On May 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments (Press release, ImmunoGen, MAY 23, 2022, View Source [SID1234614932]). The application has been granted Priority Review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.

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"FDA’s acceptance of our BLA under Priority Review reinforces our belief in the potential for mirvetuximab soravtansine to serve as a new standard of care for patients with FRα-high platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We are pleased to be one step closer to realizing the promise of our technology and are working closely with FDA to support the evaluation of our application. We are moving quickly to build out the commercial and medical infrastructure required for a successful launch and look forward to the prospect of delivering mirvetuximab soravtansine to patients later this year."

Priority Review designation is granted to applications for therapies that may offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications and shortens the FDA review period to six months following acceptance.

The BLA seeks approval of mirvetuximab soravtansine under the FDA’s accelerated approval pathway, which was instituted to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint and is based on results from the pivotal Phase 3 SORAYA trial. Top-line data from SORAYA were announced in November 2021 and full data from the study were presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting. ImmunoGen continues to enroll patients in the confirmatory MIRASOL trial, which is intended to convert the potential accelerated approval to full approval, and expects to announce top-line data from this study in early 2023.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On May 23, 2022 Modra Pharmaceuticals ("Modra") reported that the company will present new data from its Phase 2b trial evaluating ModraDoc006/r, a boosted oral taxane therapeutic versus the standard-of-care IV chemotherapy docetaxel, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) at the upcoming ASCO (Free ASCO Whitepaper) General Annual Meeting held from June 3 – 7, 2022 virtually and in-person in Chicago, IL, USA (Press release, Modra Pharmaceuticals, MAY 23, 2022, View Source [SID1234614953]).

Please see below for details on the poster abstract.

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Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Poster Title: A phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Presenter: Ulka N. Vaishampayan, MD | University of Michigan

Location: In-Person & Live Stream | Arie Crown Theater

Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT

Abstract Number: 5016

Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.

On May 23, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the publication of findings from a preclinical study showing enhanced anti-tumor function and eradication of solid tumors by combining its Amphiphile (AMP) platform vaccine, carrying cognate peptide and adjuvant cargos, with T cell receptor T cell therapies (TCR-Ts) (Press release, Elicio Therapeutics, MAY 23, 2022, View Source [SID1234614933]). These results, co-authored by Drs. Dylan Drakes and Peter DeMuth, with Elicio colleagues, were published in the preprint server, bioRxiv, and can be found here.

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"The AMP platform continues to show boosting capabilities in our preclinical studies of cancer immunotherapies by successfully targeting the lymph nodes," said Peter DeMuth, Ph.D., Chief Scientific Officer. "T cell receptor (TCR)-modified T cell therapies have historically shown promise but challenges to clinical efficacy against solid tumors persist. Often, suboptimal clinical performance can be attributed to insufficient in vivo persistence of current treatments and tumor antigen escape. With this study, we’ve shown that combining TCR-T cell therapies with our lymph node targeted AMP-vaccines can overcome these challenges to significantly improve preclinical efficacy in animal models of solid tumors."

Robert Connelly, Chief Executive Officer at Elicio, added, "Our AMP platform has huge potential to address some of the major challenges that continue to plague the field of immuno-oncology. We are delighted to share the results of this study because it provides rationale and evidence to support combining our AMP-peptide vaccine with TCR-T cell therapies to augment clinical responses."

About the Amphiphile Platform
Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.

On May 23, 2022 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported new data from Cohort 2 of the ongoing Phase 1 study evaluating JK07, the Company’s lead drug candidate, for the treatment of heart failure with reduced ejection fraction (HFrEF) (Press release, Salarius Pharmaceuticals, MAY 23, 2022, View Source [SID1234614954]). The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.

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"Our study of JK07 in heart failure with reduced ejection fraction continues to demonstrate favorable safety and promising signals of clinical activity, and we look forward to gaining further insights as we enter Cohort 3," said Sam Murphy, Chief Executive Officer of SalubrisBio. "In addition, we’re thrilled to announce that the first CTA has been filed in Europe for JK08, to evaluate this novel CTLA-4/IL-15 antibody fusion protein in the treatment of solid tumors. We have made considerable progress this year across our pipeline and remain laser-focused on advancing these important programs to bring differentiated complex biologics to patients with unmet needs," concluded Murphy.

New Cohort 2 Data for JK07 Shows Favorable Safety and Further Promising Activity in Patients with HFrEF

In this ongoing randomized, double-blind, placebo-controlled, dose-escalation Phase 1b study evaluating JK07, patients treated in Cohort 2 (n=5) demonstrated a favorable safety profile and encouraging signals of clinical activity. In addition, dose-dependent increases in biomarker surrogates of target engagement have been observed across the two completed cohorts. Enrollment in Cohort 3, of five planned cohorts, has commenced in this Phase 1b study and SalubrisBio plans to report additional data from this study at future medical meetings.

CTA for JK08 Submitted in Europe

The first CTA has been filed in Europe seeking approval to initiate a Phase 1/2 study evaluating JK08 monotherapy for the treatment of advanced solid tumors. JK08 augments the T-regulatory cell targeting of a CTLA-4-specific antibody with an IL-15/sushi domain fusion peptide, which locally induces NK cell activation and antibody-dependent cellular cytotoxicity (ADCC), two biological hallmarks predictive of response to CTLA-4 targeted therapy. The study will assess the safety, pharmacokinetics, and anti-tumor activity of JK08 at multiple dose levels and will include multiple expansion cohorts following selection of the optimal biologic dose. Upon obtaining regulatory approvals, the Company plans to initiate recruitment during the third quarter of 2022.

Appointment of Arian Pano, MD as Chief Medical Officer

Dr. Pano comes to SalubrisBio from Kiniksa Pharmaceuticals, where he served as SVP of Clinical Development, overseeing all functional groups, including medical, research, clinical operations, regulatory, safety, biometrics, and medical writing. Previously he served as SVP of Clinical Development for Galapagos NV, and concurrently served as the US country head and Global Head of Safety. Dr. Pano has an extensive background in research and development with a focus on cardiovascular, metabolic rare diseases, inflammation and fibrosis. He earned his MD degree from the University of Tirana, Albania, completing fellowships in invasive cardiology and pediatrics. In addition, he holds an MPH in Healthcare Management from Harvard’s School of Public Health.

"Since clinical data is the currency of our industry, and as we are now generating meaningful clinical results, the time was right to expand and strengthen the leadership team by bringing on Ari to build our clinical organization, chaperone our drugs through mid- and late-stage development, and ensure our data management and pharmacovigilance functions support future planned regulatory filings," added Murphy.

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF and undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

About JK08

JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and an IL-15 fusion domain. The JK08 design builds upon a breadth of clinical studies with CTLA-4 antibodies and recombinant IL-15 molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has exhibited potent stimulation of NK cell expansion and enhancement of ADCC in pre-clinical and clinical studies. Through the incorporation of a CTLA-4 antibody and IL-15 into a single molecule, JK08 can channel the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards depletion of T-regulatory cells and targeted reversal of immunosuppression which may contribute to cancer progression.

On May 23, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported acceptance of its abstract titled, "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" for presentation of a poster at this year’s Tumor Myeloid-Directed Therapies Summit (Press release, Navidea Biopharmaceuticals, MAY 23, 2022, View Source [SID1234614934]).

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The 2nd annual Tumor Myeloid-Directed Therapies Summit meeting will be held June 14-16, 2022 in Boston, MA. The presentation will take place Tuesday, June 14. Meeting information can be found on the conference website (View Source).

The poster will present information related to the synthesis of two novel bisphosphonate drugs that have been attached to Navidea’s CD206-targeted drug delivery platform molecule, Manocept. These constructs use a novel degradable linker to release the therapy only once they have been internalized into a CD206-expressing cell, such as a tumor associated macrophage. The new therapeutic constructs were evaluated in human macrophage cell culture assays to compare the ability of the new constructs with unbound free therapy to shift the phenotype of macrophages toward a proinflammatory gene expression pattern. The new drug delivery constructs successfully shifted the phenotypes of human macrophages towards a proinflammatory state and compared favorably to the unbound free therapy. The new drug constructs also induced a highly significant reduction in macrophage expression of signal regulatory protein alpha ("SIRPα"), the receptor for the "don’t eat me" signal that, when activated, suppresses the ability of macrophages to attack and phagocytize disease associated cells such as cancer cells. The ability to induce this type of phenotypic change in macrophages could have far-reaching applications in cancer immunotherapy.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "These new therapeutic constructs demonstrate the power of our adaptable platform technology to deliver a wide array of small molecule payloads in a targeted fashion to macrophages involved in the propagation of a variety of severe illnesses including cancer."