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.)

On October 12, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the pricing of an underwritten public offering of 22,000,000 shares of its common stock at a public offering price of $9.97 per share (Press release, Iovance Biotherapeutics, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371434 [SID1234529874]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be $219.3 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,300,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about October 16, 2018, subject to customary closing conditions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of Iovance TIL as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus will be filed with the SEC, copies of which may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 12, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported updated results from the Phase 1 clinical trial of its investigational BTK inhibitor zanubrutinib, in an oral presentation at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). The IWWM meeting is taking place in New York City from October 11-13, 2018 (Press release, BeiGene, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371428 [SID1234529875]).

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"As we prepare our first U.S. New Drug Application (NDA) filing for zanubrutinib, which we expect to file in the first half of 2019 in patients with Waldenström’s Macroglobulinemia (WM), we are pleased to update data in patients with WM from the Phase 1 trial that will support our filing. With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses (VGPRs)," commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We believe that the maturing data across B-cell malignancies continue to support a multi-regional approval strategy for zanubrutinib, including the ongoing NDA review in China for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma by The National Medical Products Administration. We are hopeful that zanubrutinib, if approved, will represent a valuable treatment option across the globe for patients with several forms of B-cell malignancy."

Updated Results of Zanubrutinib in WM from Phase 1 Trial

A Phase 1 trial of zanubrutinib as a monotherapy in patients with different subtypes of B-cell malignancies, including WM, is being conducted in Australia, New Zealand, the United States, Italy, and South Korea. As of July 24, 2018, 77 patients with treatment-naïve or relapsed/refractory WM have been enrolled in the trial. Seventy-three patients were evaluable for efficacy in this analysis and the median follow-up time was 22.5 months (4.1-43.9). The median time to response (>PR) was 85 days (55-749). At the time of the data cutoff, 62 patients remained on study treatment. Updated results included:

The overall response rate (ORR) was 92 percent (67/73), the major response rate (MRR) was 82 percent, and 41 percent of patients achieved a VGPR, defined as a >90% reduction in baseline IgM levels and improvement of extramedullary disease by CT scan.

The 12-month progression-free survival (PFS) was estimated at 89 percent. The median PFS had not yet been reached.

The median IgM decreased from 32.7 g/L (5.3-91.9) at baseline to 8.2 g/L (0.3-57.8).

The median hemoglobin increased from 8.85 g/dL (6.3-9.8) to 13.4 g/dL (7.7-17.0) among 32 patients with hemoglobin <10 g/dL at baseline.

MYD88 genotype was known in 63 patients. In the subset known to have the MYD88L265P mutation (n=54), the ORR was 94 percent, the major response rate was 89 percent, and the VGPR rate was 46 percent. In the nine patients known to be MYD88WT, a less common genotype that historically has had sub-optimal response to BTK inhibition, the ORR was 89 percent, the major response rate was 67 percent, and the VGPR rate was 22 percent.

Treatment with zanubrutinib was generally well-tolerated and the majority of adverse events (AEs) were grade 1 or 2 in severity. The most frequent AEs of any attribution were petechia/purpura/contusion (43%), upper respiratory tract infection (42%), cough (17%), diarrhea (17%), constipation (16%), back pain (16%), and headache (16%).

Grade 3-4 AEs of any attribution reported in three or more patients included neutropenia (9%), anemia (7%), hypertension (5%), basal cell carcinoma (5%), renal and urinary disorders (4%), and pneumonia (4%). Serious AEs (SAEs) were seen in 32 patients (42%), with events in five patients (7%) considered possibly related to zanubrutinib treatment: febrile neutropenia, colitis, atrial fibrillation, hemothorax, and pneumonia (n=1 each).

Nine patients (12%) discontinued due to AEs: abdominal sepsis (fatal), septic shoulder, worsening bronchiectasis, scedosporium infection, gastric adenocarcinoma (fatal), prostate adenocarcinoma, metastatic neuroendocrine carcinoma, acute myeloid leukemia, or breast cancer (n=1 each, all considered by the investigator to be unrelated to treatment).

Atrial fibrillation/flutter occurred in four patients (5%). Major hemorrhage was observed in two patients (3%).

Four patients (3%) discontinued study treatment due to disease progression as assessed by investigator and one patient remains on treatment post-disease progression.
"We are encouraged that additional data on zanubrutinib in patients with WM confirms the initially reported experience, with consistent demonstration of robust activity and good tolerability. We are hopeful that zanubrutinib, if approved, could potentially provide an important new treatment option to patients with WM and other hematologic malignancies," said Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center, in Australia.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas.

On October 12, 2018 The imaging agent 5-Aminolevulinic Acid (5-ALA), which helps neurosurgeons see the edges of a tumor more clearly to improve removal, was used in brain cancer surgery at University Hospitals Seidman Cancer Center today for the first time since the FDA approved it for use in the United States (Press release, University Hospitals, OCT 12, 2018, View Source [SID1234530230]). Although the drug has long been a standard of care in Germany and much of Europe, it was only approved by the FDA for use in the U.S. in 2017.

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Andrew Sloan, MD, Director, Brain Tumor and Neuro-Oncology Center at UH Seidman and UH Cleveland Medical Center, who has been doing clinical trials with the drug for almost a decade based on his own FDA-approved IND clinical trial, was the first neurosurgeon in the U.S. to use the drug on a patient with brain cancer since FDA approval.

Several published studies — including those from Dr. Sloan — have shown that removing more tumor results in improved survival. However, this often is difficult.

"Glioblastoma are tumors which derive from the brain itself. They look like brain tissue, they feel like brain tissue, and at times, it’s hard to determine where tumor ends and inflamed brain tissue begins," said Dr. Sloan.

To help identify the difference between the border of tumors and healthy tissue and improve tumor removal, Dr. Sloan used 5-ALA during surgery so that the tumor cells glowed hot pink when illuminated with a special blue light incorporated into his operating microscope.

This novel technique enabled him to see the edges of the tumors more clearly, allowing him to remove them more completely from the brain.