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Merck KGaA, Darmstadt, Germany, Grants Exclusive License to Vertex for Two DNA Damage Response Inhibitors

On January 24, 2019 Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its healthcare business in the U.S. and Canada as EMD Serono, reported that it has entered into an exclusive licensing agreement with Vertex Pharmaceuticals Incorporated, Boston, USA (NASDAQ: VRTX), for two DNA-dependent protein kinase (DNA-PK) inhibitors – M9831 (formerly known as VX-984) and an additional pre-clinical compound – in the field of gene editing for six specific genetic disease indications (Press release, Merck KGaA, JAN 24, 2019, View Source [SID1234532888]). Merck KGaA, Darmstadt, Germany will receive an upfront payment in addition to milestones and royalties on future net sales and retains the rights to both assets in all other disease areas, including oncology, with the ability to develop both these compounds in-house, or to license them to future partners in the gene editing field. Vertex has the option to add indications to the license grant. Both molecules were acquired in a licensing agreement from Vertex in 2017, and are part of the company’s broad portfolio of DNA Damage Response (DDR) inhibitors.

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"This transaction illustrates our determination to maximize value creation from our pipeline," said Belén Garijo, Member of the Executive Board and CEO Healthcare, Merck KGaA, Darmstadt, Germany. "We are rapidly advancing our leading-edge DDR portfolio in oncology and are delighted to see the potential benefit of DNA-PK in genetic diseases through the enhancement of CRISPR/Cas9-mediated gene editing."

Merck KGaA, Darmstadt, Germany is investing significant resources into the promising area of DDR, and has considerable expertise and experience in developing DDR molecules, with the objective of becoming one of the leading players in this therapeutic area. The company is currently investigating four DDR molecules, including two ATR inhibitors, an ATM inhibitor and an investigational small-molecule of DNA-PK. DNA-PK is a key enzyme that could potentially enhance the efficacy of many commonly used DNA-damaging agents such as radiotherapy and chemotherapy.

Pre-clinical studies have shown that DNA-PK inhibitors can enhance CRISPR/Cas9-mediated gene editing. CRISPR/Cas9 is a technology used to modify genetic sequences and is being investigated for the treatment of various genetic disorders. This collaboration licenses two compounds to study the potential DNA-PK-inhibitor-mediated enhancement of gene editing for the treatment of six genetic diseases included in the license grant to Vertex.

Basilea Announces Collaboration to Study Derazantinib and Atezolizumab (Tecentriq®) in Urothelial Cancer

On January 24, 2019 ArQule, Inc.’s (Nasdaq: ARQL) partner, Basilea Pharmaceutica Ltd. (SIX: BSLN), reported that it entered into a collaboration with Roche (SIX: RO, ROG) to explore a combination of derazantinib (BAL087) and Roche’s PD-L1-blocking immune-checkpoint inhibitor, atezolizumab (Tecentriq), in patients with urothelial cancer. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study in mid-2019 (Press release, ArQule, JAN 24, 2019, View Source [SID1234532887]).

The planned study will assess the safety, tolerability and efficacy of the derazantinib-atezolizumab combination in patients with advanced urothelial cancer and confirmed FGFR genomic aberrations. Basilea will be the sponsor of the study, and Roche will provide clinical supply of atezolizumab.

View Source

Peter Lawrence, President and Chief Operating Officer of ArQule, said, "This new combination trial with Tecentriq represents an important step in the development of derazantinib (BAL087, formerly ARQ087) and has the potential to expand meaningfully its therapeutic utility. We look forward to further progress and updates from Basilea."

Derazantinib was licensed to Basilea Pharmaceutica in April 2018 in the US, EU, Japan and the rest of world excluding Greater China. Under the terms of the license agreement, ArQule is eligible to receive up to $326 million in regulatory and commercial milestone payments.

Immunomic to Present at the 2019 BIO CEO & Investor Conference

On January 24, 2019 Immunomic Therapeutics, Inc. reported that its’ founder and CEO, William Hearl, Ph.D., will present an overview of the company and its UNITE technology platform at the 2019 BIO CEO & Investor Conference on February 12, 2019 at 2:00 pm EST in the Hudson/Empire Room at the Marriott Marquis in New York City (Press release, Immunomic Therapeutics, JAN 24, 2019, View Source [SID1234532885]).

Inovio Reports 2nd Patient Achieving Full Remission from HPV-Related Head & Neck Cancer after Treatment with Synthetic DNA Vaccine and a PD-1 Checkpoint Inhibitor

On January 24, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that a second patient with HPV-related head and neck cancer treated with INO-3112 (now called MEDI0457) in a Phase 1 trial achieved a sustained complete response (full remission) after subsequent treatment with a PD-1 checkpoint inhibitor (Press release, Inovio, JAN 24, 2019, View Source;Neck-Cancer-after-Treatment-with-Synthetic-DNA-Vaccine-and-a-PD-1-Checkpoint-Inhibitor/default.aspx [SID1234532884]). This marks the second patient with metastatic cancer observed in full remission (complete response) after treatment with synthetic DNA vaccine followed by a PD-1 checkpoint inhibitor.

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Achieving sustained complete responses with immunotherapy in metastatic cancer patients is what you hope for with novel cancer treatments. The fact that the treatment with our synthetic DNA vaccine followed with two different PD-1 inhibitors in this HPV-related cancer patient population showed a complete response in 2 out of 4 progressors is very encouraging as the best complete response rate by PD-1 inhibitors as a monotherapy in metastatic head and neck cancer is approximately 4%. While additional data from Phase 2 clinical studies will provide more insights to the power of synthetic DNA vaccine, this newly reported data provides additional validation for Inovio’s overall cancer combination strategy using a T cell activator combined with a checkpoint inhibitor against an array of cancers with big pharma partners providing various checkpoint inhibitors. In addition to our partnership around HPV-related cancers, Inovio is also collaborating with F. Hoffman-La Roche Ltd./Genentech and Regeneron in efficacy trials coupling Inovio’s INO-5401 with their checkpoint inhibitors designed to increase response rates in metastatic bladder and GBM, respectively, with interim efficacy data expected later this year."

Both patients who achieved full cancer remission were treated with four doses of synthetic DNA vaccine as part of a Phase 1 monotherapy trial of 22 patients with HPV-related head and neck squamous cell carcinoma in which 91% of patients (20/22) showed T cell activity in the blood or tissue. This demonstrates that synthetic DNA vaccine generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples.

Of the four patients who developed progressive disease and were subsequently administered a PD-1 checkpoint inhibitor, two patients rapidly exhibited a complete response. The most recent patient for which data was presented yesterday received pembrolizumab (KEYTRUDA); while the previously reported complete responder was treated with nivolumab (OPDIVO). The patients moved from metastatic head and neck cancer to no evidence of disease and they remain alive two years after treatment. Detailed results of the first patient with head and neck cancer who received nivolumab were published in the October issue of Clinical Cancer Research.

These results were presented on January 23 at the Keystone Symposia Conference/Cancer Vaccines being held in Vancouver, Canada, by David B. Weiner, Ph.D., executive vice president of The Wistar Institute, director of its Vaccine & Immunotherapy Center, and the W.W. Smith Charitable Trust Professor in Cancer Research.

KEYTRUDA is a registered trademark of Merck & Co. (MRK); OPDIVO is a registered trademark of Bristol-Myers Squibb Company (BMY).

About HPV-Related Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2019 an estimated 53,000 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-related oropharyngeal cancer in men, and are expected to continue growing.

ImmunoGen Announces Conference Call to Discuss Its 2018 Operating Results

On January 24, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, February 8, 2019 to discuss its 2018 operating results. Management will also provide a brief update on the business (Press release, ImmunoGen, JAN 24, 2019, View Source [SID1234532883]).

Conference Call Information
To access the live call by phone, dial 323-794-2093; the conference ID is 6271602. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through February 22, 2019.