On October 8, 2018 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib will be the subject of 13 presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23, 2018 in Munich, Germany (Press release, Exelixis, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370700 [SID1234529822]).

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Poster presentations will include results from the dose escalation stage of the phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma (RCC). Additionally, a poster discussion session will feature a late-breaking abstract evaluating the effect of PD-L1 status on clinical outcomes with cabozantinib in advanced RCC in the CABOSUN and METEOR trials.

"The data at ESMO (Free ESMO Whitepaper) showcase the potential of cabozantinib across a range of difficult-to-treat cancers," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We are especially excited to present results from the dose escalation stage of the COSMIC-021 trial evaluating the combination of cabozantinib and atezolizumab in advanced kidney cancer and look forward to sharing these data and more with the oncology community at this year’s ESMO (Free ESMO Whitepaper) Congress."

Cabozantinib to be featured in 13 presentations
The full schedule of cabozantinib presentations expected at the meeting is as follows:

Proffered Paper Session

[Abstract LBA67] "Cabozantinib in Patients with Advanced Osteosarcomas and Ewing Sarcomas: a French Sarcoma Group (FSG)/ US National Cancer Institute Phase II Collaborative Study"
Antoine Italiano, M.D., Ph.D., Early Phase Trials Unit, Institut Bergonié, Bordeaux, France
Session: Sarcoma
Proffered Paper Session Friday, October 19, 2:00 – 3:30 PM CEST, Hall B3 – Room 21

Poster Discussion

[Abstract LBA34] "PD-L1 Status and Clinical Outcomes to Cabozantinib, Sunitinib and Everolimus in Patients with Metastatic Clear-Cell RCC Treated on CABOSUN and METEOR Clinical Trials"
Toni K. Choueiri, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Genitourinary Tumors, Non Prostate
Poster Discussion Session Saturday, October 20, 2:45 – 4:05 PM, CEST, ICM – Room 1

[Abstract 1310PD] "Prospective Genome and Transcriptome Sequencing in Advanced-Stage Neuroendocrine Neoplasms"
Leonidas Apostolidis, M.D., National Center for Tumor Diseases (NCT), Heidelberg, Germany
Session: NETs
Poster Discussion Session Monday, October 22, 11:00 AM – 12:15 PM CEST, Hall B3 – Room 22

Poster Presentations

[Abstract 702P] "Outcomes by Baseline Alpha-Fetoprotein (AFP) Levels in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Previously Treated Advanced Hepatocellular Carcinoma (HCC)"
R. K. Kelley, M.D., University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 703P] "Assessment of Disease Burden in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced Hepatocellular Carcinoma (HCC)"
Jean Frederic Blanc, M.D., Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 704P] "Outcomes by Prior Transarterial Chemoembolization (TACE) in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)"
Thomas Yau, M.D., Queen Mary Hospital, Hong Kong, China
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1829TiP] "A Noninferiority Trial of Cabozantinib (C) Comparing 60 mg vs 140 mg Orally per Day to Evaluate the Efficacy and Safety in Patients (pts) with Progressive, Metastatic Medullary Thyroid Cancer (MTC)"
Jolanta Krajewska, M.D., Ph.D., M. Sklodowska-Curie Institute – Oncology Center, Gliwice, Poland
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1913P] "A Guided and Personnalized Treatment in Metastatic Breast Cancer: Optimisation of Gene and Protein Expression in Tumor Tissue"
Emmanuel Seront, M.D., Cliniques Universitaires Saint-Luc King Albert II Institute, Brussels, Belgium
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 872P] "Phase 1b Study (COSMIC-021) of Cabozantinib in Combination with Atezolizumab: Results of the Dose Escalation Stage in Patients (pts) with Treatment-Naïve Advanced Renal Cell Carcinoma (RCC)"
Neeraj Agarwal, M.D., Huntsman Cancer Center, Salt Lake City, Utah, USA
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 893P] "Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC): Data from UK Expanded Access Program (EAP)"
Alfonso Gomez de Liano Lista, M.D., Barts Cancer Institute, London, England
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 879P] "Activity of Cabozantinib (cabo) after PD-1/PD-L1 Immune Checkpoint Blockade (ICB) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)"
Bradley A. McGregor, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 882P] "Potent Natural Killer (NK) and Myeloid Blood Cell Remodeling by Cabozantinib (Cabo) in Pretreated Metastatic Renal Cell Carcinoma (mRCC) Patients (pts)"
Elena Verzoni, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 889P] "Clinical Outcomes of Patients with Metastatic Renal Cell Carcinoma (mRCC) Treated with Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) and Mammalian Target of Rapamycin Inhibitors (mTORI) after Immuno-oncology (IO) Checkpoint Inhibitors"
Jeffrey Graham, M.D., Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

About CABOMETYX (cabozantinib)

CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in the European Union, Norway, Iceland, Australia, Switzerland, South Korea and Canada for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. In May 2018, the FDA accepted Exelixis’ supplemental New Drug Application for CABOMETYX as a treatment for patients with previously treated HCC and assigned it a Prescription Drug User Fee Act action date of January 14, 2019. On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC in the European Union; on September 20, 2018 the CHMP provided a positive opinion for CABOMETYX as a monotherapy for the treatment of HCC in adults who have been previously treated with sorafenib. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

On October 8, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into a purchase agreement with several institutional investors for the purchase of common units and pre-funded units for a combined total of 4,629,630 units in a registered direct offering, for expected gross proceeds of approximately $25 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, OCT 8, 2018, View Source [SID1234529904]).

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Each common unit is being sold at a public offering price of $5.40 and consists of one share of common stock and a warrant to purchase one share of common stock at an exercise price of $5.40. Each pre-funded unit is being sold at a public offering price of $5.39 and consists of a pre-funded warrant to purchase one share of common stock at an exercise price of $0.01 per share and a warrant to purchase one share of common stock at an exercise price of $5.40. The public offering price of each pre-funded unit is equal to the public offering price of each common unit being sold to the public in this offering, minus $0.01. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The other warrants will be exercisable immediately and will expire five years from the date of issuance. The terms of the warrants and the pre-funded warrants will be substantially the same as the terms of the warrants and the pre-funded warrants issued in connection with the Company’s public offering completed October 2, 2018. For a summary of the material terms of the warrants and pre-funded warrants, please refer to Exhibit A attached to this press release.

The offering is expected to close on or about October 10, 2018, subject to customary closing conditions. Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our clinical-stage product pipeline, general corporate purposes and strategic growth opportunities.

Roth Capital Partners is acting as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 8, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that initial findings from the FORWARD II expansion cohort of mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 19-23, 2018 in Munich, Germany (Press release, ImmunoGen, OCT 8, 2018, View Source [SID1234529805]). The poster will include initial safety and preliminary anti-tumor activity for 46 patients with platinum-resistant ovarian cancer (PROC), of whom 35 have medium or high folate receptor alpha (FRα) expression.

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Encouraging activity and favorable tolerability data from the FORWARD II dose-escalation cohort assessing mirvetuximab soravtansine in combination with KEYTRUDA in 14 heavily pre-treated patients with platinum-resistant epithelial ovarian cancer (EOC) were presented in March at the Society of Gynecologic Oncology (SGO) Annual Meeting. These findings supported enrollment of additional patients in an expansion cohort with full doses of both agents to further evaluate this combination in PROC.

"Based on the data presented at SGO, we advanced mirvetuximab soravtansine plus pembrolizumab into an expansion cohort focusing on PROC patients with medium and high FRα expression," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "We look forward to presenting initial findings at ESMO (Free ESMO Whitepaper), as we evaluate several combinations that may ultimately enable us to treat more women with ovarian cancer."

Details of ImmunoGen’s poster presentation are as follows:

Title: "Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), with pembrolizumab in platinum-resistant ovarian cancer (PROC): Initial results of an expansion cohort from FORWARD II, a Phase Ib study" (presentation number 949P)
Date: October 20, 2018
Time: 12:30 CEST
Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

Mirvetuximab soravtansine is an ADC comprised of a FRα-binding humanized antibody linked to the tubulin-disrupting maytansinoid DM4. This agent activates monocytes and upregulates immunogenic cell death markers on ovarian tumor cells, providing a rationale for combining with immune checkpoint blockade. Mirvetuximab soravtansine is being evaluated in combination with pembrolizumab in patients with PROC

On October 8, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that it will present final results from the Phase 1 study of AB928, its dual adenosine receptor antagonist, in healthy volunteers during a poster display session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, being held October 19-23, 2018, in Munich, Germany (Press release, Arcus Biosciences, OCT 8, 2018, View Source [SID1234529806]). The safety data to be presented will demonstrate that in this study, there was no evidence of the physiological effects of blocking adenosine that have been observed clinically with earlier adenosine receptor antagonists. Physiological effects associated with the earlier adenosine receptor antagonists that were initially designed for CNS indications may potentially limit their optimal dosing in the oncology setting.

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The pharmacokinetic and pharmacodynamic correlations generated from this study, which will be described in the poster presentation, were used to guide dose selection in the Company’s four Phase 1/1b trials in patients.

Details of the poster presentation are as follows:

Abstract Number: 1880P
Poster Title: Final results of the Phase 1 study in healthy volunteers of AB928, a dual antagonist of the A2aR and A2bR adenosine receptors being studied as an activator of anti-tumor immune response.
Poster display session: Biomarkers, Gynecological cancers, Hematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research (ID 259)
Session Date and Time: Saturday, Oct. 20, 2018, 12:30 – 1:30 pm CEST
Location: Hall A3

The poster will be available at www.arcusbio.com/publications.

About AB928

AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits an optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties for efficacy in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue and low penetration through the healthy blood-brain barrier. In a Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen. The Company has initiated four phase 1/1b trials evaluating AB928 in combination with other agents in selected tumor types.

On October 8, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) reported that updated clinical data from the innovaTV 201 Phase II study evaluating tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer will be presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19 to 23, 2018 (Press release, Genmab, OCT 8, 2018, View Source [SID1234529808]). Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen, which is expressed on a broad range of solid tumors.

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"We look forward to presenting an update on the expanded cervical cancer cohort data showing that tisotumab vedotin continues to demonstrate tolerability and clinical activity in heavily pretreated patients with cervical cancer. We anticipate publishing the final data from this cohort in the future," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In the past year, the development program of tisotumab vedotin has also been expanded with additional trials and indications, and we are excited about the continued growth of this program."

"In the recurrent and metastatic cervical cancer setting, there remains an unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are pleased to be collaborating with Genmab to advance tisotumab vedotin in the potentially pivotal innovaTV 204 clinical trial in cervical cancer and to evaluate its potential in a broad range of other solid tumors."

Details of Poster Presentation:

Title: A Phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: updated analysis of full cervical expansion cohort
Presenter: Nicole Concin, M.D. Medical University of Innsbruck, Austria
Abstract #: 963P
Session: Poster Display Session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Date and Time: October 20, 12:30-13:30 CEST
Location: Hall A3 Poster Area

The abstract is available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org.

About the innovaTV 201 (GEN701) Study

The innovaTV 201 study is a 170 patient, two-part Phase I/II study of tisotumab vedotin in eight types of solid tumors: ovarian, cervical, endometrial, bladder, prostate, esophageal, lung, and head and neck. Part 1 is a classical 3+3 dose escalation design testing various doses of tisotumab vedotin once every three weeks to establish the recommended Phase II (RP2D) and maximum tolerated dose as well as the safety profile of tisotumab vedotin. Part 2 of the study investigates all eight indications in parallel expansion cohorts. The cervical cancer cohort includes 55 patients. Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three weeks. The primary objective of this part of the study is to further investigate the safety profile of tisotumab vedotin and preliminary efficacy.

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor cell signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is being evaluated in ongoing or planned Phase II trials in recurrent and/or metastatic cervical cancer, ovarian cancer and other solid tumors. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics.