On May 23, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company developing intratumoral gene-delivery immunotherapies, reported that the first patient has been dosed in TRIFECTA, a triple combination clinical trial of OncoSec’s TAVO, an IDO1 drug (epacadostat) and KEYTRUDA in patients with unresectable squamous cell carcinoma head and neck (SCCHN) cancer (Press release, OncoSec Medical, MAY 23, 2019, View Source [SID1234536540]). The study is being led by Dr. Chase Heaton, M.D., a leading oncologic head and neck surgeon at UCSF, and was developed in collaboration with Dr. Alain Algazi, leader of the Head and Neck Medical Oncology Program at UCSF and Clinical Strategic Advisor to OncoSec. Preliminary data from the TRIFECTA study is anticipated later this year.

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The TRIFECTA study capitalizes on findings from a 2017 plot study of TAVO in head and neck cancer patients, which demonstrated impressive clinical and biological results including evidence of synergy between TAVO, and PD-1 antibodies in the disease. One of the patients in the 2017 pilot study, who experienced a remarkable tumor response following TAVO treatment, was featured in a LA Times in an article entitled, "I have terminal cancer and I know my friends want to ask, ‘Aren’t you dead yet?’"

A link to the LA Times article can be found here: View Source

The triple combination of IL-12, IDO1 and anti-PD-1 monoclonal antibody is a first-of-its-kind clinical trial and is seeking to exploit individual anti-tumor properties of each modality. The goal of the study is to evaluate this three-way combination in SCCHN cancer and, if promising, to potentially evaluate the triple combination in other tumor types.

TRIFECTA is an investigator-initiated, single-arm, open-label clinical trial in which 35 evaluable SCCHN patients will receive TAVO, pembrolizumab, and epacadostat. The primary endpoint of the study is overall response rate (ORR) by RECIST v1.1 and will be compared to historical data for pembrolizumab monotherapy in SCCHN and to existing data regarding the combination of pembrolizumab and epacadostat. The study is being conducted by the UCSF Helen Diller Family Comprehensive Cancer Center.

"Despite advancements in the field of immunotherapy, patients with unresectable SCCHN have had limited success when treated with anti-PD-1 antibodies as a monotherapy. Given TAVO’s ability to reverse anti-PD-1 resistance in patients with a variety of tumor types, we are hopeful this triplet combination will benefit this vulnerable patient population," said Daniel O’Connor, President and CEO of OncoSec. "The start of this investigator-initiated clinical trial marks an important milestone for OncoSec and we look forward to reporting preliminary data from this study later this year."

On May 23, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is reported the grant of a new patent (number 3089749) entitled "Combined Preparations for the Treatment of Cancer" by the European Patent Office (Press release, Immutep, MAY 23, 2019, View Source [SID1234536539]).

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The new patent protects Immutep’s intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is either a platinum-based anti-neoplastic agent, such as oxaliplatin or carboplatin, or a topoisomerase I inhibitor, such as topotecan.

Dr Frédéric Triebel, Immutep CSO and CMO, commented, "This new patent is important because platinum-based chemotherapy agents and topoisomerase I inhibitors continue to be commonly used forms of chemotherapy. In addition, the past couple of years has seen, for the first time, the marketing approval and adoption of first or second line combinations of chemotherapy and active immunotherapies for the treatment of advanced solid tumors.

As such, this new patent provides patent protection in Europe for a range of novel and highly relevant chemo-immunotherapies featuring efti that may be pursued in the future."

The patent expiry date is 19 December 2034.

On May 23, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company (XYN), reported that long-term follow up data of exceptional responders to abexinostat/pazopanib will be presented by Dr. Rahul Aggarwal, a lead investigator at the University of California, San Francisco ("UCSF") (Press release, Xynomic Pharmaceuticals, MAY 23, 2019, http://xynomicpharma.com/en/xynomic-pharma-to-present-long-term-follow-up-data-showing-abexinostat-combined-with-pazopanib-has-durable-responses-in-patients-with-pre-treated-kidney-cancer/ [SID1234536538]). Dr. Aggarwal will present the information at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, IL on June 1, 2019 in a presentation titled "Exceptional Responders to Abexinostat ("ABX") Plus Pazopanib ("PAZ") in Pre-Treated Renal Cell Carcinoma ("RCC") and Other Solid Tumors: Long-Term Follow Up of a Phase 1b Study" (Abstract No: 3022).

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The initial results from the Phase 1b study of Xynomic’s potent pan-HDAC inhibitor ABX plus PAZ demonstrated acceptable toxicity profile and encouraging anti-tumor activity (Aggarwal et al. Journal of Clinical Oncology, 2017). In this trial, 51 patients (including 22 RCC patients) were enrolled between June 2012 and October 2015. Among them, 10 patients (20%) had experienced disease progression on prior PAZ; 30 patients (59%) had received prior vascular endothelial growth factor ("VEGF") targeted therapy.

The ASCO (Free ASCO Whitepaper) presentation long-term follow up data of exceptional responders and additional correlative analyses associated with clinical outcomes. In particular, as of February 2019, among the 10 patients who had experienced disease progression on prior PAZ treatment, 5 patients achieved durable partial response ("PR") lasting for more than 2 years, and 1 patient who was previously a PAZ-refractory patient with RCC, remained on treatment with ongoing PR, for more than 6 years. In addition, higher peripheral blood HDAC2 expression was associated with prolonged progression-free survival (median PFS 5.9 vs. 3.5 months, log-rank p=0.02). Induction of histone acetylation on ABX lead-in treatment was associated with subsequent time to progression (p=0.002). On-treatment plasma VEGF levels were inversely correlated with PBMC histone acetylation (p=0.02). The new data demonstrate that (1) marketed durable responses with ABX + PAZ are achievable, including in patients with PAZ- and VEGF-refractory RCC and other solid tumor malignancies, and (2) host factors including HDAC expression and acetylation status may identify those patients most likely to benefit from this combination therapy.

A global, randomized pivotal Phase 3 trial is underway of ABX + PAZ as a first- or second-line therapy in patients with locally advanced or metastatic RCC (RENAVIV; NCT03592472). The U.S. Food and Drug Administration has granted Fast Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of RCC.

On May 22, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that on May 21, 2019, it granted share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting in 2015 (the "2015 HCML Share Option Scheme") (Press release, Hutchison China MediTech, MAY 22, 2019, https://www.chi-med.com/grant-of-share-options-under-share-option-scheme/ [SID1234556762]).

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Chi-Med granted 18,000 share options under its 2015 HCML Share Option Scheme to certain employees to subscribe for Ordinary Shares subject to the acceptance of the grantees. Details of such share options granted prescribed are as follows:

Date of grant: May 21, 2019

Exercise price of share options granted: GBP42.20 per Ordinary Share

Number of share options granted: 18,000 (each share option shall entitle the holder thereof to subscribe for one Ordinary Share)

Closing market price of Ordinary Shares on the date of grant: GBP42.20 per Ordinary Share

Validity period of the share options: From May 21, 2019 to May 20, 2029

On May 22, 2019 Probiodrug AG ("Probiodrug", Euronext: PBD), reported that the company is scheduled to attend the following conferences (Press release, Vivoryon Therapeutics, MAY 22, 2019, View Source [SID1234537420]):

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(1) 2019 BIO International Convention

June 3-6, 2019, Pennsylvania Convention Center, Philadelphia, PA, USA

Dr. Ulrich Dauer, CEO, and Dr. Michael Schaeffer, CBO, to attend and host meetings

(2) Biotech CEO Summit Europe

June 17-19, 2019, Enniskerry, Ireland

Dr. Ulrich Dauer, CEO, to attend

For more information, please contact:

Probiodrug
Dr. Ulrich Dauer, CEO
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]