On December 15, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers (Press release, Hutchison China MediTech, DEC 15, 2017, View Source [SID1234522665]). The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.

About Fruquintinib Development in China

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Colorectal cancer: The China Food and Drug Administration ("CFDA") acknowledged acceptance of the New Drug Application ("NDA") for fruquintinib for the treatment of patients with advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was subsequently awarded priority review status in view of its significant clinical value, according to a CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held on June 5, 2017 (clinicaltrials.gov identifier NCT02314819). The FRESCO study followed an initial Phase I trial in 40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients.

Lung cancer: Fruquintinib is being studied in a Phase III pivotal trial in approximately 520 third-line non-small cell lung cancer ("NSCLC") patients, known as the FALUCA study (clinicaltrials.gov identifier NCT02691299), following a Phase II clinical trial in 91 third-line NSCLC patients. Fruquintinib is concurrently being studied in a Phase II study in combination with Iressa (gefitinib) in first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116).

Gastric cancer: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol (paclitaxel), known as the FRUTIGA study, for the treatment of over 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (clinicaltrials.gov identifier NCT03223376).

In China, fruquintinib is jointly developed with Eli Lilly and Company.

About Fruquintinib

Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as chemotherapy and other targeted therapies, which are being studied in our ongoing clinical trials of fruquintinib.

At an advanced stage, tumors secrete large amounts of vascular endothelial growth factor ("VEGF"), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.

Generex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On December 14, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the Company will release financial results for the fiscal year ended October 31, 2017 on Wednesday, December 20, 2017 (Press release, Advaxis, DEC 14, 2017, View Source [SID1234522644]).

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Advaxis’ senior management will host a conference call to review its financial results and provide a business update, which will include a discussion of the advantages of its Lm-based antigen delivery platform and clinical pipeline. The conference call and live audio webcast will begin at 10:00 a.m. Eastern time on Thursday, December 21, 2017.

Conference Call & Webcast Information

WHEN: Thursday, December 21, 2017 at 10:00 a.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 4682169
WEBCAST: www.ir.advaxis.com/news-events

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning December 21, 2017 two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 4682169. In addition, the audio webcast will be archived on the Company’s website for a period of time at www.ir.advaxis.com/news-events.

On December 14, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported its progress in 2017 and near-term strategic goals and initiatives (Press release, AmpliPhi Biosciences, DEC 14, 2017, View Source [SID1234522649]).

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2017 Corporate Highlights

In April, AmpliPhi received positive feedback from a U.S. Food and Drug Administration (FDA) Type B meeting in which the FDA "acknowledged that phage therapy is an exciting approach to treatment of multi-drug resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development." The FDA also stated that "the clinical safety and effectiveness data collected during development, including from emergency case studies, could inform future discussions for clinical development and ultimately, the regulatory pathway to approval."
In August, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an Emergency IND allowed by the FDA. AmpliPhi provided AB-PA01 for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection. Multiple doses of AB-PA01 were administered intravenously and by inhalation through a nebulizer and were well tolerated.
In September, AmpliPhi announced the first-in-human intravenous administration of its therapeutic candidate AB-SA01 targeting Staphylococcus aureus (S. aureus) under the Special Access Scheme of the Australian Therapeutic Goods Administration. AmpliPhi provided AB-SA01 for a patient suffering from a life-threatening S. aureus endocarditis. AB-SA01 was administered intravenously over a two week duration and was well tolerated.
A total of seven patients, suffering from serious and life-threatening infections who were not responding to antibiotic therapy, have been treated with AB-SA01 or AB-PA01 in 2017.
Raised $9.4 million in net proceeds from an equity securities offering in May, and received a $2.0 million Research and Development Tax Incentive cash rebate in September from the Australian Tax Office based on the Company’s R&D spending in Australia during 2016.
Continued to raise awareness of the Company’s bacteriophage development programs through presentations and participation in various scientific and medical meetings, including: 2017 Australian Society of Otolaryngology Head and Neck Surgery Meeting in March, Solutions for Drug-Resistant Infections Meeting in Brisbane in April, and "Bacteriophage Therapy: Scientific and Regulatory Issues" workshop sponsored by the FDA and the National Institutes of Health in July.
In December, the Company engaged Ladenburg Thalmann & Co. Inc. to assist the Company in exploring strategic alternatives in an effort to maximize shareholder value. The Company has not set a timetable for completion of this exploratory process and cannot provide any assurances that the process will result in the consummation of a strategic transaction of any kind, or that the Company will not abandon the process. The Company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or the Company otherwise determines that further disclosure is appropriate.
Potential Milestones and Initiatives for the First Half of 2018

In early 2018, the Company plans to present topline results from the treatment of seven patients with serious and life-threatening infections, not responding to antibiotics, completed under the Company’s single-patient expanded access program in 2017.

The Company intends to continue its expanded access clinical strategy in the first half of 2018, present data from approximately 25 expanded access clinical cases to the FDA in mid-2018 and initiate a Phase 2 or registrational clinical trial as early as the second half of 2018.

The Company will present an overview and update of its current business activities at the 9th Annual Biotech Showcase Conference on January 8, 2018 at 9:30 a.m. PT being held in San Francisco.

"AmpliPhi has made tremendous progress throughout 2017," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "To date, under the expanded access program, we have dosed seven patients in dire need, who were suffering from serious and life-threatening infections and were not responding to antibiotic therapies. We look forward to presenting topline results in early 2018. We have set a goal of dosing approximately 20 additional patients during the first half of 2018. We continue the dialogue with the FDA and key thought leaders in the infectious disease community regarding design of Phase 2 and registrational clinical studies of our bacteriophage therapies."

On December 14, 2017 Kyn Therapeutics, a biotechnology company advancing new immunometabolism therapies for treating cancer, reported $49 million in Series A capital available to advance a pipeline of clinical- and pre-clinical stage therapies, including a program scheduled to enter clinical studies in 2018 (Press release, KYN Therapeutics, DEC 14, 2017, View Source [SID1234522661]). Atlas Venture and OrbiMed provided the investment.

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Kyn Therapeutics is focused on immunometabolism, a rapidly growing area of immuno-oncology that leverages the powerful impact that various metabolic pathways and metabolites have on the immune system. Each Kyn Therapeutics candidate is designed to reverse the effects of an immunosuppressive metabolite promoted by cancer cells, and therefore complement or enhance the outcomes achieved by checkpoint inhibitor therapies. A majority of patients do not benefit from checkpoint inhibitors as many cancers are adept at evading or dampening an immune response through multiple mechanisms, including activation of immunosuppressive metabolic pathways. Kyn Therapeutics is focused on making the power of immunotherapy work for every patient with cancer, through strategic selection of candidates known to play key roles in major immunometabolism pathways.

"The promise of immunometabolism lies in overcoming the barriers cancer creates against treatment, and we are very excited about the opportunities we’ve created by harnessing compelling research in this area," said Mark Manfredi, chief executive officer of Kyn Therapeutics. "Our preclinical research has delivered exciting results both in single agent studies and in combination with leading checkpoint inhibitors and other mechanisms. We are moving rapidly to launch a clinical oncology study in 2018."

Kyn Therapeutics’ preclinical programs attack components of the IDO and TDO pathways by targeting their resultant immunosuppressive metabolite kynurenine as well as a downstream receptor.

The first program focuses on "Kynase", an enzyme that degrades kynurenine directly and thereby addresses both IDO- and/or TDO-driven immunosuppression. The second program blocks immunosuppression mediated by activation of the aryl hydrocarbon receptor (AHR), which is activated by various immunometabolites including kynurenine. Kyn Therapeutics believes these approaches will yield efficacy in tumors overexpressing IDO and/or TDO, granting broader clinical applicability to a therapeutic candidate. The Series A capital includes a $28 million allocation to these IDO/TDO programs.

"We believe Kyn Therapeutics has differentiated its approach in a field that is rapidly substantiating its early promise," said George Georgiou, a Kyn Therapeutics founder and professor in Engineering at the University of Texas, Austin. "We are excited at the possibility of delivering our therapeutics to the many patients who stand to benefit from the cancer immunotherapy revolution underway."

The most clinically advanced program in development by Kyn Therapeutics is named ARY-007 and blocks the EP4 receptor, which is involved in the highly characterized prostaglandin E2 pathway. The EP4 receptor is strongly associated with an immunosuppressive and tumor promotive effect via immune cell modulation. ARY-007 has demonstrated favorable therapeutic characteristics in human clinical studies for non-oncology indications, and Kyn Therapeutics will build on this earlier work as it prepares for a Phase 1b clinical oncology study, guided by well-established biomarkers. ARY-007 is held by Arrys Therapeutics, an affiliate of Kyn Therapeutics which has exclusively subcontracted the development of ARY-007 to Kyn Therapeutics. The Series A capital includes a $21 million allocation to Arrys Therapeutics for the ARY-007 program.