On January 4, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-301 (camidanlumab tesirine) in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 4, 2019, View Source [SID1234596069]).

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ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, ADC Therapeutics presented interim data on 113 patients dosed in its Phase Ia/Ib clinical trial in lymphoma. In HL patients with a median of five prior lines of therapy and no other approved therapy options, the overall response rate was 86.5 percent, including a 43 percent complete response rate, at the dose being considered for a pivotal Phase II clinical trial that the Company anticipates initiating in 2019.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We continue to be very encouraged by the anti-tumor activity of ADCT-301 in Hodgkin lymphoma and non-Hodgkin lymphoma. In addition, based on the immune-oncology potential ADCT-301 has demonstrated in preclinical studies, we are excited to be starting this clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple difficult-to-treat solid tumor cancers."

ADCT-301 in Solid Tumors

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, ADC Therapeutics presented preclinical data showing that an engineered version of ADCT-301 demonstrated highly potent anti-tumor activity, both as a monotherapy and in combination with a checkpoint inhibitor, in multiple solid tumor models with infiltrating CD25-positive regulatory T cells (Tregs).

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both as a monotherapy and in combination with a checkpoint inhibitor. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

The Phase Ib trial of ADCT-301 in patients with advanced solid tumors has both dose escalation and cohort expansion parts. The dose escalation part is designed to establish a safe and tolerated dose and dosing schedule of ADCT-301 in these patients. The identified dose and dosing schedule will be studied in the dose expansion part. Approximately 50 patients will be enrolled in the trial.

For more information about this Phase Ib clinical trial in solid tumors, please visit www.clinicaltrials.gov (identifier NCT03621982).

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. In addition to the Phase Ib clinical trial in solid tumors, ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).

On January 4, 2019 Recursion, a clinical-stage biotechnology company combining artificial intelligence (AI), experimental biology, and automation to discover and develop drugs at scale, reported it has entered into a licensing agreement with the Ohio State Innovation Foundation (OSIF), the technology transfer function of The Ohio State University, gaining rights to OSU-HDAC42, a clinical-stage compound that will be developed by Recursion as REC-2282 (Press release, Recursion Pharmaceuticals, JAN 4, 2019, View Source [SID1234556193]). Recursion plans to develop the compound in neurofibromatosis type 2 (NF2), a devastating rare tumor syndrome.

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"We leveraged our unique discovery platform to identify potential therapies for NF2 from among known compounds with the potential for accelerated development," said Chris Gibson, Ph.D., co-founder and CEO of Recursion. "We found a strong signal in our data for REC-2282 as a potential treatment for NF2, and upon further diligence, discovered the drug was already being pursued in the treatment of this disease. The universe of experimental treatments is vast, but the data arbitrage generated empirically on our platform gave us the confidence to move forward quickly."

Under the terms of this agreement, Recursion obtains exclusive worldwide rights to develop and commercialize REC-2282. Full financial terms have not been disclosed.

"Adding REC-2282 to our clinical pipeline and driving to a rapid determination of its efficacy and safety for NF2 patients marks another important step in Recursion’s growth and more importantly may offer a better treatment option for this terribly underserved patient population," said Tim Considine, Senior Vice President, Strategic Development at Recursion. "We are excited to build on existing clinical data to advance this program to human proof of concept in NF2 as rapidly as possible."

Last year, Recursion announced that its Investigational New Drug (IND) application for another disease of unmet need, cerebral cavernous malformation (CCM), was cleared by the Food and Drug Administration (FDA), and that program is currently enrolling subjects in Phase 1.

About Neurofibromatosis Type 2

Neurofibromatosis type 2 is a genetic condition most commonly associated with bilateral vestibular schwannomas, also known as acoustic neuromas. These are benign (noncancerous) tumors that occur on the nerves responsible for balance and hearing in the inner ear. Patients can also have meningiomas, a slow-growing tumor that usually develops on the surface of the brain. Although these tumors are benign, they can cause loss of hearing and balance problems, and in severe cases can be life threatening. It is estimated that about one in 40,000 people has NF2. Approximately 50% of people with NF2 do not have a family history of the condition. Current treatment involves surgical removal of the tumors, which provides temporary relief of symptoms but bears a significant risk of hearing loss and other complications.

About REC-2282 (OSU-HDAC42)

REC-2282 is a pan-histone deacetylase (HDAC) inhibitor. There are multiple lines of evidence that REC-2282 exhibits both histone-independent and acetylation-independent mechanisms, at both epigenetic and cellular levels. The compound was previously in clinical development by Arno Therapeutics (as AR-42) for various solid and liquid tumors. Exploratory investigator-initiated studies have been conducted in patients with vestibular schwannomas and meningiomas. Rights to the compound were returned to OSIF in November 2017.

On January 4, 2019 PierianDx, a leading clinical genomics informatics company, reported a strategic, non-exclusive, multi-year partnership with Illumina, Inc. to provide a variant interpretation and reporting solution based on PierianDx’s Clinical Genomics Workspace platform and Clinical Genomics Knowledgebase for select Illumina oncology products (Press release, PierianDx, JAN 4, 2019, View Source [SID1234554038]). Under the agreement, PierianDx and Illumina will offer customers the option of informatics capabilities for Illumina oncology products, including Illumina’s TruSight Tumor 170 and TruSight Oncology 500, which are currently intended for research use only (RUO). The partnership extends to support Illumina’s future oncology in vitro diagnostic (IVD) offerings. Advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide is a key focus of both parties.

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"Accessibility of genomic testing in clinical oncology is critical to realizing the promise of immuno- and targeted therapies and personalized medicine," states Rakesh Nagarajan, MD, PhD, Founder and Executive Chairman, PierianDx. "Today, few laboratories have the ability to offer comprehensive tumor profiling because of the complexities associated with validating large NGS assays and interpreting genomic results. This agreement between PierianDx and Illumina has the potential to provide laboratories clinically-optimized solutions that may accelerate assay validation and deployment and simplify genomic interpretation."

"The combination of Illumina’s comprehensive tumor profiling assays with Pierian Dx’s variant interpretation and reporting solutions will provide customers with a seamless experience," said Garret Hampton, PhD, Executive Vice President of Clinical Genomics at Illumina.

"PierianDx is thrilled to receive this substantial validation of our genomics Software as a Service (‘SaaS’) platform by a global leader in our space. Our relationship with Illumina will allow us to greatly accelerate our U.S. and international strategic plans as we seek to be the wisdom behind every genomics report," said Michael L. Sanderson, CEO of PierianDx.

Under the agreement Illumina and its affiliates will be responsible for the distribution of the RUO oncology products and packaged solutions. Laboratories that purchase the RUO products from Illumina will have an option to receive from PierianDx standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories who purchase the bundled RUO oncology product with the PierianDx informatics solution will receive access to PierianDx’s Clinical Genomics Workspace for analysis, interpretation, and reporting of genomic results. Laboratories will also have the opportunity to engage PierianDx for additional services such as genomic interpretation, medical sign-out, and electronic medical record integration.

On January 4, 2019 Synaffix B.V. reported it has entered into a license agreement with Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need (Press release, Synaffix, JAN 4, 2019, View Source [SID1234532772]). This agreement provides Mersana access to Synaffix’s industry-leading site-specific GlycoConnect ADC technology that has consistently demonstrated an ability to improve both the safety and the efficacy profiles of ADC product candidates. Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a projected total deal value of $295 million, plus royalties­­.

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Under the terms of the agreement, Mersana has been granted a non-exclusive license to incorporate GlycoConnect into one of its ADC development candidates, as well as an option to expand to additional programs. This agreement follows a research collaboration between the two companies that was centered around multiple product candidates.

"After evaluating several site-specific conjugation platforms, we have chosen Synaffix’s GlycoConnect technology for use in future ADC candidates," said Anna Protopapas, President and Chief Executive Officer of Mersana. "We are excited about the potential of this technology as it is designed not to require additional antibody engineering or cell-line modifications, which would offer us the potential to create site-specific antibodies for use in our ADCs when required."

"We are particularly excited to enter into this agreement with a leading company in the field of ADCs such as Mersana," said Peter van de Sande, CEO of Synaffix, who added "This collaboration is another testimony of the additional value that GlycoConnect is able to provide to already cutting-edge ADC technologies, thereby enabling novel medicines that are uniquely positioned to address areas of unmet medical need."

Per the agreement, Mersana is responsible for the research, development, manufacturing and commercialization of any resulting ADC product while Synaffix will supply components that are specifically related to its proprietary GlycoConnect technology.

About GlycoConnect

The proprietary GlycoConnect technology of Synaffix is a platform ADC technology that utilizes proprietary enzymes and metal-free click conjugation to stably attach ADC payloads specifically to the native glycan of any antibody, a privileged site for ADC applications. This approach can be applied directly to an existing antibody without any DNA and or protein engineering and is compatible with all ADC payload classes. The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

On January 4, 2019 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that it will be presenting at the Biotech Showcase 2019 conference on Tuesday, January 8, 2019, at 11:30 a.m. PST in the Yosemite C ballroom at the Hilton San Francisco Union Square. Jeff Wolf, CEO of Heat Biologics, will be presenting (Press release, Heat Biologics, JAN 4, 2019, View Source [SID1234532578]).

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