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."

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 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 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces that its CEO, Pierre Belichard, will provide a company update (in person) at the Jefferies Healthcare Conference in New York City, US which will take place June 8-10, 2022 (Press release, Enterome, MAY 23, 2022, View Source [SID1234614931]).

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In his presentation, Dr. Belichard will provide an overview of the progress the Company has made with its advanced OncoMimics pipeline, including its first-in-class off-the-shelf therapeutic cancer vaccine, EO2401, as well as its other fully owned EndoMimics pipeline for immune diseases using its Mimicry drug discovery platform.

On May 23, 2022 AstraZeneca reported that advances its ambition to redefine cancer care with new data to be presented across its diverse and industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 3 to 7 June 2022 (Press release, AstraZeneca, MAY 23, 2022, View Source [SID1234614930]).

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A total of 18 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts, including nine oral presentations and a plenary presentation of the DESTINY-Breast04 Phase III trial for Enhertu (trastuzumab deruxtecan) in HER2-low metastatic breast cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our five leading Oncology medicines have each set new standards for patient outcomes across many cancers. Our data at ASCO (Free ASCO Whitepaper) will showcase our continued investment in driving innovation with these medicines as well as their long-term impact in real-world settings. In particular, the groundbreaking data from DESTINY-Breast04 will show the potential of Enhertu to treat patients with HER2-low metastatic breast cancer who have never before been eligible for HER2-targeted treatments."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "At AstraZeneca, we are pioneering new biomarkers and novel therapeutic modalities in our ambition to attack cancer from every angle and deliver personalised medicines to more patients. The results from DESTINY-Breast04 support the potential for Enhertu to redefine the classification and treatment of breast cancer across the spectrum of HER2 expression. We are also excited to share promising clinical data for our bispecific PD1-CTLA4 antibody MEDI5752 in advanced renal cell carcinoma, designed to have both of these clinically validated checkpoint targets in one molecule, delivering efficacy with an improved tolerability profile."

Leading through disruption in breast cancer
A late-breaking plenary presentation will highlight the potentially practice-changing results of the DESTINY-Breast04 trial of Enhertu in patients with HER2-low metastatic breast cancer. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status compared to standard-of-care chemotherapy.

Additionally, data from a retrospective study will estimate the prevalence of HER2-low breast cancer and describe its clinical and pathological characteristics, to help identify patients with HER2-low expressing tumours who may benefit from HER2-targeted therapy.

Further results will be shared from dose-finding and dose-expansion studies of Enhertu in combination with other anti-cancer agents in patients with advanced or metastatic HER2-positive breast cancer (DESTINY-Breast07) and HER2-low breast cancer (DESTINY-Breast08).

Data will also be presented from a safety follow-up of the DESTINY-Breast03 Phase III trial of Enhertu in the treatment of patients with unresectable or metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane. Enhertu was recently approved in the US for patients in this setting.

Revealing the full potential of an industry-leading portfolio and pipeline
Beyond breast cancer, AstraZeneca will share results from multiple trials highlighting its focus on delivering life-changing cancer medicines for patients with high unmet need. Data will also support the Company’s commitment to realising the full potential of its leading medicines with ongoing analyses, real-world data and research into novel combinations.

· MEDI5752 – An oral presentation will share safety and clinical activity results for MEDI5752 in patients with advanced renal cell carcinoma as a monotherapy treatment. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.

· Calquence (acalabrutinib) – Updated data from the ELEVATE-TN and ASCEND Phase III trials will highlight long-term safety and efficacy results of Calquence in patients with chronic lymphocytic leukaemia (CLL) regardless of line of therapy.

Presentations include updated data with approximately five-years of median follow-up from the ELEVATE-TN trial, which has demonstrated sustained clinical benefit of Calquence either in combination with obinutuzumab or as monotherapy compared to obinutuzumab plus chlorambucil, providing flexibility to tailor treatment for adults with treatment-naïve CLL.

Additionally, updated results from the ASCEND Phase III trial with approximately four years of median follow-up will highlight the sustained reduction of disease progression or death for Calquence compared to idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed or refractory CLL, as well as a maintained safety profile.

· Imfinzi (durvalumab) – Patient-reported outcomes from the HIMALAYA trial will highlight quality of life for patients treated with a single priming dose of tremelimumab added to Imfinzi in 1st-line unresectable liver cancer (STRIDE regimen). HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS versus sorafenib in this setting. Tremelimumab with Imfinzi was recently accepted under Priority Review in the US by the Food and Drug Administration (FDA) based on this trial.

Patient-reported outcomes will also be presented from the TOPAZ-1 trial of Imfinzi plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line advanced biliary tract cancer. TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination versus chemotherapy alone in this setting.

An additional regional subgroup analysis for the TOPAZ-1 trial will compare efficacy outcomes, including OS, for Asian patients with other geographies. Imfinzi plus chemotherapy was recently granted Priority Review in the US by the FDA based on this trial.

Further clinically relevant safety data from the positive POSEIDON Phase III trial of Imfinzi, tremelimumab and chemotherapy in 1st-line metastatic non-small cell lung cancer (NSCLC) will also be presented.

· Lynparza (olaparib) – Data from the PROpel Phase III trial will further reinforce the safety profile of Lynparza plus abiraterone in the treatment of 1st-line metastatic castration-resistant prostate cancer (mCRPC). These data build on PROpel efficacy data, which demonstrated that this combination significantly delayed disease progression versus standard-of-care abiraterone in 1st-line mCRPC in patients with or without homologous recombination repair gene mutations. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent versus abiraterone alone in this setting.

· Tagrisso (osimertinib) – Results will be shared from the externally sponsored OPAL Phase II trial in previously untreated EGFR-mutated (EGFRm) NSCLC that evaluated whether the addition of platinum-based chemotherapy to Tagrisso can improve patient outcomes. This combination is also being tested in the ongoing FLAURA2 Phase III trial.

Real-world data will also be presented to better inform unmet needs and treatment strategies among patients with resectable early-stage NSCLC, providing valuable insights into EGFRm disease prevalence and rates of recurrence, despite adjuvant chemotherapy, in this population. Tagrisso is approved for the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC based on the ADAURA Phase III trial.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 2022

Lead author

Abstract title

Presentation details

Antibody drug conjugates

Modi, S

Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study.

Abstract #LBA3

Plenary Session

5 June 2022

2:17pm (CDT)

Hamilton, EP

Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive (HER2+) unresectable and/or metastatic breast cancer (mBC): Safety follow-up of the randomized, phase 3 study DESTINY-Breast03.

Abstract #1000

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

1:15pm (CDT)

Andre, F

Dose-finding and -expansion studies of trastuzumab deruxtecan in combination with other anti-cancer agents in patients (pts) with advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer (BC).

Abstract #3025

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

5 June 2022

8:00am (CDT)

Immuno-Oncology

Cho, BC

Durvalumab (D) +/- tremelimumab (T) + chemotherapy (CT) in first-line (1L) metastatic (m) NSCLC: AE management in POSEIDON.

Abstract #9035

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Sangro, B

Patient-reported outcomes from the phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

Abstract #4074

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Burris III, HA

Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

Abstract #4070

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Vogel, A

Regional subgroup analysis of the phase 3 TOPAZ-1 study of durvalumab (D) plus gemcitabine and cisplatin (GC) in advanced biliary tract cancer (BTC).

Abstract #4075

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Özgüroğlu, M

Adverse events self-reported by patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with durvalumab (D) plus platinum-etoposide (EP) or EP in the CASPIAN study.

Abstract #8571

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6 June 2022

8:00am (CDT)

Albiges, L

Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renal cell carcinoma (RCC): Preliminary results from an FTIH trial.

Abstract #107

Clinical Science Symposium Bispecifics: Are Two Better Than One?

5 June 2022

10:33am (CDT)

DNA damage response

Pignata, S

Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.

Abstract #5519

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Thiery-Vuillemin, A

Tolerability of abiraterone (abi) combined with olaparib (ola) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Further results from the phase III PROpel trial.

Abstract #5019

Poster Discussion Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

5:26pm (CDT)

Armstrong, AJ

Olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer: Pharmacokinetics data from the PROpel trial.

Abstract #5050

Poster Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

1:15pm (CDT)

Eskander, RN

Real-world effectiveness of first-line maintenance olaparib in women with BRCA-mutated advanced ovarian cancer: U.S. retrospective cohort study.

Abstract #5518

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Tumour drivers and resistance

Jones, RH

Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor–positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis.

Abstract #1005

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

2:39pm (CDT)

Nakamura, A

A phase II study of osimertinib in combination with platinum plus pemetrexed in patients with EGFR-mutated, advanced non–small cell lung cancer: The OPAL study (NEJ032C/LOGIK1801).

Abstract #9097

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Haematology

Sharman, JP

Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN.

Abstract #7539

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

4 June 2022

8:00am (CDT)

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.