On May 30, 2018 MonTa Biosciences reported that attend Bio in Boston from June 4-7th to meet and discuss partnership, collaborations and investment opportunities (Press release, MonTa Biosciences, MAY 30, 2018, View Source [SID1234618632]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 30, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company at the Jefferies Global Healthcare Conference being held in New York on June 5-8 (Press release, Sierra Oncology, MAY 30, 2018, View Source [SID1234526943]). The presentation is scheduled for 8:30 a.m. ET on Thursday, June 7. A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 30, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported it has entered into a collaboration with Roche to develop immunohistochemistry (IHC) companion diagnostic assays for use with Five Prime’s first-in-class investigational drug candidates, bemarituzumab, an anti-FGFR2b antibody (also known as FPA144), and FPA150, a B7-H4 antibody (Press release, Five Prime Therapeutics, MAY 30, 2018, View Source [SID1234526960]).

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"We are pleased to collaborate with Roche, a world leader and innovator of tissue-based diagnostic solutions, to identify patients with advanced cancers who might be eligible for treatment with our targeted immuno-oncology agents," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics, Inc. "We believe targeted therapies, such as bemarituzumab and FPA150, could provide clinical benefit to patients. Roche’s tissue-based assays will be important tools to help us identify the patients who might benefit most from these treatments."

Five Prime and Roche are collaborating to develop, validate and commercialize a tissue-based IHC companion diagnostic (CDx) assay to help identify patients whose tumors overexpress FGFR2b and are eligible for treatment with bemarituzumab. The CDx assay will be used in Five Prime’s global registrational study of bemarituzumab in combination with 5-fluorouracil (5-FU), leucovorin, and oxaliplatin, a regimen known as mFOLFOX6, as front-line treatment in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification (the FIGHT trial) that Five Prime expects to start in the second half of 2018. Five Prime plans to use the Roche IHC assay along with a circulating tumor DNA (ctDNA) test in the FIGHT trial to identify the estimated 10 percent of patients with gastric and gastroesophageal junction cancer who would be eligible for treatment with bemarituzumab.

Five Prime and Roche will also collaborate to develop and validate a tissue-based IHC diagnostic assay for use as a laboratory developed test (LDT) to help identify patients whose tumors overexpress B7-H4. Five Prime plans to use this IHC assay in the expansion portion of the ongoing Phase 1 clinical trial of FPA150 to identify patients with advanced or metastatic breast, ovarian, endometrial and bladder cancers whose tumors overexpress B7-H4.

Financial terms of the agreement were not disclosed.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family, or amplify the FGFR2 gene. Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

Bemarituzumab is being evaluated in the FGF2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) Phase 1/3 clinical trial, a global registrational study in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification. The Phase 3 portion of the trial is expected to begin in the second half of 2018. In December 2017, Five Prime and Zai Lab announced a collaboration for the development and commercialization of bemarituzumab in Greater China. Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

About FPA150

FPA150 is a first-in-class, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent ADCC against tumor cells expressing B7-H4. B7-H4 is being studied in a Phase 1 trial of monotherapy FPA150 with a dose-escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers.

On May 30, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will present at the upcoming Jefferies 2018 Global Healthcare Conference (Press release, ImmunoGen, MAY 30, 2018, View Source [SID1234526961]). The presentation is scheduled for 1:30 p.m. ET on June 7, 2018.

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A webcast of the presentation will be accessible live through the "Investors" section of the Company’s website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.

On May 30, 2018 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2018 (Press release, Nordic Nanovector, MAY 30, 2018, View Source [SID1234553502]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Tone Kvåle, CFO and Interim CEO, commented: "We have been focusing our efforts, since the beginning of the year, on getting PARADIGME approved and started. While our progress with the start-up of this pivotal study has been encouraging, we saw reason in April to announce adjustments to the timelines for its duration and are now targeting the first data read-out from the study in the first half of 2020.

"We remain convinced of the significant potential of Betalutin based on the promising clinical data generated to-date. We also believe that PARADIGME provides a robust trial design to generate the data needed to support our regulatory and commercialisation strategy for Betalutin to become an important new treatment option for 3L FL patients."

Operational Highlights Q1’18

• Start-up activities ongoing for pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed/refractory follicular lymphoma (3L R/R FL)

o As at May 29th, 23 sites in 8 countries are open for enrolment

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Events after Q1’18

• Luigi Costa stepped down as CEO

o Tone Kvåle appointed as Interim CEO in addition to existing role as CFO

o Search for new CEO underway

• PARADIGME timelines revised with first results targeted for 1H 2020 (previously 2H 2019)

o Start-up activities and site initiations progressing

• Clinical development of Humalutin postponed for the foreseeable future as resources are re-focused on PARADIGME and the Betalutin development programme

Financial Highlights Q1 ‘18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues in the first quarter 2018 amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the quarter were NOK 82.3 million (NOK 65.8 million).

o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 76.2 % of total operating expenses in the first quarter 2018 (72.2 %).

• Operating loss for the quarter was NOK 82.3 million (loss of NOK 65.7 million).

• Comprehensive loss for the quarter was NOK 90.7 million (loss of NOK 55.8 million).

• Cash and cash equivalents as at 31 March 2018 amounted to NOK 641.5 million, down from NOK 756.6 million at the end of 31 December 2017.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial data read-outs from the study targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Presentation and webcast – First quarter 2018 results and webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast