On September 10, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that following a meeting with the U.S. Food and Drug Administration (FDA), it was determined that rPFS is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Endocyte, SEP 10, 2018, View Source [SID1234529396]).

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"We are very pleased with the FDA’s support of the rPFS endpoint as the basis for a submission for full approval of 177Lu-PSMA-617. This change provides an opportunity to obtain a full approval sooner than we previously anticipated and highlights the Agency’s commitment to addressing the urgent need for a new mechanism of action to treat mCRPC," said Mike Sherman, president and CEO of Endocyte. "Under the updated protocol, we now expect the analysis of rPFS for potential full approval to occur before the end of 2019. We also retained the final, fully powered OS analysis, which is expected to occur near the end of 2020. This provides two potential paths for approval and preserves a robust OS analysis to support a potential label."

Under the updated VISION trial design, the two interim assessments previously planned at 50% and 70% of OS events will be replaced with a single assessment of rPFS. This assessment is expected to occur at approximately the same time that the first interim OS assessment would have occurred under the prior trial design and shortly after the time the trial is fully enrolled. If 177Lu-PSMA-617 meets the primary endpoint in the rPFS assessment, no unexpected safety issues arise, and it demonstrates no detriment in OS relative to the control arm, Endocyte intends to submit an NDA to seek full approval in the United States. The rPFS analysis will include approximately 450 rPFS events. Regardless of the outcome of the rPFS assessment, Endocyte intends to continue to follow patients in the VISION trial in order to assess the final OS alternative primary endpoint. Other aspects of the trial, including patient treatment and assessments, trial size, overall duration, and follow up remain unchanged. The acceptance of rPFS as a primary endpoint for full approval in Europe will be determined in upcoming regulatory interactions.

VISION Phase 3 Trial Design

VISION will enroll up to 750 patients worldwide with PSMA-positive scans, randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care versus best supportive/best standard of care alone. Best supportive/best standard of care is palliative in nature and, at the discretion of the clinical trial investigator, may include a novel anti-androgen drug such as enzalutamide or abiraterone. Patients treated with 177Lu-PSMA-617 will receive 7.4 gigabecquerel (GBq) intravenously every six weeks for a maximum of six cycles.

The alternative primary endpoints of the trial agreed to by the FDA are radiographic progression-free survival (rPFS) and overall survival (OS). A positive assessment on either is sufficient for full approval. In the case of the rPFS assessment, a corresponding assessment of OS will be made to ensure no detriment in OS has occurred. Secondary endpoints include response evaluation criteria in solid tumors (RECIST) response and time to first symptomatic skeletal event. An efficacy analysis of rPFS and OS will be conducted at approximately 450 and 490 events, respectively. Further information on the global phase 3 VISION trial can be found at View Source

Conference Call

Endocyte management will host a conference call today at 8:30 a.m. EDT.

U.S. and Canadian participants: (877) 845-0711
International participants: (760) 298-5081

A live, listen-only webcast of the conference call may be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com

The webcast will be recorded and available on the company’s website for 90 days following the call.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On September 9, 2018 Innovent Biologics (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that its IND application for IBI188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical trials (Press release, Innovent Biologics, SEP 9, 2018, View Source [SID1234529358]). Innovent will launch several clinical trials based on this mAb drug to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer. This is the fourth IND approval the company has received this year, including anti-CTLA-4 mAb, anti-RANKL mAb, anti-OX40 mAb and anti-CD47 mAb.

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As one of the key targets in the field of anti-tumor immunotherapy, CD47 is regarded by many experts to have the possibility of becoming the next "star" in the field of immuno-oncology following the ground-breaking success of PD1 / PD-L1 antibodies. The IND approval signals that Innovent’s discovery and development on CD47 has advanced IBI188 as a leading player for this target to enter into clinical development stage.

"Innovent, with a relentless focus on innovation and quality, has developed programs that are advancing into cutting edge drug development frontiers. We hope that through our efforts, we can advance the field of cancer treatment, provide better treatment options to increase patients’ survival rate and improve their quality of life," said Michael Yu, Founder, Chief Executive Officer and Chairman.

"Emerging data suggests that CD47 antibody in combination with other treatments, including anti-PD-1 monoclonal antibodies, could result in higher levels of anti-tumor efficacy. Innovent’s current rich pipeline will allow multiple drug combinations with IBI188 creating many opportunities to achieve breakthroughs in cancer treatment to meet more unmet patient needs in the future," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

CD47 is one of the most important targets in the field of immuno-oncology. The development of anti-CD47 monoclonal antibody has recently attracted much attention. Innovent will be among one of a few companies pursuing the development of an anti-CD47 antibody in the early clinical stage.

About IBI188

IBI188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent with independent intellectual property rights. Both in vitro and in vivo experiments showed that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "Don’t Eat Me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. It has stronger receptor blocking ability than similar drugs. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.

On September 9, 2018. Xspray Pharma reported positive data from a clinical bioequivalence study with the company’s lead product candidate HyNap-Dasa (Press release, Xspray, SEP 9, 2018, View Source [SID1234649534]). The study results confirmed its primary aim to show bioequivalence of an optimized formulation of HyNap-Dasa compared to Sprycel. The data will be instrumental in the design of the planned registration study for an ANDA application.
The completed clinical Phase I study examined HyNap-Dasa’s bioavailability compared to the dasatinib cancer drug, currently marketed as Sprycel for the treatment of chronic myeloid leukemia (CML). In the study, bioavailability of two different tablet formulations of HyNap-Dasa was tested in comparison with Sprycel tablets in 16 healthy subjects. The results are very positive and confirm the validity of Xspray’s patented formulation technology. The planned studies required to take HyNap-Dasa to final registration studies will now be performed as planned. The results also strengthen the potential for additional product candidates in the pipeline being developed with the same technology to reach the market.

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"I am happy to see that the data so strongly confirm our technology. The outcome of this study represents an important milestone for Xspray Pharma as it means that we now can initiate the preparation of the pivotal phase of the clinical program, taking us closer to a commercial launch of HyNap-Dasa. Furthermore, the results pave the way also for additional product candidates in our pipeline. It signifies a new and important step in our development as a company" said Per Andersson, CEO of Xspray Pharma.

The clinical results in summary:

The study compared the pharmacokinetic parameters Cmax and AUC for the originator product Sprycel and two different HyNap tablet formulations of dasatinib. Sixteen healthy volunteers received single doses of each product in a cross-over design. Although this study was not powered to demonstrate formal bioequivalence, an analysis of preliminary data indicate that bioequivalence with Sprycel was achieved for one of the HyNap formulations. The results demonstrate a high likelihood that formal bioequivalence will be achieved in an adequately powered study.

Sprycel is a registered trademark of Bristol-Myers Squibb.

On September 7, 2018, Propanc Biopharma, Inc. (the "Company")reported that it has released a corporate presentation (the "Corporate Presentation") which it utilized at the 25th Annual NewsMakers in the Biotech Industry Conference held on September 7, 2018 at the Millennium Broadway Hotel and Conference Center in New York City (Presentation, Propanc, SEP 7, 2018, View Source [SID1234529355]).

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On September 7, 2018 Advaxis, Inc. (NASDAQ:ADXS) ("Advaxis" or the "Company") reported the pricing of an underwritten public offering of 16,666,666 shares of its common stock and warrants to purchase up to 14,166,666 shares of common stock (Press release, Advaxis, SEP 7, 2018, View Source [SID1234529381]). Each share of common stock is being sold together in a fixed combination with a warrant to purchase 0.85 shares of common stock. The warrants will be exercisable immediately, will expire six years from the date of issuance and will have an exercise price of $1.50 per share, subject to anti-dilution adjustments. The gross proceeds of the offering to the Company are expected to be approximately $20 million, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants.

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The closing of the offering is expected to occur on or about September 11, 2018, subject to the satisfaction of customary closing conditions.

Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering.

The Company intends to use the net proceeds of the offering to fund its continued research and development initiatives in connection with expanding its product pipeline and for other general corporate purposes, including, but not limited to (i) progression of ADXS-HOT into clinical research in both monotherapy and combination therapy; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, both in monotherapy and combination therapy; and (iii) investment in ongoing clinical research with axalimogene filolisbac in head and neck cancer and other HPV associated cancers, including any wind down costs associated with ongoing trials.

The securities described above were offered by the Company pursuant to a "shelf" registration statement (File No. 333-226988) previously filed with the Securities and Exchange Commission (the "SEC") on August 23, 2018 and declared effective by the SEC on August 30, 2018.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 6, 2018 and is available on the SEC’s website at View Source The final prospectus supplement relating to the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that Advaxis has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus relating to this offering, when available, may be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, Telephone: (212) 667-8055, Fax: (212) 667-6141 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.