On October 12, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that it has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma (Press release, Sutro Biopharma, OCT 12, 2018, View Source [SID1234529894]). STRO-001 is a potential first-in-class antibody drug conjugate (ADC) targeting CD74, a protein highly expressed in B-cell malignancies such as multiple myeloma.

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"There is a growing need for new treatment options for patients with multiple myeloma," commented Bill Newell, Sutro’s Chief Executive Officer. "This Orphan Drug Designation is a great step towards advancing our uniquely designed STRO-001 that could bring new treatment options to patients in need."

STRO-001 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+, which facilitate precision design and rapid empirical optimization of ADCs. Sutro’s technology enables design and manufacture of a highly optimized single molecular species within the product, rather than the usual mixture of imprecisely conjugated antibodies that comprise an ADC development product made by conventional cell-based manufacturing platforms.

"STRO-001 was designed to directly target cancer cells to deliver a cytotoxic payload. Building upon our XpressCF+ platform we plan to develop better options to treat tumors with greater precision," Bill Newell added.

STRO-001 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.

About Orphan Drug Designation

The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

On October 10, 2018, the Company delivered notice to Cantor Fitzgerald & Co. ("Cantor") terminating the Controlled Equity OfferingSM Sales Agreement, dated February 1, 2013 (the "Sales Agreement"), with Cantor effective as of October 20, 2018 (Filing, 8-K, Celsion, OCT 12, 2018, View Source [SID1234530287]). The Sales Agreement permitted the Company to sell additional shares of our Common Stock having an aggregate offering price of up to $25 million through "at the market" equity offerings from time to time. From February 2013 through the date of termination, the Company sold 1,784,396 shares of Common Stock under the Sales Agreement generating gross proceeds of $12.8 million. The Company has no further obligations under the Sales Agreement.

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On October 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the Company and its collaborators will present data and analyses from its non-clinical and clinical studies with Betalutin (177Lu-lilotomab satetraxetan) at the 32nd Annual Congress of the European Association of Nuclear Medicine (13-17 October 2018, Düsseldorf, Germany) (Press release, Nordic Nanovector, OCT 12, 2018, View Source [SID1234553493]).

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The presentations are:

Therapeutic efficacy of 177Lu-lilotomab satetraxetan in non-Hodgkin B-cell Lymphoma is controlled by G2/M cell cycle progression

Authors: A. Pichard et al.

Session: 305 – M2M: Therapy Effects, Preclinical

Abstract No. OP-069

Format: Oral presentation

Date/time: Sunday 14 October, 11:30-12:45 CEST

Tumor Absorbed Dose and Changes in FDG PET Parameters in Non-Hodgkin Lymphoma Patients Treated with 177Lu-lilotomab satetraxetan

Authors: A. Løndalen et al.

Session: 608 – Clinical Oncology – Rapid Fire Session: It’s in the Blood!

Abstract No. OP-252

Format: Oral presentation

Date/time: Monday 15 October, 08:00-09:30 CEST

On October 12, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that they will present at Jefferies London Healthcare Conference on November 14th at 3.20 PM local time (GMT), the presentation will be webcasted (Press release, Oncopeptides, OCT 12, 2018, View Source [SID1234530258]).

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Oncopeptides is a research and development stage pharmaceutical company developing drugs for the treatment of cancer. Since the founding of the company, the focus has primarily been on the development of the lead product candidate melflufen (Ygalo), an alkylating peptide, belongs to a novel class of peptidase-enhanced compounds (PEnCs), intended for effective and focused treatment of hematological cancers, and in particular multiple myeloma.

Melflufen (Ygalo) has been used to treat late-stage RRMM patients in the phase II clinical study called O-12-M1 that is completed with favorable results which have been reported previously. Currently, Oncopeptides conduct four clinical trials with melflufen for the treatment of multiple myeloma. These are HORIZON, OCEAN, ANCHOR and BRIDGE.

The current clinical study program is intended to demonstrate better results from treatment with melflufen (Ygalo) compared to established alternative drugs for patients with late-stage multiple myeloma. This could potentially provide physicians with a new treatment option for patients suffering from this serious disease.

For further information, please contact:

Rein Piir, Head of Investor Relations at Oncopeptides AB
E-mail: [email protected]

This information was submitted for publication at 09.00 CET October 12, 2018

On October 12, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that cabozantinib (Cabometyx), irinotecan liposome injection (Onivyde), lanreotide (Somatuline) and the combination of lanreotide and telotristat (Xermelo) are the subject of 12 presentations at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual congress (Press release, Ipsen, OCT 12, 2018, View Source [SID1234529884]). The meeting takes place in Munich, Germany, October 19-23, 2018.

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"Ipsen has had a momentous 12 months since ESMO (Free ESMO Whitepaper) 2017, particularly with the positive regulatory milestones achieved for Cabometyx in renal cell and hepatocellular carcinoma, and for Xermelo in neuroendocrine tumours. Our story continues with a strong presence at ESMO (Free ESMO Whitepaper) 2018 with 12 posters presenting meaningful data for patients with hepatocellular carcinoma, renal cell carcinoma, medullary thyroid cancer, pancreatic cancer and neuroendocrine tumours," said Alexandre Lebeaut M.D, Executive Vice President, Research & Development and Chief Scientific Officer, Ipsen.

"Our oncology products, notably Cabometyx, Onivyde, Somatuline and Xermelo have been evaluated by scientific teams around the world; either directly by investigators, by our partners, or by Ipsen, and results from some of these investigations will be shared at ESMO (Free ESMO Whitepaper) 2018. We are committed in our efforts against cancer, and through our interactions at ESMO (Free ESMO Whitepaper) will continue to advance innovation for patient care in oncology", added Dr Lebeaut.

Cabozantinib (Cabometyx) will be featured in 5 posters:

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

CELESTIAL study

[Poster 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) (Kelley et al.)
Presenting author: R.K. Kelley [Sponsor: Exelixis]

[Poster 703P] Assessment of disease burden in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (HCC) (Blanc et al.)
Presenting author: JF Blanc [Sponsor: Exelixis]

[Poster 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) (Yau et al.)
Presenting author: T Yau [Sponsor: Exelixis]

Poster session, Monday October 22nd, 13:15 ‐ 14:15, Hall A3

COSMIC-021 study (Cabozantinib + atezolizumab)

[Poster 872P] Phase 1b study (COSMIC-021) of cabozantinib in combination with atezolizumab in solid tumors: Results of the dose escalation stage in patients with treatment-naïve advanced RCC (Agarwal et al.)
Presenting author: N Agarwal [Sponsor: Exelixis]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

EXAMINER study

[Poster 129TiP] A noninferiority trial of cabozantinib (C) comparing 140 mg vs 60 mg orally per day to evaluate the efficacy and safety in patients (pts) with progressive, metastatic medullary thyroid cancer (MTC) (Krajewska et al.)
Presenting author: J Krajewska [Sponsor: Exelixis]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Irinotecan liposome injection (Onivyde) will be featured in 4 presentations:

[Poster 749P] The prognostic value of the Modified Glasgow Prognostic Score (mGPS) in predicting overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving liposomal irinotecan (nal-IRI)+5-fluorouracil and leucovorin (5-FU/LV). (Chen, et al.)
Presenting author: L-T Chen [Sponsor: Ipsen]

[Poster 734P] Impact of dose reduction or dose delay on the efficacy of liposomal irinotecan (nal-IRI)+5-fluorouracil/leucovorin (5-FU/LV): Survival analysis from NAPOLI-1. (Chen, et al.)
Presenting author: L-T Chen [Sponsor: Ipsen]

[Poster 735P] Real-world dosing patterns of patients (pts) with metastatic pancreatic cancer (mPC) treated with liposomal irinotecan (nal-IRI) in US oncology clinics. (Ahn, et al.)
Presenting author: D Ahn [Sponsor: Ipsen]

[Poster 733P] NAPOLI-1 Phase 3 trial outcomes by prior surgery, and disease stage, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). (Macarulla, et al.)
Presenting author: T Macarulla [Sponsor: Shire]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline) will be featured in 2 presentations:

PRELUDE (TGR)

[Poster 1331P] Tumour growth rate (TGR) when using lanreotide Autogel (LAN) before, during and after peptide receptor radionuclide therapy (PRRT) in advanced neuroendocrine tumours (NETs). (Prasad, et al.)
Presenting author: V Prasad [Sponsor: Ipsen]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

CLARINET (diabetes)

[Poster 1319P] Post-hoc analysis of CLARINET phase III study to investigate the influence of diabetic status on progression-free survival (PFS) of patients with neuroendocrine tumours (NETs) treated with lanreotide (LAN) or placebo (PBO). (Pusceddu, et al.)
Presenting author: V Pusceddu [Sponsor: Ipsen]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline) & telotristat (Xermelo) will be featured in 1 presentation:

TELESTAR & TELECAST (LAN patients)

[Poster 4378P] Efficacy and safety of telotristat ethyl (TE) in combination with lanreotide (LAN) in patients with a neuroendocrine tumour and carcinoid syndrome (CS) diarrhoea (CSD): Meta-analysis of phase 3 double-blind placebo (PBO)-controlled TELESTAR and TELECAST studies. (Hörsch, et al.)