What’s Driving ESMO 2018?

A recent analysis from 1stOncology/BioSeeker reveals the direction of commercial drug development emerging from the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 congress, featuring more than 2000 abstracts detailing the latest ground-breaking science/clinical development in oncology.

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While this analysis tells you all from which immunotherapies are dominating at E.S.M.O to development of novel targets, never previously pursued in oncology, the center stage for the “Commercial Interest at E.S.M.O Annual Meeting 2018” is to feature where E.S.M.O makes a footprint in the commercial cancer drug development landscape. What’s so compelling with the analysis is that is constructed from an exceedingly solid knowledge-base of more than 12,500 drugs, 4,000 companies/organizations and tens of thousands of interventional clinical trials in oncology.

The hotbed of this conference is energized from an underlying cluster of roughly 300 drugs ranging from preclinical to marketed in maturity (see pipeline breakdown by stage above). Two fifths (40%) of these are Immune-Oncology drugs including Immune Checkpoint drugs, Cancer vaccines, Bispecific immunomodulators, CAR/TCR therapies and Oncolytic virotherapies. In the spotlight of this year’s Nobel Prize in Physiology or Medicine E.S.M.O 2018 features nearly 40 different immune checkpoint drugs, by far the most reported on immunotherapy and even more so if we take into account all combination therapy reports with the same. Other hot progress areas in cancer therapeutics include DNA Damage Response (DDR) drugs, epigenetic therapies, protein kinase inhibitors and antibody-drug conjugates (ADCs).

The number of targets related to the aforementioned drugs is close to 200 were the top five drug targets are: KDR/VEGFR2 (17), EGFR (15), HER2 (14), KIT (13) and FLT4 (11) (see target breakdown above).

On the contrasting end of these we find fourteen unique targets belonging to first-in-class drugs like Astellas’ enfortumab vedotin, a fully humanized monoclonal antibody that delivers the microtubule-disrupting agent monomethyl auristatin E to tumors expressing Nectin-4, which is highly expressed in 97% of metastatic urothelial cancer patient samples.

There is a global presence of companies at E.S.M.O 2018 ranging from big pharma to startups like Arcus Biosciences (USA), CStone Pharmaceuticals (China), Neon Therapeutics (USA), NEOMED Therapeutics 1 (Canada) and Oblique Therapeutics (Sweden).

It is noteworthy to mention that both Arcus Biosciences and Neon Therapeutics are 2016 winners of the prestigious Fierce 15 Biotech award (see 2018 cancer winners here). This prestigious award has come to symbolize novelty and being at the forefront of biotechnology development among businesses. The winners of this award are aiming at breakthroughs and big things, not at being ‘me-too’. For an example Arcus Biosciences is reporting stellar safety data from its phase 1 study of AB928, a dual antagonist of the A2aR and A2bR adenosine receptors. This development is of course only the tip of the iceberg of clinical trial reports presented at this year’s conference. In a late breaking abstract (LBA) Friday (October 19) Merrimack Pharmaceuticals will be providing more information to their previous report in June about their failed CARRIE study, evaluating the addition of istiratumab (MM-141) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (For more LBAs see Saturday, Sunday and Monday releases). The study did not meet its primary or secondary efficacy endpoints in patients who received istiratumab in combination with nab-paclitaxel and gemcitabine, compared to nab-paclitaxel and gemcitabine alone. These results were consistent in all subgroups analyzed.

In overall the late breaking abstracts presented at ESMO (Free ESMO Whitepaper) 2018 are testament to years of rapid growth of and interest in combination therapy trials and in particular with immune-checkpoint inhibitors. On Saturday (October 20th) Genentech/Hoffman-La Roche got the world’s attention with “game changing” results from their IMpassion130 study, a global, randomised, double-blind, phase 3 study of atezolizumab + nab-paclitaxel versus placebo + nab-paclitaxel in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). Among those who received the combination, the median survival was 21.3 months, compared with 17.6 months for those who received chemotherapy alone. The difference was not statistically significant. However, looking only at women with positive PD-L1 expressing tumors the median survival was 25 months in the combination group, versus 15.5 months with just chemotherapy. That finding has however not been analyzed statistically, and the patients are still being followed. These finds were simultaneously published in View Source">The New England Journal of Medicine and presented at ESMO 2018.

In spite of limited representation of a major therapeutic class like CAR/TCR therapies or the latest progress on targeting the CD47-SIRPA axis, all in all the ESMO (Free ESMO Whitepaper) congress is Europe’s largest clinical oncology meeting and a go-to place that acts as a sign-post on the road ahead in cancer drug development.

PharmaMar will present at ESMO results of the phase III CORAIL study with lurbinectedin in platinum-resistant Ovarian Cancer

On October 18, 2018 During the congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), that will be held from the 19th to the 23rd of October in Munich, Germany, PharmaMar’s (MSE:PHM) Zepsyre (lurbinectedin) abstract #9320 entitled "Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial" will be presented orally on the 19th of October (Press release, PharmaMar, OCT 18, 2018, View Source [SID1234529959]).

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Dr. Ali Zeaiter, Director of Clinical Development of the Oncology Business Unit at PharmaMar explains: "While we are disappointed that the CORAIL trial didn´t meet its primary endpoint of PFS, the data obtained support that lurbinectedin has activity in platinum-resistant Ovarian Cancer."

Data obtained from other PharmaMar compounds of marine origin, lurbinectedin and Yondelis (trabectedin) will also be presented. These include four other posters with the latest advances in the clinical development of trabectedin, including the results of the randomized phase III (TSAR) study evaluating the quality of life of patients with Advanced Soft Tissue Sarcoma (ASTS).

The studies that will be presented during the ESMO (Free ESMO Whitepaper) 2018 Congress are available at: View Source

Lurbinectedin

Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial (#932O)
Oral presentation – 19.10.2018, 14:00 – 15:15, in Hall A1 – Room 15.
Principal Author: S. Gaillard, Baltimore, US.

SAKK 17/16 – Lurbinectedin monotherapy in patients with progressive malignant pleural mesothelioma: A multicenter, single-arm phase II trial (#1817TiP)
Poster – 20.10.2018, 13:30 Hall A3 – Poster Area – Networking Hub
Principal Author: Y. Metaxas. Chur, Switzerland.

Yondelis (trabectedin)

Health-related quality of life in patients with advanced soft tissue sarcoma (ASTS): Results from the TSAR randomized phase III trial of the French Sarcoma Group (#1604PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Axel Le Cesne, Villejuif, France.

Quality of Life in patients with soft tissue sarcoma undergoing palliative treatment – A multicenter, cluster-randomized trial within the German Interdisciplinary Sarcoma Group, GISG-12 (#1606PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Leopold Hentschel, Dresden, Germany.

Trabectedin and radiotherapy in advanced sarcoma: experience of a Reference Center (#1626P)
Poster – 22.10.2018, 12:45 – 13:45, in Hall A3 – Poster Area Networking Hub
Principal Author: Javier Martín-Broto, Seville, Spain.

Trabectedin plus pegylated liposomal doxorubicin (PLD) in patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior use of antiangiogenics: First results of an observational, prospective study (#987P)
Poster – 20.10.2018, 12:30 – 13:30, in Hall A3 – Poster Area Networking Hub
Principal Author: Sandro Pignata, Naples, Italy.

Legal warning
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.

About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com.

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close to 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

Revenue for the nine-month period to September 30, 2018

On October 18, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER) a company specializing in in vitro diagnostics and theranostics, reported its consolidated revenue for the nine-month period to September 30, 2018

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Sales for the third quarter of 2018 are up sharply at +9% compared to the third quarter of 2017. This performance is mainly due to the very strong growth in sales of Tracker kits for routine use, which rose by 34% over the period.

Theradiag’s revenue in the nine-months period to September 30, 2018 totaled €6.5 million, down 5% on its nine-months 2017 level, compared to a 9% contraction in the first half of 2018.

Nine-months sales of Tracker kits for routine use moved up 18% from their nine-months 2017 level. Growth in Tracker sales for routine use accelerated from 8% in the first, to 15% in the second and 34% in the third quarter.

As in the previous quarter, total theranostics revenue declined by 9% because no non-recurring theranostics revenue was recorded in the first nine months of the year. In contrast, substantial revenue was received in the same period of 2017 under agreements with pharmaceutical groups.

IVD revenue remained stable at September 30,2018

NewLink Genetics to Host Its Third Quarter 2018 Financial Results Conference Call on November 1, 2018

On October 18, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that it will release its third quarter 2018 financial results on Thursday, November 1, 2018 (Press release, NewLink Genetics, OCT 18, 2018, View Source [SID1234530683]). The company has scheduled a conference call for 4:30 PM ET the same day to discuss the results and to give an update on its clinical development activities.

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NewLink Genetics’ senior management team will host the conference call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1753698.

ENDOCYTE ENTERS INTO AGREEMENT TO BE ACQUIRED BY NOVARTIS AG FOR $2.1 BILLION

On October 18, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for cancer treatment, reported that it has entered into an agreement and plan of merger with Novartis AG ("Novartis") pursuant to which Novartis will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1 billion, in cash (Press release, Endocyte, OCT 18, 2018, View Source [SID1234529960]). This offer represents a premium of 54% percent to Endocyte’s closing price of $15.56 on October 17, 2018. The transaction was unanimously approved by the board of directors of Endocyte.

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"Since acquiring exclusive worldwide rights to develop and commercialize PSMA-617 agents in 2017, the entire Endocyte team, along with our partners, have worked tirelessly to build a leading radioligand (RLT) portfolio and create value for patients and shareholders alike. We are thrilled that Novartis recognizes the potential for 177Lu-PSMA-617 to change the treatment landscape for men with metastatic castration-resistant prostate cancer (mCRPC), as well as the broader role that RLTs may potentially play in the treatment of cancer," said Mike Sherman, president and CEO of Endocyte. "The global reach and expertise of Novartis in developing and commercializing RLT therapies will be critical in efforts for patients to benefit from these therapies as quickly as possible."

Completion of the transaction is expected in the first half of 2019, subject to approval by Endocyte stockholders, antitrust and regulatory approvals and other customary closing conditions. Until that time, Endocyte will continue to operate as a separate and independent company.

Centerview Partners LLC is acting as lead financial advisor to Endocyte. Jefferies LLC is also acting as financial advisor to Endocyte. Faegre Baker Daniels LLP is acting as legal counsel to Endocyte.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.