On May 20, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based drug approach to treat solid tumor cancers through direct tumor injection, reported that data highlighting the safety and efficacy results from the Company’s clinical trial of lead product candidate, INT230-6 dose alone and in combination with pembrolizumab, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, as part of an oral discussion session (Press release, Intensity Therapeutics, MAY 20, 2020, View Source [SID1234558341]). The 2020 ASCO (Free ASCO Whitepaper) conference is being held virtually from May 29 to May 31, 2020.

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Details of the presentations are as follows:

Title: Pharmacodynamic, safety and efficacy results of a phase I/II trial of intratumoral INT230-6 alone (IT-01) or in combination with pembrolizumab (PEM) (Keynote A10) in patients with advanced solid tumors.
Abstract Number: 3016
Discussion Date/Time: Friday May 29, 2020 from 8AM to 11AM ET live, then on demand
Expert Discussing the Results: Stephanie L. Goff, M.D., Associate Research Physician, Center for Cancer Research, National Cancer Institute, Bethesda MD.
Poster Date/Time: Beginning Friday, 8AM May 29 ET
Poster Session: Developmental Immunotherapy and Tumor Immunobiology
Poster Presenter: Jacob Stephen Thomas, MD, Assistant Professor of Clinical Medicine, University of Southern California.

Methods: Patients with advanced solid tumors that progressed on standard treatment were enrolled. INT230-6 dose was set by the tumor’s volume. Escalation occurred by increasing number of tumors injected, loading per tumor and total dose. INT230-6 was injected once every 2 weeks up to a total of 5 doses with an option for retreatment. In the Keynote A10 arm PEM (200mg IV Q3weeks) was combined with the INT230-6 regimen. In addition to pharmacokinetic (PK) evaluation, pharmacodynamics was assessed by measuring immune subsets via flow cytometry of peripheral blood and multiplex IHC of tumor samples.

Results: 52 patients (18 unique cancer types) were enrolled in the monotherapy arm and 7 patients (5 unique tumor types) in the PEM combination arm (59 total). Subjects had received a median of 3 prior treatments. Doses from 0.3 ml up to 160 ml of INT230-6 (80 mg CIS and 16mg of VIN) were injected. Over 200 injections into deep tumors have occurred. PK results indicate ~95% of the drugs are retained in the injected tumors when compared to historical IV dosing. The most frequent related adverse events for the INT230-6 alone treatment were pain at injected site (50%), fatigue (35%) and nausea (33%). There were 2 drug related SAE’s (both pain). No events limited dosing.

In the Keynote A10 combination arm INT230-6 injections were administered only into superficially palpable tumors. There were similar types and severity of events due to injections with no treatment related SAE’s. The most common side effect was localized pain (71.4%) a rate similar to dosing of INT230-6 alone into superficial tumors. There were no immune related adverse events (irAE) reported during the two-months of combination dosing. The study steering committee approved initiating testing of the combination of PEM and INT230-6 in four phase 2 cohorts enrolling patients with MSI stable colon, pancreatic, bile duct cancers and PD-1 refractory squamous cell carcinoma.

Efficacy: INT230-6 is dosed per volume tumor and doses are set for each patient’s level of disease. Enrolled subjects’ tumor burden varied from 2 to 11,000 cm3. Use of INT230-6 for two months as monotherapy resulted in thirteen (13) highly refractory patients having disease stabilization for more than 6 months. Some subjects’ tumors increase from baseline, then regress on subsequent scans (potential pseudo progression). Ten (10) patients showed some size reduction of one or more non-injected lesions in lymph nodes, liver, lung, perineum, and retroperitoneal areas (abscopal effects to visceral lesions). Blood and tissue biomarkers suggest increases in immune activation of CD4 and CD8 T cells. Analysis of dose response relationship is ongoing. However, a minimum threshold of dose per volume that was shown to saturate tumors in preclinical models appears to be relevant for responses in humans.

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunology, showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

On May 20, 2020 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for LYNPARZA (olaparib), which was also approved today in the U.S. for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone (Press release, Foundation Medicine, MAY 20, 2020, View Source [SID1234558340]). FoundationOne CDx is the only FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims.

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Prostate cancer is the second most common cancer in men; 1 in 9 will be diagnosed during their lifetime.1 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.2 Because there have previously been limited treatment options for this specific disease area, there is generally a high mortality rate.

"This therapy and companion diagnostic approval underscores the value of comprehensive genomic profiling in advanced cancer patients as it validates our ability to identify alterations in the 14 HRR pathway genes within FoundationOne CDx’s 324 gene panel that indicate a patient may be eligible for treatment with Lynparza, a process not possible through single gene or hot spot testing," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "This is an important advancement for patients with HRR-mutated metastatic castration-resistant prostate cancer, as there have previously been limited treatment options available for this specific condition."

FoundationOne CDx is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. FoundationOne CDx is currently approved as a companion diagnostic for more than 20 targeted therapies.

LYNPARZA was approved based on the PROfound study, which was supported by Foundation Medicine and was the first phase III biomarker-selected study using a molecularly targeted treatment in men with metastatic castration-resistant prostate cancer (mCRPC) to demonstrate improved outcomes. The PROfound trial is the largest prospective study to date performing central tissue testing for homologous recombination repair (HRR) gene mutations in mCRPC patients. The clinical trial assay (CTA) is an NGS assay based on FoundationOne CDx.

LYNPARZA is jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and Merck & Co., Inc.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

On May 20, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that Dr. David Giljohann, Chief Executive Officer of Exicure, will present at the virtual Jefferies 2020 Healthcare Conference on Thursday, June 4, 2020 at 1:00 p.m. EDT (Press release, Exicure, MAY 20, 2020, View Source [SID1234558339]).

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On May 20, 2020 Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported that a total of six distinct abstracts on REBLOZYL (luspatercept-aamt) will be presented at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, held May 29-31, and at the 25th Annual European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25) Virtual Congress, held June 11-21 (Press release, Acceleron Pharma, MAY 20, 2020, View Source [SID1234558338]).

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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

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Poster Presentations at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program

Title: Longer-Term RBC Transfusion Reduction in the Phase 3 MEDALIST Study of Luspatercept in Patients (Pts) With Lower-Risk myelodysplastic syndromes (MDS) with Ring Sideroblasts (RS) – Abstract: #7518

Session:

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Title: Clinical Benefit of Luspatercept in Patients (Pts) With Lower-Risk MDS (LR-MDS) and High Transfusion Burden in the Phase 3 MEDALIST Study – Abstract: #7554

Session:

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Poster presentations and poster discussions will be available on demand through the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on May 29, 2020, at 8:00 a.m. EDT.

Presentations at EHA (Free EHA Whitepaper)25 Virtual Congress

Title: Assessment of Response to Luspatercept by β-Globin Genotype in Adult Patients With β-Thalassemia in the BELIEVE Trial – Abstract: Oral presentation S295

Title: Assessment of Longer-Term Efficacy and Safety in the Phase 3 BELIEVE Trial of Luspatercept to Treat Anemia in Patients (Pts) with β-Thalassemia – Abstract: e-Poster 1548

Title: Assessment of Dose-Dependent Response to Luspatercept in Patients (Pts) With Lower-Risk Myelodysplastic Syndromes (LR-MDS) With Ring Sideroblasts in the Phase 3 MEDALIST Trial – Abstract: e-Poster 812

Title: Effects of Luspatercept on Serum Ferritin in Patients (Pts) With Lower-Risk Myelodysplastic Syndromes (MDS) With Ring Sideroblasts (RS) in the Phase 3 MEDALIST Trial – Abstract: e-Poster 807

Title: Longer-Term RBC Transfusion Reduction in the Phase 3 MEDALIST Study of Luspatercept in Patients (Pts) With Lower-Risk myelodysplastic syndromes (MDS) with Ring Sideroblasts (RS) – Abstract: e-Poster 813

Title: Clinical Benefit of Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) and High Transfusion Burden (HTB) in the Phase 3 MEDALIST Study – Abstract: e-Poster 798

All e-Poster and oral abstract presentations will be made available on the on-demand EHA (Free EHA Whitepaper)25 Virtual Congress Platform beginning on June 12, 2020 at 8:30 a.m. CEST.

About REBLOZYL (luspatercept-aamt)

REBLOZYL is the first and only U.S. Food and Drug Administration-approved erythroid maturation agent designed to promote red blood cell production through a novel mechanism. Luspatercept-aamt is being developed to treat anemia in patients with beta-thalassemia, MDS, and myelofibrosis. REBLOZYL is part of the global collaboration between Acceleron and Bristol Myers Squibb.

On May 20, 2020 McKesson Corporation (NYSE:MCK) reported results for the fourth quarter and fiscal year ended March 31, 2020 (Press release, McKesson, MAY 20, 2020, View Source [SID1234558337]).

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"McKesson delivered a strong finish to fiscal 2020, reflecting continued momentum in the business and meaningful progress in our transformation towards becoming a more focused organization as we look to capture future growth opportunities," said Brian Tyler, chief executive offer. "During fiscal 2020, we achieved adjusted operating profit growth in all three operating segments, generated $3.9 billion of free cash flow, and successfully completed the exit of our investment in Change Healthcare."

"As we enter fiscal 2021, McKesson is leveraging our expertise, leadership and scale to play a critical role in the fight against the COVID-19 pandemic," Mr. Tyler continued. "We continue to remain focused on supporting our people, our customers and our communities during this challenging time. I want to thank caregivers worldwide for their heroic efforts and acknowledge the entire McKesson team, particularly our frontline workers, for their extraordinary dedication. Despite the uncertainties in the near-term macro environment, we remain confident in the resiliency of our business model and committed to creating long-term shareholder value."

Fourth-quarter revenues were $58.5 billion, up 12%, and full-year revenues were $231.1 billion, up 8%, driven by growth in the U.S. Pharmaceutical and Specialty Solutions segment, largely due to branded pharmaceutical price increases and higher volumes from retail national account customers.

Fourth-quarter earnings per diluted share of $5.82 included an after-tax gain of $414 million, recognized upon the separation of the company’s investment in Change Healthcare LLC ("Change Healthcare"). Full-year earnings per diluted share of $4.99 also included after-tax impairment and dilution charges of $1 billion related to Change Healthcare and after-tax charges of $275 million within our European Pharmaceutical Solutions segment for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance.

Fourth-quarter Adjusted Earnings per diluted share was $4.27 compared to $3.69 a year ago, an increase of 16%, primarily driven by a lower share count and growth in the European Pharmaceutical Solutions segment. Full-year Adjusted Earnings per diluted share was $14.95 compared to $13.57 a year ago, an increase of 10%, primarily driven by a lower share count and growth in the U.S. Pharmaceutical and Specialty Solutions and Medical Surgical segments, partially offset by higher corporate expenses and the lapping of a prior year pre-tax benefit of $90 million related to a reversal of a contractual liability associated with McKesson’s investment in Change Healthcare.

For the full year, McKesson returned $2.2 billion of cash to shareholders via $1.9 billion of common stock repurchases and $294 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.4 billion, and invested $506 million internally, resulting in free cash flow of $3.9 billion.

U.S. Pharmaceutical and Specialty Solutions Segment

Fourth-Quarter:

Revenues were $46.3 billion, up 13%, driven by branded pharmaceutical price increases and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Operating profit was $862 million and operating margin was 1.86%. Adjusted operating profit was $772 million, up 3% from a year ago, driven by continued growth in the specialty businesses. Adjusted operating margin was 1.67%, down 17 basis points.
Full-Year:

Revenues were $183.3 billion, up 9%, driven by branded pharmaceutical price increases and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Operating profit was $2.8 billion and operating margin was 1.51%. Adjusted operating profit was $2.7 billion, up 6% from a year ago, driven by growth in the specialty businesses and the lapping of a prior year approximately $60 million pre-tax charge related to a customer bankruptcy. Adjusted operating margin was 1.46%, down 4 basis points.
European Pharmaceutical Solutions Segment

Fourth-Quarter:

Revenues were $7.2 billion, up 6% on a reported basis and up 9% on an FX-adjusted basis, driven by growth in the pharmaceutical distribution business.
Operating profit was $36 million and operating margin was 0.50%. Adjusted operating profit was $75 million, up 226%, and adjusted operating margin was 1.05%. On an FX-adjusted basis, adjusted operating profit was $78 million, up 239%, and adjusted operating margin was 1.06%, up 72 basis points, driven by expense rationalization and the lapping of a prior year inventory charge of approximately $20 million.
Full-Year:

Revenues were $27.4 billion, up 1% on a reported basis and up 5% on an FX-adjusted basis, driven by growth in the pharmaceutical distribution business.
Operating loss was ($261) million and operating margin was (0.95%), driven by after-tax charges of $275 million for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance. Adjusted operating profit was $231 million, up 5%, and adjusted operating margin was 0.84%. On an FX-adjusted basis, adjusted operating profit was $240 million, up 10%, and adjusted operating margin was 0.84%, driven by expense rationalization and the lapping of a prior year inventory charge of approximately $20 million.
Medical-Surgical Solutions Segment

Fourth-Quarter:

Revenues were $2.2 billion, up 13%, driven by growth in the Primary Care business, due to higher pharmaceutical volumes and a stronger influenza season.
Operating profit was $121 million and operating margin was 5.49%. Adjusted operating profit was $170 million, down 1%, driven primarily by higher operating expenses, partially offset by growth in the Primary Care business. Adjusted operating margin was 7.71%, down 109 basis points.
Full-Year:

Revenues were $8.3 billion, up 9%, driven by growth in the Primary Care business.
Operating profit was $499 million and operating margin was 6.01%. Adjusted operating profit was $679 million, up 12%, and adjusted operating margin was 8.18%, up 24 basis points, driven by growth in the Primary Care business.
Other remaining businesses

Fourth-Quarter:

Revenues were $2.9 billion, up 3% on a reported basis and up 4% on an FX-adjusted basis, driven by growth in the Canadian and MRxTS businesses.
Operating profit was $514 million, driven by an after-tax gain of $414 million, recognized upon the separation of the company’s investment in Change Healthcare. Adjusted operating profit was $242 million, down 6% on both a reported and FX-adjusted basis, driven by a lower contribution from the company’s investment in Change Healthcare, partially offset by growth in the MRxTS business.
Full-Year:

Revenues were $12.0 billion, up 3% on a reported basis and up 4% on an FX-adjusted basis, driven by growth in the Canadian and MRxTS businesses.
Operating loss was ($595) million, primarily driven by a previously disclosed impairment in the second quarter, in connection with McKesson’s separation of its investment in Change Healthcare. Adjusted operating profit was $953 million, down 4% on both a reported and FX-adjusted basis, driven by the lapping of the $90 million contractual liability reversal in the prior year partially offset by organic growth in the MRxTS and Canadian businesses.
Company Updates

On March 10, 2020, McKesson completed the separation of its investment in Change Healthcare.
McKesson awarded approximately $30 million in special one-time bonus payments in the fourth-quarter to recognize frontline workers and other non-bonus eligible employees for their contributions.
McKesson invested approximately $20 million into the McKesson Foundation in the fourth-quarter, designating $5 million for deployment to McKesson’s "Taking Care of Our Own Fund" to provide support for employees impacted by the COVID-19 pandemic.
Fiscal 2021 Outlook

McKesson expects full-year fiscal 2021 Adjusted Earnings per diluted share of $13.95 to $14.75, which reflects anticipated headwinds in fiscal 2021 as a result of the COVID-19 pandemic and a continuation of disciplined, efficient capital deployment, including investments in the business. McKesson expects Adjusted Earnings per diluted share growth in the second half of fiscal 2021.

Conference Call Details

The company has scheduled a conference call for today, Wednesday, May 20th at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’. A telephonic replay of this conference call will be available for 14 calendar days. For individuals wishing to listen to the replay, the dial-in number is 404-537-3406 and the passcode is 6206708. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Jefferies Virtual Healthcare Conference, June 2, 2020
Goldman Sachs 41st Annual Global Healthcare Conference, June 9, 2020
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website.