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Xencor and Astellas Enter Collaboration for Novel Bispecific Antibody Program

On April 2, 2019 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, reported it has entered into a research and license agreement in which Astellas Pharma Inc. will access Xencor’s bispecific technology to advance a novel bispecific antibody program in oncology (Press release, Xencor, APR 2, 2019, Xencor and Astellas Enter Collaboration for Novel Bispecific Antibody Program [SID1234534925]). Xencor and Astellas will collaborate to generate bispecific antibodies directed toward a selected anti-tumor target for the potential treatment of patients with cancer, and Astellas will have an exclusive worldwide license to develop and commercialize novel drug candidates.

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"Xencor’s modular antibody engineering platform enables the rapid generation of proprietary programs for our broad pipeline of drug candidates and for our partners, as well. Our XmAb bispecific Fc domains enable antibodies and other protein structures that bind two or more different targets simultaneously, which inherently provides a wide range of potential drug candidates," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Our partnership with Astellas further expands the potential of XmAb bispecifics to create new therapies for patients with cancer."

Under the terms of the agreement, Xencor will apply its bispecific technology to create multiple bispecific antibody candidates against the target specified by Astellas and will perform initial characterization of the molecules. Astellas will conduct all preclinical and clinical development and regulatory and commercial activities. Xencor will receive an upfront payment and will be eligible to receive development, regulatory and sales milestone payments and high-single digit to low-double digit percentage royalties on net sales.

Seres Therapeutics Presents New Preclinical Data Supporting the Development of SER-401 for Immuno-Oncology at the 2019 American Association for Cancer Research Annual Meeting

On April 2, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported that new preclinical data supporting the development of microbiome therapeutics for immuno-oncology (poster title "Leveraging gut microbiota networks to impact tumor immunotherapy")1 will be presented by Sceneay et al. at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in Atlanta, Georgia (Press release, Seres Therapeutics, APR 2, 2019, View Source [SID1234534924]). The data presented provide new insights on the potential mechanism by which Seres’ microbiome therapies, including the Company’s SER-401 program, could improve outcomes of cancer patients treated with immune checkpoint inhibitors.

"The novel data presented at AACR (Free AACR Whitepaper) provide mechanistic insights into the biological activity of our microbiome therapeutic candidates to augment immune checkpoint inhibitors," said Matthew Henn, Ph.D., Chief Scientific Officer and Executive Vice President at Seres. "The valuable learnings obtained from this work have informed the development of SER-401, which is being evaluated in combination with an FDA approved immunotherapy in the ongoing MCGRAW Phase 1b study in patients with metastatic melanoma."

Seres presented preclinical results evaluating the impact of various consortia of bacterial species on the anti-tumor immune response in murine models following treatment with an anti-PD-1 checkpoint inhibitor. Results demonstrated that germ-free or antibiotic-treated mice lacking a functional gastrointestinal microbiome failed to mount an effective anti-tumor response when administered anti-PD-1 checkpoint inhibitor treatment. The response to anti-PD-1 treatment was restored by the introduction of a specific consortia of commensal bacteria rationally designed using insights from both in vivo and human microbiome signatures of response and the functional properties of specific bacterial strains in Seres’ strain library of gastrointestinal bacteria.

These data provide support for the continued development of SER-401, an oral microbiome therapeutic candidate sourced from screened healthy individuals who have been identified to have a microbiome bacterial signature similar to that observed in responders to cancer immunotherapy. The therapeutic aim of SER-401 is to modify the microbiome of cancer patients to increase the efficacy of immunotherapy. SER-401 is being evaluated in a Phase 1b clinical study (NCT03817125) conducted in collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy in patients with metastatic melanoma. In addition, Seres has an ongoing collaboration with AstraZeneca to advance the mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including in combination with agents in AstraZeneca’s oncology pipeline.

Fusion Pharmaceuticals Raises $105 Million in Oversubscribed Series B Financing

On April 2, 2019 Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, reported the completion of a $105 million Series B financing led by Varian and new investor OrbiMed (Press release, Fusion Pharmaceuticals, APR 2, 2019, View Source [SID1234534923]).

Additional investors participating in the round are Perceptive Advisors, Pivotal bioVenture Partners, and Rock Springs Capital, along with the existing group of leading international investors, that include HealthCap, Adams Street Partners, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), TPG Biotech, Seroba Life Sciences, Genesys Capital, and FACIT.

In conjunction with the new financing, Deepak Khuntia, Senior Vice President (SVP) and Chief Medical Officer (CMO) at Varian, Chau Q. Khuong, Partner at OrbiMed, and Heather Preston, Managing Director at Pivotal bioVenture Partners, will join Fusion’s Board of Directors.

The financing will be used to advance and broaden the scope of Fusion’s ongoing clinical program in targeted alpha therapeutics, and accelerate a pipeline of new radiopharmaceuticals and combination therapy strategies. The company’s lead product candidate [225Ac]-FPI-1434, combines the precision targeting of an antibody with the potency of alpha-particle emitting medical isotopes to specifically attack and eradicate cancer cells across multiple tumor types.

"Fusion is delighted to welcome this group of preeminent healthcare investors to our existing and highly distinguished series A investors. We have made tremendous progress in the last two years, and this financing reflects strong support for our platform, people and pipeline," said John Valliant, Ph.D., Fusion’s Chief Executive Officer. "The investment positions us to implement our clinical and partnering strategies around [225Ac]-FPI-1434, expand our team and fully exploit the unique advantages of our linker technology."

Fusion’s proprietary Fast-Clear Linker Technology Platform promotes the rapid excretion of medical isotopes that are not specifically bound to cancer cells. The Fast-Clear Linker (the "connector" between a molecule and a medical isotope) is engineered to clear medical isotopes at a faster rate, compared to traditional technologies, with the aim of expanding the therapeutic window. Given the power and versatility of the Fast-Clear Platform, Fusion is applying this technology to different classes of molecules.

"We were attracted to Fusion by the excellent science, broad patient applicability, and great promise for its targeted alpha therapeutics, which have the potential to eradicate even the most resistant types of cancer," said Deepak Khuntia, SVP, CMO, at Varian. "The investment will enable Fusion to advance a pipeline of novel therapeutics that can deliver effective and personalized radiation therapies to cancer patients."

"OrbiMed is excited to co-lead the financing of Fusion, which is the industry leader in targeted alpha therapeutics. Fusion has a unique platform and an exciting lead program in early stage clinical trials that holds promise for improving the lives of cancer patients," said Chau Q. Khuong, Partner at OrbiMed. "There is significant re-emerging commercial interest in radiopharmaceuticals given recent advances in the field and Fusion is at the forefront. We are excited to work with the Fusion team to meet the aggressive goals of the company."

Novocure to Report First Quarter 2019 Financial Results

On April 2, 2019 Novocure (NASDAQ:NVCR) reported that it will report financial results for the first quarter 2019 on Thursday, May 2, 2019, before the U.S. financial markets open (Press release, NovoCure, APR 2, 2019, View Source [SID1234534922]). Novocure management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2019, at 8 a.m. EDT on Thursday, May 2, 2019.

Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8956998. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call.

AVEO Oncology to Present at the H.C. Wainwright Global Life Sciences Conference

On April 2, 2019 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will present at the H.C. Wainwright Global Life Sciences Conference in London on Tuesday, April 9, 2019 at 2:10 p.m. BST (Press release, AVEO, APR 2, 2019, View Source [SID1234534921]).

A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.