McKesson Declares Quarterly Dividend

On January 27, 2022 The Board of Directors of McKesson Corporation (NYSE:MCK) reported that declared a regular dividend of 47 cents per share of common stock (Press release, McKesson, JAN 27, 2022, View Source [SID1234607454]). The dividend will be payable on April 1, 2022, to stockholders of record on March 1, 2022.

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!


Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

On January 27, 2022 Lupin Pharmaceuticals Inc., (Lupin) and Exeltis USA Inc. reported a promotional agreement for Exeltis to promote SOLOSEC along with Exeltis’ existing line of Women’s Health products, further enhancing value to OBGYNs and their patients (Press release, Lupin, JAN 27, 2022, View Source [SID1234607606]). SOLOSEC is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the U.S.).1-4

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!

"This partnership will expand the reach of SOLOSEC, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis," said Vinita Gupta, Chief Executive Officer of Lupin "We are extremely excited to partner with Exeltis." Salustiano Perez, Chief Executive Officer of Exeltis added, "Our team is thrilled to embark on this partnership. The addition of Solosec fits precisely within our current portfolio of products, enhancing our commercial strategy, and offering numerous solutions to our customers and their patients".

About SOLOSEC

SOLOSEC (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1-4 SOLOSEC is designed to be easy to take and one oral dose contains a complete course of treatment.1

Additional information about SOLOSEC can be found at www.SOLOSEC.com.

INDICATION

SOLOSEC (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.

DOSAGE AND ADMINISTRATION

SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.

IMPORTANT SAFETY INFORMATION

SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives.
Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Important Safety Information.

Or

Please click here for full Prescribing Information.

Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ 07932

SOLOSEC is a registered trademark owned by Lupin Inc.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

Ostentus Therapeutics, Inc., and City of Hope to Initiate Studies of Novel OST Natural Products for Treatment of Leukemia and Other Cancers

On January 27, 2022 Ostentus Therapeutics, Inc., reported that it has entered into a Sponsored Research Agreement with City of Hope, a world-renowned cancer treatment and research organization and a National Cancer Institute-designated Comprehensive Cancer Center, to conduct preclinical research on OST compounds, which could be used as future therapies for leukemia and other cancers (Press release, City of Hope, JAN 27, 2022, View Source [SID1234607455]).

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!

"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy"

OST compounds are natural products derived from plants native of tropical and subtropical America, which have been used in alternative and traditional medicine. At City of Hope, these compounds will undergo rigorous pharmacologic and toxicologic testing at specialized laboratories. The compounds’ active principles will be investigated individually and in combination to identify their mechanisms of action and anticancer activity.

Guido Marcucci, M.D., director of City of Hope’s Gehr Family Center for Leukemia Research, Chair of the Department of Hematologic Malignancies Translational Science and Chief of its Division of Leukemia Research, will lead the research, which is expected to culminate into a first-in-human clinical trial.

"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy," said Elisabetta Graff, Ostentus President and Chief Financial Officer.

"We look forward to working with Ostentus on this exciting preclinical project and the potential application of the OST natural products to our personalized therapeutic approaches for cancer and leukemia patients," Dr. Marcucci added.

Signify Health to Report Fourth Quarter 2021 Earnings and Host Earnings Call on Thursday, March 3, 2022

On January 27, 2022 Signify Health, Inc. (NYSE: SGFY), a leading value-based healthcare platform enabled by advanced analytics, technology and nationwide healthcare networks, reported that it will release its financial results for the fourth quarter 2021 after the market closes on Wednesday, March 2, 2022, and will hold a conference call at 8:30am ET on Thursday, March 3, 2022 to discuss the results (Press release, Signify Health, JAN 27, 2022, View Source [SID1234607607]).

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!

Pre-registration is required for participation in the conference call. Please follow the link below to pre-register. After registering, you will be provided with your access details via email.

View Source

A webcast of the conference call will also be available live on the investor relations section of Signify Health’s website at View Source Please go to the website at least 15 minutes prior to the call to complete the registration process.

The webcast replay will be available through June 3, 2022 on Signify Health’s website at View Source

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides a Corporate Update

On January 27, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the fourth quarter and fiscal year ended November 30, 2021 and provided a corporate update (Press release, Nurix Therapeutics, JAN 27, 2022, View Source [SID1234607439]).

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!

"2021 was a remarkable year for Nurix with the advancement of four wholly owned drug candidates into clinical development. We are very encouraged by our early clinical results having obtained positive proof-of-mechanism data from all patients treated in the first two cohorts with advanced B-cell malignancies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to an exciting year as we advance our proprietary protein modulation portfolio for patients with significant unmet medical need in both solid tumors and hematologic malignancies."

Recent Business Highlights

Initiated Phase 1 clinical development for four wholly owned and internally developed drug candidates: Nurix proprietary protein modulation clinical programs include two targeted protein degraders of Bruton’s tyrosine kinase (BTK), NX-2127 and NX-5948, for the treatment of relapsed and refractory B-cell malignancies, a first-in-class oral E3 ligase inhibitor, NX-1607, for the treatment of a variety of solid tumors and hematologic malignancies, and a first-in-class cell therapy program, DeTIL-0255, that combines tumor infiltrating lymphocytes (TIL) with a small molecule E3 ligase inhibitor with the aim of generating a superior T-cell product with enhanced efficacy.
Presented initial data from its first-in-human, Phase 1 dose-escalation trial of NX-2127 in adults with relapsed or refractory B-cell malignancies: In October 2021, Nurix reported initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the first six patients in its Phase 1a clinical trial of NX-2127, including completed cohorts 1 and 2 treated at 100 mg and 200 mg once daily. The data showed BTK levels in peripheral blood significantly decreased in all patients in the trial starting on day 1 and remained suppressed throughout the dosing period. BTK degradation exceeded 80% at steady state in the first dose cohort and exceeded 90% in the second dose cohort. Such levels of BTK degradation have been associated with anti-tumor effects in preclinical animal models. Clinical observations were presented for the one patient in cohort 1, a 78-year-old man with chronic lymphocytic leukemia (CLL) and significant mutations in the BTK gene associated with resistance to standard of care BTK inhibitors, who achieved a partial remission with lymphocytosis.
Strengthened financial position: In March 2021, Nurix completed an underwritten public offering of 5,175,000 shares of its common stock, at a public offering price of $31.00 per share, which included 675,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock. The net proceeds to Nurix from the offering were approximately $150.2 million, after deducting underwriting discounts, commissions and offering expenses. Combined with additional capital from partners in 2021, Nurix ended fiscal year 2021 with $432.9 million in cash and equivalents compared to $372.0 million as of November 30, 2020.
Upcoming Program Highlights

NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity. Nurix plans to initiate the Phase 1b expansion phase of its ongoing Phase 1a/1b clinical trial of NX-2127 in adults with relapsed or refractory B-cell malignancies in mid-2022 and to present additional data from Phase 1a in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to begin dosing at multiple clinical centers in the United Kingdom in the first half of 2022 and to have initial safety and PK/PD data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107739).
Fiscal Fourth Quarter and Full Year 2021 Financial Results

Collaboration revenue for the three months and twelve months ended November 30, 2021 was $7.4 million and $29.8 million, respectively, compared with $6.7 million and $17.8 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily due to the continued scale up of internal resources and external spending for Nurix’s collaborations with Sanofi and Gilead as compared to the prior year, resulting in a higher percentage of completion in the current year. The increase was also due to partial revenue recognized during the year ended November 30, 2021 for the achievement of certain preclinical milestones under Nurix’s collaborations with Gilead and Sanofi.

Research and development expenses for the three months and twelve months ended November 30, 2021 were $36.5 million and $116.4 million, respectively, compared with $20.4 million and $66.5 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to an increase in compensation and personnel costs attributable to an increase in headcount; increases in supplies and contract research, preclinical activities and contract manufacturing costs attributable to an increase in Nurix’s preclinical development activities and drug discovery research and preparation for upcoming clinical programs for its lead drug candidates; an increase in clinical costs due to ongoing clinical trial startup and patient enrollment; an increase in non-cash stock-based compensation expense; and an increase in facility and other costs primarily due to the expansion of leased premises and investments in information technology.

General and administrative expenses for the three months and twelve months ended November 30, 2021 were $8.8 million and $31.2 million, respectively, compared with $6.3 million and $16.3 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to non-cash stock-based compensation expense, compensation related expenses attributable to higher headcount, and consultant and other professional services costs primarily related to becoming a public company.

Net loss for the three months and twelve months ended November 30, 2021 was $37.7 million or ($0.85) per share and $117.2 million or ($2.73) per share, respectively, compared with $19.9 million or ($0.51) per share and $43.2 million or ($2.76) per share for the three and twelve months ended November 30, 2020, respectively.

Cash, cash equivalents and investments: As of November 30, 2021, Nurix had cash, cash equivalents and investments of $432.9 million, compared with $372.0 million as of November 30, 2020.