On May 29, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the Jefferies 2018 Global Healthcare Conference in New York, NY (Press release, Bicycle Therapeutics, MAY 29, 2018, View Source [SID1234526927]). The presentation will take place at 1:30 p.m. on Tuesday, June 5, 2018.

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On May 29, 2018 Ipsen (Euronext: IPN; ADR: IPSEY), a global biopharmaceutical group, and The University of Texas MD Anderson Cancer Center reported a global licensing and joint development agreement for a pre-clinical oncology drug candidate discovered by researchers in MD Anderson’s Institute for Applied Cancer Science (IACS) (Press release, Ipsen, MAY 29, 2018, View Source [SID1234527087]).

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MD Anderson will progress the drug candidate through Phase I clinical development with Ipsen being responsible for further global development and commercialization.

Alexandre Lebeaut, M.D., Executive Vice President, Research & Development and Chief Scientific Officer, Ipsen, commented, "We are very pleased to partner with the IACS at the MD Anderson Cancer Center whose reputation in scientific excellence and clinical care in Oncology is outstanding. Through this collaboration, we aim to synergize IACS’ scientific expertise with Ipsen’s drug development capabilities to deliver innovative therapies more rapidly to patients in need, and advance patient care in Oncology"

MD Anderson and Ipsen also will collaborate to conduct additional pre-clinical studies to further explore the potential of the drug candidate’s mode-of-action and expanded indications. The detailed financial terms of the agreement, including development and commercial milestones and royalties, have not been disclosed.

"We believe this partnership has the potential to deliver a new therapeutic option to our patients," said Stephen Hahn, M.D., chief medical executive at MD Anderson. "This focus on accelerating the development of efficient treatments is vital to our mission of ending cancer and to providing the very best care we can to those who need it most."

On May 29, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that they will present at Jefferies annual Healthcare Conference in New York on June 7th at 1.30PM EST, the presentation will be webcasted (Press release, Oncopeptides, MAY 29, 2018, View Source [SID1234527103]).

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Oncopeptides is a research and development stage pharmaceutical company developing drugs for the treatment of cancer. Since the founding of the company, the focus has primarily been on the development of the lead product candidate Ygalo, an innovative, peptidase-potentiated alkylator intended for effective and focused treatment of hematological cancers, and in particular multiple myeloma.

Ygalo has been used to treat late-stage RRMM patients in both phase I and phase II clinical studies (O-12-M1) with favorable results. Currently, Ygalo is being studied in three clinical trials for the treatment of multiple myeloma. The current studies are HORIZON, OCEAN and ANCHOR. A fourth study, BRIDGE in RRMM patients with impaired renal function will be initiated during Q3 this year to further investigate Ygalo in multiple myeloma.

The current clinical study program is intended to demonstrate better results from treatment with Ygalo compared to established alternative drugs for patients with late-stage multiple myeloma. Ygalo could potentially provide physicians with a new treatment option for patients suffering from this serious disease.

On May 29, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2018 (Press release, Surface Oncology, MAY 29, 2018, View Source [SID1234527443]).

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"2018 has already been an enormously productive year for Surface with the advancement of our lead program, SRF231, into clinical development and the completion of our IPO," said Jeff Goater, chief executive officer of Surface Oncology. "In addition, we recently selected lead development candidates and initiated IND-enabling studies for our CD39 and IL-27 programs. We look forward to additional pipeline progress later this year, including the advancement of SRF373, targeting CD73, into clinical trials."

Program Highlights:

SRF231, a fully human monoclonal antibody targeting CD47: In February 2018, Surface initiated a Phase I trial of SRF231. The multi-center, open-label Phase I trial will evaluate the safety and tolerability of SRF231 in multiple ascending doses with the goal of establishing a recommended dose for further study. Following the dose escalation phase, the Company intends to evaluate the safety and efficacy of SRF231 in a targeted set of solid and hematologic malignancies. Initial clinical results from this trial are expected in the first half of 2019. Surface holds worldwide rights to SRF231.
SRF373, a fully human monoclonal antibody targeting CD73: An IND for SRF373 was sponsored and filed by Surface’s collaborator, Novartis, in February 2018. A Phase 1 trial is anticipated to begin later this year. SRF373 has been licensed on a worldwide basis by Novartis.

SRF617, a fully human monoclonal antibody targeting CD39: Surface recently identified a development candidate and has initiated IND-enabling studies for SRF617. Surface holds worldwide rights to SRF617.
SRF388, a fully human monoclonal antibody targeting IL-27: Surface recently identified a development candidate and has initiated IND-enabling studies for SRF388. Novartis has the right to purchase an option to SRF388.
Corporate Highlights:

Completed upsized initial public offering (IPO): In April 2018, Surface completed its IPO of 7,200,000 shares of common stock at a public offering price of $15.00 per share and a concurrent private placement of 766,666 shares of common stock to Novartis at the public offering price. Total gross proceeds to Surface were $119.5 million, or $108.7 million after underwriting discounts and offering expenses.
Received $45.0 million milestone payment from Novartis: In February 2018, Surface received an additional milestone payment of $45.0 million from Novartis related to SRF373.

Expanded board of directors with the appointment of three industry and scientific leaders: Elliott Sigal, M.D., Ph.D., former Chief Scientific Officer and President of R&D for Bristol-Myers Squibb; Geoff McDonough, M.D., Chief Executive Officer of Generation Bio; and Laurie Stelzer, Chief Financial Officer of Halozyme Therapeutics.

Expanded management team: In April 2018, Bob Steininger joined Surface as Senior Vice President, CMC. He brings over three decades of biologics manufacturing experience. Previously, he was Director, Manufacturing Operations at Voyager Therapeutics, SVP of Manufacturing and Process Development at Acceleron Pharma and held multiple manufacturing roles of increasing responsibility at Millennium Pharmaceuticals (now Takeda) and Genetics Institute (now Pfizer).
Financial Results
As of March 31, 2018, cash, cash equivalents and marketable securities were $93.8 million, compared to $63.3 million on December 31, 2017. Total cash, cash equivalents and marketable securities at March 31, 2018 did not include total net proceeds of approximately $108.7 million from the Company’s IPO and concurrent private placement completed in April 2018.

Research and development (R&D) expenses were $11.1 million for the first quarter ended March 31, 2018, compared to $8.7 million for the same period in 2017. The increase was largely due to expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.8 million in stock-based compensation expenses for the first quarter of 2018.

General and administrative (G&A) expense were $3.4 million for the first quarter ended March 31, 2018, compared to $1.5 million for the same period in 2017. The increase was largely due to increased G&A personnel associated with the growth of the company and increased professional fees. G&A expenses included $0.5 million in stock-based compensation expenses for the first quarter of 2018.

For the first quarter ended March 31, 2018, net income was $31.2 million, or $1.59 per share attributable to common shares outstanding basic or $1.05 per share attributable to common shares outstanding diluted compared to a net loss of $8.6 million, or $3.60 per share, for the same period in 2017. The increase in net income was primarily driven by the receipt of a $45 million milestone payment under the Novartis collaboration during the first quarter of 2018.

Cautionary Note Regarding Forward-Looking Statements:

Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to: our limited operating history and historical losses, our liquidity to fund the development of SRF231 and our other product candidates through current and future milestones, our ability to raise additional funding to complete the development and any commercialization of our product candidates, our dependence on the success of our lead product candidates, SRF231 and SRF373, results from preclinical studies or early clinical trials may not be representative of larger clinical trials, results from the clinical trials and preclinical studies of third parties working in immuno-oncology and our dependence on third parties in connection with our manufacturing, clinical trials and pre-clinical studies. Additional risks and uncertainties that could affect our future results are included in the section titled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Prospectus dated April 18, 2018, which is available on the SEC’s website at www.sec.gov and our website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that we make from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that we believe to be reasonable as of this date. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

On May 29, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that new data generated from its comprehensive genomic profiling (CGP) assays will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 1-5, 2018 in Chicago (Press release, Foundation Medicine, MAY 29, 2018, View Source [SID1234526928]). The company and its collaborators will present a total of 28 studies, including two oral presentations. Highlights of these presentations include:

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studies demonstrating the importance of known and novel genomic biomarkers of immunotherapy response, including tumor mutational burden (TMB), microsatellite instability (MSI) and PBRM1 alterations across a diverse range of cancer types that could inform more precise use of these treatments;
new data from PURE-01, a phase II study evaluating neo-adjuvant pembrolizumab in urothelial bladder cancer demonstrates the ability of CGP to detect genomic biomarkers (RB1, PBRM1 and TMB) when combined with T-cell inflammation signatures to potentially predict response to immunotherapy;
new data showing that high tissue TMB is associated with higher likelihood of response and longer duration of response to atezolizumab in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma;
data from FoundationACT liquid biopsy assay, describing the landscape of kinase fusions and rearrangements from ctDNA in more than 9,000 clinical cases across multiple cancer types; and
updated data from the precision oncology I-PREDICT clinical trial showing improvements in patient outcomes with integration of molecular tumor boards informed by CGP into treatment planning.
These studies further underscore the importance of Foundation Medicine’s portfolio of CGP assays and molecular data services in supporting precision treatment approaches using tissue or blood samples.

"The role of comprehensive genomic profiling in cancer treatment is evolving very quickly, particularly in predicting who will respond best to new treatments, such as immunotherapy. Foundation Medicine has led essential discoveries in advancing TMB and other genomic biomarkers of immunotherapy response that will help shape the treatment landscape and advance our understanding of how best to use personalized immunotherapy treatment in clinical care," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Our studies presented at ASCO (Free ASCO Whitepaper) underscore our patient-centric approach using CGP to further refine the clinical utility of existing biomarkers while discovering new ones that can help better inform precision treatments across a broad range of cancer types with the ultimate goal of improving patient care."

Comprehensive genomic profiling is helping to uncover the predictive power of TMB and other pathogenic biomarkers in different types of cancer. In data to be presented in an oral session, biomarker analysis by CGP in metastatic urothelial carcinoma has the potential to identify patients who could benefit from a bladder sparing approach through the opportunity to respond to immune checkpoint inhibitors.

"The near 40% frequency of complete pathologic response to the neoadjuvant pembrolizumab regimen in this bladder muscle invasive urothelial carcinoma trial is unprecedented. These results substantially improved by selecting patients harboring molecular alterations, regardless of PD-L1 expression," said Andrea Necchi, M.D., department of medical oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. "Our data indicate that biomarker-based patient selection using the comprehensive genomic profiling and gene expression profiling has the potential to identify patients destined to achieve complete tumor eradication and raises the possibility that this sub-group of patients could be managed in the future without radical cystectomy."

In another oral presentation, a pooled analysis of seven clinical studies of the anti-PD-L1 immunotherapy agent atezolizumab found that high TMB was associated with improved response and duration of response in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma. Additionally, in a separate presentation, investigators from the Moffitt Cancer Center worked with Foundation Medicine scientists utilizing CGP to show that within a group of 57 advanced Merkel cell carcinoma (MCC) patients, nearly all had either high TMB or evidence of the Merkel cell polyomavirus as measured by viral content detection. Patients with neither marker were unlikely to respond to immunotherapy, which may help guide use of this treatment in MCC in which high response rates to immunotherapy have been observed but predictive factors of response have not been well elucidated.

New studies also characterize the landscape of PBRM1 alterations, a new potential biomarker of immunotherapy response. Recent evidence suggests that PBRM1 alterations are associated with clinical benefit from checkpoint inhibitor immunotherapy in clear cell renal carcinoma (ccRCC), an immunotherapy-responsive tumor type which characteristically lack high MSI or TMB. In a new study presented at ASCO (Free ASCO Whitepaper), CGP was performed on more than 140,000 solid tumors and hematologic malignancies and found that PBRM1 alterations were highly enriched in ccRCC (45 percent) compared with other tumor types (2.6 percent). Another study of mesothelioma found that PBRM1 alterations were present in 11 percent of samples, suggesting that immunotherapy may also serve as an important treatment option in this cancer type.

Because a tissue sample may not be readily available for some cancer patients, especially those with advanced disease, liquid biopsy is becoming an increasingly important option to help inform personalized treatment approaches. In new data presented, FoundationACT was used to help describe the pan-cancer landscape of kinase rearrangements, which are established therapeutic targets. Analysis of circulating tumor DNA (ctDNA) from blood samples of nearly 9,000 clinical cases showed that kinase fusions and rearrangements exist across tumor types and can be detected using FoundationACT, which may help inform both treatment decisions and clinical development.