On October 21, 2019 The board of directors of Eli Lilly and Company (NYSE: LLY) reported that it has declared a dividend for the fourth quarter of 2019 of $0.645 per share on outstanding common stock (Press release, Eli Lilly, OCT 21, 2019, View Source [SID1234542379]).

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The dividend is payable December 10, 2019, to shareholders of record at the close of business on November 15, 2019.

On October 21, 2019 INNATE PHARMA S.A. (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate Pharma" or the "Company"), a French biotechnology company focused on discovering, developing and commercializing first-in-class therapeutic antibodies designed to harness the immune system for the treatment of oncology indications with significant unmet medical need, reported the closing of its previously announced global offering to specified categories of investors of an aggregate of 14,375,000 new ordinary shares, comprising an offer of 9,922,227 ordinary shares in the form of American Depositary Shares ("ADSs"), each representing one ordinary share, in the United States at an offering price of $5.50 per ADS (the "U.S. Offering"), and a concurrent private placement of 4,452,773 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.97 per ordinary share (the "European Private Placement," and together with the U.S. Offering, the "Global Offering") (Press release, Innate Pharma, OCT 21, 2019, View Source [SID1234542380]). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately $79.1 million (€71.4 million*). All of the ADSs and ordinary shares in the Global Offering were offered by Innate.

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Innate Pharma’s ordinary shares are listed on Euronext Paris under the symbol "IPH" and its ADSs are listed on the Nasdaq Global Select Market under the symbol "IPHA". The ADSs began trading on the Nasdaq Global Select Market on October 17, 2019.

Citigroup Global Markets Inc., SVB Leerink LLC and Evercore Group LLC acted as joint bookrunners for the U.S. Offering and Citigroup acted as global coordinator for the European Private Placement. Namsen Capital acted as capital markets advisor to the Company.

A registration statement relating to these securities, including a prospectus, was declared effective by the U.S. Securities and Exchange Commission ("SEC") on October 16, 2019. The registration statement can be accessed through the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On October 21, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; Nasdaq: MOR) reported that it will publish its first nine months’ 2019 results on October 29, 2019 at 10:00pm CET (9:00pm GMT; 5:00pm EDT) (Press release, MorphoSys, OCT 21, 2019, View Source [SID1234542381]).

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The Management team of MorphoSys AG will host a conference call and webcast on October 30, 2019 at 2:00pm CET (1:00pm GMT; 9:00am EDT) to present MorphoSys’s third quarter results 2019 and provide further details on the Company’s latest developments.

Date of the conference call: Wednesday, October 30, 2019
Time: 2:00pm CET (1:00pm GMT, 9:00am EDT)
Dial-in numbers:
Germany: +49 69 201 744 220
United Kingdom: +44 203 009 2470
USA: +1 877 423 0830
Participant PIN: 97683318#

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a secure line and a prompt start.

The presentation slides and webcast link will be available at the Company’s website at View Source

A replay of the conference will also be available at the corporate website following the live event.

On October 21, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported data demonstrating the clinical validity of its next-generation Percepta Genomic Sequencing Classifier (GSC) and the clinical utility of its first-generation test in a real-world setting in improving lung cancer diagnosis when bronchoscopy results are inconclusive (Press release, Veracyte, OCT 21, 2019, View Source [SID1234542382]). The findings will be presented on Thursday, October 23, at the annual meeting of the American College of Chest Physicians (CHEST) in New Orleans.

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"These data confirm the performance of our Percepta classifier and its ability to guide care for lung nodule patients when bronchoscopy findings are inconclusive," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We have been especially pleased by physicians’ positive response to our next-generation Percepta GSC, which we introduced in June of this year and which provides expanded information to physicians."

For the first study, researchers prospectively validated the Percepta GSC on a blinded, independent set of 412 samples from patients with lung nodules that were referred for bronchoscopy evaluation. Among a subset of patients with low or intermediate pre-test risk for whom malignancy was confirmed, the Percepta GSC significantly improved sensitivity for lung cancer detection in combination with bronchoscopy (95.5 percent), compared to bronchoscopy alone (40.9 percent). The genomic classifier demonstrated improved sensitivity compared to bronchoscopy regardless of nodule size or location or cancer subtype.

Among a subset of 188 patients with an intermediate pre-test risk of cancer, which account for the majority of lung nodules, the Percepta GSC demonstrated high accuracy when it down-classified patients to "low risk" for cancer (negative predictive value of 91 percent). The test also had a positive predictive value of 65 percent when it up-classified patients to "high risk" for cancer. The American College of Chest Physicians recommends that patients with a low risk of cancer undergo monitoring with CT imaging and that patients with a cancer risk of 65 percent or greater undergo surgical treatment.

"Bronchoscopy is often used to evaluate potentially cancerous lung nodules because it offers a nonsurgical way to detect lung cancer. However, bronchoscopy results are often inconclusive, which leaves physicians with a dilemma of whether to direct the patient for more invasive procedures or just monitor them with imaging at the risk of missing a cancer," said Giulia C. Kennedy, Ph.D., chief scientific officer and chief medical offer for Veracyte, who was a researcher in the study. "Our findings suggest that use of the Percepta GSC can improve the performance of bronchoscopy, making it a potentially more useful diagnostic tool that can help lung nodule patients at low risk for cancer avoid unnecessary invasive procedures or those at high risk get more timely treatment."

The next-generation Percepta GSC was developed on Veracyte’s RNA whole-transcriptome sequencing and machine learning platform and is based on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is performed on a sample from the patient’s main lung airway, which is collected during a bronchoscopy. Veracyte estimates that approximately 360,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 60 percent of these produce inconclusive results.

A second, independent study is being presented at the CHEST meeting by researchers from LAC+USC Medical Center, a county hospital in Los Angeles, on their experience using the original Percepta classifier.

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking.

On October 20, 2019 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported positive updated results from the Incyte-sponsored Phase 2 trial of pemigatinib in patients with previously treated, advanced cholangiocarcinoma which were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 (Press release, Innovent Biologics, OCT 20, 2019, View Source [SID1234542371]).

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In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan.

The updated results from the Phase 2 FIGHT-202 trial evaluating pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma presented at ESMO (Free ESMO Whitepaper) 2019 include the final result for the primary endpoint. In patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median progression free survival (PFS) of 6.9 months (secondary endpoint) with a median follow-up of 15 months. Pemigatinib was generally well tolerated.

The data support the planned submission of a New Drug Application (NDA) by Incyte to the U.S. Food and Drug Administration (FDA) for pemigatinib before the end of 2019.

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor. The incidence of cholangiocarcinoma varies regionally and ranges between 0.3– 3.4 per 100,000 in North America and Europe. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients.

Key Findings from FIGHT-202

Updated data presented at ESMO (Free ESMO Whitepaper) show that in patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements (Cohort A, n=107), pemigatinib monotherapy resulted in a confirmed overall response rate (ORR) of 36 percent based on an independent central radiographic review, including 3 patients with a complete response (CR) and 35 patients with a partial response (PR). In these patients, the disease control rate (DCR) was 82 percent, median duration of response (DOR) was 7.5 months, and median progression free survival (PFS) was 6.9 months. Preliminary overall survival (OS) data were encouraging (median: 21.1 months) and follow-up will continue as these data are not yet mature.

FIGHT-202 Overall Response Rates (ORR). Durability of Response (DOR). Disease Control Rates (DCR) and Progression-Free Survival (PFS) by Patient Cohort

Cohort A

FGFR2 Fusions or Rearrangements

Cohort B

Other FGF/FGFR Genetic Alterations

Cohort C

No FGF/FGFR Genetic Alterations

(N=107)

(N=20)

(N=18)

ORR, % (95% CI)

36 (27-45)

0

0

3 CR (3)

0

0

Best OR, n（%）

35 PR (33)

0

0

50 SD (47)

8 SD (40)

4 SD (22)

Median DOR,

Months (95% CI)

7.5 (5.7-14.5)

–

–

DCR, % (95% CI)

82 (74-89)

40 (19-64)

22 (6-48)

Median PFS,

Months (95% CI)

6.9 (6.2-9.6)

2.1 (1.2-4.9)

1.7 (1.3-1.8)

Median OS,

Months（95% CI）

21.1 (14.8-NE)

6.7 (2.1-10.6)

4.0 (2.3-6.5)

NE: not evaluable

Note: One patient did not have confirmed FGF/FGFR status by central laboratory and was included in the safety analysis but was not assigned to any cohort for efficacy.

The safety analysis, including 146 patients, showed that pemigatinib was generally well tolerated. Grade 1 or 2 hyperphosphatemia, the most common treatment-emergent adverse event (TEAE; 60 percent), was managed with a low phosphate diet, phosphate binders and diuretics, or dose reduction or interruption. The most common Grade ≥3 TEAE was hypophosphatemia (12 percent); none of the cases was considered clinically significant or serious and none led to dose reduction or discontinuation. Serous retinal detachment was observed in 4 percent of patients (Grade ≥3, 1 percent) with none of the cases resulting in clinical sequelae.

About FIGHT-202

The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit:

View Source

About FIGHT

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy in patients with previously untreated, metastatic or unresectable bladder cancer harboring FGFR3 mutations or fusions/rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a recently initiated Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About FGFR and Pemigatinib

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations discovered and developed by Incyte. The U.S. Food and Drug Administration (FDA) has granted pemigatinib Breakthrough Therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines.