On December 14, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) as part of the NBI’s annual re-ranking of biotechnology and pharmaceutical companies listed on The NASDAQ Stock Market (NASDAQ) that meet NBI’s eligibility criteria (Press release, Puma Biotechnology, DEC 14, 2017, View Source [SID1234522653]). Puma will be added to the NBI effective prior to market open on Monday, December 18, 2017.

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The NASDAQ Biotechnology Index is a modified market capitalization weighted index that is designed to track the performance of a set of securities listed on The NASDAQ Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB) and is re-ranked annually in December.

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 .

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On December 14, 2017 Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, reported that researchers at Massachusetts Eye and Ear (MEE), Emory University and the National Cancer Institute (NCI) have generated preclinical data that demonstrate the ability of light-activated AU-011 to target and selectively destroy ocular melanoma tumors, both in vitro and in vivo, in an orthotopic animal model that highly mimics the location and progression of the disease in humans(Press release, Aura Biosciences, DEC 14, 2017, View Source [SID1234522650]). These results have been published in the peer-reviewed journal, Molecular Cancer Therapeutics.

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Aura’s lead program, light-activated AU-011, is being developed for the treatment of primary ocular melanoma, a rare and life-threatening disease with no approved FDA therapies, and is currently in Phase 1b/2 clinical testing. Researchers believe AU-011’s high tumor specificity and targeting capability, due to its ability to selectively bind to heparan sulfate proteoglycans (HSPG) on the surface membrane of tumor cells, may be key to avoiding damage to the main ocular structures and preserving patients’ vision

"These data offer strong support for the basis of our clinical program, which we are currently investigating in patients with primary ocular melanoma," said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. "Our ultimate goal is to offer a first-line treatment option that can achieve local tumor control, while enabling patients to maintain their vision."

Currently available treatment options to control local tumor growth, such as plaque radiotherapy, are highly invasive and not tumor-specific, often resulting in severe and vision-threatening complications. The data published today suggest that AU-011 may be further investigated as a novel first-line treatment option that can enable early intervention and potentially become the standard of care for patients with early-stage ocular melanoma.

About ocular melanoma
Ocular melanoma, also known as uveal or choroidal melanoma, is a rare and aggressive eye cancer. Ocular melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long-term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011
AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma. The therapy consists of viral nanoparticle conjugates that bind selectively to unique receptors on cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. This therapy can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.