TILT Biotherapeutics Initiates Collaboration With Merck KGaA, Darmstadt, Germany and Pfizer Investigating the Combination of Oncolytic Virus, TILT-123, And Anti-PDL1 Antibody, Avelumab

HELSINKI, Finland I June 25, 2019 I TILT Biotherapeutics Ltd, the leading company globally working in the area of enabling tumor T-cell therapies and checkpoint inhibiting antibodies with oncolytic viruses, announces that it has entered into an agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate its armed oncolytic virus, TILT-123, with avelumab in patients with solid tumors refractory to routine modalities.

“We are pleased to initiate a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to translate our findings into patients. Preclinical results with TILT®-technology and anti-PD(L)1 agents suggest immune activation and efficacy in certain animal models”, explains Akseli Hemminki (MD, PhD, eMBA), CEO and Founder of TILT Biotherapeutics.

*Avelumab is under clinical investigation in combination with TILT-123 for treatment of solid tumors and has not been demonstrated to be safe and effective for this use. There is no guarantee that avelumab in combination with TILT-123 will be approved by any health authority worldwide.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab Approved Indications

Avelumab (BAVENCIO®) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO® in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO®, please see www.BAVENCIO.com.

About TILT Biotherapeutics

TILT Biotherapeutics Ltd, a privately funded company, is focused on enabling tumor T-cell therapies including checkpoint antibodies, with armed oncolytic viruses. The company’s patented technology is uniquely based on human observations on the effect of oncolytic adenoviruses on the adaptive immune system.

The lead candidate of the company is an armed oncolytic adenovirus TILT-123 (Ad5/3-E2F-D24-TNFa-IRES-IL2). TILT-123 replicates selectively only in cancer cells producing immunostimulatory cytokines (TNFa and IL-2) locally at the tumor as demonstrated in different in vivo and in vitro studies. The product has been engineered to have increased entry to cancer cells, and its administration is possible by both systemic and local routes, making it potentially applicable to treatment of wide variety of cancers. These unique characteristics of TILT-123 make it particularly suitable for assessment with checkpoint inhibition as both therapies are thought to work in parallel to sustain anti-tumor immune responses. Virus replication, tumor antigen spreading and the cytokines together counteract immunosuppression in tumor microenvironment. Anti-PD-(L)1 is necessary for disabling cancer cells’ ability to suppress T-cell activity via PD-1 signaling. Thus, there is a potential beneficial interplay between the two treatments: TILT-123 is thought to help achieve the conditions in the tumor that lead to durable responses in patients successfully treated with immune checkpoint blockade. Clinical trials with TILT-123 will be carried out in Europe and U.S. in different solid tumor indications. www.tiltbio.com

SOURCE: TILT Biotherapeutics

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