On September 21, 2018 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (Press release, Oasmia, SEP 21, 2018, View Source [SID1234556569]). The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.

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The CHMP’s positive opinion will now be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.

The CHMP recommendation is based on clinical trials including the pivotal study OAS 07OVA. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after Cremophor EL (CrEL)-formulated paclitaxel in combination with carboplatin.

Key efficacy results in the per protocol population from the pivotal randomized clinical trial OAS-07OVA

Progression-free survival (PFS)
(N=644) Overall survival (OS)
(N=644)
Hazard ratio, HR1
(95% CI) 0.86
(0.72-1.03)
0.95

(0.78-1.16)

Apealea2 CrEL-paclitaxel2 Apealea2 CrEL-paclitaxel2
Median, months
(95% CI) 10.3
(10.1-10.7) 10.1
(9.9-10.2) 25.7
(22.9-28.1) 24.8
(21.7-27.1)

1A longer PFS or OS for Apealea compared to CrEL-formulated paclitaxel is indicated by a HR less than 1.0.
2In combination with carboplatin.

The most frequently reported adverse reactions after Apealea treatment in combination with carboplatin (≥10%) were neutropenia, anorexia, peripheral sensory neuropathy, neuropathy peripheral, diarrhea, nausea, vomiting, alopecia, arthralgia, myalgia, asthenia, fatigue and infusion site reaction.

About epithelial ovarian cancer

Ovarian cancer is the seventh most common cancer in women. Approximately 239,000 women are annually diagnosed with ovarian cancer globally and 152,000 dies from the disease. Epithelial ovarian cancer is the most common form and accounts for about 90% of ovarian cancers. The disease is often diagnosed at an advanced staged since it has no symptoms at early stages. The five-year survival rate (i.e. survival of patients with ovarian cancer compared to survival in the general population at the same age) for ovarian cancer has been estimated to 38% in Europe. During 2018, approximately 68,000 women will be diagnosed with ovarian cancer in Europe and 45,000 are predicted to die from the disease. Carboplatin and paclitaxel are common chemotherapy drugs for treatment of ovarian cancer, and are often used in combination.

About Apealea

Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion.

On September 21, 2018 Takeda Pharmaceutical Company Limited ( TSE: 4502 ) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the unreserved approval of ALUNBRIG (brigatinib) used as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK +) previously treated with crizotinib (Press release, Takeda, SEP 21, 2018, View Source [SID1234529518]).

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The original text of this announcement, written in the source language, is the official version that is authentic. Translations are offered solely for the convenience of the reader and must refer to the original text, which is the only legally valid one.

On September 21, 2018 XOMA Corporation (NASDAQ: XOMA), reported that for $15.0 million, it has acquired from Agenus (NASDAQ: AGEN) a partial interest position in the rights to potential milestone and royalty payments associated with seven immuno-oncology antibodies currently being developed by Merck and Incyte under their collaborations with Agenus (Press release, Xoma, SEP 21, 2018, View Source [SID1234529553]).

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"This is an important deal reflecting our new royalty-aggregator strategy to acquire milestone and royalty payments associated with therapeutic candidates partnered by others. The basket of Agenus immuno-oncology assets is advancing in the hands of two of the leading companies in oncology drug development," said Jim Neal, Chief Executive Officer at XOMA. "These assets possess all the characteristics we have established for our business model: outstanding development partners, mid-stage to early stage assets, important therapeutic categories, and sizable royalty commitments. We believe this investment could generate potential future cash flows over an extended period from milestones and royalties on some exciting potential commercial opportunities."

The seven royalty interest antibodies are:

One Phase 1 antibody being developed by Merck on an undisclosed novel target;

Incyte’s INCAGN1876, a GITR agonist in Phase 1/2 studies;

Incyte’s INCAGN1949, an OX-40 agonist in Phase 1/2 studies;

Incyte’s INCAGN2385, a LAG-3 antagonist in Phase 1 studies;

Incyte’s INCAGN02390, a TIM-3 antagonist expected to enter the clinic in 2018; and,

Two preclinical antibodies being developed by Incyte on undisclosed targets.

Under the terms of the agreement, XOMA will receive low- to mid-single-digit royalties on future sales of these seven immuno-oncology assets. Additionally, XOMA is entitled to a portion of milestone payments associated with the assets. XOMA has drawn $7.5 million from its line of credit with Silicon Valley Bank ("SVB") to partially fund this transaction.

On September 21, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib (Press release, Ipsen, SEP 21, 2018, View Source [SID1234529520]). The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

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Alexandre Lebeaut, MD, Executive Vice President, R&D and Chief Scientific Officer,
Ipsen, said:

"The global burden of liver cancer is increasing and despite the recent introduction of new agents, it remains the second leading cause of cancer mortality worldwide. Following today’s positive CHMP opinion and if approved by the European Commission, Cabometyx as monotherapy will give patients with HCC a much-needed new oral therapeutic option."

Dr Lorenza Rimassa, Medical Oncology Unit, Humanitas Cancer Center, Milan, said:

"The medical community is pleased that the CHMP has given a positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma. The fact that Cabometyx demonstrated clinically significant benefits in both overall survival and progression-free survival in the phase 3 CELESTIAL study confirms the value it brings to this difficult treatment landscape"

The EMA filing is based on the results of the global placebo-controlled phase 3 CELESTIAL trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC who have been previously treated with sorafenib. In July 2018, CELESTIAL phase 3 pivotal trial results were published in the New England Journal of Medicine1.

Today’s CHMP positive opinion follows two earlier European Commission approvals for Cabometyx in renal cell carcinoma (RCC).

On September 20, 2018: ENB Therapeutics Inc., a biopharmaceutical company pioneering pathways in endothelin-based oncologics, reported that it has closed its Series A private equity financing (Press release, ENB Therapeutics, SEP 21, 2018, View Source [SID1234634055]). Proceeds from the financing will be used to advance the company’s lead investigational drug compound, ENB-003,a first-in-class, selective inhibitor of the endothelin B receptor ("ETBR") through pre-clinical and early clinical development for the treatment of immunotherapy-resistant cancers.

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Remiges Ventures served as lead investor for the financing with participation from New York State Development, BioAdvance and Alexandria Ventures.

"We are extremely gratified to have attracted a leading group of investors to complete our Series A financing who recognize the potential of ENB-003 to overcome resistance to immunotherapy across multiple tumor types and indications," said Sumayah Jamal, Founder, President and Chief Scientific Officer of ENB. "We have already demonstrated robust pre-clinical efficacy in relevant mouse models across multiple resistant cancers and a favorable safety profile. We now have the capital necessary to advance ENB-003 into Phase 1 clinical trials during the second half of 2019."

Taro Inaba, Managing Partner at Remiges, added, "We believe that ENB Therapeutics’ novel compounds have the potential to enhance the efficacy of immunotherapies and potentially prolong patient survival and thereby address the high unmet medical need which still exists despite the successful development and widespread use of immunotherapies. Therefore, we are very pleased to have the opportunity to support the continued clinical development of ENB-003, which could improve the lives of patients with cancer."