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Five Prime Therapeutics to Announce Third Quarter 2018 Financial Results and Host Conference Call on November 6

On October 23, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will report its third quarter 2018 financial results on Tuesday, Nov. 6, 2018, after the U.S. financial markets close (Press release, Five Prime Therapeutics, OCT 23, 2018, View Source [SID1234530071]). Five Prime will host a conference call and live audio webcast on Tuesday, Nov. 6, 2018, at 4:30 p.m. (ET)/1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

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The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 6489275.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

Pulse Biosciences to Report Third Quarter 2018 and Operational Highlights and Financial Results

On October 23, 2018 Pulse Biosciences, Inc. (NASDAQ: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation platform, reported that the Company will report third quarter 2018 operational highlights and financial results on Tuesday, October 30, 2018 (Press release, Pulse Biosciences, OCT 23, 2018, View Source [SID1234530070]). Pulse Biosciences management will host a conference call and webcast at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT).

Analysts and investors can participate in the conference call by dialing (844) 494-0190 (domestic) and (508) 637-5580 (international) using the conference ID# 2098843. The webcast of the conference call can be accessed live on the Investor Relations section of the Pulse Biosciences website at www.pulsebiosciences.com.

Context Therapeutics Reports Encouraging Phase 1 Safety and Efficacy Data of Apristor® in Progesterone Receptor Positive Cancers

On October 23, 2018 Context Therapeutics reported Phase 1 data for its investigational new drug, Apristor (Onapristone extended release), an oral progesterone receptor antagonist that is being developed for progesterone receptor-positive (PR+) cancers (Press release, Context Therapeutics, OCT 23, 2018, View Source [SID1234530069]). Data from the study showed that Apristor, a novel extended release formulation of onapristone, was well tolerated and provided a clinical benefit in patients with previously treated recurrent or metastatic progesterone receptor-driven breast, ovarian and endometrial cancers. These findings were published in the medical journal PLOS One and can be accessed here.

"I’m encouraged by the early data seen in this Phase 1 study of Apristor. Apristor appears to be well tolerated, with responses seen across a broad range of PR+ cancers," commented Paul Cottu, M.D., Ph.D., Deputy Head, Department of Oncology, Institute Curie, and lead investigator for the trial. "Many hormonally-driven malignancies are difficult to treat, and new agents are clearly needed. Targeted therapies, including Apristor, have the potential not only to add therapeutic options for our patients but also to reduce or delay the need for chemotherapy, possibly changing the way many of these malignancies are treated."

"Context is pleased with the Phase 1 Apristor study results demonstrating clinical efficacy across PR+ cancers in heavily pretreated patients who are typically unresponsive to currently approved hormonal treatments," stated Martin Lehr, CEO of Context Therapeutics. "We believe Apristor has the potential to be the first anti-progestin approved to treat cancer and we are rapidly advancing Apristor into multiple Phase 2 trials with a goal of addressing significant medical needs."

Apristor Phase 1 Data in Patients with PR+ Breast, Ovarian, or Endometrial Cancer

Design
52 patients were randomized to five cohorts of Apristor (onapristone extended release tablets 10, 20, 30, 40 or 50 mg BID; n=46), or immediate release onapristone 100 mg QD (n=6) until progressive disease or intolerability. Primary endpoint was to identify the recommended phase 2 dose. Secondary endpoints included safety, clinical benefit and pharmacokinetics.

Results
Tumor diagnosis includes: endometrial carcinoma 12; breast cancer 20; ovarian cancer 13; and other 7. Median age was 64 (36-84). No dose limiting toxicity was observed with reported liver function test elevation related only to liver metastases. The recommended Phase 2 dose (RP2D) was 50mg BID. For patients on Apristor (n=46), dose responsive activity was noted, and 20% (9 of 46) patients had clinical benefit ≥24 weeks. The most common side effects were asthenia and low-grade, transient gamma-glutamyl transferase elevations.

Clinical Activity
Tumor assessments strongly suggested anti-cancer efficacy, even in heavily pretreated patients. In Apristor treated patients, 20 of 46 patients experienced stable disease as best response and 9 of 46 patients had durable disease stabilization.

The new extended release formulation of Onapristone (Apristor) was well tolerated and resulted in clinical benefit in heavily pretreated patients with ovarian, breast and uterine endometrial cancers. The recommended Phase 2 dose for Apristor is 50mg BID. There were no grade 3-4 LFT elevations in the absence of progressive liver metastases, no new safety signals were observed, and dose limiting toxicity was not observed. The data support the development of Apristor in PR+ cancers.

About Apristor

Apristor, an investigational new drug, is an oral progesterone receptor (PR) antagonist. PR is an oncogene that is enriched in up to 70% of all breast, ovarian, and endometrial cancers. Apristor is being developed to treat metastatic breast, ovarian and endometrial cancers.

Humanetics Corporation to Present at the Annual Meeting of the American Society for Radiation Oncology

On October 23, 2018 Humanetics Corporation (Humanetics) reported that it has been invited to present at the annual meeting of the American Society for Radiation Oncology (ASTRO) being held October 21st through the 24th in San Antonio, Texas. Dr. Michael Kurman, M.D., Chief Medical Officer for Humanetics, will be presenting an overview of the study design and providing an update on the status of the Company’s on-going, multi-site, Phase 1b/2a trial in non-small cell lung cancer patients (Press release, Humanetics, OCT 23, 2018, View Source [SID1234530068]). The trial is investigating the safety and efficacy of BIO 300, a new drug candidate focused on mitigating toxicities to normal tissues resulting from cancer radiotherapy.

Lung cancer is the most common cause of cancer-related deaths in the United States and affects more than 230,000 individuals per year. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, comprising approximately 87% of all cases. A common treatment for NSCLC is radiotherapy, which is often accompanied by chemotherapy. Radiation can cause unwanted side-effects to otherwise healthy tissue surrounding the tumor or in the path of the radiation beam. These effects include esophagitis, pulmonary pneumonitis and fibrosis, all of which can contribute to lasting health problems and in severe cases can be fatal.

"Drugs that can prevent the unwanted side effects of radiotherapy are an urgent need for patients," said Dr. Charles Simone, Associate Professor of Radiation Oncology and Medical Director of the Maryland Proton Therapy Center in Baltimore, Maryland. "Radiotherapy is an important standard of care and its use is forecast to grow. Drugs such as BIO 300 have the potential to significantly improve the quality of life and outcomes for our patients." Dr. Simone is serving as a Principal Investigator for the BIO 300 clinical trial.

BIO 300 is an oral medication, taken once daily by the patient prior to their radiation treatment. Its properties as a radioprotectant were discovered by researchers at the U.S. Department of Defense, where it was studied as a potential agent to be used by warfighters to prevent injury from radiation on the battlefield. Humanetics acquired the rights to the drug and has active development programs ongoing in both oncology and for biodefense.

NextCure Initiates Clinical Development for NC318, a Siglec-15 Targeting Antibody, for Solid Tumors

On October 23, 2018 NextCure, Inc., a privately-held biopharmaceutical company discovering and developing next generation immunomedicines for cancer and other diseases, reported the initiation of a Phase 1/2 clinical trial for NC318, a Siglec-15 (S15) antibody (Press release, NextCure, OCT 23, 2018, View Source [SID1234530067]).

The Phase 1 dose-escalation portion of this open-label trial will evaluate the safety and tolerability of NC318 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of NC318 will be evaluated in select tumor types. The trial is being conducted at five clinical sites in the United States. Details can be found at clinicaltrials.gov – NCT03665285.

"NC318 is the first antibody drug candidate developed at NextCure to enter clinical trials, marking an exciting milestone for our company," says Michael Richman, CEO of NextCure. "The trial marks a major advancement in our plan to develop our pipeline of next generation immunomedicines for cancer patients who do not respond to currently approved therapies."

S15 is a novel immunomodulatory target expressed on a restricted set of myeloid cells in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. Preclinical research shows that S15 promotes the survival and differentiation of suppressive myeloid cells and negatively regulates T cell function, allowing cancer growth. In preclinical studies, NC318 blocks the negative effects of S15. NC318 is a first-in-class immunomedicine that has the potential to treat multiple cancer types.

"Immunotherapies targeting T cell function have significantly improved patient outcomes; however, a substantial proportion of patients do not respond to currently approved PD-1 or PD-L1 antibody therapies," said Kevin N. Heller, M.D., CMO of NextCure. "Laboratory studies demonstrate that Siglec-15 modulates immune suppression in a manner independent of the PD-1/PD-L1 pathway, suggesting that NC318 may have the potential to be used in patients who do not express PD-L1. Blocking S15 with NC318 is expected to diminish immunosuppression and normalize the immune response, resulting in a clinically relevant anti-tumor immune response. A goal of our trial is to test that hypothesis."

The immune regulatory function of S15 was initially discovered in the lab of Lieping Chen, M.D., Ph.D., Founder of NextCure and United Technologies Endowed Professor of Cancer Research, Professor of Immunobiology, Dermatology, and Medicine at the Yale University School of Medicine. Dr. Chen is a renowned leader in immuno-oncology and has discovered many novel immune-related targets, including the PD-1/PD-L1 pathway. "The discoveries made by our group and others have paved the way for the first generation of immunotherapies, leading to major breakthroughs in cancer treatment. Building upon these early discoveries, and in collaboration with NextCure, we continue our research to identify new targets for modulating the immune system," stated Dr. Chen. "We expect that S15, one of the first new targets identified, will be the first in a series of next generation immunomedicines. Through a comprehensive and streamlined process, NextCure has efficiently brought NC318 to the clinic."