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Bicycle Therapeutics to Present New Translational Data for BT1718 and Preclinical Data for Other Bicycle® Toxin Conjugates at AACR-NCI-EORTC 2019

On October 16, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported that new translational data for BT1718 and preclinical data for BT5528 and BT8009 will be presented during poster sessions at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 26-30, 2019 in Boston, MA (Press release, Bicycle Therapeutics, OCT 16, 2019, View Source [SID1234542316]).

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New translational data will be presented for BT1718, the Company’s lead Bicycle Toxin Conjugate (BTC) product candidate, which define enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial with BT1718. The Phase I/IIa study, sponsored by Cancer Research UK, is currently in Phase I dose escalation in patients with advanced solid tumors who have not been pre-selected for MT1-MMP status. Once a recommended once-weekly Phase II dose is established, the Company expects to initiate the Phase IIa expansion, which will include patients determined to be MT1-MMP-postive based on a prespecified tumor membrane H-score. Initially, patients will be enrolled into two expansion cohorts, one in squamous lung cancer and the other in an all-comers "basket" cohort. Depending on results from these first two cohorts, additional cohorts may be initiated.

"We are creating a pipeline of Bicycle Toxin Conjugates, which selectively deliver toxin payload to tumors in a manner we believe is unique and differentiated to that of antibody drug conjugates," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We intend to maximize chances of success in the clinic for these innovative medicines by applying well-validated translational approaches to inform tumor type selection and patient enrollment criteria. As the data to be presented supports, we believe we have developed a compelling rationale for the design of the Phase IIa part of the ongoing trial and look forward to advancing BT1718 into the expansion cohorts, following dose selection."

Additional preclinical data will also be presented for Bicycle’s other BTC programs, BT5528 and BT8009, which show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively.

Details on Bicycle’s presentations at AACR (Free AACR Whitepaper)-NCI-EORTC are as follows:

Session Title: Poster Session A
Location: Level 2, Hall D
Poster Presentation Title: MT1-MMP Immunohistochemistry (IHC) analysis of tumor microarrays (TMAs) using a novel scoring system guides patient selection for BT1718 expansion cohorts
Abstract #: A047
Date & Time: October 27, 2019, 12:30 p.m. – 4:00 p.m. ET

Session Title: Poster Session C
Location: Level 2, Hall D
Poster Presentation Title: BT5528, a Bicycle Toxin Conjugate targeting EphA2: mechanism of action and clinical translation
Abstract #: C066
Date & Time: October 29, 2019, 12:30 p.m. – 4:00 p.m. ET

Session Title: Poster Session C
Location: Level 2, Hall D
Poster Presentation Title: BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, shows target selectivity, and efficacy in preclinical large and small tumor models
Abstract #: C061
Date & Time: October 29, 2019, 12:30 p.m. – 4:00 p.m. ET

The posters will be available on the Publications section of bicycletherapeutics.com following the presentation.

About BT1718

BT1718 is a Bicycle Toxin Conjugate being developed by Bicycle Therapeutics that targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which has an established role in cell invasion and metastasis, is linked to poor outcomes and is over-expressed in many solid tumors. BT1718 has demonstrated promising target-dependent efficacy in preclinical models, including both cell- and patient-derived xenografts that are resistant to treatment with standards of care. In addition, it shows only a subset of the toxicities typically associated with other highly potent cancer treatments.

Exelixis to Release Third Quarter 2019 Financial Results on Wednesday, October 30, 2019

On October 16, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2019 financial results will be released on Wednesday, October 30, 2019 after the markets close (Press release, Exelixis, OCT 16, 2019, View Source [SID1234542315]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 5489464 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 1, 2019. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 5489464. A webcast replay will also be archived on www.exelixis.com for one year.

Amarna Therapeutics Raises €10 million to Progress lead Development Candidate into Clinical Trials and Appoints a new Supervisory Board

On October 16, 2019 Amarna Therapeutics, a privately held biotechnology company developing a next-generation SV40-based gene delivery vector platform named SVac that promises to transform gene-replacement and immunotherapy across many disease areas, reported that it has raised €10 million (Press release, amarna therapeutics, OCT 16, 2019, View Source [SID1234542314]). The round was led by Flerie Invest AB, a Swedish investment company with another substantial contribution coming from an innovation credit from the "Netherlands Enterprise Agency" (RVO.nl) and existing shareholder Pim Berger.

The Company plans to use this funding to progress development of its SVac platform towards a first in man clinical study to commence in two to three years from now.

In addition to raising new funds, Amarna has recruited a new Supervisory Board to help underpin this new ‘clinical’ phase of its growth and development. Thomas Eldered has been appointed as Supervisory Board Chairman. Bernhard Kirschbaum, Maarten de Chateau, Ted Fjällman, Pim Berger and Guillaume Jetten have also joined the Supervisory Board (see biographies at the end of the release).

Ben van Leent, CEO of Amarna said:
"We are very happy to have attracted such strong investors. This significant new funding allows Amarna to accelerate the development of SVac and our lead product AMA001, and to help us achieve our ultimate goal: to become a leading global gene therapy player".
"We would like to extend a warm welcome to all of the members of our new Supervisory Board, led by the outstanding healthcare and biotech pioneer Thomas Eldered. They bring many years of in-depth life science knowledge and entrepreneurship to Amarna".

Thomas Eldered, new Chairman of Amarna’s Supervisory Board, commented:
"I’m very much looking forward to working at Amarna. Its viral gene delivery vector platform has the potential to make major medical breakthroughs possible, so that patients can be actually cured of "significant" diseases for which, to date, effective treatment have not become available. Together with my highly qualified and experienced colleagues in our new Supervisory Board, I’m fully committed to help progress Amarna into the next important clinical stages of development of its groundbreaking technology".

SV40 Vectors are non-immunogenic in humans
Viral gene delivery vectors that are currently used for in vivo gene therapy are ineffective because the particles are instable upon injection (in the case of lentiviral vectors) or because the particles are immunogenic in humans (in the case of AAV vectors). Gene delivery vectors derived from the macaque polyomavirus Simian Virus 40 (SV40) are an attractive alternative to lentiviral and AAV vectors for clinical gene therapy. Humans can be considered naïve to SV40 since the virus only replicates in macaques, where it causes symptomless infections. Replication-defective SV40 vectors are non-immunogenic in humans and moreover, have the capacity to induce immune tolerance to the transgene products. SV40 vectors therefore hold a great potential for clinical applications treating genetic disorders, cancer, allergies and degenerative/inflammatory conditions such as neurodegenerative and psychiatric diseases, atherosclerotic cardiovascular disease, diabetes mellitus, arthritis, chronic obstructive pulmonary disease and many more.

Amarna’s SVac platform: the benefits
Amarna has genetically engineered the SV40 genome used for the production of vector particles and in parallel generated a novel Vero-based packaging cell line named SuperVero that produces similar numbers of vector particles to the currently used packaging cell lines but without contaminating wild type SV40 particles. Since SVac is safe, highly efficient, non-immunogenic in humans and vector particles can be cost effectively produced in SuperVero cells, Amarna’s vector platform paves the way to clinically evaluate a whole new generation of SVac-based therapeutics for today’s major diseases.

Results from STELLAR Trial of Tumor Treating Fields with Chemotherapy in Malignant Pleural Mesothelioma Published in The Lancet Oncology

On October 16, 2019 Novocure (NASDAQ: NVCR) reported that results from the STELLAR trial were published in The Lancet Oncology (Press release, NovoCure, OCT 16, 2019, View Source [SID1234542313]). The STELLAR trial was a prospective, single-arm trial including 80 patients that studied the use of Tumor Treating Fields, delivered via the NovoTTF-100L System, in combination with pemetrexed plus cisplatin/carboplatin as a first-line treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM).

Data showed a median overall survival of 18.2 months (95 percent CI, 12.1 months-25.8 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. One- and two-year survival rates were 62.2 percent (95 percent CI, 50.3 percent-72.0 percent) and 41.9 percent (95 percent CI, 28.0 percent-55.2 percent), respectively. No serious systemic adverse events were considered to be related to the use of NovoTTF-100L. The most common mild to moderate adverse event was skin irritation beneath the transducer arrays.

"The STELLAR trial demonstrated encouraging overall survival results with no increase in systemic toxicity observed in MPM patients treated with Tumor Treating Fields and standard chemotherapy," said Giovanni Luca Ceresoli, MD, Head of Pulmonary Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy, and Principal Investigator in the STELLAR trial. "The median overall survival of 18.2 months is impressive given that MPM is a tumor with a dismal prognosis and few effective therapeutic options."

"Mesothelioma is an aggressive cancer that is extremely difficult to treat," said Rupesh Kotecha, MD, Chief of Radiosurgery, Radiation Oncology, Miami Cancer Institute in Florida. "With such limited treatment options, I’m encouraged by the FDA approval of NovoTTF-100L, adding another therapy with the potential to improve outcomes for people with unresectable MPM."

Median progression free survival was 7.6 months (95 percent CI, 6.7 months-8.6 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. There was a 97 percent disease control rate in patients with at least one follow-up CT scan performed (n=72). 40 percent of patients had a partial response, 57 percent had stable disease and 3 percent had progressive disease.

"MPM patients are in need of better treatment options," said Novocure CEO Asaf Danziger. "We are proud that NovoTTF-100L is the first FDA-approved therapy for MPM in more than 15 years. We hope it is just the beginning of continued innovation for patients with this disease."

About Malignant Pleural Mesothelioma (MPM)

Malignant pleural mesothelioma is a rare thoracic solid tumor cancer that has been strongly linked to asbestos exposure. Mesothelioma has a long latency period of 47.9 years on average for men and 53.3 years on average for women following asbestos exposure. There are approximately 3,000 new cases of mesothelioma annually in the United States. Globally, more than 14,000 people are diagnosed with mesothelioma each year. Global mesothelioma incidence is increasing in countries where asbestos is still in use. The prognosis of mesothelioma patients is very poor.

About STELLAR

STELLAR was a phase 2, prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L, a Tumor Treating Fields delivery system, and pemetrexed plus cisplatin or carboplatin as a first-line treatment for 80 patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). The trial was designed for patients to receive Tumor Treating Fields at 150 kHz at least 18 hours a day until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included objective response rate, progression-free survival and safety.

Eligible patients had no prior chemotherapy or radiation treatment for MPM, were at least 18 years old, had an Eastern Cooperative Oncology Group performance status of 0-1, and had at least one measurable or evaluable lesion according to the modified RESIST criteria. Adequate hepatic, renal and hematological functions were required, as well as a life expectancy of at least 3 months. The study was conducted at 12 sites in Europe.

About the NovoTTF-100L System

NovoTTF-100L is a noninvasive, antimitotic cancer treatment for MPM. NovoTTF-110L delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

Approved Indications

The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

Important Safety Information

Contraindications

Do not use the NovoTTF-100L System in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of the NovoTTF-100L System together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use the NovoTTF-100L System in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with the NovoTTF-100L System may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

The NovoTTF-100L System can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving the NovoTTF-100L System in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

If the patient has an underlying serious skin condition on the chest, evaluate whether this may prevent or temporarily interfere with the NovoTTF-100L System treatment.

Do not prescribe the NovoTTF-100L System for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of the NovoTTF-100L System in these populations have not been established.

Please visit www.novottf100l.com to see the NovoTTF-100L System Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

IMV Inc. to Present at Upcoming Investor Conference

On October 16, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that company management will be attending the BIO Investor Forum to be held on October 22-23 at the Westin St. Francis, San Francisco (Press release, IMV, OCT 16, 2019, View Source [SID1234542312]).

BIO Investor Forum Oct. 23 2:00 PM PST / 5:00 PM EST

A live webcast of this presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.