On December 6, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas Equels, Chief Executive Officer of AIM, will be participating in two upcoming investor conferences (Press release, AIM ImmunoTech, DEC 6, 2021, View Source [SID1234596532]).

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BioFlorida Conference
Mr. Equels will be participating in the "COVID-19: What’s Next in Prevention, Treatment & Diagnostics" panel taking place on Thursday, December 9, 2021 at 1:45 PM EST during the BioFlorida Conference. He will also be participating in the CEO Forum at 5:30 PM EST.

The BioFlorida conference will consist of a series of roundtable panel discussions that will be moderated by Maulik Shah, MD, PhD, from Applied Ingenuity Diagnostics.

For more information on the BioFlorida Conference, please visit BioFlorida.com or contact [email protected].

Benzinga All-Access Event
Mr. Equels is scheduled to participate on December 16, 2021 at 11:20 AM EST during the Benzinga All Access event. The event will be broadcast live and can be viewed here. An archived recording of the presentation will be available on the investor relations section of the AIM website at View Source

The Benzinga All Access Show is a 2-hour talk-show event where a select number of companies are chosen to give a 20-minute interview to discuss their companies. Benzinga All Access is a first-of-its-kind show: part interview, part investor presentation. On All Access, Benzinga partners with companies to bring you in-depth one-on-one conversations with executives across a wide range of industries and asset classes.

On December 6, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, and Cancer Research UK, the world’s leading cancer charity, reported that the first patient has been dosed in a Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013) (Press release, Hummingbird Bioscience, DEC 6, 2021, View Source [SID1234596530]).

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The Phase 1 clinical trial in the United Kingdom is being sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The trial intends to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and explore preliminary evidence of HMBD-001 activity in patients with advanced HER3-expressing solid malignancies, including NRG1 fusion-driven cancers.

HMBD-001 is the first of Hummingbird Bioscience’s deep pipeline of antibody drug candidates to enter clinical trials. Rationally developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery (RAD) platform, HMBD-001 is the only reported anti-HER3 antibody in clinical development that uses a highly differentiated mechanism of action designed to block the formation of all active HER3 dimers, regardless of NRG1 ligand binding or HER2/EGFR overexpression.

"Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced program, marks the beginning of a potentially transformative approach to treating HER3-driven cancers," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "I am immensely proud of the teamwork that has brought our differentiated program to this point. Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform."

"This significant milestone brings us a step closer to provide a much-needed and highly differentiated therapy for patients with HER3-driven cancers," said Dr. Eric Rowinsky, Chief Medical Officer, Hummingbird Bioscience. "We are pleased to partner with Cancer Research UK for this trial, and we look forward to advancing the clinical development of HMBD-001 for cancer patients."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said, "We are thrilled to be working with Hummingbird Bioscience to advance its novel drug candidate into clinical trials. Although HER3 was discovered over 30 years ago, no therapies able to block its cancer-promoting action have been approved. Hummingbird Bioscience has taken fresh aim at a difficult drug target and has come up with a novel, potentially transformative antibody for cancer patients who desperately need new treatments."

Initial data from the Phase 1 dose escalation is expected in the second half of 2022.

About HMBD-001

HMBD-001 is a clinical-stage IgG1 antibody designed to target HER3. Discovered using our proprietary RAD platform, HMBD-001 is now in development for the treatment of multiple solid tumors. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR, independent of the process leading to such dimerization. In preclinical models evaluating HMBD-001, we have observed superior affinity and more potently inhibited tumor growth compared to other existing anti-HER3 antibodies. Our near-term development plan for HMBD-001 focuses on four priority, high-value indications with strong scientific rationale and supporting preclinical data: NRG1 fusion-driven cancers, metastatic castrate resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC), and squamous cell carcinoma of the head and neck (SCCHN).

On December 6, 2021 Carisma Therapeutics., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that it has entered into a clinical study collaboration with Merck (known as MSD outside the US and Canada) to evaluate their proprietary targeted chimeric antigen receptor macrophages (CAR-M) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing cancers (Press release, Carisma Therapeutics, DEC 6, 2021, View Source [SID1234596529]).

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Based on pre-clinical findings outlined in Human chimeric antigen receptor macrophages for cancer immunotherapy, Carisma’s novel CAR-M platform has the potential ability to reprogram the solid tumor microenvironment, leading to immune activation, T cell recruitment, and anti-tumor adaptive immunity.

"The mechanisms of action behind CT-0508 and KEYTRUDA suggest they may be complementary and could help to drive meaningful clinical benefits in patients with HER2 positive cancers, where a high unmet medical need exists," said Steven Kelly, President and Chief Executive Officer at Carisma Therapeutics. "We are extremely pleased to enter into this collaboration with Merck and further expand the potential of macrophage-based cell therapy."

This collaboration announcement comes on the heels of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting where lead investigators shared early data from the landmark Phase 1 multi-center clinical trial of CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted CAR-M. The preliminary findings represent the first clinical data with genetically engineered macrophages in humans and demonstrated that CT-0508 was well tolerated after infusion and there were no dose limiting toxicities; data show the immunotherapy was successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and showed high CAR expression, viability, and purity; and that the administered therapy remodeled the tumor microenvironment and mediated expansion/activation of T cells within the tumors.

Additional pre-clinical data generated by Carisma has shown the potential additive benefit of CAR-M in combination with PD-1 blockade in solid tumor models that are resistant to anti-PD-1 monotherapy.

The landmark CT-0508 clinical trial remains open for enrollment and the U.S. Food and Drug Administration recently granted Fast Track designation to CT-0508 for the treatment of patients with solid tumors. The clinical study evaluating CAR-M in combination with KEYTRUDA (pembrolizumab) is expected to launch in 2022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On December 6, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that several abstracts relating to the Secura Bio product COPIKTRA (duvelisib) will be presented at the 63rd annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia (Press release, Secura Bio, DEC 6, 2021, View Source [SID1234596527]).

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These abstracts feature new data from important ongoing or recently completed clinical trials, including:

Duvelisib in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from the Phase 2 Primo Trial: Results of an Interim Analysis (click on title to see full abstract)

This abstract will be presented by Dr. Jonathan Brammer on Sunday, December 12, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).

The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis (click on title to see full abstract)

This abstract will be presented by Dr. Steven Horwitz on Monday, December 13, 2021: 10:30 AM-12:00 PM Hall A1 (Georgia World Congress Center).

TEMPO: A Phase 2, Randomized, Open-Label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL) (click on title to see full abstract)

This abstract will be presented by Dr. Vladimir Vorobyev on Monday, December 13, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).

"The presentations of new data for COPIKTRA at ASH (Free ASH Whitepaper) reflect the dedication of Secura Bio and the researchers with whom we work to develop products for the treatment of challenging hematologic malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Please click here to see full U.S. Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).

On December 6, 2021 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported that it has completed patient enrollment in its Pivotal Phase 3 trial of I/ONTAK, an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) (Press release, Citius Pharmaceuticals, DEC 6, 2021, View Source [SID1234596526]). The treatment phase for the study has been completed with topline results expected in the first half of 2022 and a biologics license application (BLA) expected to be filed with the U.S. Food and Drug Administration (FDA) in the second half of 2022.

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"Completing enrollment in the Pivotal Phase 3 study of I/ONTAK moves us another step closer to expanding treatment options for patients suffering from advanced CTCL. We expect I/ONTAK’s unique mechanism-of-action to offer oncologists an important therapeutic alternative to current targeted therapies which have limited duration of response and are often discontinued due to toxicity. We look forward to reviewing the complete safety and efficacy data and anticipate providing topline results in the first half of next year, followed by a BLA submission in the second half of 2022," stated Myron Holubiak, Chief Executive Officer of Citius.

A total of 70 patients were enrolled in the main part of the I/ONTAK Phase 3 study, a multicenter, open-label, single-arm Pivotal study of I/ONTAK in participants with recurrent or persistent CTCL (NCT01871727). Positive efficacy data from an initial 21-subject lead-in study supported proceeding with the main study with an optimal dose level of 9 micrograms per kilogram (mcg/kg) of I/ONTAK. Subjects were administered I/ONTAK by intravenous infusion over 60 minutes (+/-10 minutes) on 5 consecutive days per cycle every 21 days.

The primary outcome measure for the main study is the Objective Response Rate (ORR). The ORR is defined as the proportion of subjects with a significant reduction in tumor size that can be classified as achieving either a partial response (PR) or a complete response (CR). The primary endpoint and quality of life analyses of the study will be performed on the combined data set from subjects in the main study plus subjects in the lead-in part of the study who received 9 micrograms per kilogram through the data cutoff date. Multiple secondary endpoints including duration of response, time to response, and safety will be evaluated.

About I/ONTAK

I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 2008 to 2014, when it was voluntarily withdrawn from the market to enable manufacturing improvements. These improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively, making it eligible for seven years of market exclusivity post-approval.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sezary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and has usually spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple systemic agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no cure for advanced CTCL. Approximately 3,000 new cases are reported in the United States every year, with an estimated 30,000 – 40,000 individuals living with the disease.