Calithera to Present at the H.C. Wainwright Virtual Global Life Sciences 2021 Conference

On Mach 2, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the H.C. Wainwright Virtual Global Life Sciences Conference (Press release, Calithera Biosciences, MAR 2, 2021, View Source [SID1234576172]). The presentation will be available on March 9, 2021, at 7:00 a.m. EST, and a webcast for replay for up to 30 days at www.calithera.com in the Investor Relations section.

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Look for Eli Lilly’s Verzenio to hit $4.6B, thanks to early breast cancer win: analyst

On March 2, 2021 Pfizer reported its Ibrance has held a strong lead in market share—and sales—over Eli Lilly’s Verzenio (Press release, Eli Lilly, MAR 2, 2021, View Source [SID1234576169]).

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But on the heels of Verzenio’s strong showing in HR+/HER2- early breast cancer—and Ibrance’s miss—one influential analyst figures the Lilly drug will quickly pick up steam. The upshot? About $4.6 billion in sales at the peak, significantly more than most pharma watchers now expect from the med.

Since its launch in 2017, Verzenio’s share of the market in metastatic breast cancer has been "steadily growing," from 12% early last year to 20% now, Bernstein analyst Ronny Gal wrote in a Monday note to clients. And with a potential launch in HR+/HER2- early breast cancer, the drug’s sales are set to ramp up considerably, he said.

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Lilly is "showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval" in early breast cancer, the analyst wrote. The prediction comes after Verzenio posted impressive data in HR+/HER2- early breast cancer—and after Ibrance failed two studies in early breast cancer.

RELATED: Lilly’s Verzenio pressures Pfizer with practice-changing win in early breast cancer

Pfizer’s drug won an FDA approval in 2015 and generated $5.4 billion in sales last year. Verzenio, for its part, scored an FDA approval in 2017—giving Pfizer a considerable head start—and brought in $913 million last year.

While Pfizer’s drug is already on a strong sales trajectory, Gal says Lilly can expect Verzenio to not only pass the $1 billion blockbuster threshold but gin up billions more than that each year.

Ibrance will "retain market leadership" in metastatic breast cancer, Gal wrote, but he sees Verzenio snagging 28% of that market by 2024. With those share gains plus a potential FDA nod in early breast cancer, Bernstein analysts project $4.6 billion in Verzenio sales in 2024, significantly higher than consensus Wall Street estimates of $3.2 billion.

RELATED: Pfizer’s Ibrance kisses early breast cancer hopes goodbye with 2nd study failure

Last summer, Lilly’s drug—added to standard endocrine therapy after surgery—showed it could significantly reduce the risk of cancer recurrence by 25.3% in patients with high-risk HR-positive, HER2-negative early breast cancer.

One expert said the findings would "change practice." The company filed the data with regulators in the fourth quarter of 2020, according to its recent annual SEC filing.

Meanwhile, Pfizer’s Ibrance has failed two studies in early breast cancer. After the second failure, SVB Leerink analyst Geoffrey Porges wrote that there’s "no saving adjuvant for Ibrance."

Cytokinetics to Participate in Upcoming Investor Conferences

On March 2, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present at the virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021 and participate in a fireside chat at the virtual Barclays Global Healthcare Conference on March 11, 2021 at 9:45 AM ET (Press release, Cytokinetics, MAR 2, 2021, View Source [SID1234576019]).

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Interested parties may access the pre-recorded presentation from the H.C. Wainwright Global Life Sciences Conference and the live webcast of the fireside chat from the Barclays Global Healthcare Conference by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Monopar Partners with Seasoned Medtech Executive to Explore the Potential of MNPR-101 as a uPAR Imaging Agent in Cancer Surgery

On March 2, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers (Press release, Monopar Therapeutics, MAR 2, 2021, View Source [SID1234575996]).

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Mr. Cittadine is an experienced healthcare executive with a track record of building new businesses from concept through acquisition, including successful exits of Sensant Corp. to Siemens and American Biooptics to Olympus. Mr. Cittadine was the co-founder and Vice President of Marketing at Sensant Corp., and co-founder and CEO of American Biooptics. Sensant was an oncology imaging startup that developed 3D ultrasound imaging systems, and American Biooptics was a startup that developed an advanced oncology diagnostic test for gastrointestinal cancers. His most recent endeavors include serving as the CEO of Diagnostic Photonics, an imaging systems company for cancer surgeries.

"It is a strong fit," said Chandler Robinson, MD, Chief Executive Officer of Monopar, speaking to Mr. Cittadine’s expertise and the recent MNPR-101 bladder cancer imaging data published in a peer-reviewed article in the European Journal of Cancer.

"Mr. Cittadine’s extensive experience in the oncology diagnostics and surgical imaging space combined with his previous successes makes for an ideal collaboration on exploring the potential of MNPR-101," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

"The MNPR-101 based imaging agent has shown early promise in in vivo human bladder cancer models. I am excited to work with the Monopar team exploring ways to further the development of MNPR-101, be it through a spin-out, an out-licensing, a partnership, or developing it in-house," said Andrew Cittadine, MBA.

Myriad Genetics Joins Forces with Intermountain Precision Genomics for a Comprehensive Offering of Germline and Somatic Tumor Testing Services

On March 2, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported a new strategic precision oncology collaboration with Intermountain Precision Genomics, a service of Intermountain Healthcare (Press release, Myriad Genetics, MAR 2, 2021, View Source [SID1234575994]). This collaboration creates a comprehensive germline genetic testing and somatic tumor offering that combines Myriad’s advanced hereditary cancer and companion diagnostic tests with Intermountain Precision Genomics’ world-class laboratory services, utilizing the TheraMap test—powered by the TruSight Oncology 500 (TSO 500) next-generation sequencing test from Illumina, Inc. (NASDAQ: ILMN).

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TSO 500 is rapidly becoming a standard in oncology. Through the offering, oncologists will obtain a complete genetic analysis in one, easy-to-interpret report, enabling them to leverage the benefits of comprehensive genomic profiling.

"As cancer treatment continues to evolve, most oncologists seek both germline and somatic tumor testing results to best guide treatment decisions. Advancing precision oncology requires strong collaboration between forward-looking organizations across the healthcare ecosystem. This alliance with Intermountain Precision Genomics is an example of our drive to improve health outcomes for patients with cancer and expand innovative treatment options for the healthcare providers who care for them," said Paul J. Diaz, president and CEO, Myriad Genetics. "We are successfully merging the power of companion diagnostics, next-generation tumor sequencing, and world-class testing services to help raise the global standard of care in precision oncology."

"As a physician, I’m excited to make this comprehensive offering available to more patients," said Lincoln Nadauld, MD, PhD, oncologist and vice president and chief of precision health and academics at Intermountain Healthcare. "This partnership allows us to make a tremendous impact by providing the best that precision cancer care has to offer."

Strategic Partnership with Intermountain Precision Genomics
Intermountain Precision Genomics is a nationally recognized program focused on building partnerships to accelerate the field even further. The new, comprehensive offering – set to be available in the second half of 2021 – will utilize germline genetic testing with the Myriad myRisk Hereditary Cancer test, and somatic tumor profiling with Myriad myChoice CDx. Intermountain Precision Genomics will perform tumor profiling and tissue analysis using its TheraMap test that is powered by Illumina’s TSO 500 assay.

Myriad myChoice CDx is widely supported by private insurance payers. Both myChoice CDx and TheraMap are covered by Medicare.

About TheraMap
TheraMap: Solid Tumor is a hybrid capture DNA- and RNA-based test that detects SNV, INDELs, Copy Number Variants (CNV), and fusions in solid tumors. TheraMap is validated for all solid tumor types and includes sequencing over 500 genes identified as relevant to cancer treatment, relevant gene fusion events, including NTRK fusions, as well as the important microsatellite instability (MSI) and tumor mutational burden (TMB) biomarkers. TheraMap is powered by Illumina’s TSO 500 assay.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information, visit View Source

About myChoice CDx
Myriad myChoice is the most comprehensive HRD test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test includes tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions). For more information, visit View Source