On September 17, 2020 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 36 cents per share (Press release, Abbott, SEP 17, 2020, View Source [SID1234565292]).

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This marks the 387th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Nov. 16, 2020, to shareholders of record at the close of business on Oct. 15, 2020.

Abbott has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

On September 17, 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 an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response of onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC) patients at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cardiff Oncology, SEP 17, 2020, View Source [SID1234565291]).

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"We are pleased to observe the clinical benefit and durability of response to treatment, with confirmed PRs and patients exceeding one year on treatment without disease progression," said Daniel H. Ahn, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona. "The addition of onvansertib to standard-of-care shows promise as a novel second-line option for patients with difficult-to-treat KRAS-mutated mCRC. A critical unmet need exists for these patients, as second line treatment has a relatively low response rate and generally confers a poor prognosis."

Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology added, "As we continue to advance our lead clinical program in KRAS-mutated mCRC, we are highly encouraged by the efficacy signal in our ongoing trial. Our analysis of changes in plasma KRAS mutation levels, from baseline to the end of cycle 1 of treatment, appears to be predictive of subsequent tumor shrinkage and may prove to be a useful clinical tool to quickly assess patient response to treatment with onvansertib."
Highlights of the ESMO (Free ESMO Whitepaper) Poster Presentation:

•10 of 11 (91%) patients achieved disease control (SD – stable disease plus PR – partial response) with only 1 patient progressing in <6 months while on treatment
•5 (45%) patients achieved a partial response (PR); 4 patients had a confirmed PR with 1 patient going on to curative surgery; 1 patient with an initial PR went off study prior to confirmatory scan due to non-treatment related event
•8 of 11 (73%) patients demonstrated durable response ranging from 6 to >12 months, and 4 patients remain on treatment

Biomarker Analyses:
•All 5 PRs were associated with different KRAS mutation variants, including the 3 most common that comprise nearly 80% of mutations in CRC
•Patients achieving a PR showed the greatest decreases in plasma KRAS mutation levels (ranging from -78% to -100%) after one cycle of therapy

Safety:
•The first two onvansertib dose levels (12 and 15 mg/m2) have been cleared for safety; four patients have been treated at the third dose level (18 mg/m2) and two more will be enrolled
•Onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated with only 9% of AEs being grade 3 or 4; none being attributed to onvansertib and all being resolved within 2.5 weeks
•No major or unexpected toxicities have been attributed to onvansertib

The poster presented as part of the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 is 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 KRAS-mutated metastatic colorectal cancer clinical trial is a single-arm Phase 1b/2 study assessing the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab in second line KRAS-mutated metastatic colorectal cancer. Trial participants are treated with onvansertib on Days 1-5, and FOLFIRI and bevacizumab on Day 1, of 14-day treatment courses. 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 Mayo Clinic Cancer Centers. For more information on the trial, please visit View Source

On September 17, 2020 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has established a collaboration with the Moffitt Cancer Center to characterize combination therapies pairing Elicio’s CD19 Amphiphile and a universal FITC Amphiphile with CD19 CAR T cells (Press release, Elicio Therapeutics, SEP 17, 2020, https://elicio.com/2020/09/elicio-therapeutics-and-moffitt-collaborate-to-study-amp-cd19-in-combination-with-cd19-car-t-cells/ [SID1234565287]). The research will be led by Marco Davila, M.D., Ph.D. associate member of the Blood and Marrow Transplant and Cellular Immunotherapies Department and Medical Director of Cell Therapies at Moffitt.

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"Despite high initial response rates, patients with B-cell malignancies have limited durable long-term disease control," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "We are excited to work with Dr. Davila, a pioneer and expert in cell therapy for hematologic malignancies, to study the pharmacology of the combination of AMP-CD19 with CD19 CAR T cells. Dr. Davila’s laboratory is uniquely positioned to evaluate lymph node targeted immunotherapy, since his team evaluates CD19+ malignancies in mice with a normal immune system and normal lymph nodes, a great advantage over more common mouse models conducted in immunosuppressed mice. Positive results would set the stage for clinical trials combining AMP-CD19 with marketed CD19 CAR T cells to increase response rate and durability."

"Our research, as well as research by other groups, suggest one avenue for improving outcomes for lymphoma patients treated with gene-engineered T cells is to combine this therapy with other agents to enhance response. We believe the highly novel AMP vaccine holds great promise as a combination to increase the efficacy of T cells targeted to B cell malignancies and look forward to developing and evaluating this therapy at Moffitt," said Dr. Davila.

The AMP-CD19 is a CAR binding peptide modified to traffic into lymph nodes for display on native immune cells. AMP-CD19 can activate engineered T cells, enhance their persistence, and proliferation, as well as enhance their activity in treatment of B-cell malignancies including diffuse large B cell lymphoma (DLBCL) and acute lymphocytic leukemia (ALL).

The AMP modification reprograms the biodistribution of peptides by the addition of an albumin binding and cell membrane insertion domain, which results in improved trafficking into lymph nodes where dendritic cells take in the peptides and present them to the CAR T receptors on the surface of T cells.

Elicio is broadly developing AMP technologies, with ELI-002 targeting solid tumors with mutated KRAS in oncology, the universal adjuvant ELI-004 (AMP-CpG) enhancing efficacy across oncology and infectious disease applications, and discovery programs identifying solid tumor AMP CAR T combinations. In addition, the combination of both Elicio’s Amphiphiles (AMPs) with CAR Ts led to synergy that enhanced solid tumor CAR T therapy in mice (Ma et al., 2019; Singh et al., 2019).

On September 17, 2020 Amunix Pharmaceuticals, Inc. ("Amunix"), a biopharmaceutical company developing prodrugs of potent immune-activating biotherapeutics for the treatment of patients with solid tumor cancers, reported that it will present preclinical data on two T cell engager programs: AMX-818, the company’s lead clinical candidate which targets HER2, and a second targeting EGFR (EGFR-XPAT), which is in lead optimization, at the European Society for Medical Oncology Virtual Congress taking place September 19 – 21, 2020 (Press release, Amunix, SEP 17, 2020, View Source [SID1234565286]).

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"We are very excited to present progress on our most advanced T cell engager programs," said Angie You, Ph.D., CEO of Amunix. "Both programs demonstrate the potential of our XPAT platform to significantly widen the therapeutic index of T cell engagers and overcome the challenge of on-target, off-tumor toxicity that is limiting the use of potent immune activators to treat solid tumors. For our HER2-XPAT clinical candidate, AMX-818, we have initiated IND-enabling studies. We are also excited to share progress with EGFR-XPAT, which offers a potential orthogonal approach to small molecule kinase inhibitors to target KRAS mutant tumors. As we progress these two most advanced programs, we are also leveraging our plug and play platform to rapidly develop XPATs against additional tumor targets such as PSMA and TROP2."

Amunix will present two posters at ESMO (Free ESMO Whitepaper), titled, "HER2-XPAT, A Novel Protease-Activatable Pro-Drug T Cell Engager (TCE), Engineered to Address On-Target, Off-Tumor Toxicity and Provide Large Predicted Safety Margins in Non-Human Primate (NHP)" and "EGFR-XPAT, A Novel Pro-Drug T Cell Engager (TCEs) Engineered to Address On-Target, Off-Tumor Toxicity and an Orthogonal Approach for Cancer Immunotherapy in EGFR, KRAS/BRAF Cancers". Both posters show that Amunix’s XPAT technology can improve the toxicity profile of T cell engagers while maintaining their potency against solid tumors. In vitro, protease-activated XPATs showed potent cytotoxic activity against tumor cell lines with EC50s in the single-digit pM range. For both molecules, masking reduced target-directed T cell cytotoxicity and T cell activation by ~5,000 to >10,000-fold. In established xenograft models, both HER2-XPAT and EGFR-XPATs induced complete tumor regressions with efficacious doses within an order of magnitude of the unmasked (active) T cell engager. Importantly, EGFR-XPAT showed strong in vitro cytotoxicity in a KRAS mutant and BRAF mutant setting, as well as potent in vivo anti-tumor xenograft activity in a BRAF mutant background.

Safety data from cynomolgus monkeys demonstrate that masked XPATs have a markedly lower risk of CRS and enable a significant increase in maximum tolerated exposures relative to unmasked, active forms. In contrast to traditional unmasked T cell engagers, which have MTDs in the µg/kg range, HER2-XPAT can be safely dosed up to 42 mg/kg in cynos and EGFR-XPAT up to 1 mg/kg, representing ~500-fold and ~200-fold, respectively, increases in tolerated exposures from masking. Combined with the potency of XPATs in xenograft models, these data suggest a favorable therapeutic index even for targets as broadly expressed as EGFR.

Poster Presentation Details
Title: HER2-XPAT, A Novel Protease-Activatable Pro-Drug T Cell Engager (TCE), Engineered to Address On-Target, Off-Tumor Toxicity and Provide Large Predicted Safety Margins in Non-Human Primate (NHP)
Poster number: 1060P
Abstract Number: 2472
Session: Virtual On-Demand Poster Display
Date: Sep 17, 2020

Title: EGFR-XPAT, A Novel Pro-Drug T Cell Engager (TCEs) Engineered to Address On-Target, Off-Tumor Toxicity and an Orthogonal Approach for Cancer Immunotherapy in EGFR, KRAS/BRAF Cancers
Poster number: 1062P
Abstract Number: 3054
Session: Virtual On Demand Poster Display
Date: Sep 17, 2020

On September 17, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of the cancer, reported that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Yervoy (ipilimumab), Bristol Myers Squibb’s (BMS) Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor therapy in Phase 2 (Press release, Intensity Therapeutics, SEP 17, 2020, View Source [SID1234565284]). The combination is being studied in a series of phase 2 expansion cohorts within IT-01, Intensity’s ongoing international clinical study (NCT03058289), which evaluates the safety and efficacy of the combination in patients with three different types of cancer (breast cancer, liver cancer, and sarcoma).
"Bringing INT230-6 into phase 2 human testing in combination with Yervoy is an important achievement for Intensity Therapeutics," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Our preclinical and clinical data have resulted in favorable safety for INT230-6 as a single agent or in combination with immunotherapies. The phase 1 escalation portion of our INT230-6 development program is complete. We are excited about starting the phase 2 portion of our trial using INT230-6 at proper doses early in the treatment process especially in combination with Yervoy."

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"The phase 2 Yervoy combination studies accrue patients with breast cancer, liver cancer, and sarcoma that are refractory to standard of care and have high unmet medical need" said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "We are optimistic that our trial design enables us to quickly evaluate safety and efficacy in patients having cancers that are difficult to treat. Physicians desperately need better therapies for their patients. Our approach to safely debulk tumors and recruit an immune response by releasing tumor antigens derived from the patient’s own tumors may be amplified by blocking a checkpoint signal using Yervoy."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, release of tumor antigens and recruitment of immune cells to the tumor. Results generated by both the Company and the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers. The Company’s research published in the International Journal of Molecular Sciences earlier this year and published jointly with the NCI as part of Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunology, also showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy. In the combination cohort with pembrolizumab the Company reported the safety of the combination was comparable to INT230-6 monotherapy.