On April 24, 2018 Checkmate Pharmaceuticals (Checkmate)  reported that it had initiated treatment with CMP‐001 combined with atezolizumab (TECENTRIQ) in a Phase 1b clinical trial of patients with advanced non‐small cell lung cancer (NSCLC) and disease progression on prior anti‐PD‐1/PD‐L1 therapy (Press release, Checkmate Pharmaceuticals, APR 24, 2018, View Source [SID1234525653]).

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CMP-001 is designed to activate innate immunity to convert "uninflamed" tumors, which generally do not respond to anti-PD-1/L1 therapy, into "inflamed" tumors, which are responsive to PD-1 inhibition. When used in combination with PD-1/PD-L1 inhibitors, CMP-001 has the potential to increase the number of cancer patients who respond to checkpoint inhibitor therapies and to increase the magnitude and duration of the antitumor responses, possibly providing added clinical benefit.

"We are pleased to be advancing the clinical development of CMP-001 into a second tumor type," stated Art Krieg, founder and CEO of Checkmate Pharmaceuticals. "The mechanism of action of CMP-001 should apply across most or all tumor types, and so we expect CMP-001 to reverse PD-1 resistance in NSCLC, just as we reported for PD-1 resistant advanced melanoma last week at the 2018 American Association of Cancer Research Annual Meeting in Chicago," noted Dr. Krieg.

The trial is designed as a multi-center, open label, two-part Phase 1b study of CMP-001 administered in combination with atezolizumab with and without low-level radiation therapy. Part one of the study will evaluate CMP-001 (5 mg dose) administered subcutaneously (SC) weekly for two weeks and then intratumorally (IT) weekly for three weeks, followed by either SC or IT injection every three weeks.

In the second part of the trial, the combination of CMP-001 and atezolizumab therapy will be preceded by low-level radiation therapy to the target lesion. "In our ongoing melanoma trial we learned that patients whose tumors contain more plasmacytoid dendritic cells (pDC) appear to be more likely to respond to CMP-001 in combination with checkpoint inhibitor therapy. Low dose radiation therapy recruits pDC into tumors, and so we expect this triple combination regimen to increase the response rate to our therapy," explained Dr. Krieg. Patients will be monitored for safety and tolerability, as well as clinical response. Correlative studies will also be undertaken to characterize the immune effects of treatment in the blood and tumors.

About CMP-001

CMP-001, is a first-in-class CpG-A Toll-like receptor 9 (TLR9) agonist, that is encapsulated in a virus-like particle (VLP) and is designed to activate the innate immune system via TLR9 and mediate tumor control by the subsequent induction of both innate and adaptive anti-tumor immune responses, thereby converting immunologically "cold" tumors to immunologically "hot" tumors. It is the only CpG-A class TLR9 agonist in clinical trials and differs from other CpG classes in clinical development by having a native DNA backbone that induces the highest levels of type I IFN. Based on analysis of gene expression in human tumors showing that increased IFN gene expression is associated with better response to PD-1 inhibition, it is believed that this mechanism of action may restore, enable or improve responses to anti-PD-1/PD-L1 therapeutics.

CMP-001 is being evaluated in multiple tumor types to assess its safety, activity, alternative routes of administration and combination with other immunotherapies and modalities. For information on CMP-001 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On April 24, 2018 Atossa Genetics Inc. (ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has received a positive interim review on its Phase 1 study of topical endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), which is a common condition in patients being treated for prostate cancer (Press release, Atossa Genetics, APR 24, 2018, View Source [SID1234525619]). The Independent Safety Committee reviewed the blinded data generated from the first group in the study (eight subjects) and concluded that the study may advance to the next dosing level.

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"This positive safety determination is on the critical path for a successful outcome of this Phase 1 study in men," stated Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa. "It is the first assessment of our clinical safety and tolerability data and it indicates that proceeding to the next dosing level with our proprietary topical endoxifen is warranted. We can now advance to the next level of the study which is to escalate the dosage in a new cohort of subjects as we continue to monitor safety and tolerability in the first cohort of the study." Dr. Quay added, "We believe this is the first clinical trial ever conducted of a topical pharmaceutical for the treatment of gynecomastia. There are no approved drugs, either topical or oral, for this important, unmet medical need which affects 25% of men ages 50-69."

The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

About Gynecomastia

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.

On April 24, 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 first quarter 2018 financial results on Tuesday, May 8, 2018, after the U.S. financial markets close (Press release, Five Prime Therapeutics, APR 24, 2018, View Source [SID1234525637]). Five Prime will host a conference call and live audio webcast on Tuesday, May 8, 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 6585139.

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. (Press release, Five Prime Therapeutics, APR 24, 2018, View Source [SID1234525637])

On April 24, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that it has dosed the first patient in a Phase 1/2a study evaluating PEN-866 in patients with advanced solid tumors (Press release, Tarveda Therapeutics, APR 24, 2018, View Source [SID1234525654]). miniature drug conjugate that selectively binds to the intracellular target Heat Shock Protein 90 (HSP90) and is linked to SN-38, a known and potent anti-cancer payload. The multi-center, dose escalation and expansion study will assess safety and efficacy across a range of tumor types including those previously shown to be sensitive to topoisomerase 1 inhibitors. This includes but is not limited to small cell lung, pancreatic, triple negative breast, colon and ovarian cancers and sarcomas.

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"This innovative approach of a drug conjugate which uses an HSP90 inhibitor to facilitate intracellular, tumor-targeted delivery of the topoisomerase 1 inhibitor SN-38 is a promising treatment for patients with cancer," said Anish Thomas, MBBS, M.D., Lasker Clinical Research Scholar and Principal Investigator, Developmental Therapeutics Branch, Center for Cancer Research, at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). "Preclinical studies of PEN-866 by a number of groups, including NCI researchers, have demonstrated efficacy and durability of response in multiple preclinical patient-derived and xenograft tumor models in a wide range of tumor types. Patients with these cancers are very much in need of effective new treatment options." Dr. Thomas and Dr. Yves Pommier, NCI’s Developmental Therapeutics Branch, are collaborating with Tarveda through a Cooperative Research and Development Agreement (CRADA).

Drew Fromkin, President and Chief Executive Officer of Tarveda commented, "There exists a large body of evidence demonstrating that HSP90 is upregulated and activated in tumors. This results in a change in HSP90’s binding conformation allowing for the extended retention and accumulation of cancer cell killing payloads in diverse, difficult-to-treat tumor types versus normal tissue. The dosing of our first patient with PEN-866 is a major accomplishment for our Company and demonstrates our commitment to linking potent, anti-cancer payloads to HSP90 small molecule targeting ligands."

Earlier this year, Tarveda announced plans to initiate the Phase 2a portion of the Phase 1/2a clinical trial for PEN-221, a Pentarin miniature conjugate designed to selectively bind to solid tumors expressing somatostatin receptor 2 (SSTR2). The Phase 2a portion of the trial has now been initiated and enrollment has begun in patients with small cell lung cancer as well as GI-midgut and pancreatic neuroendocrine tumors that express SSTR2.

The company is actively advancing its two clinical stage programs, PEN-221 and PEN-866, and other novel pre-clinical miniature conjugates.

Additional information on clinical trials being conducted by Tarveda is available at clinicaltrials.gov, through identifier number NCT03221400 for PEN-866 and NCT02936323 for PEN-221. Patients interested in enrolling in the PEN-866 clinical trial can contact Tarveda at [email protected] or call the National Cancer Institute’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615).

About PEN-866
PEN-866 exploits the activation of Heat Shock Protein 90 (HSP90) in tumors to accumulate and release its potent anti-cancer payload, SN-38. PEN-866 is a miniature conjugate that comprises a small molecule, HSP90-targeting ligand linked to SN-38, the active metabolite of irinotecan. The conjugate accumulates and is retained in tumors and, by way of a sustained release of SN-38, causes prolonged DNA damage and tumor regressions in multiple patient-derived and other xenograft tumor models.

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

On April 24, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2018 financial results on Tuesday, May 8, 2018, after the close of the U.S. financial markets (Press release, Clovis Oncology, APR 24, 2018, View Source [SID1234526547]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss first quarter 2018 results on May 8 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s website at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 4198438.