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.

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"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.

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.

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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.

On July 9, 2019 PureTech Health plc (LSE: PRTC) ("PureTech"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,344,091 to support the Company’s internal immuno-oncology product candidate, LYT-200 (Press release, PureTech Health, JUL 9, 2019, View Source [SID1234537440]). The patent covers compositions of matter directed to fully human anti-galectin-9 antibodies, which PureTech intends to develop for historically difficult-to-treat cancers including pancreatic, colorectal, and cholangiocarcinoma, among other cancer types. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.

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"PureTech’s galectin-9 antibody has been designed to address the challenges encountered with current immuno-oncology treatments due to redundancies in the immunosuppressive tumor microenvironment. Our now patented antibody composition leverages a new mechanism of action to disrupt the immunosuppressive environment, potentially enabling the body’s immune system to attack cancers that have historically been hard to treat," said Joe Bolen, Ph.D., chief scientific officer of PureTech. "This patent provides important coverage for our immuno-oncology program, and we look forward to continuing the development of LYT-200 to address the tremendous patient need that exists."

Galectin-9 induces robust immunosuppression that allows tumors to evade immune system attack. It is a foundational immune modulator that is expressed in the tumor microenvironment, on tumor cells, and in the blood of cancer patients, globally inducing and maintaining immunosuppression in cancer. High galectin-9 expression has been demonstrated in a number of patient tumor samples, including those that do not respond well to current checkpoint inhibitors. By blocking galectin-9, PureTech’s potentially first-in-class, fully human, monoclonal antibody is designed to intercept the immunosuppressive pathways that galectin-9 stimulates, potentially enabling an immune-mediated response against tumors. While existing therapies have not been sufficiently effective in the treatment of aggressive tumors, PureTech’s approach has shown favorable drug properties and safety in pre-clinical models, and it is being explored as both a single-agent and in combination with other modalities for cancer treatment, including other immunotherapies and chemotherapies.

About LYT-200
PureTech’s immuno-oncology program, LYT-200, is a fully human, potentially first-in-class, IgG4 monoclonal antibody designed to target galectin-9, which is a fundamental immunosuppressive mechanism in hard-to-treat cancers such as pancreatic, colorectal, and cholangiocarcinoma, among other tumor types. LYT-200 has demonstrated proof-of-concept in both mouse and preclinical human cancer models, indicating that targeting galectin-9 activates T cells in tumors and reduces tumor growth, which could significantly extend survival. These data suggest that LYT-200 has strong potential to be used as both a monotherapy and in combination with existing immuno-oncology therapies. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.

On July 9, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported that it has entered into a non-exclusive license and collaboration agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) (Press release, ImaginAb, JUL 9, 2019, View Source [SID1234537478]). Under the terms of the agreement, Roche will use ImaginAb’s novel minibody CD8 T cell imaging agent in immuno-oncology clinical trials for multiple types of cancers. Financial terms of the agreement were not disclosed.

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ImaginAb’s CD8 T cell imaging agent is designed to be used with PET scan technology to non-invasively determine changes in CD8 T cell tumor infiltrates induced by immunotherapy treatments. This investigational approach has the potential to guide the development of immunomodulatory agents and combinations by assessing whether a patient’s immune system responds to such agents, thereby offering an early prediction of therapeutic response.

Ian Wilson, Chief Executive Officer of ImaginAb, said: "We are thrilled about our collaboration with Roche, a leading pharmaceutical company focused on cancer treatment and diagnostics. We believe our platform offers real potential to accelerate clinical development of next-generation immunotherapeutics and ultimately provides guidance for personalized use of mono or combination therapies for patients suffering from different types of cancer. This collaboration further expands the network of companies, clinical investigators, and PET centers utilizing our 89-Zr CD8 ImmunoPET technology, demonstrating the utility and value of this technology in the field of immuno-oncology."

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144

On July 9, 2019 CSI Laboratories (CSI) and Synergy Capital Investments (Synergy) reported the transition of a convertible note to equity stake in CSI, a state of the art, specialized cancer diagnostic center (Press release, CSI Laboratories, JUL 9, 2019, View Source [SID1234537441]).

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"The security purchase agreement, originally issued in 2017, supported a significant transformation around revenue cycle, sales and operational management that improved our profitability," said Chief Executive Officer and Chief Financial Officer, Chris Wicker. "The note positioned CSI to expand capabilities through the implementation of cutting-edge informatics and the addition of the second testing facility in Jupiter, FL that opened earlier in 2019. We are very pleased to continue our partnership with Synergy as a shareholder and build on CSI’s robust performance."

CSI executed a considerable financial turnaround in the past two years, and the financial outlook is positive for sustained planned growth.

Munir Karimi, Chief Executive Officer of Synergy, assumes a seat on the Board of Directors of CSI. Said Karimi, "We have been working closely with the CSI team for the past couple of years. This is an excellent time to participate on the equity side given their strong financial performance, outstanding executive guidance, and medical thought leadership. The investment reflects our excitement and optimism for CSI’s continued momentum and reinforces our support of CSI Laboratories."