On September 18, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple data presentations from its solid tumour portfolio, including key prostate cancer data, will be featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, taking place 27th September to 1st October in Barcelona, Spain (Press release, Janssen Pharmaceuticals, SEP 18, 2019, View Source [SID1234539622]). Among Janssen’s 12 accepted abstracts is an oral presentation reporting overall survival from the Phase 3 SPARTAN study investigating the use of apalutamide in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC); patient-reported outcomes from the Phase 3 TITAN study in patients with metastatic hormone-sensitive prostate cancer (mHSPC) demonstrating maintenance of overall health-related quality of life with apalutamide; and a late-breaking interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD).

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"We are delighted to share key data from our solid tumour portfolio at this year’s ESMO (Free ESMO Whitepaper) Congress, including new findings for apalutamide and niraparib in the treatment of prostate cancer," said Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. "We continue to pursue areas of oncology where there is the greatest unmet need, and the data being presented in Barcelona reflects our ongoing passion and commitment to improving patient outcomes."

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Apalutamide

Oral Presentation

Abstract #843O

Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study

Friday 27th September

14:00 – 14:15 CET

Poster Presentations

Abstract #851PD

Patient-Reported Outcomes (PROs) From TITAN: A Phase 3, Randomized, Double-Blind Study of Apalutamide Versus Placebo

Added to Androgen Deprivation Therapy in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Sunday 29th September

09:20 CET

Abstract #883P

Androgen Receptor Aberrations in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Treated with Apalutamide Plus Androgen Deprivation Therapy in TITAN

Monday 30th September

12:00 – 13:00 CET

Abstract #900TiP

A Phase 2 randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy with LHRH agonist or antagonist versus anti-androgen therapy with apalutamide in patients with biochemical progression after radical prostatectomy

Monday 30th September

12:00 – 13:00CET

Abiraterone acetate

Poster Presentation

Abstract #95P

Evaluation of markers associated with efficacy of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer (mCSPC) from the LATITUDE study

Monday 30th September

12:00 – 13:00 CET

Niraparib

Poster Presentations

Abstract #LBA50

Pre-specified interim analysis of GALAHAD: A Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects

Sunday, 29th September

08:30 CET

Abstract #897TiP

A Phase 3 randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate

and prednisone in patients with metastatic prostate cancer (NCT03748641)

Monday 30th September

12:00 – 13:00 CET

Abstract #1412P

Analytical performance of the Resolution-HRD plasma assay used to identify mCRPC patients with biallelic disruption of DNA repair genes for

treatment with niraparib

Monday 30th September

12:00 – 13:00 CET

Erdafitinib

Poster Presentations

Abstract #925P

Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients with metastatic urothelial carcinoma

Monday 30th September

12:00 CET

Abstract #926P

Erdafitinib versus available therapies in advanced urothelial cancer: A matching adjusted indirect comparison

Monday 30th September 30

12:00 CET

Abstract #932P

Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Antitumor Activity Among Patients with Advanced Urothelial Carcinoma

Monday 30th September

12:00 CET

Solid Tumor Portfolio

Poster Presentation

Abstract #488P

Correlation of Progression Free Survival-2 and Overall Survival in Solid Tumors

Saturday 28th September

12:00 CET

About ERLEADA (apalutamide)

ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).1 In the U.S. apalutamide is indicated for the treatment of nmCRPC.2

About ZYTIGA (abiraterone acetate)

ZYTIGA (abiraterone acetate) in combination with prednisone is indicated in Europe and the U.S. for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).3,4

About BALVERSATM (erdafitinib)

BALVERSA (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is currently being studied for the treatment of patients with advanced or metastatic urothelial cancer.5 In the U.S. it is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.6

About niraparib

Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.7 In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer.8 In the U.S., niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9 Niraparib is currently marketed by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer.10

On September 18, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported its participation and poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on September 27 – October 1, 2019 at Fira Gran Via, Av. Joan Carles, 64, 08908 L’Hospitalet de Llobregat, Barcelona, Spain (Press release, Noxxon, SEP 18, 2019, View Source [SID1234539621]).

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Poster Title: Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer

The poster will be presented on Sunday, September 29 from 12.00-01.00 p.m. CEST in Hall 4 and the authors will be available for questions. The poster will also be uploaded to the NOXXON website.

The abstract which is based on an earlier interim dataset will be published on Monday, September 23, at 00.05 a.m. CEST on the ESMO (Free ESMO Whitepaper) website.

Aram Mangasarian, CEO of NOXXON, and Dr. Jarl Ulf Jungnelius, CMO, will host a webcast poster presentation on September 30, 2019, at 09.00 a.m. CEST, to discuss the data from this trial and its relevance for further clinical development of NOX-A12. The presentation will be followed by a Q&A session. To join the webcast, please send an email to [email protected].

On September 18, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported its financial results for the six-month period ended June 30, 2019, and provides an update on its portfolio (Press release, Transgene, SEP 18, 2019, View Source [SID1234539620]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"Transgene has made significant progress with its new technology platforms, its clinical pipeline, and in strengthening its financial position in 2019. Our collaboration with AstraZeneca provides strong validation of the potential of the multi-armed OVs that we are developing thanks to our innovative Invir.IO platform. I am also pleased that we have gained regulatory clearance to begin the clinical development of our lead myvac individualized immunotherapy TG4050 in both the US and Europe before the end of 2019.

Following the negative interim analysis of the PHOCUS trial of Pexa-Vec, we have decided to focus our oncolytic development efforts in indications other than hepatocellular carcinoma. We are looking forward to announcing important clinical data for our candidates TG4001, TG4010 and TG6002 before year end and initiating soon new trials with TG4050 and oncolytic products.

With financial visibility until 2022, Transgene is well placed to leverage these clinical data and move its novel OV and immunotherapy technology platforms into the clinic."

Clinical Pipeline Review

TG4010

+ Opdivo (ICI) (nivolumab)
+ chemotherapy

Phase 2

Non-small cell lung cancer (NSCLC) – 1st line

Trial of TG4010 in combination with nivolumab and with chemotherapy in patients whose tumor cells express low or undetectable levels of PD-L1

✓Last patient enrolled in May 2019

✓Clinical collaboration with Bristol-Myers Squibb, for the supply of nivolumab

→Six-month overall response rate, on at least 35 evaluable patients, expected in December 2019

TG4001

+ Bavencio (ICI)

(avelumab)
Phase 2

HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line

✓Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓Publication of the results of a Phase 2b trial of TG4001 in Gynecologic Oncology, demonstrating the biological activity of this immunotherapeutic in CIN 2/3 lesions; editorial in The Lancet Oncology (April 2019)

→Poster presentation of the translational and efficacy data of the Phase 1b part of the trial at ESMO (Free ESMO Whitepaper)1 (Sept. 27 – Oct. 1, 2019)

→Interim Phase 2 results expected in 1H 2020

TG6002

Phase 1/2a

Gastro-intestinal adenocarcinoma (colon cancer for Phase 2) – Intravenous (IV) route

✓Publication in Molecular Therapy Oncolytics highlighting the promising activity of TG6002 in preclinical colorectal carcinoma models

✓Multicenter trial ongoing in Belgium, France and Spain

→First clinical results (safety) expected at the end of the year 2019

TG6002

Phase 1/2a

Colon cancer with liver metastasis – Intrahepatic artery (IHA) route

✓Multicenter trial authorized in the United Kingdom (July 2019)

→First patient enrolled in 4Q 2019

TG4050 is an individualized therapeutic vaccine, based on the patient’s specific tumor mutations. TG4050 is the first product candidate generated from the myvac technological platform. It is being developed in collaboration with NEC, a partner that brings its know-how in artificial intelligence and co-finances two clinical trials. Through the NEOVIVA consortium, TG4050 also benefits from the support of Bpifrance.

myvac

TG4050

Phase 1

Ovarian cancer – after first-line surgery and adjuvant therapy

✓Trial authorized in the United States (May 2019) and in France (Sept. 2019)

✓Principal investigator: Matthew Block (Mayo Clinic)

→First patient to be enrolled in 4Q 2019

myvac

TG4050

Phase 1

HPV-negative head and neck cancer – after surgery and adjuvant therapy

✓Trial authorized in the United Kingdom (July 2019) and in France (Sept. 2019)

✓Principal investigator: Christian Ottensmeier (Southampton University)

→First patient to be enrolled in 4Q 2019

The first oncolytic virus generated from the Invir.IO platform is armed with BioInvent’s patented anti-CTLA-4 antibody. This development program is co-financed by our partner BioInvent. Our new generation of immunotherapeutics uses an optimized Vaccinia Copenhagen strain; it carries a double deletion TK-RR-, which makes its replication more selective. Its arming involves well-established immunotherapy mechanisms to better attack tumors by combining several complimentary mechanisms of action.

Invir.IO

VV-α-CTLA-4

Phase 1

Solid tumors

✓Collaboration with BioInvent

→Preclinical data to be presented at upcoming scientific conferences in 4Q 2019

→Regulatory filing for first-in-human trial planned in 1Q 2020

Update on the development of Pexa-Vec

On August 2, 2019, Transgene announced that the Independent Data Monitoring Committee (IDMC) of the PHOCUS Phase 3 trial recommended stopping the study based on the IDMC’s assessment that the trial would be unlikely to meet its primary objective at the time of the final analysis.

Transgene has reviewed the PHOCUS data; the Company has also interacted with clinicians, notably with respect to the recent failures in other first-line hepatocellular carcinoma trials. Transgene has decided to stop the ongoing trial evaluating Pexa-Vec in combination with nivolumab in this indication (first-line treatment of advanced liver cancer), which remains a hard-to-treat disease.

Key events of the period

Invir.IO: Collaboration agreement with AstraZeneca and extension of the collaboration with BioInvent

Transgene and AstraZeneca signed a collaboration agreement with exclusive license options with the aim to codevelop five new multifunctional oncolytic viruses based on the Invir.IO platform. Transgene received $10 million (€8.9 million) payment upon signing. The company could also receive up to $3 million payments based on the preclinical development milestones and an option exercise payment for each candidate in the event AstraZeneca exercises its license option, as well as development and commercial milestones and royalties (press release distributed on May 2, 2019). In March 2019, Transgene extended its collaboration with BioInvent for the development of new oncolytic viruses encoding for undisclosed antibody sequences capable of treating a broad range of solid tumors.

myvac platform: agreement finalized with NEC and support from Bpifrance

In January 2019, Transgene and NEC finalized their collaboration agreement. NEC is applying its Artificial Intelligence (AI) "NEC the Wise" technology to TG4050, the first individualized immunotherapeutic derived from the myvac platform. This AI has been developed by NEC for several years in the field of oncology; it will be used to analyze the mutational profiles of the patients’ tumors and select the most relevant mutations that will be integrated in the therapeutic vaccine. This collaboration combines Transgene’s expertise in viral vectors with the power of NEC’s AI. Thanks to this collaboration, therapeutic vaccination is entering the digital age, allowing the design of individualized treatments to fight against cancer. NEC is also cofinancing 50% of the first two clinical trials of TG4050. In March 2019, the NEOVIVA project was selected by the "Investments for the Future" Program (Programme d’Investissements d’Avenir) operated by Bpifrance for the development of the myvac platform. The NEOVIVA project has been granted €5.2 million over five years, of which Transgene is allocated €2.6 million. The NEOVIVA project aims at strengthening the development of an industrial sector focused on this innovative technology together with three partners: HalioDx, Traaser and Institut Curie. The NEOVIVA project is complimentary to the collaboration between Transgene and NEC.

€48.7 million rights issue completed in July 2019

On June 14, 2019, Transgene announced a €48.7 million share capital increase through a rights issue with preferential subscription rights, extending the Company’s financial visibility until 2022. This transaction was completed on July 2, 2019; the settlement and delivery of the shares were executed on July 4, 2019. After the rights issue, the Institut Mérieux (through its subsidiary TSGH) and Dassault Belgique Aviation respectively own 60.44% and 4.98% of Transgene’s equity.

€20 million credit line from Natixis

Transgene obtained a renewable €20 million credit line from Natixis. The credit facility has a 30-month term and Transgene is able to draw down on and repay the facility at its discretion until July 2021. Transgene has used its shares in the Chinese biotech company Tasly Biopharmaceuticals as collateral for this loan. On June 24, 2019, Tasly Biopharmaceuticals filed its draft initial public offering document with the Hong Kong Stock Exchange. To date, the Company had not drawn down on this credit facility.

Operating revenues amounted to €4.9 million for the first six months of 2019 compared to €3.6 million for the same period in 2018.

Revenues from collaboration and licensing agreements amounted to €1.5 million for the first six months of 2019 versus €0.6 million in the same period in 2018. Under the collaboration agreement with AstraZeneca on Invir.IO program, Transgene received, in May 2019, a €8.9 million payment. This initial payment is recognized in income against the progress of the associated activities until 2020. As of June 30, 2019, the income recognized was €0.7 million.
The research tax credit amounted to €3.1 million for the first half of 2019, compared to €2.8 million for the first half of 2018.
Research and Development (R&D) expenses amounted to €14.7 million in the first half of 2019 compared to €13.8 million for the same period in 2018. External expenses for clinical projects increased to €4.7 million from €3.8 million in the first half of 2018, as we continued to progress the clinical development of our products.

General and administrative expenses amounted to €3.6 million for the first half of 2019 compared to €3.0 million for the same period in 2018.

Net loss amounted to €15.3 million for the first half of 2019 compared to €14.9 million for the same period in 2018.

As of June 30, 2019, the Company’s cash, cash equivalents and other financial assets amounted to €12.8 million versus €16.9 million as of December 31, 2018. In addition, Transgene received the net proceed of the rights issue (€47.1 million) on July 4, 2019, which significantly strengthened the Company’s cash position.

Transgene’s cash burn amounted to €4.1 million in the first half of 2019, compared with €8.3 million for the same period in 2018.

Transgene confirms its net cash burn target of approximately €20 million for 2019.

"Our financials for the first half of 2019 are in line with our expectations as we continue to progress our clinical and preclinical assets. The success of our rights issue in June and July 2019 has extended our financial visibility until 2022," commented Jean-Philippe Del, Chief Financial Officer of Transgene.

The Board of Directors of Transgene met on September 18, 2019, and adopted the financial statements for the six-month period ended June 30, 2019. The Statutory Auditors have conducted a limited review of the interim consolidated financial statements. The half-year financial report is available on Transgene’s website, View Source

A conference call in English is scheduled today, on September 18th, 2019, at 6:30 p.m. CET.

Webcast link to English language conference call:

https://channel.royalcast.com/webcast/transgene/20190918_1/

Participant telephone numbers:

France: +33 (0) 1 7037 7166

United Kingdom: +44 (0) 20 3003 2666

United States: +1 212 999 6659

Confirmation code: Transgene

A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event.

On September 18, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat age-related diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present at the 2019 Cantor Global Healthcare Conference, which is being held October 2-4 at the Intercontinental New York Barclay Hotel in New York City (Press release, CohBar, SEP 18, 2019, View Source [SID1234539618]). The conference features more than 200 innovative public and private companies offering insights into developing trends shaping healthcare today.

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CohBar Presentation: Friday, October 4th at 12:35 PM ET.

Webcast: The CohBar presentation may be accessed via webcast at the scheduled time, or following the presentation, by clicking this weblink, View Source

On September 18, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the Ladenburg Thalmann 2019 Healthcare Conference on Tuesday, September 24, 2019 at 9:30 AM ET at the Sofitel Hotel in New York City (Press release, Stemline Therapeutics, SEP 18, 2019, View Source [SID1234539616]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.