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Alexion to Report Second Quarter 2019 Results On Wednesday, July 24, 2019

On July 10, 2019 Alexion Pharmaceuticals (Nasdaq:ALXN) reported that the Company will report its financial results for the second quarter ended June 30, 2019 before the US financial markets open on July 24, 2019 (Press release, Alexion, JUL 10, 2019, View Source [SID1234537459]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00am Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 5564357 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

Jazz Pharmaceuticals Acquires Pre-clinical Pan-RAF Inhibitor Program from Redx Pharma

On July 10, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company has signed a definitive agreement under which Jazz has acquired Redx Pharma’s (Redx) pan-RAF inhibitor program for the potential treatment of RAF and RAS mutant tumors (Press release, Jazz Pharmaceuticals, JUL 10, 2019, View Source [SID1234537445]). Redx will perform certain pre-clinical activities for the program under a separate collaboration agreement with Jazz. Jazz will be responsible for further development, regulatory activities and commercialization.

Under the terms of the agreement, Jazz will pay Redx an upfront payment of $3.5 million. Redx is eligible to receive up to $203 million in development, regulatory and commercial milestone payments from Jazz, and incremental tiered royalties in mid-single digit percentage, based on any future net sales.

"We are excited to acquire Redx’s pan-RAF inhibitor program. It has the potential to work in RAF driven tumors where current selective B-RAF inhibitors and their respective combinations are ineffective due to acquired resistance mechanisms. In addition, there is the potential to address RAS driven tumors," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "We look forward to advancing the pan-RAF inhibitor program that is part of a novel class of next generation precision oncology drugs and is highly complementary to our growing R&D portfolio of early-stage, innovative, hematology/oncology therapies."

About Pan-RAF Inhibitors1,2,3
Mutations leading to uncontrolled signalling via the RAS-RAF-MAPK pathway are seen in more than one third of all cancers. The pan-RAF inhibitor program aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs.

The RAF kinases (A-RAF, B-RAF and C-RAF) are an integral part of this pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E mutant skin cancers are sensitive to approved B-RAF selective drugs, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these agents as monotherapy due to the functions of other RAF family members and require combination therapy.

B-RAF selective therapies fail to show clinical benefit against atypical B-RAF (non-V600E), other RAF and RAS driven tumors. Pre-clinical study results of Redx’s pan-RAF program have demonstrated in vivo efficacy in a B-RAFV600E mutant colorectal cancer xenograft model as a single agent, where approved B-RAF selective drugs are ineffective as monotherapy. It has also shown promising activity in RAS-mutated cancer cells.

ADC Therapeutics Announces Final Close of Series E Financing Expansion

On July 9, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), reported the final close of a $103 million Series E financing expansion, bringing the total gross proceeds of the Series E round to $303 million (Press release, ADC Therapeutics, JUL 9, 2019, View Source [SID1234596058]). The final close of the expansion round includes a $25 million investment from a new U.S.-based institutional investor, as well as additional investment from existing investors that participated in the previously announced $76 million Series E financing expansion.

Chris Martin, DPhil, Chief Executive Officer of ADC Therapeutics, said, "We are delighted to welcome a new blue-chip institutional investor to our shareholder base. This financing provides us with a strong balance sheet to fund preparations for a potential Biologics License Application (BLA) for ADCT-402 (loncastuximab tesirine) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the second half of 2020, as well as for initiating in the coming months a pivotal Phase II trial of ADCT-301 (camidanlumab tesirine) in Hodgkin lymphoma based on our recent end of Phase I meeting with the U.S. Food and Drug Administration."

ADC Therapeutics plans to complete enrollment in its pivotal Phase II trial of ADCT-402 in a broad population of patients with relapsed or refractory DLBCL imminently and report interim results in the second half of 2019. ADCT-402 is also being evaluated in a Phase Ib trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL) and a Phase Ib trial in combination with durvalumab in patients with relapsed or refractory DLBCL, MCL or follicular lymphoma. In addition, the Company plans to commence a pivotal Phase II trial of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma in the coming months. ADCT-301, with its novel mechanism of action targeting regulatory T cells, is also being evaluated in a Phase Ib trial in patients with selected advanced solid tumors.

Avammune Therapeutics Announces Series A Funding and Formation of Scientific Advisory Board

On July 9, 2019 Avammune Therapeutics Inc., (formerly known as Straximm Therapeutics), a spin-off from Aten Porus Lifesciences (Bangalore, India), reported the raise of its Series A funding (Press release, Avammune Therapeutics, JUL 9, 2019, View Source [SID1234556066]). The undisclosed Series A investment was raised through a consortium of private investors. Avammune also announced the appointment of its scientific advisory board comprised of:

Prof. George Church is Professor of Genetics at Harvard Medical School and Director of PersonalGenomes.org, which provides the world’s only open-access information on human Genomic, Environmental & Trait data (GET). His innovations have contributed to nearly all "next generation" DNA sequencing methods and companies (CGI-BGI, Life, Illumina, Nanopore). This plus his lab’s work on chip-DNA-synthesis, gene editing and stem cell engineering resulted in founding additional application-based companies spanning fields of medical diagnostics (Knome/PierianDx, Alacris, AbVitro/Juno, Genos, Veritas Genetics) & synthetic biology / therapeutics (Joule, Gen9, Editas, Egenesis, enEvolv, WarpDrive). He is director of an IARPA BRAIN Project and NIH Center for Excellence in Genomic Science. His honors include election to NAS & NAE & Franklin Bower Laureate for Achievement in Science. He has co-authored 514 papers, 143 patent publications & one book (Regenesis).

Prof. Kate Fitzgerald is the Professor of Medicine, Director of the Program in Innate Immunity and The Worcester Foundation Chair in Biomedical Sciences at the University of Massachusetts (Amherst) Medical School. Prof. Fitzgerald received her Ph.D. in 1999 from Trinity College Dublin, Ireland, and later a post-doctoral fellow in the Department of Biochemistry working with Luke O’Neill (1999-2002). She joined the Division of Infectious Disease at the UMass Medical School as a Wellcome Trust Fellow in 2002 and joined the faculty in 2004. Her lab is focused on understanding the molecular mechanisms controlling the inflammatory response and employs multifaceted approaches including immunology, biochemistry, molecular biology and genetics to understand these mechanisms in both health and disease.

Prof. Jean-François Paquin studied chemistry at the Université Laval where he graduated with a BSc degree. In 2004, he received his PhD degree under the supervision of Professor Mark Lautens at the University of Toronto (Canada). After a postdoctoral stay in Professor Erick M. Carreira’s lab at the ETH Zürich (Switzerland), he was appointed assistant professor in 2005 at the Université Laval in Quebec City (Canada) as a Tier 2 Canada Research Chair in Organic and Medicinal Chemistry (2005–2010). In 2010, he was promoted to associate professor and his Canada Research Chair in Organic and Medicinal Chemistry was renewed (2010–2015). In June 2014, he was promoted to full professor. His current research interests include organofluorine chemistry, organic synthesis, catalysis, and medicinal chemistry. He has co-authored > 80 papers and received many prizes including the Keith Fagnou Award from the Canadian Society for Chemistry and a Research Fellowship from the Alexander von Humboldt Foundation.

"The rebranding of our company to Avammune emphasises our focus on harnessing the immune system to fight cancer and infectious diseases. This financing is the beginning of our Series A investment and we shall continue to raise additional funding for the round to drive further development of our programs," said Arun B Papaiah, MBA, Founder and Chief Executive Officer of Avammune Therapeutics Inc.

"We are delighted to welcome George, Kate, and Jean-François on board who bring in unique sets of experience and expertise to Avammune. George being a pioneer in the area of genomics and precision medicine will be an asset as we continue to build our platform and grow our company. Similarly, Kate and Jean-François’ expertise in their respective fields of innate immunity and medicinal chemistry will help guide our R&D decision making process," said Aditya Kulkarni, Ph.D., Founder and Chief Scientific Officer, Avammune Therapeutics Inc.

"The STING pathway has gained tremendous attention in recent years for its ability to not just attack cancer on its own but also improve the efficacy of other immuno-oncology therapeutics such as checkpoint inhibitors. This financing allows us to advance our proprietary STING modulator platform through preclinical development enabling us to expand our pipeline of treatments," said Srinivasan Namala, Founder and Director, Avammune Therapeutics Inc.

Avammune shall be presenting results of its lead asset at the Immuno-Oncology Summit 2019 in Boston.

REVOLUTION Medicines Closes $100 Million Financing to Advance Pipeline of Novel Therapies Addressing Frontier Targets in RAS-Dependent Cancers

On July 9, 2019 REVOLUTION Medicines, Inc., a clinical-stage leader in the discovery and development of novel small molecule inhibitors of frontier oncology targets within notorious pathways, reported the closing of a $100 million Series C equity financing (Press release, Revolution Medicines, JUL 9, 2019, View Source [SID1234553325]). Proceeds will support continued advancement of the company’s pipeline, which includes programs addressing elusive targets within the RAS pathway such as KRASG12C(GTP) and other specific tumorigenic mutants of RAS. The financing was supported by a syndicate of premier life science investors led by Boxer Capital of the Tavistock Group and joined by Cormorant Capital, Deerfield Management, Fidelity Management & Research Company, Vivo Capital and Biotechnology Value Fund, as well as all Series B investors, including Nextech Invest, Schroder Adveq, The Column Group, Third Rock Ventures and Casdin Capital.

"This strong support comes at an exciting time for REVOLUTION Medicines as we advance novel programs addressing multiple frontier oncology targets within the resilient and adaptable RAS cancer pathway, including our clinical-stage inhibitor of SHP2," said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer of REVOLUTION Medicines. "Our position at the forefront of RAS pathway-focused therapeutics development is powered by a deep commitment to RAS pathway biology and our differentiated drug discovery capabilities. Our innovation engine enables the creation of sophisticated drug candidates that inhibit protein targets that defy conventional drug discovery methods, which we believe will bring the promise of targeted therapy to inadequately served cancer patients."

SHP2 Program

The company’s lead clinical development candidate, RMC-4630, is a potent, orally bioavailable small molecule that selectively inhibits the activity of SHP2, a protein that plays a central role in modulating cell growth signaling activity through the RAS pathway. RMC-4630, which is the focus of an exclusive global research, development and commercialization agreement with Sanofi, is currently being evaluated in a Phase 1/2 clinical program for a range of tumor types featuring specific oncogenic mutations.

Targeted Mutant RAS Program

REVOLUTION Medicines is advancing multiple innovative programs directed toward inhibiting the oncogenic actions of a broad range of mutants within the RAS protein family and across multiple RAS isoforms. The most advanced of these programs is focused on KRASG12C(GTP), which has been shown to drive multiple cancer types including lung, colorectal, endometrial and pancreatic cancers, among others. This target has been the focus of significant recent attention following the presentation of promising early-stage data regarding a first-generation KRASG12C inhibitor, AMG 510, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

First-generation inhibitors, including those profiled at ASCO (Free ASCO Whitepaper) 2019, target the inactive (GDP-bound) state of mutant KRAS. By contrast, REVOLUTION Medicines has leveraged its proprietary tri-complex drug discovery platform to create novel second-generation compounds designed to selectively bind to and inhibit the active, oncogenic (GTP-bound) forms of various RAS mutants. Preclinical evidence suggests that this mechanism of action confers a superior biological profile compared with first-generation inhibitors and thereby potentially offers significant competitive advantages. The company’s KRASG12C(GTP) program is currently advancing through lead optimization.

For the financing, REVOLUTION Medicines received legal counsel from Latham and Watkins, LLP and strategic advice from Guggenheim Securities.

Other News

In related company news, REVOLUTION Medicines has completed its integration of the oncology-focused assets from Warp Drive Bio into its in-house technology platform and product pipeline following its acquisition of the company in late 2018. The company has also completed the recently announced divestiture of Warp Drive Bio’s antibiotic-related genome mining platform in order to maintain focus on its oncology mission.