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Presage Sets the Stage for Commercial Expansion with Closing of $13M Financing and Execution of New Phase 0 Trial Agreements with Merck and Maverick Therapeutics

On March 2, 2021 Presage Biosciences, Inc., a biotechnology company pioneering a new cancer drug development approach using its Comparative In Vivo Oncology (CIVO) intratumoral microdosing platform, reported the closing of a $13 million financing and commencement of new research collaborations with Merck, known as MSD outside of the United States and Canada, and Maverick Therapeutics (Press release, Presage Biosciences, MAR 2, 2021, View Source [SID1234575925]).

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The financing includes $7 million raised from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners Ltd. An additional $6 million convertible note from Takeda Ventures will convert to equity. The proceeds from this financing will support expansion of Presage’s existing network of clinical sites in the U.S. and Australia, as well as development of next-generation CIVO microdose injection devices designed to access a wider spectrum of cancers. Presage has pioneered a new approach to early evaluation of investigational cancer drugs and combinations in clinical trials with a technology that enables detailed assessment of multiple drugs simultaneously in patients with solid tumors. This investment brings the total equity raised by Presage to date to $35 million.

"At Labcorp, we recognize that the future of cancer drug development will rely heavily on clinically relevant and innovative data-driven approaches to early drug candidate assessment," said Dr. Steve Anderson, Chief Scientific Officer, Labcorp Drug Development. "Presage’s CIVO technology and unique approach to early anticancer drug evaluation represent a potential solution that typical preclinical models cannot address."

The research collaborations with Merck and Maverick will utilize CIVO to evaluate novel investigational oncology agents in Phase 0 trials, bringing the total number of partners utilizing Presage’s approach to early drug evaluation to five. Presage has ongoing collaborations with Takeda and other large pharmaceutical organizations for Phase 0 trials with CIVO.

"The tumor microenvironment presents complexities that cannot be modeled outside the context of the cancer patient. Presage’s technology may provide valuable insights as an analytical tool to investigate the activation of our novel, conditionally active T cell engager and subsequent modulation of immune and anti-tumor responses early on in the drug development process," said Jeremiah Degenhardt, PhD, Vice President, Translational Oncology & Bioinformatics, Maverick Therapeutics.

"It’s gratifying to have the support of venture investors to help expand the reach, capacity and applications of our CIVO platform," said Rich Klinghoffer, PhD, Presage CEO. "In addition, we are excited to collaborate with Merck and Maverick to help investigate the potential of CIVO to streamline their early drug development efforts. We remain committed to transforming translational oncology and are actively engaged with our pharma collaborators as we apply our approach to maximize their drug discovery and development efforts."

About CIVO and Phase 0 Trials
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables intratumoral microdosing and analysis of multiple cancer agents. Phase 0 trials, or Exploratory Investigational New Drug studies, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. Presage is advancing the use of CIVO in Phase 0 trials in order to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. A recently completed clinical trial demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

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

On May 2, 2021 Cytocom, Inc., a leading biopharmaceutical company creating second generation immune therapies, reported that Mike Handley, President and Chief Executive Officer, will present at the H.C. Wainwright Global Life Sciences Conference taking place March 9, 2021 to March 10, 2021 (Press release, Cytocom, MAR 2, 2021, https://www.cytocom.com/2021/03/02/cytocom-to-present-at-the-h-c-wainwright-global-life-sciences-conference/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-to-present-at-the-h-c-wainwright-global-life-sciences-conference [SID1234575924]). The presentation will be available on demand during the virtual event for all registered attendees.

During the presentation, Mr. Handley will provide an overview of Cytocom’s business and recent corporate achievements, as well as the anticipated milestones in its clinical programs for COVID-19, pancreatic cancer, Crohn’s disease, fibromyalgia and multiple sclerosis.

Details of the events are as follows:

Event: H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021 to Wednesday, March 10, 2021
Time: Available on Demand
Registration: View Source

Members of the Cytocom’s management team will also be available to participate in virtual one-on-one meetings with investors who are registered to attend the conference. Following the conclusion of the event, a recording of Mr. Handley’s presentation will be available under "Recent Presentations" in the Investors section of the Company’s website at www.cytocom.com.

New Cardinal Health cancer research study published in JAMA

On March 2, 2021 Cardinal Health Specialty Solutions reported that it is making important strides in cancer research using real-world evidence (RWE) (Press release, Cardinal Health, MAR 2, 2021, View Source [SID1234575923]). Research developed by Cardinal Health, published today in the Journal of the American Medical Association, suggests that RWE may be able to be applied more broadly in cancer research and regulatory filings, and could lead to accelerated clinical trials in cancer research . Real-world evidence is generated during routine clinical practice and outside the context of randomized controlled trials.

"The potential to use RWE to complement and supplement traditional data from randomized controlled trials is exciting because it could significantly accelerate the speed at which clinical trials are conducted, and as a result, innovative medicines could be approved and reach patients faster," said Bruce Feinberg, DO, Chief Medical Officer at Cardinal Health Specialty Solutions and lead author of the study.

Although randomized controlled trials remain the standard for assessing the safety and efficacy of new cancer therapies, there is increasing recognition that this research method is costly, time consuming and does not accurately represent the general population. These factors – combined with the growth of targeted therapies and the rapidly expanding field of drug development – have researchers and policy makers like the Federal Drug Administration (FDA) exploring how real-world evidence can be used to accelerate the drug development process.

The Cardinal Health study included 956 patients who were receiving first-line treatment for thyroid cancer, breast cancer or melanoma between 2014 and 2017. The research used a novel, real-world application of the Response Evaluation Criteria in Solid Tumors (RECIST) methodology to assess how the patients’ tumors responded to the therapy.

"The study findings show that applying RECIST methodology to real-world data may allow for accurate comparisons between real-world data and RCT data in solid tumors. We believe these findings may open the door for broader use of RWE across many areas of cancer research," said Ajeet Gajra, MD, Sr. Medical Director at Cardinal Health and one of the co-authors of the study.

Fusion Pharmaceuticals to Expand Pipeline with Acquisition of IPN-1087, a Small Molecule Targeting NTSR1, from Ipsen

On March 2, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported it has entered into an asset purchase agreement (APA) to acquire Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087 (Press release, Fusion Pharmaceuticals, MAR 2, 2021, View Source [SID1234575921]). IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1.

"The acquisition of IPN-1087 augments and further diversifies our pipeline of potent alpha-emitting radiopharmaceuticals and leverages our expertise to create targeted alpha therapies (TATs) using different classes of targeting molecules," said Chief Executive Officer John Valliant, Ph.D. "In clinical imaging studies, IPN-1087, which targets an established tumor target, has shown uptake in multiple tumor types. Combining IPN-1087 with the power of actinium-225, an alpha-emitter, we believe FPI-2059 will precisely target and kill tumor cells, leading to a significant opportunity to advance the treatment of high unmet need diseases, such as colorectal cancer and pancreatic ductal adenocarcinoma (PDAC)."

Under the terms of the APA, Fusion will issue to Ipsen 400,000 shares of its common stock upon closing and an additional 200,000 shares upon the achievement of a patent-related milestone. Such shares will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the APA. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

Covington & Burling and Goodwin Proctor represented Fusion as legal advisors in the transaction. Barclays represented Ipsen as exclusive financial advisor and Hogan Lovells acted as Ipsen’s legal advisor.

About FPI-2059

FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

Sorrento Receives FDA Clearance to Start Clinical Trial of Anti-CD47 Antibody, Discovered from Fully Human G-MAB Library, for Treatment of Multiple Malignancies

On March 2, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that the FDA has cleared Sorrento’s internally developed anti-CD47 monoclonal antibody, STI-6643, which was discovered from Sorrento’s G-MAB library, for an initial clinical trial (Press release, Sorrento Therapeutics, MAR 2, 2021, View Source [SID1234575920]). The initial clinical trial will be a basket trial entitled "A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Patients with Selected Relapsed or Refractory Malignancies."

Cluster of differentiation 47 (also known as integrin-associated protein) ("CD47") is a ubiquitously-expressed glycoprotein of the immunoglobulin superfamily that plays a critical role in self-recognition. Various solid and hematologic cancers exploit CD47 expression to evade immunological eradication, and its overexpression is clinically correlated with poor prognoses. One essential mechanism behind CD47-mediated immune evasion is that it can interact with signal regulatory protein-alpha (SIRPα) expressed on myeloid cells, causing phosphorylation of the SIRPα cytoplasmic immunoreceptor tyrosine-based inhibition motifs and recruitment of Src homology 2 domain-containing tyrosine phosphatases to ultimately result in delivering an anti-phagocytic "don’t eat me" signal. Given its essential role as a negative checkpoint for innate immunity and subsequent adaptive immunity, the CD47/SIRPα axis has been explored as a new target for cancer immunotherapy and its disruption has demonstrated great therapeutic promise.

In preclinical evaluations, STI-6643 displayed decreased red blood cell binding and hemolysis, while maintaining potent anti-tumor activity in solid tumor disease models. Clinical trials with anti-CD47 mAbs have historically experienced limitations due to significant anemia, hemagglutination, and thrombocytopenia due to CD47 expression on normal red blood cells, ultimately requiring employment of complicated clinical dosing regimens. These issues have not been seen to date with STI-6643 in preclinical studies conducted head-to-head against synthesized versions of other CD47 mAbs. Additionally, STI-6643 showed minimal T, B or NK cell depletion as opposed to other synthesized mAb clones, which could potentially result in improved efficacy by preserving infiltrating anti-tumor immune cells. STI-6643 has the potential to be a "best-in-class" product if these preclinical benefits are able to be reproduced in human trials. Sorrento is also conducting preclinical studies to compare the safety and efficacy of lymphatic delivery of STI-6643 to established parenteral routes of administration using Sorrento’s Sofusa technology. This study will be conducted at the Moffitt Cancer Center in Tampa, FL with Dr. David A. Sallman as the coordinating lead investigator.

STI-6643 is the second anti-CD47 antibody that has been developed from the G-MAB library. The other anti-CD47 antibody (IMC-002) discovered from the G-MAB library was previously cleared by the FDA, and is currently in Phase 1 human studies sponsored by ImmuneOncia Therapeutics, LLC, a joint venture company between Sorrento (35% ownership) and Yuhan Corporation.

Regarding the recent clearance for a clinical trial for STI-6643 by the FDA, Dr. Henry Ji, Chairman and CEO of Sorrento, commented, "We have seen great performance from STI-6643 in our IND-enabling studies. Our internal anti-CD47 program has now yielded two clinical candidates, a signal of our continued commitment to the development of innovative, safe and efficacious cancer treatments in addition to our commitment to fighting COVID-19."