On November 6, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a reception for investors and analysts on Friday, November 10, 2017, from 6:00 a.m. to 8:00 a.m. to discuss the clinical development of IPI-549, including a review of data from the ongoing Phase 1/1b clinical study. The reception will take place in conjunction with the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting at the Gaylord National Hotel and Convention Center in National Harbor, MD (Press release, Infinity Pharmaceuticals, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314510 [SID1234521584]). IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma) and is believed to be the only PI3K-gamma inhibitor in clinical development.

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Featured speakers at the reception will include:

David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Taha Merghoub, Ph.D., Co-Director, Ludwig Collaborative Laboratory and the Swim Across America Laboratory at Memorial Sloan Kettering
The presentation portion of the reception will be webcast beginning at 6:30 a.m. ET. The webcast and accompanying slides can be accessed in the "investors/media" section of the company’s website, www.infi.com. A replay of the event will also be available.

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion will also include a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 6, 2017 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported an exclusive license agreement with NanoCarrier Co., Ltd (Press release, VBL Therapeutics, NOV 6, 2017, View Source [SID1234521592]). (TSE Mothers: 4571) for the development, commercialization, and supply of ofranergene obadenovec ("VB-111") in Japan. VBL Therapeutics (VBLT) retains rights to VB-111 in the rest of the world.

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"Japan is potentially a large market opportunity for VBLT, and this agreement provides us with access into this important market as we continue to prepare for commercialization of VB-111 in recurrent glioblastoma (rGBM), and in other indications," said Dror Harats, M.D., chief executive officer of VBL Therapeutics. "We see this agreement with NanoCarrier as providing further validation of the potential of VB-111 and we look forward to working together to bring this important anticancer therapy to patients and health care professionals in Japan."

"We are continually looking for new opportunities in the treatment of cancer, and VB-111 is an innovative gene therapy which, if approved, could have significant market potential in Japan," said Ichiro Nakatomi, Ph.D., President and Chief Executive Officer of NanoCarrier. "VB-111 is a perfect fit for our portfolio of cancer drug candidates."

Under terms of the agreement, VBLT has granted NanoCarrier an exclusive license to develop and commercialize VB-111 in Japan for all indications, VBLT will supply NanoCarrier with VB-111, and NanoCarrier will be responsible for all regulatory and other clinical activities necessary for commercialization in Japan. In exchange, VBLT receives an up-front payment of $15 million, and is entitled to receive greater than $100 million in development and commercial milestone payments. VBLT will also receive tiered royalties on net sales in the high-teens. Other terms of the agreement are not being disclosed.

In addition to this agreement, VBL Therapeutics and NanoCarrier intend to explore future collaborations in oncology.

About VB-111 (ofranergene obadenovec)

VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead product currently being studied in a global Phase 3 pivotal trial for rGBM. VB-111 has demonstrated statistically significant overall survival and a progression-free survival in a Phase 2 trial in patients with rGBM, versus current standard of care. VBL-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum resistant ovarian cancer.

Xoma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Xoma, 2017, NOV 6, 2017, View Source [SID1234521616]).

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On November 6, 2017 Sino Biopharmaceutical presented Promising Pipeline Presentation (Presentation, Sino Biopharmaceutical, NOV 6, 2017, View Source [SID1234525137]).

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On November 6, 2017 Heron Therapeutics, Inc. (Nasdaq:HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, NOV 6, 2017, View Source [SID1234521583]).

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Recent Corporate Progress

Pain Franchise

Initiated Phase 3 Program for HTX-011 in Postoperative Pain. Heron is enrolling patients in two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron’s Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain and the need for opioid analgesics for 72 hours following surgery. Heron anticipates completing the pivotal Phase 3 efficacy studies in the first half of 2018 and expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.
Fast Track Designation Granted for HTX-011. The FDA has granted Fast Track designation for HTX-011 for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is intended to facilitate the development and expedite the review of new therapies to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA. HTX-011 is the first opioid alternative for local administration into the surgical site to receive Fast Track designation.
Patent Issued Covering Novel Bupivacaine/Meloxicam Combination. The U.S. Patent and Trademark Office issued to Heron U.S. Patent No. 9,801,945, which covers HTX-011 and all clinically relevant combinations of bupivacaine and meloxicam for the prevention of postoperative pain.
CINV Franchise

SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2017 were $8.6 million and $20.7 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Guidance for full-year 2017 net product sales of SUSTOL remains $25 million to $30 million.
CINVANTI FDA Action Date in Q4 2017. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017 for a decision on the Company’s NDA for CINVANTI.
“Heron made good progress in the third quarter of 2017, highlighted by the start of Phase 3 studies for HTX-011, which recently has been granted Fast Track designation, and SUSTOL’s continued commercial success, outperforming all other CINV new drug launches in the last decade,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “Looking ahead, we are focused on FDA approval of CINVANTI, which, if approved, we expect to launch in January 2018, reporting top-line Phase 3 results for HTX-011 in the first half of next year and filing an NDA for HTX-011 in 2018.”

Financial Results

Net product sales of SUSTOL for the three months ended September 30, 2017 were $8.6 million and totaled $20.7 million for the nine months ended September 30, 2017. Heron commenced commercial sales of SUSTOL in October 2016.

Heron’s net loss for the three and nine months ended September 30, 2017 was $41.9 million and $135.0 million, or $0.77 per share and $2.55 per share, respectively, compared to a net loss of $48.5 million and $125.2 million, or $1.24 per share and $3.34 per share, respectively, for the same periods in 2016. Net loss for the three and nine months ended September 30, 2017, included non-cash, stock-based compensation expense of $7.5 million and $23.6 million, respectively, compared to $7.5 million and $18.7 million, respectively, for the same periods in 2016.

Heron’s cash, cash equivalents and short-term investments were $74.0 million as of September 30, 2017. The Company also had accounts receivable of $28.9 million, the majority of which the Company expects to collect in the fourth quarter of 2017 and the first quarter of 2018. Net cash used for operating activities for the three months ended September 30, 2017 was $40.5 million, compared to $36.1 million for the three months ended September 30, 2016. Net cash used for operating activities for the nine months ended September 30, 2017 was $123.2 million, compared to $95.6 million for the nine months ended September 30, 2016.