On September 14, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported the publication of an abstract for an electronic poster to be presented as part of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cardiff Oncology, SEP 14, 2020, View Source [SID1234565103]). The abstract highlights preliminary clinical data from the Company’s ongoing Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated metastatic colorectal cancer.

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The preliminary data published in the abstract continue to show the safety and efficacy of onvansertib, as well as the durability of response, in combination with FOLFIRI and bevacizumab in KRAS-mutated metastatic colorectal cancer patients on their second line of therapy. The data also show that changes in plasma KRAS mutation levels during the first cycle of treatment are predictive of clinical response.

Updated results from the ongoing Phase 1b/2 trial will be presented as part of the abstract’s corresponding electronic poster. Details on the poster presentation are shown below:

Abstract ID: 2969
Presentation number: 436P
Title: Phase 1b/2 Study of the Polo-like kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of KRAS-Mutated Metastatic Colorectal Cancer
Session Name: Poster Display Session
Presentation Date: September 17, 2020

The electronic poster will be available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 1b/2 Trial of Onvansertib in Metastatic KRAS-mutated Colorectal Cancer

Cardiff Oncology’s ongoing clinical trial is a multi-center, single-arm Phase 1b/2 study assessing the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab in second line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). Trial participants are treated with onvansertib on Days 1-5, and FOLFIRI and bevacizumab on Day 1, of 14-day cycles. Primary outcome measures include safety and tolerability assessments. Secondary outcome measures include preliminary efficacy determined by radiographic scans every 8 weeks and reduction in KRAS mutant allelic burden evaluated by liquid biopsy. The trial is being conducted at the USC Norris Comprehensive Cancer Center and the three Mayo Clinic Cancer Centers. For more information on the trial, please visit View Source

On September 14, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported it will host an investor briefing to discuss data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Exelixis, SEP 14, 2020, View Source [SID1234565102]). The online-only event will be held following the closing of the Congress’ sessions on Saturday, September 19, 2020, beginning at 22:00 (10:00 p.m.) CEST / 4:00 p.m. EDT / 1:00 p.m. PDT.

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During the briefing, Exelixis management and invited guests from the clinical community will discuss and provide context for the cabozantinib clinical data presented at the Congress. Exelixis previously announced that detailed results from CheckMate -9ER, the phase 3 pivotal trial evaluating CABOMETYX (cabozantinib) in combination with Opdivo (nivolumab) compared with sunitinib in previously untreated patients with advanced or metastatic renal cell carcinoma, will be presented during the Congress’ Presidential Symposium I earlier in the day. The investor briefing will also review data from COSMIC-021, the phase 1b trial of CABOMETYX in combination with TECENTRIQ (atezolizumab) in patients with locally advanced or metastatic solid tumors, presented at the Congress.

To access the investor briefing, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the event to ensure adequate time for any software download that may be required to view the webcast. After the event concludes, a replay will be available at that same location for a minimum of one year.

On September 14, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported that Joseph Truitt, Chief Executive Officer, will present at the virtual Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit on Monday, September 21, 2020 at 4:10 p.m. ET (Press release, BioSpecifics Technologies, SEP 14, 2020, View Source;Co.-Fall-Healthcare-Life-Sciences-and-MedTech-Summit/default.aspx [SID1234565101]).

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A live webcast of the presentations may be accessed by visiting the Events and Presentations section of the BioSpecifics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On September 14, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that management will host an investor conference call to discuss the updated clinical data from the low-grade serous ovarian cancer (LGSOC) cohort of the ongoing investigator-initiated Phase 1/2 FRAME study (Press release, Verastem, SEP 14, 2020, View Source [SID1234565100]). The ongoing study is evaluating VS-6766, Verastem’s RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor.

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The investor conference call is scheduled for Wednesday, September 16, 2020 at 8:00 a.m. ET. The conference call coincides with the oral presentation of this data at the 2nd Annual RAS-Targeted Drug Development Summit.

The call will feature members of the Company’s management team and Rachel Grisham, MD, Memorial Sloan Kettering Cancer Center, a medical oncologist and an expert in LGSOC.

Verastem Oncology plans to commence a Phase 2 registration-directed trial investigating the VS-6766/defactinib combination in patients with recurrent LGSOC, as well as patients with KRAS-mutant NSCLC, by the end of 2020.

Details for the RAS-Targeted Drug Development Summit oral presentation are as follows:

Title: Clinical Combinations: Dual RAF-MEK Inhibitor & FAK for Treatment of KRAS Mutant Cancers With a Focus Low Grade Ovarian Cancer
Lead author: Udai Banerji, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research, London, and Honorary Consultant in Medical Oncology, MBBS, MD, DNB, PhD, FRCP at The Royal Marsden NHS Foundation Trust, London.
Date and Time: Wednesday, September 16, 2020; 3:35 p.m. ET (12:35 p.m. PT)

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast on Wednesday, September 16, 2020, at 8:00 AM ET to discuss the updated Phase 1/2 FRAME study data. The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 5278200.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About VS-6766

VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.

About Defactinib

Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2

About the VS-6766/Defactinib Combination

RAS mutant tumors are present in 30% of all human cancers and have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.

The combination of VS-6766 and defactinib has been found to be clinically active in KRAS mutant tumors (KRASmt). In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRASmt NSCLC and colorectal cancer (CRC). Based on an observation of higher response rates seen in patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRASmt endometrial cancer and KRAS-G12V NSCLC.

On September 14, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (the "Company" or "Actinium") today provided an update on the Actimab-A CLAG-M combination Phase 1 trial being conducted at the Medical College of Wisconsin ("MCW") in patients with Relapsed or Refractory ("R/R") Acute Myeloid Leukemia (AML) age 18 and above who are fit for intensive therapy (Press release, Actinium Pharmaceuticals, SEP 14, 2020, View Source [SID1234565099]). All patients in the third dosing cohort, which was scheduled as the final cohort of the planned Phase 1 dose escalation trial, completed treatment with a 0.75 uCi/kg dose of Actimab-A followed by CLAG-M and have cleared their initial safety evaluation. Results from the planned portion of the Phase 1 trial including complete safety and efficacy data are expected to be presented by year end. Previously, it was reported that the second dose cohort demonstrated an 86% complete remission rate with 71% of patients achieving negative minimal residual disease status. Investigators at MCW have indicated that based on safety results thus far, they intend to expand the Phase 1 portion of the trial assuming FDA clearance.

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Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "We are excited that the planned portion of the Actimab-A CLAG-M trial has been completed and look forward to presenting results of the trial by year-end. The high rates of remission and MRD negativity with good tolerability seen in this trial thus far demonstrate the potential of our Antibody Radiation Conjugate (ARC) approach and the power of delivering radiation to a highly relevant target such as CD33, particularly in combination with other synergistic modalities. In the second dose cohort in this study, 0.50 uCi/kg of Actimab-A was administered, which was previously shown to be a subtherapeutic dose as a single agent. Despite receiving a subtherapeutic dose of Actimab-A, the second cohort in this study demonstrated an 86% complete remission rate, an improvement of nearly 60% over CLAG-M alone—implying mechanistic synergy. We look forward to the results of the full trial including the third cohort and a matured data set. If the trial continues to yield such strong results, we believe that the Actimab-A plus CLAG-M combination regimen will warrant further development as relapsed or refractory patients continue to have high unmet needs despite current treatments."

Antibody Radiation Conjugate (ARC) Actimab-A targets the CD33 antigen that is expressed on virtually all AML cells with the antibody lintuzumab which delivers potent alpha radiation via its Actinium-225 radioisotope payload. Blood cancers like AML are highly sensitive to radiation but cannot treated with the current standard of external beam delivery because the disease is too widespread throughout the body. The combination of targeted radiation with Actimab-A potentially allows for greater cancer cell death than a standalone chemotherapy regimen such as CLAG-M (cladribine, cytarabine, and filgrastim, with mitoxantrone), which is used frequently in the treatment of fit patients with relapsed or refractory AML.

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer, said, "We believe that Actimab-A can be utilized in multiple AML treatment settings in combination with other drugs or drug regimens where there is the potential for synergy between their different mechanisms of action. We are initially focusing in R/R AML as there is still a significant unmet need. The Actimab-A CLAG-M combination trial is focused on the fit population while the Actimab-A Venetoclax combination trial addresses the unfit population of R/R AML. These two combination regimens are being studied for their utility as therapeutics with curative intent or as a bridge to transplant. Our expanding focus on R/R AML fits strategically with our pivotal stage Iomab-B program. Our Iomab-B SIERRA trial is in the later stages of a Phase 3 pivotal trial as a conditioning regimen that enables older patients with R/R AML to get a potentially curative bone marrow transplant for which they otherwise are not eligible. We look forward to updates from all three trials by year-end."

Patients in the Phase 1 combination trial, for which data has been presented, have been high-risk with intermediate or poor risk cytogenetics with most patients having received three or more prior therapies including bone marrow transplant in some cases. Patients in the first cohort received 0.25 uCi/kg of Actimab-A and in the second cohort received 0.50 uCi/kg of Actimab-A. In a prior Phase 1/2 trial consisting of 58 patients, Actimab-A as a single agent in newly diagnosed AML a 0.5 uCi/kg dose was shown to be sub-therapeutic, while higher dose levels of 1.0, 1.5 and 2.0 uCi/kg demonstrated response rates of 17%, 22% and 69%, respectively. As previously reported, the second cohort with CLAG-M plus the 0.50 uCi/kg dose showed that 86% (6/7) of patients achieved complete remission (CR/CRi) after receiving the 0.50 uCi/kg dose of Actimab-A. This is a nearly 60% increase over the remission rate reported in a trial of seventy-four patients with relapsed or refractory AML who received CLAG-M alone. Further, 71% (5/7) of patients achieved negative minimal residual disease (MRD) status following treatment with the combination. MRD negative status means the patient had no detectable disease after treatment. Results from the completed Phase 1 trial including the third dose cohort will be available by the end of the year.