On September 24, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, and Nektar Therapeutics (Nasdaq: NKTR) reported that the companies are expanding their ongoing research collaboration into a new clinical partnership (Press release, BioXcel Therapeutics, SEP 24, 2018, View Source [SID1234529853]). The collaboration will clinically evaluate the novel combination of BTI’s BXCL701, a small molecule immune-modulator, DPP 8/9 and FAP inhibitor; Nektar’s NKTR-214, a CD122-biased agonist; and a checkpoint inhibitor as a potential therapy for pancreatic cancer.

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Under the terms of the expanded collaboration agreement, BTI will be responsible for initiating and managing the clinical program. The primary objectives of the study are to evaluate safety and efficacy of the triplet combination of BXCL701, NKTR-214 and a checkpoint inhibitor for the treatment of patients with unresectable or metastatic pancreatic cancer. Additionally, correlative immune activation markers will also be evaluated in blood and tumor tissue.

"We are excited to expand our collaboration with Nektar to initiate a clinical program for this novel triplet combination regimen," said Vimal Mehta, Chief Executive Officer of BTI. "Mechanistically, we believe the action of BXCL701 on macrophages and neutrophils within the tumor tissue can activate the innate immune system and then in combination with NKTR-214 and an anti-PD1, we can then prime adaptive immune cells in order to trigger T-cell driven anti-cancer activity and the generation of T-cell memory. The exciting preclinical data presented at this year’s ASCO (Free ASCO Whitepaper) Meeting highlighted the complementary mechanisms by which these three agents can synergize to generate durable responses in various animal models."

"We believe it is essential to target multiple dimensions of the immune system in parallel in order to address the multi-faceted etiologies underlying cancer cell growth in difficult-to-treat tumors such as pancreatic cancer," said Jonathan Zalevsky, Senior Vice President, Biology & Preclinical Development of Nektar Therapeutics. "This experimental triplet combination regimen of BXCL701, NKTR-214 and a checkpoint inhibitor is designed to leverage multiple mechanisms of action at once to better fight pancreatic cancer while potentially generating long-term cancer immunity. We’re pleased to be working with BTI on this program."

BTI and Nektar Therapeutics initially announced a preclinical research collaboration in November 2017. This collaboration focused on utilizing the complementary mechanisms of BXCL701 and NKTR-214 to stimulate the body’s own immune system to overcome immunosuppressive mechanisms in the tumor microenvironment.

On September 24, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the company will participate in two investor conferences in October (Press release, Valeant, SEP 24, 2018, View Source [SID1234529771]).

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Joseph C. Papa, chairman and chief executive officer, and Sam Eldessouky, senior vice president and corporate controller, are scheduled to participate at the Cantor Fitzgerald Global Healthcare Conference in New York on Oct. 1, 2018 at 3:30 p.m. EDT.

Paul S. Herendeen, executive vice president and chief financial officer, William Woodfield, vice president and treasurer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Deutsche Bank 26th Annual Leveraged Finance Conference in Scottsdale, Ariz. on Oct. 2, 2018 at 10:40 a.m. MST (1:40 p.m. EDT).

Live webcasts and audio archives of the events will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

On September 24, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, reported that it will participate in the following upcoming healthcare conferences in October (Press release, Intellia Therapeutics, SEP 24, 2018, View Source [SID1234529769]):

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Monday, October 1, 2018
Cantor Fitzgerald Healthcare Conference
Location: New York, NY
Time: 4:40pm ET

Tuesday, October 2, 2018
Leerink Partners Roundtable Series: Rare Disease & Oncology
Location: New York, NY
Time: 10:30am ET

Tuesday, October 9, 2018
Chardan Genetic Medicines Conference
Location: New York, NY
Time: 1:30pm ET

A live webcast of Intellia’s presentations will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com. To access the webcasts, please log on to the Intellia website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcasts will be available on Intellia’s website for approximately 14 days following each conference.

On September 24, 2018 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") reported that LineaRx, Inc. ("LineaRx"), its wholly-owned subsidiary focused on next-generation biotherapeutics, has signed a Joint Development Agreement (the "Agreement") with Takis S.R.L. and Evvivax S.R.L. ("Takis/Evvivax"), biotechnology companies focused on the discovery and development of DNA based anti-cancer vaccines for the human and animal markets, respectively (Press release, Applied DNA Sciences, SEP 24, 2018, View Source [SID1234529732]).

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Under the terms of the Agreement, LineaRx and Takis/Evvivax will jointly develop linear DNA expression vectors for two of Takis/Evvivax’s anti-cancer vaccine candidates utilizing LineaRx’s linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to preclinical animal models via Takis/Evvivax’s proprietary electroporation technology. Antigen-specific immune responses aimed at achieving therapeutic effects will be studied.

The previously announced collaboration between the companies has already shown promise of yielding immunity in mice that were DNA-vaccinated against the human protein telomerase, which is over-expressed in more than 85% of all cancers.

Dr. Luigi Aurisicchio, CEO of Takis/Evvivax stated: "We are excited to co-develop linear DNA expression vectors for our DNA vaccine candidates with LineaRx. Initial data from the use of LineaRx’s amplicons in our vaccine candidates is promising. The advantages of linear DNA over plasmids would provide a clear market edge over plasmid-based DNA sources. We look forward to a mutually beneficial collaboration".

"This Agreement serves to validate LineaRx’s technology as critical and necessary to the field of biotherapeutics in its ability to deliver potentially powerful approaches to the treatments of chronic diseases," stated Dr. James Hayward, president and CEO of Applied DNA. "Takis/Evvivax are ideal partners of LineaRx given their innovative anti-cancer vaccine candidates for both humans and animals together with their expertise in preclinical animal models."

Dr. Hayward continued, "The use of PCR-produced linear DNA, as opposed to bacterially produced plasmids, is an innovative concept that provides the potential for increased patient safety, ease of manufacture and vaccine logistics, and reduced costs. Our know-how in the fields of bulk linear DNA production and in bioconjugate chemistry enable us to create novel and highly efficient expression vectors."

With their stability at room temperature, low risk of infection or secondary illness, and stability during transportation, DNA vaccines overcome many of the undesirable properties of conventional vaccines. The global DNA based human vaccine market is expected to grow at a CAGR of 55% and reach a value of $2.7 billion by 20191. The global veterinary vaccine market is expected to reach $20.6 billion by 20212, with DNA based animal vaccines gaining rapid market share.

Takis/Evvivax emerged from a Merck-supported research center in Rome and has relationships across Big Pharma (View Source). The companies have agreed to seek sponsorship for their work together.

On September 24, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that the results of its Phase 1a study with single-agent navicixizumab in patients with refractory solid tumors were published in Investigational New Drugs (Press release, OncoMed, SEP 24, 2018, View Source [SID1234529672]). The results showed that 19 of the 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy. Navicixizumab is a bispecific antibody that was designed to enhance the anti-tumor effect observed with inhibition of DLL4 or VEGF alone.

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"These study results demonstrate that navicixizumab has single-agent anti-tumor activity in several tumor types and is particularly active in heavily pretreated ovarian cancer, a cancer with limited treatment options," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "We look forward to presenting interim data from our Phase 1b study, which is evaluating navicixizumab in combination with paclitaxel in patients with heavily pretreated platinum-resistant ovarian cancer at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting."

This Phase 1a multicenter, open-label, dose-escalation trial enrolled sixty-six patients with previously treated solid tumors. The primary endpoint was to determine the maximum tolerated dose. Secondary endpoints included safety, pharmacokinetics, immunogenicity and antitumor activity.

The most commonly enrolled tumor types were ovarian (12), colorectal (11) and cancers of the breast, pancreas, uterus and endometrium (four patients of each). Four patients (three ovarian cancer and one uterine carcinosarcoma) had a partial response, and 17 patients had stable disease. There were 19 patients that had a reduction in the size of their target lesions, including seven patients with ovarian cancer. Six of these seven ovarian cancer patients had prior bevacizumab. Four patients remained on study for >300 days and two of these patients were on study for >500 days. The most common drug related adverse events of any grade were hypertension (58%), headache (29%), fatigue (26%), and pulmonary hypertension (18%). Infusion reactions associated with anti-drug antibodies impacting drug exposure occurred in 11% of patients. The maximum tolerated dose for navicixizumab was not determined based on protocol-defined criteria, but doses of 3-4 mg/kg once every 2 weeks were chosen for the subsequent Phase 1b studies.

A Phase 1b multicenter, open-label, dose-escalation and expansion trial of navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer who have previously received bevacizumab and/or have failed at least two prior therapies is ongoing. Interim study results will be presented in a poster presentation on October 20, 2018 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting to be held in Munich, Germany.

About Navicixizumab
OncoMed’s anti-DLL4/VEGF bispecific antibody, navicixizumab, is designed to inhibit the function of both DLL4 and VEGF and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. Navicixizumab was developed utilizing OncoMed’s BiMAb bispecific platform technology, which enables the design of bispecific antibodies comparable to traditional monoclonal antibodies but possessing dual target-binding specificity. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. Further, in preclinical studies dual inhibition of DLL4 and VEGF appeared to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity.