On December 6, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that it will be participating in the Lytham Partners Winter 2021 Investor Conference taking place from December 13-16, 2021 (Press release, Mannkind, DEC 6, 2021, View Source [SID1234596492]). During the event, the Company’s Chief Executive Officer, Michael Castagna, PharmD, will be participating in a webcasted Fireside Chat discussing its vision for 2022 and Mr. Castagna and the Company’s Chief Financial Officer, Steven B. Binder will be conducting 1×1 virtual investor meetings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcasted Fireside Chat will be available for viewing at 11:00 AM ET on Monday, December 13, 2021, on the Company’s website at View Source The webcast will also be archived and available for replay.

To arrange a 1×1 meeting with management, please contact Lytham Partners at 1×[email protected] or register at www.lythampartners.com/winter2021invreg.

On December 06, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has completed its acquisition of Cernostics, Inc. (Cernostics). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies (Press release, Castle Biosciences, DEC 6, 2021, View Source [SID1234596508]). Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to continue the evolution of the Castle story with the closing of the Cernostics acquisition and our entry into the gastrointestinal space through the TissueCypher platform," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "The TissueCypher Barrett’s Esophagus Assay is designed to help predict the likelihood of BE’s progression to the more serious HGD or highly aggressive esophageal adenocarcinoma (EAC). Annually, approximately 400,000 endoscopies are performed on BE patients who meet the validated intended use population. We believe we have a unique opportunity to help physicians and patients make more informed disease management decisions based on deep interrogation of the biology of an individual patient’s esophageal biopsy."

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics has become a wholly owned subsidiary of Castle Biosciences. At closing, Castle paid approximately $30 million in initial consideration to Cernostics security holders, which consisted entirely of cash. Up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The purchase price is subject to customary working capital and other adjustments.

TissueCypher Platform and the TissueCypher Barrett’s Esophagus Assay

The TissueCypher platform combines a unique approach designed to bring together the key elements of biologically aware artificial intelligence to deliver the spatialomics revolution to the clinician and enable individualized decision-making. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of HGD and/or esophageal cancer in patients with BE. The TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia; it has been validated in multiple, independent studies of BE progressor patients. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported the presentation of interim clinical data from the company’s ongoing Phase 1/2 study of BDC-1001, the company’s lead immune-stimulating antibody conjugate (ISAC) in a poster session at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021, being held virtually from Dec. 6-11, 2021 (Press release, Bolt Biotherapeutics, DEC 6, 2021, View Source [SID1234618691]). The lead author for the poster is Manish Sharma, M.D., START Midwest, with contributions from Ecaterina Dumbrava, M.D., MD Anderson Cancer Center, and other colleagues from the U.S. and South Korea.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company reported data from 57 subjects participating in an ongoing Phase 1/2 study of BDC-1001, across 16 different types of HER2-expressing solid tumors. BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist.

"The favorable safety profile and early indications of clinical disease control in the BDC-1001 study are encouraging," said Dr. Sharma, Associate Director of Clinical Research at START Midwest. "There is a clear need for well tolerated, durable treatments in the fight against cancer and I’m excited to see if BDC-1001 can deliver on that potential as we explore higher drug exposure levels."

The poster presentation at ESMO (Free ESMO Whitepaper) I-O reported new safety, pharmacokinetic/pharmacodynamic, and efficacy results for the ongoing Phase 1 dose-escalation portion of the BDC-1001 monotherapy trial. Fifty-seven subjects have been treated at increasing dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks, and data from these subjects demonstrate that:

BDC-1001 continues to have a favorable safety and tolerability profile with mild (grade 1/grade 2) infusion related reactions in some patients and no dose-limiting toxicities at dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks. There was no indication of cytokine release syndrome (CRS), and a maximum tolerated dose (MTD) has not been reached.
Early signs of clinical activity are noted in 13 of 40 tumor evaluable subjects with one durable partial response maintained through 52 weeks and multiple subjects achieving stable disease for >12 weeks.
The pharmacokinetic (PK) data demonstrate increasing peak drug levels with increasing dose, and linearity of PK above the 5 mg/kg dose level. Clinical PK modeling predicts that target exposure levels can be achieved with weekly dosing.
Plasma and tissue biomarker results show increase in multiple biomarkers indicative of myeloid cell and TLR 7/8 activation that is consistent with BDC-1001’s mechanism of action. Increasing drug exposure correlates with increases in plasma cytokines and corresponding biomarker changes in the tumor microenvironment of multiple post-treatment tumor biopsies, with intriguing signs of clinical disease control.
These encouraging data point to the need for increased drug exposure to optimize clinical benefit. The favorable safety profile of BDC-1001 allows for continued enrollment in the dose escalation portion of the study, and the Company’s refined PK model based on data from more than 50 patients predicts that weekly administration will provide BDC-1001 exposures at or above the target exposure threshold. The data also support initiation of the combination therapy study with nivolumab (PD-1 inhibitor).

"Bolt Biotherapeutics is committed to agile clinical development based on data. In this Phase 1/2 study of BDC-1001, we have gained tremendous insight into the ability of this novel candidate to mobilize the patient’s immune system in targeting the tumor and its microenvironment. The increases in myeloid cell infiltration and repolarization of macrophages we’ve seen in multiple post-treatment biopsies are provocative and consistent with our proposed mechanism of action," said Edith Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. "We look forward to exploring weekly dosing as we get closer to determining the recommended Phase 2 dose for BDC-1001 as monotherapy, and to initiating combination therapy with a checkpoint inhibitor."

Presentation Details
Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Lead author: Manish R. Sharma, M.D.
Presentation Number: 164P
Timing: On-demand access beginning Dec. 6 at 12:00 p.m. CET.

The poster presentation will be available on the ESMO (Free ESMO Whitepaper) I-O conference website and on Bolt’s website.

Conference Call and Webcast Details

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study today, Monday, December 6, 2021, at 8:00 a.m. ET/5 a.m. PT.

The conference call can be accessed by dialing +1 (833) 665-0609 within the U.S. or Canada or by dialing +1 (929) 517-0400 from international locations. The passcode for the call is 2633068. A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On December 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that it will host an investor event on updated data from the ongoing MARIO-3 clinical study during the San Antonio Breast Cancer Symposium (SABCS 2021) on Friday, December 10th at 9:30 am ET (Press release, Infinity Pharmaceuticals, DEC 6, 2021, View Source [SID1234596477]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webinar will feature a presentation from Key Opinion Leader (KOL) Hatem Soliman, MD, MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center.

Dr Soliman will discuss the evolving treatment landscape in TNBC and the significant unmet medical need that remains for patients with frontline, metastatic TNBC.
Importantly, Dr Soliman will review the MARIO-3 study design and summarize patient demographics and baseline characteristics as well as the updated safety and efficacy data from the MARIO-3 study.
Infinity’s Chief Medical Officer, Dr. Robert Ilaria, will review of eganelisib’s mechanism of action and translational data from the MARIO-3 study.

A Q&A session will follow the formal presentations. To register for the webinar please click here.

Hatem Soliman, MD is one of the leading breast cancer physicians in the country and an investigator on the MARIO-3 study. Dr. Soliman serves as the Medical Director of the Clinical Trials Office at the Moffitt Cancer Center, with extensive experience as a clinical investigator conducting both translational research in breast cancer immunotherapy and leading numerous clinical trials as principal investigator since joining the faculty at Moffitt in 2008. He also serves as the Course Director for the fellowship clinical research rotation, medical director of the phase 1 program, chair of Moffitt’s clinical research leadership council, chair of clinical research feasibility committee, and principal investigator for Moffitt’s CPDM CCSG application, which was recently rated as outstanding and awarded funding for an additional five years.

Dr. Soliman received his BS in Genetics from the University of Georgia Athens in 1996 and then went on to receive his medical degree from the Medical College of Georgia in 2002. His residency and fellowship training in oncology/hematology was completed through the University of South Florida/Moffitt Cancer Center program in 2008. During fellowship, he authored investigator initiated early phase trials with mentorship from Dr. Daniel Sullivan, former ACD and EVP of Moffitt, in collaboration with the NCI CTEP RAID program investigators Drs. Jaime Zwiebel and Howard Streicher. Upon graduation, Dr. Soliman was offered an assistant member position at Moffitt as a clinical investigator to continue early drug development and translational research activities.