trial include:

– The Company has added more frequent sampling and testing of patients over longer time frames and plans to utilize improved technologies to analyze immune response.

– A third open-label arm treating up to 100 patients has been added to the Phase III trial to test GLSI-100 in HLA types other than HLA-A*02 and to assess immune response and clinical outcome. This third arm will function similar to a Phase II trial, thus creating potential for early immune response data analysis and proof of concept in other HLA types, which would expand GLSI-100’s market by HLA type from 50% up to 80% or more.

– The recurrence rate data from the third arm, along with injection site reaction and immune response data from any arm across all HLA types will be available for analysis throughout the study and may provide meaningful data until the interim analysis of the recurrence rate data from the blinded HLA-A*02 arms of the Phase III trial is completed.

– In both of the blinded, randomized, placebo-controlled HLA-A*02 arms of the Phase III trial, the approximately 500 patient trial design will include an event-driven interim analysis for superiority or futility. This analysis will be conducted when approximately half of the expected breast cancer recurrences or 14 events have occurred. While a hazard ratio of HR = 0 was observed in the Phase IIb trial, a more conservative HR = 0.3 was selected for the sizing of the Phase III trial with plans in place to adaptively adjust the size of the trial as necessary.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 10, 2021 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported that CEO Masoud Tavazoie, M.D., Ph.D., will present at the Stifel 2021 Virtual Healthcare Conference at 10:40 A.M. EST on November 17, 2021 (Press release, Inspirna, NOV 10, 2021, View Source [SID1234595064]).

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To view this virtual presentation, live, register for the event here.

Links to the live and archived version of this presentation will also be available on Inspirna’s website within the News section.