On September 10, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported business highlights and financial results for the fiscal year 2018 third quarter, ended July 31, 2018 (Press release, Advaxis, SEPT 10, 2018, View Source [SID1234529374]).

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Recent key accomplishments include:

Dosing of the first patient in the Company’s Phase 1 trial with ADXS-NEO, a personalized immunotherapy approach targeting neoantigens identified by sequencing a patient’s own cancer cells, partnered with Amgen.
U.S. Food and Drug Administration (FDA) allowance of the Company’s Investigational New Drug (IND) application for its first ADXS-HOT drug candidate, ADXS-503, for non-small cell lung cancer. ADXS-HOT is an off-the-shelf cancer-type specific immunotherapy approach that leverages the Company’s proprietary Lm technology platform to target hotspot mutations and other tumor-associated antigens that commonly occur in specific cancer types.
Selecting prostate and bladder cancers as the second and third ADXS-HOT drug candidates to take into the clinic.
Granting of a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma, a rare and aggressive tumor that forms in the bone.
Pricing of its public offering of common stock and warrants. The planned underwritten public offering is expected to result in gross proceeds of approximately $20 million and close on or around September 11, 2018.
Management Commentary

"We are encouraged by the momentum achieved with both of our neoantigen-focused programs during our third fiscal quarter and continue on our path of achieving our goal of having five neoantigen-based product candidates in clinical evaluation by the end of 2019," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We believe in the powerful impact neoantigens may have on the cancer treatment paradigm. Several of the unique attributes of our Lm platform including the capacity of our vector to contain a large number of neoantigens in each single drug construct, as well as the vector’s ability to generate strong T-cell responses to neoantigens as demonstrated in previously reported studies, provide us with an opportunity to lead in this potentially revolutionary field of cancer treatment.

"ADXS-NEO, partnered with Amgen, takes a personalized approach to therapy and has the potential to make an important contribution among underserved cancer patient populations with few or no treatment options," he added. "Similarly, the IND allowance by the FDA of our ADXS-HOT drug candidate for non-small cell lung cancer enables us to finalize our Phase 1 trial design and dose our first patient by the end of the year. The ADXS-HOT program, in general, is focused on shared hotspot mutations and other cancer antigens commonly found in cancers with large patient populations such as non-small cell lung cancer and prostate cancer."

"We are also excited about the licensing transaction executed with OS Therapies to evaluate our HER-2 therapy for the treatment of human osteosarcoma. This is a product candidate we believe in, although it falls outside our neoantigen focus. The transaction supports continued clinical development by a team of experts exclusively focused on finding new treatments for osteosarcoma and allows us to remain dedicated to our corporate strategy," he added.

Financial Results for Third Quarter Fiscal Year 2018

The net loss for the third quarter ended July 31, 2018 was $14.0 million or $0.27 per share. This compares with a net loss for the third quarter of fiscal year 2017 of $32.6 million or $0.80 per share. The $18.6 million reduction in the net loss compared to prior year was primarily a result of the significant reduction in spending in research, development and administrative areas.

Research and development expenses for the third quarter of fiscal year 2018 were $10.8 million, compared with $17.8 million for the third quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies supporting the MAA, which we withdrew in July 2018.

General and administrative expenses for the third quarter of fiscal year 2018 were $4.5 million, compared with $18.0 million for the third quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in stock-based compensation of approximately $11.4 million related to the resignation of the Company’s Chief Financial Officer and Chief Executive Officer in April 2018 and July 2017, respectively, two Board members who did not seek re-election in March 2018, a reduction in headcount and the elimination of stock-based compensation paid to consultants.

Balance Sheet Highlights

As of July 31, 2018, the Company had approximately $40.4 million in cash, restricted cash and cash equivalents on its balance sheet. The Company is anticipating closing on an underwritten public offering of its common stock and warrants on or around September 11, 2018 which is expected to result in gross proceeds of approximately $20 million to the Company.

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 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in its Phase 1 clinical trial of COM701, a first-in-class cancer immunotherapy antibody targeting PVRIG (Press release, Compugen, SEP 7, 2018, View Source [SID1234529393]). PVRIG is a novel immune checkpoint identified by Compugen using its computational discovery capabilities.

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"Dosing the first patient with COM701, a first-in-class drug opportunity targeting a novel immune checkpoint we identified with our computational predictive platform, is a landmark event for us. We look forward to clinically testing it," stated Anat Cohen-Dayag, Ph.D., Compugen’s President and CEO. "It also serves as a proof of concept for our discovery capabilities and marks Compugen as a leader in the field of computational discovery. We will continue leveraging this core competency in expanding our therapeutic pipeline and achieving our corporate and business goals."

Drew W. Rasco, M.D., Associate Director of Clinical Research at the START Center for Cancer Care and a Principal Investigator in the Phase 1 COM701 study, said, "Immunotherapy has revolutionized the landscape for oncology treatments by providing a new treatment option leading to lasting benefits for patients. Yet, response rates vary greatly across different cancer indications, leaving a significant unmet medical need for many patients and a continuing challenge to discover new biological pathways that can result in the development of new cancer immunotherapies for non-responsive and refractory patients. COM701 preclinical data suggest that the newly-discovered PVRIG pathway may be a dominant pathway in certain cancer subpopulations, including those that are unresponsive to PD‑1 or PDL-1 inhibitors. As such, it is important to evaluate COM701 in clinical trials with these patient populations who have exhausted available standard therapy."

Henry Adewoye, M.D., Chief Medical Officer of Compugen, said, "COM701 is a promising and differentiated asset in the crowded landscape of immuno-oncology trials. Our clinical and biomarker strategy for testing COM701 is premised on a robust biological rationale which suggests that targeting PVRIG may be necessary to induce a sufficient anti-tumor immune response in cancer patient subpopulations where both the PVRIG and TIGIT pathways are operative, thereby addressing the high unmet need of relapsed and refractory disease following treatment with existing immunotherapies. We look forward to exploring the full clinical potential of COM701."

This Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with a PD-1 inhibitor in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as a monotherapy as well as in combination with a PD-1 inhibitor in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The study will be conducted in multiple leading oncology clinical centers in the United States, which are expected to enroll approximately 140 patients. Additional information will be available shortly at www.clinicaltrials.gov.

About COM701
COM701 is a humanized hybridoma antibody that binds with high affinity to PVRIG, a novel B7/CD28-like immune checkpoint target candidate discovered by Compugen, blocking its interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. In addition, COM701 combined with antagonist anti-PD-1 antibodies has demonstrated synergistic effects on human T cell stimulation, indicating the potential of these combinations to further enhance immune response against tumors.

Preclinical data for COM701 suggest that PVRIG may be a dominant checkpoint in diverse patient populations with tumors that express elevated PVRL2 as compared to expression of the TIGIT ligand PVR. This include patients with breast, endometrial, and ovarian cancers. In addition, expression studies show that PVRIG and TIGIT, and their respective ligands, are expressed in a broad variety of tumor types, such as those noted above, as well as lung, kidney, and head & neck cancers. In these tumors the blockade of both TIGIT and PVRIG may be required to sufficiently stimulate an anti-tumor immune response, with or without additional PD-1 pathway blockade.

On September 7, 2018 Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported the closing of its previously announced registered direct offering of its American Depositary Shares ("ADSs") (Press release, Adaptimmune, SEP 7, 2018, View Source;p=RssLanding&cat=news&id=2366583 [SID1234529380]). Adaptimmune sold 10,000,000 ADSs at a price of $10.00 per ADS.

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Net proceeds of the offering are approximately $100.0 million. Adaptimmune intends to use the net proceeds from this offering to advance the company’s wholly-owned pipeline of SPEAR T-cell candidates through clinical trials as well as for other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the ADSs described above was filed with the Securities and Exchange Commission ("SEC") and became effective on July 12, 2018. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. The prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at View Source, or may be obtained, when available, by contacting Adaptimmune Therapeutics plc, Attn: Investor Relations, 351 Rouse Boulevard, Philadelphia, PA 19112, or by telephone at: (215) 825-9310.

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

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this communication is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term "Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the offering described in this press release or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) ("Investment professionals") of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) ("High net worth companies, unincorporated associations etc") of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.