On May 15, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present results from eight studies at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held June 1 to 5, 2018 in Chicago, Ill (Press release, Myriad Genetics, MAY 15, 2018, View Source [SID1234526646]). Abstracts of the Company’s presentations will be available at: abstracts.asco.org on May 16 at 5:00 p.m. EDT.

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"We look forward to presenting exciting new discoveries at ASCO (Free ASCO Whitepaper) that we believe will expand the reach of personalized medicine for patients with cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "Importantly, our presentations will focus on new advances in predicting breast cancer recurrence and the need for chemotherapy, the role of hereditary cancer testing in preventing cancer or optimizing treatment plans, and novel companion diagnostics for helping guide medication selection for patients with breast or ovarian cancers."

A list of Myriad presentations at ASCO (Free ASCO Whitepaper) 2018 are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #ASCO18.

Title Presenter Abstract Number Day/Time Myriad Product

Oral Presentation

Validation of a Combined Residual Risk Score
for Healthy Unaffected Women Presenting to Breast
Cancer (BC) Screening Centers Kathryn Dalton Presentation 1507 Sunday, June 3, 2018: 8:00-11:30 a.m. CDT. riskScore

Poster Presentations

Predicting Expected Absolute Chemotherapy
Treatment Benefit in Women with Early-Stage
Breast Cancer using a 12-Gene Expression
Assay William Gradishar Abstract 525 Saturday, June 2, 2018: 8:00-11:30 a.m. EndoPredict

In Silico Evaluation of the 12-gene molecular
score (EndoPredict) and the Recurrence Score
(Oncotype DX) as Predictors of Response to
Neo-adjuvant Chemotherapy in Estrogen
Receptor Positive (ER+), HER2 Negative
(HER2-) Breast Cancer Hatem Soliman Abstract 539

Saturday, June 2, 2018: 8:00-11:30 a.m. CDT. EndoPredict

Promoting Colorectal Cancer (CRC) Screening
after Multiplex Genetic Testing and Genetic
Counselling Gregory Idos Abstract 1582 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Promoting Breast Cancer Screening after
Multiplex Genetic Panel Testing (MGPT) and
Genetic Counselling Gregory Idos Abstract 1581 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Evaluation of Homologous Recombination
Deficiency (HRD) status with pathological
response to carboplatin +/- veliparib
in BrighTNess, a randomized phase 3 study in
early stage TNBC Melinda Telli Abstract 519 Saturday, June 2, 2018: 3:00-4:15 p.m. CDT. myChoice HRD

Locus-specific loss of heterozygosity (LOH) in
BRCA1/2 mutated (mBRCA) ovarian tumors
from the SOLO2 (NCT01874353) and Study 19
(NCT00753545) clinical trials Kirsten Timms Abstract 5563 Monday, June 4, 2018: 1:15-4:45 p.m. CDT.

myChoice HRD
About EndoPredict
EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with ER+, HER2- early-stage breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer panel uses validated technologies and algorithms in an 850 step laboratory process to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information, please visit: View Source

About riskScoreTM
riskScore is a clinically validated algorithm that predicts a women’s remaining 5-year and lifetime risk of developing breast cancer. The algorithm combines the analysis of over 80 well-studied genetic markers and the Tyrer-Cuzick model to accurately estimate breast cancer risk for woman of European descent. For more information, please visit: View Source

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information, please visit: View Source

On May 15, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the first quarter ended March 31, 2018 (Press release, Heat Biologics, MAY 15, 2018, View Source [SID1234526617]).

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”We had an eventful first quarter, with a number of positive clinical developments,” said Jeff Wolf, CEO of Heat. ”Most notably, we announced positive interim results from our Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers had progressed after treatment with one or more lines of therapy. These data are especially encouraging in patients with low levels of TIL and PD-L1, who are among the most difficult-to-treat patients. Importantly, we believe the data are consistent with the mechanism of action of our T-cell Activation Platform, which has been shown to promote a robust T-cell immune response. We believe the ability of our platform to convert ”cold tumors” to ”hot tumors” will be an important component in effective immunotherapy combinations against cancer.”

”Given the strength of our recent data, we recently completed a capital raise for gross proceeds of $20.7 million. Consequently, Heat should have sufficient capital to accomplish the following key objectives over the next 5 quarters: 1) complete enrollment in our Phase 2 trial for HS-110 in NSCLC, 2) begin patient enrollment for our ComPact platform, 3) undertake our Phase I study with our first-in-class T cell costimulator antibody, PTX-35, and 4) report preliminary data for each of these trials.”

First Quarter 2018 Corporate Highlights

On March 26, 2018, the Company reported 2-year recurrence rate data from the Phase 2 trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC); achieved 100% (10 out of 10) disease free survival rate over 2 years in the subgroup of patients that generated a positive immune response to low-dose HS-410 and BCG.
On March 19, 2018, the Company announced the appointment of Anthony Tolcher, M.D., FRCPC, FACP, to the scientific advisory boards of Heat Biologics and its subsidiary, Pelican Therapeutics.
On March 12, 2018, the Board of Directors adopted a stockholder rights plan intended to ensure that all stockholders of the Company receive fair and equal treatment in the event of an attempted hostile takeover of the Company.
On February 28, 2018, the Company announced positive interim data from its Phase 2 clinical trial of HS-110 and Nivolumab in NSCLC; reported tumor shrinkage and disease control in a majority of evaluable patients; HS-110 + nivolumab combination showed durable responses in difficult-to-treat low TIL patients and low PD-L1 patients who respond poorly to checkpoint inhibitors.
On February 20, 2018, the Company reported that the Independent Data Monitoring Committee (DMC) recommended continuing patient enrollment in the ongoing Phase 2 Clinical Trial for HS-110.
On February 14, 2018, the Company announced its abstract highlighting interim results of its Phase 2 study on HS-110 had been accepted as a scientific poster presentation during the 2018 Keystone Symposia Conference XI: Immunological Memory: Innate, Adaptive and Beyond, February 25 – March 1, 2018 which took place in Austin, TX.
First Quarter 2018 Financial Results

Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased to $2.9 million for the quarter ended March 31, 2018 compared to $1.8 million for the quarter ended March 31, 2017. The $1.1 million increase is due to an increase in CMC activity in our HS-110 and PTX-35 programs as well as continued patient enrollment as we progress in our phase 2 HS-110 clinical trial.
General and administrative expense increased approximately 20% to $1.8 million for the quarter ended March 31, 2018 compared to $1.5 million for the quarter ended March 31, 2017. The $0.3 million increase is primarily attributable to the increase in personnel costs as we establish our Texas operations associated with our Pelican subsidiary.
Net loss attributable to Heat Biologics was approximately $3.5 million, or ($0.75) per basic and diluted share for the quarter ended March 31, 2018 compared to a net loss of approximately $3.2 million, or ($1.18) per basic and diluted share for the quarter ended March 31, 2017.
As of March 31, 2018, the Company had approximately $9.0 million in cash and cash equivalents. Subsequent to the end of the first quarter, the Company raised approximately $20.7 million in gross proceeds in a public offering of common shares and warrants.

On May 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the first quarter of 2018 (Press release, Nanobiotix, MAY, 15, View Source [SID1234526647]).

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Activity and result during the first quarter of 2018

There has been no revenue booked during the first quarter of 2018, which is fully in line with the Company’s
expectations. In January, Nanobiotix presented first promising data from I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Annual Meeting (ASCO-GI).

The product has demonstrated a very good safety profile, with no adverse event (serious or not) related to NBTXR3
and no dose-limiting toxicity (DLT). Out of 10 patients treated, 7 were evaluable. Out of these 7 patients, 3 patients
achieved a complete response and 3 patients achieved a partial response as best overall response. These data are only first preliminary response data which will be completed with additional data. This is the third indication in the global development of NBTXR3 confirming transferability across different cancers.

Also in January, Nanobiotix partnered with the Providence Cancer Institute to run immunotherapeutic preclinical
research in pancreatic cancers. The collaboration with Providence Cancer Institute, located at the Robert W. Franz
Cancer Center in Portland, Ore., one of the world’s leading oncological research centers, will provide essential
preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response.

Genprex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genprex, 2018, MAY 15, 2018, View Source [SID1234527544]).

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On May 14, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune/inflammatory, and other diseases, reported financial results for the first quarter ended March 31, 2018 (Press release, Alpine Immune Sciences, MAY 14, 2018, View Source [SID1234526574]).

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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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"We are increasingly encouraged by our promising preclinical results, which demonstrate the potential of our platform to change the way we approach and treat both cancer and autoimmune/inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We continue to make progress on our lead programs and remain on track to file INDs for ALPN-101, a dual ICOS/CD28 antagonist for the treatment of autoimmune/inflammatory diseases in the fourth quarter of this year, and ALPN-202, our lead oncology program, in 2019."

Corporate and Scientific Development Highlights

Presentation of ALPN-202 immuno-oncology program data: Alpine’s poster at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting debuted preclinical data for the ALPN-202 program, representing a potentially novel immuno-oncology approach to the treatment of cancer. Results demonstrated molecules in the ALPN-202 program are able to antagonize PD-L1 and CTLA-4 while providing a CD28 costimulatory signal, resulting in the elimination of tumors, complete resistance to tumor rechallenge, and superiority to an approved anti PD-L1 therapeutic in a murine cancer model. The potentially unique mechanism of ALPN-202 seeks to address the lack of costimulatory activity in many current immuno-oncology therapies and may improve the immune system’s response to cancer. With preclinical results demonstrating both checkpoint blockade and immune system costimulation, Alpine’s ALPN-202 program could potentially be a more potent and broadly applicable therapeutic for the treatment of cancer.

Chris Peetz appointed to Board of Directors: On April 24, 2018, Alpine announced the appointment of Chris Peetz to its Board of Directors. Currently serving as Chief Executive Officer of Flashlight Therapeutics, Mr. Peetz is an experienced life sciences executive. He previously served as Chief Financial Officer and Head of Corporate Development at Tobira Therapeutics (acquired by Allergan in November 2016) and, prior to that, held senior management roles at Jennerex Biotherapeutics and Onyx Pharmaceuticals (now Amgen). Earlier, he was at LaSalle Corporate Finance, Abgenix, and Solazyme.

First Quarter 2018 Financial Results

Alpine ended the first quarter of 2018 with $76.7 million in cash, cash equivalents, and short-term investments compared to $81.2 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $4.4 million.
Revenue for the first quarter of 2018 was $0.3 million compared to $0.7 million in the first quarter of 2017. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, a Gilead (NASDAQ:GILD) company. As previously announced, under the terms of the research collaboration and license agreement with Kite, which was extended on October 30, 2017, Alpine received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term.
Research and development expenses for the first quarter of 2018 were $3.8 million compared to $1.9 million for the same period in 2017. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the first quarter of 2018 were $2.1 million compared to $0.9 million for the same period in 2017. The $1.2 million increase was primarily attributable to higher professional and legal service fees and increased headcount to support our operations as a public company.
Cash Guidance

The company expects to have cash to fund operations into 2020, including the clinical advancement of ALPN-101 for the treatment of autoimmune/inflammatory diseases and ALPN-202 for the treatment of cancer.