On May 22, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the Parker Institute for Cancer Immunotherapy will utilize Personalis’ cancer immunogenomics platform, ImmunoID NeXT, for the investigation of biomarkers of response to immunotherapies in clinical trial participants (Press release, Personalis, MAY 22, 2019, View Source [SID1234536523]). The trials include melanoma, pancreatic, and all-comer solid tumor patients treated with checkpoint inhibitors, either as monotherapy or in combination with other cancer therapeutics. This project builds on Personalis’ existing relationship with the Parker Institute as a contributing industry member of the TESLA Consortium, which focuses on improving neoantigen prediction algorithms.

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Unlike traditional biomarker interrogation approaches that require several individual assays, which may be costly and time-consuming, and which may exhaust limited tumor tissue sample, ImmunoID NeXT consolidates multiple biomarker assays into one, meaning researchers no longer need to make the difficult choice regarding which biomarkers to analyze. The platform represents an end-to-end solution for immuno and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor mutations, neoantigens, immune repertoire clonality, tumor escape mechanisms (including HLA-related somatic mutations and genotyping), tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and more.

"Personalis’ platform could help us better understand which patients will respond or not respond to immunotherapy and why," said Theresa LaVallee, PhD, VP Translational Medicine and Regulatory Affairs at the Parker Institute.

"We’re excited to work with the Parker Institute on this important new project," said Dr. Richard Chen, MD, Personalis’ Chief Scientific Officer. "Both organizations are focused on improving outcomes for cancer patients, and we believe that ImmunoID NeXT is the catalyst that our partners and customers can leverage to discover more effective biomarkers of response to immunotherapies."

On May 22, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company developing intratumoral gene-delivery immunotherapies, reported the pricing of an underwritten public offering led by fundamental, healthcare institutional investors consisting of 3,492,063 shares of Common Stock together with Warrants to purchase up to 2,619,047 shares of Common Stock at a combined price to the public of $3.15 (Press release, OncoSec Medical, MAY 22, 2019, View Source [SID1234536522]). The Warrants will have an exercise price of $3.45, will be exercisable upon issuance and will expire five years from the date of issuance. The gross proceeds to the Company from this offering are expected to be approximately $11,000,000 before deducting underwriting discounts, commissions and other offering expenses. OncoSec has granted the underwriter a 45-day option to purchase additional shares of Common Stock and/or additional Warrants to cover over-allotments, if any. The offering is expected to close on May 24, 2019, subject to customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-213036) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that OncoSec has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about OncoSec and such offering.

This press release shall not constitute an offer to sell or 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.

On May 22, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Iovance TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy (Press release, Iovance Biotherapeutics, MAY 22, 2019, View Source [SID1234536521]).

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"We are very excited that the FDA has granted LN-145 in advanced cervical cancer Breakthrough Therapy designation. Cervical cancer patients who have progressed on or after chemotherapy have limited treatment options. We hope to bring LN-145 to these patients as quickly as possible," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. "The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review."

Breakthrough Therapy designation (BTD) is designed to expedite the development and review of therapeutic candidates intended to treat serious or life-threatening diseases in the case where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The FDA decision on BTD for LN-145 in advanced cervical cancer was based on clinical data from the ongoing innovaTIL-04 (C-145-04) trial. The company will present the data on June 1, 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

On May 22, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that argenx has selected a second target under the collaboration and license agreement the companies announced in February 2019 (Press release, Halozyme, MAY 22, 2019, View Source [SID1234536520]).

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The second target selected for development by argenx is human complement factor C2 associated with the product candidate ARGX-117, which is being developed to treat severe autoimmune diseases. Halozyme will receive a $10 million milestone payment during the current quarter from argenx for this target nomination and potential future payments of up to $160 million subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on future commercial sales products. argenx has now selected two targets for development and can select one additional target in the future according to the terms of the collaboration and license agreement.

"We are excited about this opportunity to expand our partnership with argenx," said Dr. Helen Torley, president and chief executive officer. "Planning is well underway for the second half 2019 phase 1 study initiation for the first selected target, FcRn. This second development stage target to be used with our ENHANZE drug delivery technology is yet another example of the potential for ENHANZE to provide dosing optionality for patients. We look forward to continuing our work with argenx as they seek to improve the lives of patients suffering with severe autoimmune diseases."

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On May 22, 2019 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported the upcoming presentation of clinical data from the First-In-Human C101 phase Ia/Ib study of murlentamab (GM102), during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 1, in Chicago, USA (Press release, GamaMabs Pharma, MAY 22, 2019, View Source [SID1234536519]).

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In this study, 68 heavily pre-treated patients with advanced or recurrent AMHRII-positive epithelial ovarian (EOC), granulosa cell tumor (GCT), cervical and endometrial cancers, received murlentamab as a single agent (n=59) or in combination with carboplatin and paclitaxel (n=9).

No dose limiting toxicity was reported at all doses and schedules tested, as a single agent and in combination with chemotherapy. One partial response with murlentamab single agent (RECIST 1.1) was observed in a patient with GCT. In combination with chemotherapy, 4 of 9 patients (44%) responded to treatment (1 complete and 3 partial responses). Among patients treated ≥ 6 months, 6 of 9 (67%) GCT patients with murlentamab single agent and 4 of 5 (80%) patients in combination (2 cervical and 2 endometrial cancers) had a longer Progression-Free Survival than under their previous systemic treatment (mean improvement of 3.9 and 2.1 months respectively). Blood samples from 25 patients treated with murlentamab single agent showed an increase in classical monocytes, as well as T cell and neutrophil activation.

"These updated data for these heavily pre-treated patients are really encouraging," said Pr. Alexandra Leary, Gustave Roussy Institute (France), principal investigator of the study. "We are very satisfied, especially regarding the combination with chemotherapy that supports the development of murlentamab in all gynecological cancers. This is crucial for patients with cervical cancers who have so few options. The excellent safety of the drug will allow testing combinations of murlentamab with all standard and experimental treatments."

"Murlentamab seems to rewire the tumor microenvironment and reinitiate the immunological antitumoral cascade from macrophage to cytotoxic T lymphocyte activation. It opens the field to a number of indications and combinations for murlentamab, given the AMHRII re-expression found in many solid tumors," said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma. "In addition to these gynecological data, the first results of murlentamab in advanced colorectal cancers will be presented at the upcoming 21st ESMO (Free ESMO Whitepaper) World Congress on GI Cancers."

Murlentamab is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa cell tumors (GCT) and is re-expressed in a majority of gynecological cancers and a variety of non-gynecological cancers. Murlentamab is currently being evaluated in two clinical trials, phase 1b in gynecological cancers and phase 2 in advanced or metastatic colorectal cancers. Murlentamab exerts its anti-tumor activity through tumor-associated macrophages reprogramming, resulting in enhanced tumor phagocytosis and subsequent cytotoxic T cell reactivation.

Results will be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting in Chicago, during the Developmental Immunotherapy and Tumor Immunobiology session to be held on Saturday June 1, 8:00 AM-11:00 AM (Hall A) and during the poster discussion session at 1:15 PM – 2:45 PM (Hall D).

Abstract # 2521; ‘First-in-human phase I trial of murlentamab, an anti-Mullerian-hormone receptor II (AMHRII) monoclonal antibody acting through tumor-associated macrophage (TAM) engagement, as single agent and in combination with carboplatin (C) and paclitaxel’ by A Leary and co-authors.