On February 5, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Adelene Perkins, Infinity Pharmaceutical’s chief executive officer, will present at the BIO CEO & Investor Conference on Monday, February 12, 2018, at 11:00 a.m. EST at The New York Marriott in New York, NY (Press release, Infinity Pharmaceuticals, FEB 5, 2018, View Source [SID1234523725]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On February 5, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that it will be attending and presenting at the BIO CEO & Investor Conference being held on February 12 – 13, 2018 at the New York Marriott Marquis (Press release, Actinium Pharmaceuticals, FEB 5, 2018, View Source [SID1234523729]). Details of Actinium’s presentation are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Date: Tuesday, February 13, 2018
Time: 9:15 AM ET
Room: Odets, 4th Floor
Venue: New York Marriott Marquis, 1535 Broadway, New York, NY 10036

Management will be conducting 1-on-1 meetings during the conference. To arrange a meeting with Actinium please contact, Steve O’Loughlin, Actinium’s Principal Financial Officer at [email protected] or utilize the conference’s partnering system View Source

On February 5, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that clinical data from its lead product candidate CB-839, a firstin-class glutaminase inhibitor, will be presented at the 2018 Genitourinary Cancer Symposium, February 8-10, 2018 in San Francisco, California (Press release, Calithera Biosciences, FEB 5, 2018, View Source [SID1234535247]). This is the first disclosure of clinical experience evaluating CB-839 in combination with cabozantinib, an oral receptor tyrosine kinase inhibitor. Preliminary results show the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients, and 100% disease control, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. The data will be presented on Saturday February 10, 2018 in Poster Session C: Renal Cell Cancer from 11:30am-1:00pm PT (Board F18).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Despite the advances in the treatment of renal cell carcinoma, there remains a significant unmet need in the treatment of patients with advanced disease," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer, and President of Calithera Biosciences. "Based on these promising clinical results, we plan to initiate a global, randomized Phase 2 trial of CB-839 in combination with cabozantinib in the second quarter of 2018, and focus our efforts on developing a potential new therapeutic option that could benefit patients who have failed their first therapies."

Dr. Nizar Tannir from MD Anderson Cancer Center will present the results in a poster session, "Phase I study of glutaminase inhibitor CB-839, combined with everolimus or cabozantinib in patients with clear cell and papillary renal cell carcinoma." As of December 22, 2017, 12 advanced renal cell carcinoma patients were treated with CB-839 plus cabozantinib and evaluable for response, including 10 clear cell patients, and two papillary patients. One hundred percent of evaluable patients experienced tumor shrinkage and disease control; this includes four patients who had a partial response and eight patients who had stable disease. In the clear cell patient population, the disease control rate was 100% and the response rate was 40%. Patients enrolled in the trial had advanced or metastatic disease and had received a median of three prior treatments, which included tyrosine kinase inhibitors, mTOR inhibitors, and checkpoint inhibitors. Patients were administered CB-839 in oral doses that ranged from 600-800 mg twice a day in combination with a fixed oral dose of cabozantinib at 60 mg once a day. On the basis of this efficacy and safety data which compares favorably to treatment with cabozantinib, Calithera plans to initiate the CANTATA trial, a Phase 2 randomized, placebo-controlled trial in approximately 300 clear cell renal cell carcinoma patients whom have previously received one or two prior lines of therapy. Exelixis has entered into a material supply agreement with Calithera. The CANTATA trial is expected to begin in the second quarter of 2018.

The updated results of CB-839 in combination with everolimus were also presented. As of the data cut off, 24 renal cell carcinoma patients, with a median of 3 prior therapies, were treated and evaluable for response. Ninety-two percent (92%) of patients experienced control of their disease, including one patient with a partial response and 21 patients with stable disease. The median progression free survival was 5.8 months, which compares favorably to historical data in this patient population. On the basis of this efficacy and safety data, Calithera plans to continue development in combination with everolimus for the treatment of advanced clear cell renal cell carcinoma. The randomized Phase 2 ENTRATA trial of CB-839 in combination with everolimus in later stage patients is currently enrolling, and has been modified to enroll approximately 65 patients.

About CB-839

Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

On February 5, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the year ended December 31, 2017. Net loss in 2017 was $11.9 million, or $1.82 per share, compared to a net loss in 2016 of $14.9 million, or $2.28 per share (Press release, Pain Therapeutics, FEB 5, 2018, View Source [SID1234523726]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Net cash used during the year ended December 31, 2017 was $8.2 million. Cash and investments were $10.5 million as of December 31, 2017, with no debt. We believe net cash usage in 2018 will decrease significantly compare to 2017 and may be in the range of $5-6 million.

"In 2018, our focus will be on REMOXY and its potential to receive marketing clearance this year," said Remi Barbier, Chairman, President & CEO. "As part of this focus, we intend to resubmit the REMOXY NDA to the FDA in Q1 with Priority Review; to maintain fiscal discipline; and to advance the progress of our earlier‐stage programs with non-dilutive funding."

Financial Highlights for 2017

At December 31, 2017, cash and investments were $10.5 million, compared to $18.7 million for the same period in 2016. We have no debt.
Net cash used in the year ended December 31, 2017 was $8.2 million.
We received $1.4 million in research grant funding in the year ended December 31, 2017 from the National Institutes of Health (NIH) that we recorded as a reduction to our research and development expenses.
Research and development expenses for the year ended December 31, 2017 decreased to $7.6 million, from $9.2 million for the same period in 2016, primarily due to decreases in REMOXY ER (oxycodone CII) related expenses and non-cash stock related compensation costs as compared to the same period in 2016. Research and development expenses included non-cash stock related compensation costs of $1.2 million for the year ended December 31, 2017 and $1.8 million for the same period in 2016.
General and administrative expenses for the year ended December 31, 2017 decreased to $4.3 million, respectively, from $5.8 million for the same period in 2016, primarily due to a decrease in non-cash stock related compensation costs as compared to the same period in 2016. General and administrative expenses included non-cash stock-related compensation costs of $1.8 million in the year ended December 31, 2017 and $2.6 million for the same period in 2016.
Operating Highlights for 2017

In Q4, we concluded a ‘pre-NDA’ meeting with the U.S. Food and Drug Administration (FDA), which gives us regulatory clearance to resubmit the New Drug Application (NDA) for REMOXY in Q1 2018 with Priority (six-month) Review.
In Q4, we concluded a successful nasal abuse potential study with REMOXY, whereby peak oxycodone concentrations (Cmax) were at least 4-fold lower for REMOXY compared to crushed OxyContin ER (oxycodone HCl) or oxycodone immediate-release (p<0.01).
In Q4, we concluded a series of successful in vitro studies comparing the abuse potential of REMOXY to OxyContin ER and Xtampza ER (oxycodone) in various household liquids.
In Q2, we filed an Investigational New Drug (IND) application with the FDA for PTI-125, a small molecule drug to treat Alzheimer’s disease. In Q4, we announced successful results of a first-in-human, Phase I clinical study with PTI-125.
In Q2 and in Q4, we announce new scientific publications in peer-reviewed journals regarding our program in Alzheimer’s disease.
In Q1, we announced written agreement was reached with the FDA on additional studies needed for REMOXY’s regulatory approval.
Throughout 2017, we announced that the National Institutes of Health (NIH) had awarded us research grants following a competitive, peer-reviewed evaluation of our technology for scientific and technical merit. Research awards included a grant to develop a simple blood-test to detect Alzheimer’s disease; a grant to study PTI-125, our clinical drug candidate to treat Alzheimer’s disease; and a grant to further develop FENROCK, an abuse-deterrent transdermal patch.
Our Pipeline of Drug Assets Includes:
REMOXY ER (extended-release oxycodone CII) – Proprietary abuse-deterrent, twice-daily, oral oxycodone capsules for severe chronic pain. NDA resubmission remains on-track for resubmission to the FDA in Q1 2018.

FENROCK (transdermal fentanyl patch system) – Proprietary abuse-deterrent skin patch for severe pain. Early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).

PTI-125 – Proprietary small molecule drug for the treatment of Alzheimer’s disease. Phase I clinical-stage program, substantially funded by a research grant award from the National Institutes of Health (NIH).

PTI-125Dx – Blood-based diagnostic/biomarker to detect Alzheimer’s disease. Early-stage program, substantially funded by a research grant award from the NIH.

We own worldwide commercial rights to all of our drug assets.

About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Drug overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, we have pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

On February 5, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present preliminary Phase I data on its investigational anti-PD-1 antibody, tislelizumab, in urothelial carcinoma (bladder cancer) at the upcoming 2018 Genitourinary Cancers Symposium, to be held February 8-10 in San Francisco (Press release, BeiGene, FEB 5, 2018, View Source;p=RssLanding&cat=news&id=2330396 [SID1234523733]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Poster Title: Preliminary Results from Patients with Urothelial Carcinoma (UC) in a Phase 1A/1B study of BGB-A317, an Anti-PD-1 Monoclonal Antibody
Abstract: 445; Poster Board: G16
Presenter: Shahneen Sandhu, M.D.
Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers
Date & Times: Friday, February 9, 2018 at 12:15-1:45 PM (PT) and 6:00-7:00 PM (PT)
Location: Moscone West Building, San Francisco

About Tislelizumab (BGB-A317)
Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).