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Synaffix Announces $125m License Agreement with Shanghai Miracogen

On April 10, 2019 Synaffix B.V., a Dutch biotechnology company exclusively focused on continued advancement of its clinical-stage antibody-drug conjugate (ADC) technology for the development of best-in-class ADCs, reported that it has entered into a license agreement with Shanghai Miracogen Inc., a Chinese biotechnology company with a clinical-stage pipeline of ADCs (Press release, Synaffix, APR 10, 2019, View Source [SID1234535087]).

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Under the terms of the agreement, Miracogen has been granted non-exclusive rights to Synaffix’s proprietary GlycoConnect and HydraSpace ADC technologies for use in its next clinical candidate. Synaffix is eligible to receive upfront and potential milestone payments that total $125 million, plus royalties.

Miracogen will be responsible for the research, development, manufacturing and commercial-ization of the ADC product while Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect and HydraSpace technologies.

This agreement follows a research collaboration between the two companies which was centered around a specific drug candidate that has now been selected for clinical development.

Mary Hu, Chairman and CEO of Miracogen, said:

"We are very pleased to have reached this license agreement with Synaffix. We believe that their GlycoConnect and HydraSpace technologies will further differentiate our pipeline of ADCs by delivering valuable expansion of the therapeutic index. Our efficient and collaborative relationship during the research phase has provided us with a highly competitive new asset for the Miracogen pipeline in just a five-month timeframe. We look forward to continuing our collaboration as we advance this candidate into the clinic and beyond to benefit cancer patients."

Peter van de Sande, CEO of Synaffix, said:

"Working with Miracogen has been a rewarding experience. As we transition into the development phase together, this license agreement with Miracogen provides additional validation of our GlycoConnect and HydraSpace technologies."

"There is a clear trend in China towards developing innovative products and as such, ADCs have emerged as a strong area of growth within the field of oncology. Our proprietary technologies can address the current unmet need for clinical candidates with an enhanced therapeutic index, thereby driving further growth of our activities in China and other markets."

About GlycoConnect and HydraSpace

The clinical-stage GlycoConnect and HydraSpace technologies enable best-in-class ADCs with significantly enhanced efficacy and tolerability. GlycoConnect is the conjugation technology that exploits the native glycan for site-specific and stable payload attachment. HydraSpace is the compact and highly polar spacer technology. These technologies can be applied directly to any existing antibody without any protein engineering and are compatible with all ADC payload classes.

The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect and HydraSpace to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

Immatics Initiates Third Phase I Clinical Trial of its Unique ACTengine® Platform in Patients with Advanced Solid Cancers

On April 9, 2019 Immatics, a leading company in the field of cancer immunotherapy, reported that it has initiated enrollment of patients into a phase I trial of IMA203, its third T-cell receptor (TCR)-transduced adoptive cell therapy program (Press release, Immatics Biotechnologies, APR 9, 2019, View Source [SID1234569546]). IMA203 is an investigational immunotherapy which uses Immatics’ proprietary ACTengine approach and is based on genetic engineering of the patient’s own T cells to express an exogenous TCR. The goal is to redirect and activate the T cells to treat solid tumors.

The clinical study (IMA203-101) is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas. It will initially include approximately 15 patients with relapsed and/or refractory solid tumors, for which no standard of care therapy is available.

Immatics’ ACTengine approach engineers the patient’s own T lymphocytes (a type of white blood cell) to express a novel, exogenous T-cell receptor (TCR) which is targeted to a site on the tumor identified by Immatics’ proprietary XPRESIDENT target discovery platform. ACTengine combines several innovative features:

Patients are eligible for ACTengine cell therapy if the target of interest is present on the patient’s tumor as demonstrated by biomarker profiling.
The TCR used in this trial has been selected from the human T-cell repertoire of more than one hundred TCRs for highest specificity, using Immatics’ XPRESIDENT-guided on- and off-target toxicity screening.
The novel TCR recognizes its target with optimal affinity to enable an adoptive cellular therapy (ACT) approach that uses a proprietary TCR chain pairing enhancement technology for IMA203 to maximize the efficacy and safety features of ACTengine.
The TCR-transduced T cells are activated and multiplied outside of the body before being infused into the patient. For IMA203, this process requires only 5-6 days of manufacturing time, allowing patients to be treated earlier than with most other comparable therapies.
The primary objective of the study is to evaluate the safety and tolerability of the ACTengine approach, and specifically IMA203, in target-positive solid cancer patients.
The secondary objectives include the evaluation of feasibility, the persistence of T cells in vivo, and the assessment of anti-tumor activity and biomarkers.
The IMA203 phase I trial will be conducted by the Department of Investigational Cancer Therapeutics and the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson Cancer Center in Houston, Texas. The principal investigators are Dr. Apostolia Tsimberidou and Dr. Amir Jazaeri.
Stephen L. Eck, M.D., Ph.D., Chief Medical Officer of Immatics US, commented: "This new study will be the third in Immatics’ series of ACTengine studies which modify a patient’s existing T cells to recognize highly specific tumor antigens. These studies were built from Immatics’ unique XPRESIDENT target discovery technology, which identifies novel tumor-specific T-cell targets. IMA203 will focus on a patient population distinct from that of our other studies, expanding the tumor indications Immatics seeks to treat. Collectively, the ACTengine series of studies address a broad spectrum of human cancers by providing a therapy for each patient that is based on each individual’s unique tumor biology."

Case Report in the Journal of Neurosurgery Highlights Potential of ONC201 in H3 K27M-mutant DIPG

On April 9, 2019 Oncoceutics reported the publication of an article entitled "First clinical experience with DRD2/3 antagonist ONC201 in H3 K27M–mutant pediatric diffuse intrinsic pontine glioma: a case report" in the Journal of Neurosurgery (authored by Matthew D. Hall, M.D., MBA) (Press release, Oncoceutics, APR 9, 2019, View Source [SID1234558359]). The article summarizes the medical history of a 10-year-old girl with a diffuse intrinsic pontine glioma (DIPG) brain tumor. Following radiation therapy and treatment with ONC201 on a compassionate use basis, she developed near complete resolution of her presenting neurological symptoms for almost one year, enabling her return to school and participation in many normal activities.

DIPG is a serious and rare disease with a dismal prognosis and no viable treatment options. It predominantly affects children and young adults, and it is the most common form of brainstem glioma in this age group. DIPG.org, a resource network for the disease, summarizes the disease characteristics as follows: "Currently, outcomes for most patients are poor, with a median survival of less than 1 year from diagnosis. Radiation therapy can shrink tumors, temporarily improving some symptoms and delaying the progression of the disease, but in almost all cases, the tumor continues to grow. So far, clinical trials have not shown that currently available chemotherapy drugs, radiosensitizing drugs (drugs that make tumor cells more likely to be killed by radiation therapy), or biologics (medical products created by biological processes, such as vaccines or gene therapy) benefit patients. Because of their location in the brainstem, DIPGs cannot be removed surgically. New approaches to treating DIPG are urgently needed."

ONC201 is an investigational drug developed by Oncoceutics that is being studied in several clinical trials for use against DIPG and other brain tumors. The underlying mechanism of the drug involves the interception of a specific receptor for dopamine, called DRD2. DRD2 is a neurotransmitter that is misused by malignant glioma cells to boost their growth. Tumors that harbor a certain mutation of a highly conserved histone protein, i.e. H3 K27M, are particularly sensitive to ONC201 in spite of the otherwise aggressive growth that this mutation confers. DIPG is one of the tumor types that exhibit a high prevalence of this mutation.

The patient described in the article has shown prolonged clinical benefits and is approaching almost two years from diagnosis, although ONC201 was administered only when symptoms progressed after radiation was completed. This supports further investigation of ONC201 in H3 K27M-mutant gliomas, including DIPG. As a result, Oncoceutics has significantly expanded its pediatric clinical program for ONC201. The company’s ongoing pediatric trial for ONC201 in H3 K27M-mutant high-grade gliomas including DIPG (NCT03416530) was extended with additional treatment arms, a pediatric oral solution formulation was introduced, and ONC201 treatment was extended to newly diagnosed DIPG patients with concomitant radiation.

The company further implemented an intermediate size Expanded Access Protocol (EAP) to provide access to ONC201 for patients that might benefit from the drug but are not eligible for participation in the ongoing clinical trials. The EAP was made possible by the support of the Food and Drug Administration and their high priority effort to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or satisfactory alternative therapy options are available (see recent FDA statement). The program is also supported by The Musella Foundation, The Cure Starts Now Foundation, The Michael Mosier Defeat DIPG Foundation, Cancer Commons and xCures.

"We are delighted to see a novel concept to treat this horrible disease emerge and show traction in clinical settings," said Keith Desserich, Chairman of the Board and Co-Founder of The Cure Starts Now. "We have followed the development of ONC201 for some time and are excited about the emerging data in both, children as well as young adults that are expected to become public later in this year.

Bio-Techne To Host Conference Call On April 30, 2019 To Announce Third Quarter 2019 Financial Results

On April 9, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that management will host a conference call on Tuesday, April 30, 2019 at 8:00 a.m. CDT to review third quarter 2019 financial results (Press release, Bio-Techne, APR 9, 2019, https://investors.bio-techne.com/news/detail/133/bio-techne-to-host-conference-call-on-april-30-2019-to-announce-third-quarter-2019-financial-results [SID1234536923]).

Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CDT

Date:

April 30, 2019

Dial-in:

1-866-548-4713 or 1-323-794-2093 (for international callers)

Conference ID:

9482573

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call. To access the recording, U.S. callers should dial 1-844-512-2921 or international callers should dial 1-412-317-6671 and enter the replay access code 9482573. The recording can also be accessed by going to:

View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, April 30, 2019 until 11:00 p.m. CDT on Thursday, May 30, 2019.

Horizon Pharma plc to Release First-Quarter 2019 Financial Resultsand Host Webcast on May 8, 2019

On April 9, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported that its first-quarter 2019 financial results will be released on Wednesday, May 8, 2019. Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results (Press release, Horizon Pharma, APR 9, 2019, View Source [SID1234535313]).

The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.