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.

On December 14, 2017 OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported the initiation of patient dosing in PISCES/KEYNOTE-695, the company’s global, multi-center, registration-directed open-label Phase 2b clinical trial (Press release, OncoSec Medical, DEC 14, 2017, View Source [SID1234522642]). The trial will evaluate the combination of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.

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"There remains a significant unmet medical need in oncology for patients in whom the existing PD-1 therapies do not work. Based on the encouraging data we presented at SITC (Free SITC Whitepaper), we believe the combination of ImmunoPulse IL-12 and pembrolizumab may offer a differentiated approach to reshaping the tumor microenvironment by converting immunologically cold tumors to hot," said Sharron Gargosky, Chief Clinical and Regulatory Officer of OncoSec. "We look forward to the continued advancement of this trial and to sharing data in 2018."

The Phase 2b, multicenter study of intratumoral tavo with electroporation in combination with intravenous pembrolizumab will enroll approximately 48 patients with a histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

The Company’s prior Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in 22 patients unlikely to respond to anti-PD-1 therapy demonstrated a 50% best overall response rate and a 41% complete response rate. In addition, the trial showed a 57% progression free survival (PFS) rate at 15 months (median PFS not yet reached) and 100% (11/11) duration of response. In clinical studies to date, intratumoral tavo has demonstrated a favorable safety profile and has been well tolerated.

PISCES/KEYNOTE-695 is the second combination study conducted with pembrolizumab and, if successful, could form the basis for a BLA under the accelerated approval pathway.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.

About Metastatic Melanoma

Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses, melanoma becomes more difficult to treat once it spreads beyond the skin, such as the lymphatic system (metastatic disease). Given its occurrence in young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will occur in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)/KEYNOTE-695

PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.

Generex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Generex, 2017, DEC 14, 2017, View Source [SID1234522647]).

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On December 13, 2017 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it is hosting an Analyst Day, Wednesday, December 13, 2017, beginning at 9:00am ET, in New York City (Press release, Iovance Biotherapeutics, DEC 13, 2017, View Source;p=RssLanding&cat=news&id=2322493 [SID1234522621]). During the event, the company will provide an update on its lead program in metastatic melanoma, including a presentation of updated data showing partial responses in four out of 10 patients in cohort 2 in the C-144-01 trial. The company will also review its two additional company-sponsored trials in recurrent, metastatic, or persistent cervical cancer and recurrent or metastatic squamous cell carcinoma of the head and neck as well as an expansion of the TIL pipeline into lung cancer. Additionally, the company’s proprietary Generation 2 (Gen 2) manufacturing process has now been selected for all ongoing and future TIL clinical development.

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"Iovance has made substantial progress in 2017 and we are eager to showcase our work during today’s Analyst Day. We have formally selected Gen 2 as the manufacturing process to be used for registration and have switched all the ongoing study protocols over to this process," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also enthusiastic about our expansion into lung cancer. In collaboration with two industry-leading partners, we will explore the potential of TIL therapy alone and in combination with approved systemic agents. The study at Moffitt has been initiated and the Iovance study, with MedImmune, combining TIL and durvalumab will start in the first half of 2018. We also will provide an update regarding data from cohort 2 of the C-144-01 melanoma study confirming partial responses in four out of 10 patients."

Manufacturing Update

Iovance announced today that it has selected its Gen 2 manufacturing process for all three Phase 2 trials and for all future TIL clinical development. The protocols for the company’s three existing studies have all been amended to allow for enrollment of new patients with TIL manufactured with the Gen 2 process. Cohort 1 of the C-144-01 melanoma study will be closed and new patients will be enrolled in cohort 2. The Gen 2 manufacturing process takes 22 days and the final cell product is cryopreserved for ease of scheduling and handling. The decision to use the Gen 2 manufacturing process was based on data recently presented at the SITC (Free SITC Whitepaper) 2017 Annual Meeting in November, the approximately 35 percent reduction in cost of manufacturing as well as the benefits to patients which include minimizing the time a patient has to wait to receive their TIL and flexibility of scheduling the dosing. Iovance has filed multiple provisional patent applications specific to this process, which if granted, could provide exclusive rights through 2038.

Highlights from Three Lead Clinical Programs

Phase 2 trials are ongoing with adoptive cell transfer (ACT) therapies that utilize an autologous TIL manufacturing process in metastatic melanoma, recurrent, metastatic, or persistent cervical cancer and recurrent and/or metastatic squamous cell carcinoma of the head and neck.

C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of LN-144, Iovance’s lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling. To date, Iovance has 11 active clinical sites in the United States and intends to start enrolling patients at clinical sites in Europe in early 2018. In November 2017, the company reported results from cohort 2 of the C-144-01 study at the SITC (Free SITC Whitepaper) Annual Meeting. The data being presented today show an objective response rate of 40 percent, with four of ten patients showing a partial response. The most common side effects were pyrexia, anemia and decreased neutrophil count. These patients had a high tumor burden despite a median of 3.6 prior therapies including anti-CTLA and PD-1 treatment.

C-145-03 is a Phase 2, multicenter study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The trial has met the efficacy threshold for the first stage of the Simon’s two stage design and will therefore continue to enroll patients to the full sample size of 47 per protocol. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process. Iovance anticipates reporting early data from this study in 2018.

C-145-04 is a Phase 2, multicenter, study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The study is enrolling patients in the Unites States and is expected to start enrollment of patients in Europe in the first half of 2018. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process.

TIL Pipeline Expansion into Lung Cancer

The company announced today that patient enrollment has begun in a study in collaboration with researchers at H. Lee Moffitt Cancer Center and Research Institute (Moffitt), Stand Up to Cancer, and other collaborators. Patients with advanced non-small cell lung cancer (NSCLC) will be enrolled in a study combining TIL and nivolumab in patients who have progressed on nivolumab.

The company also announced that a Phase 2 study in PD-1 and PD-L1 naïve NSCLC patients, sponsored by Iovance, in collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, will initiate in the first half of 2018. The study with MedImmune will allow for enrollment with LN-145 alone or in combination with durvalumab.

MD Anderson Collaboration Update

Iovance provided an update on its collaboration with the MD Anderson Cancer Center (MDA). Under the collaboration, MDA will initiate two basket studies in sarcoma and platinum resistant ovarian cancer. One study will utilize TIL manufactured by Iovance and for the second study, TIL will be manufactured by MDA. Under the agreement with MDA, Iovance also retains the rights to MDA preclinical research in expanding the understanding of TIL and certain intellectual property related to the MDA TIL manufacturing process.

Today’s Guest Speakers

Key Opinion Leaders will discuss current treatment options and the role of TIL in melanoma, head and neck, lung and cervical cancers. Invited guest speakers include:

Sylvia Lee, MD, University of Washington, Fred Hutch Cancer Research Center
Jason Chesney, MD, PhD, University of Louisville, Brown Cancer Center
Emese Zsiros, MD, PhD, Roswell Park Cancer Institute
Webcast Information
A live webcast of today’s presentation can be accessed on the investor page of Iovance Biotherapeutics’ website at View Source A replay of the webcast will be archived on Iovance Biotherapeutics’ website for 30 days following the presentation.