On September 17, 2020 Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) reported that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab (Press release, Incyte, SEP 17, 2020, View Source [SID1234565294]).

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Dr. Gilles Salles will join Incyte and MorphoSys leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA (Free EHA Whitepaper) 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The conference call and webcast will be held on Tuesday, September 29, 2020 from 9:00 – 11:00 a.m. EDT / 3:00 – 5:00 p.m. CEST. The live webcast and replay will be available via www.morphosys.com and investor.incyte.com.

To access the conference call, U.S. domestic callers please dial 877-423-0830. Callers outside of the U.S. please dial +49 69201744220 or +44 2030092470. When prompted, provide the conference pin number, 83557299#.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

On September 17, 2020 HiFiBiO Therapeutics reported that a novel approach for patient stratification demonstrating its proprietary Drug Intelligent Science (DIS) single-cell platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Heterogeneity Virtual Special Conference taking place today (Press release, HiFiBiO Therapeutics, SEP 17, 2020, View Source [SID1234565293]). The company is a pioneer of novel antibody drug discovery and development, leveraging single-cell analytics to treat cancer, autoimmune and infectious disorders. HiFiBiO invites members of the scientific and medical communities to listen to the poster presentation online at the AACR (Free AACR Whitepaper) meeting website or, after the AACR (Free AACR Whitepaper) meeting has concluded, on the HiFiBiO Therapeutics website.

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"This presentation demonstrates the potential of our DIS single-cell platform to identify biomarkers that can predict if patients will respond to treatment," said Andreas Raue, PhD, Senior Director and Head of Drug Intelligent Science at HiFiBiO Therapeutics. "Given our depth of experience in immune modulation and single-cell science, we believe our DIS platform has the potential to transform how we mine immune biomarkers to identify the best immunotherapies for each and every patient."

Poster Presentation Details
Title: Single-cell immune profiling identifies signature that predicts PD-L1 blockade outcome
Presenter: Dean Lee, Scientist, Drug Intelligent Science at HiFiBiO Therapeutics
Poster: PO-048, Link to presentation

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).