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Varian Installs World’s First ProBeam® 360° Proton Therapy System at Penn Medicine Lancaster General Health

On February 4, 2021 Varian (NYSE: VAR) reported that it has started the installation of the cyclotron and gantry for its ProBeam 360° single-room proton therapy system at Penn Medicine Lancaster General Health’s Ann B. Barshinger Cancer Institute (Press release, Varian Medical Systems, FEB 4, 2021, View Source [SID1234574663]). The cyclotron and gantry are core pieces of equipment of the ProBeam 360° system.

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The Ann B. Barshinger Cancer Institute, which is part of Penn Medicine Lancaster General Health, has become the first treatment center in the world to have a ProBeam 360° system from Varian. The center is expected to treat its first patients in 2022.

"Varian is proud of our longstanding collaboration with Penn Medicine, which goes back decades and encompasses joint innovation, clinical research, training and education, and bringing new technologies to cancer patients," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "We’re especially pleased to be taking this next step with them, delivering the latest innovations in proton therapy technology for the cancer patients of South Central Pennsylvania."

The cyclotron is a particle accelerator that accelerates protons to extremely fast speeds; roughly 100,000 miles per second or roughly two thirds the speed of light, to create a beam that can precisely reach tumors wherever they are in the body. The finished ProBeam 360° system will incorporate the fully rotational gantry that rotates around the patient to target tumors from virtually any angle, robotic patient positioning tools, integrated iterative cone-beam CT imaging and pencil-beam scanning for delivery of high-definition intensity-modulated proton therapy (IMPT).

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects is reduced because a proton beam deposits dose within the tumor site rather than passing all the way through the patient. Proton therapy can be used for many of the most common types of cancer.

In addition to the ProBeam 360° system, Varian will also provide its ARIA information management system and Eclipse treatment planning—software that can be used to enable a cloud-based "hub and spoke" operations model for managing key functions centrally to avoid costly duplication of resources across the larger University of Pennsylvania Health System. The Eclipse software will also incorporate RapidPlan PT— the first clinical application of machine learning in proton treatment planning. RapidPlan PT is a knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from previous cases in order to develop high-quality, personalized plans for patients.

"This is yet another key milestone in a multi-year journey that will marry the extensive research and clinical protocols we’ve developed over the past 11 years at Penn Medicine’s Roberts Proton Therapy Center with the considerable expertise at Lancaster General," said James Metz, MD, Chair of Radiation Oncology, Perelman School of Medicine.

Replimune Reports Third Fiscal Quarter Financial Results and Provides Corporate Update

On February 4, 2021 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal third quarter ended December 31, 2020 and provided a business update (Press release, Replimune, FEB 4, 2021, View Source [SID1234574662]).

"It has been a productive start to 2021," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "We started the current quarter with the news that dosing has commenced with our third product candidate, RP3, which like RP2 is intended to treat tumor types that are not traditionally thought of as ‘immune-responsive’. The later stage clinical development pathway for these programs is currently being defined. We continue to enroll into our two registration-directed clinical trials with RP1 in cutaneous squamous cell carcinoma (CSCC), the "CERPASS" study, and anti-PD1 failed melanoma, the "IGNYTE" study, and commercial planning activities are underway. We also expect to start dosing RP1 combined with Opdivo in anti-PD1 failed non-small cell lung cancer (NSCLC) patients and anti-PD1 failed CSCC patients at approximately the quarter end and look forward to releasing data on all our product candidates during the course of 2021."

Corporate Updates

Commenced GMP Manufacturing in completed state of the art facility. The Company has completed buildout of its 63,000-square-foot state-of-the-art manufacturing facility in Framingham, MA, which will support late-stage development and full commercialization of all of its products. GMP production is underway with the first RP1 batch having been filled. RP2 tech-transfer is scheduled to commence this quarter.

Extended cash runway into the second half of 2024. In October, the company closed on an offering of common stock and pre-funded warrants raising approximately $287 million in gross proceeds and received aggregate net proceeds of approximately $270 million after deducting underwriting discounts, commissions, and other offering expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. Based on its current operating plan, Replimune expects that its cash, cash equivalents and short-term investments of $493.3 million as of December 31, 2020 will fund its operating expenses and capital expenditure requirements into the second half of 2024.

Potential impact of COVID-19 on milestones: Enrollment into the Company’s clinical trials, in particular the clinical trial of RP1 in solid organ transplant patients with CSCC, which represents a highly immune-compromised patient population, has been slower than expected, which the Company attributes to the global pandemic. While mitigation plans have been and are being implemented, as the clinical trial sites continue to evaluate their capacity to enroll patients into clinical trials, the Company could see additional impact on the pace of enrollment across its clinical trial programs.
Program Highlights and Upcoming Milestones

RP1 in combination with Libtayo in CSCC: The Company is actively enrolling patients into its global registration-directed Phase 2, randomized, controlled, clinical trial. The Company remains on track to report the primary data read out in 2022.

RP1 in combination with Opdivo in anti-PD-1 failed melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort Phase 2 clinical trial of RP1 in combination with Opdivo in the first half of 2020 and continues to enroll patients. The Company remains on track to report the primary data readout in 2022.

RP1 in combination with Opdivo in melanoma and non-melanoma skin cancers (NMSC): In October 2020, Replimune provided positive Phase 2 data updates in melanoma and NMSC which demonstrated deep and durable responses to RP1 combined with Opdivo, including in anti-PD1 failed melanoma that continues to support the Company’s ongoing registration-directed development in this setting and in CSCC. Enrollment of the initial melanoma cohort (including anti-PD1 naïve and anti-PD1 failed patients) was completed in the first half of 2020 with the NMSC cohort now being expanded from 30 to 45 patients to also include 15 patients with anti-PD1 failed disease.

RP1 in anti-PD1 failed NSCLC: The Company has opened for recruitment a new cohort of 30 anti-PD1 failed NSCLC patients treated with RP1 combined with Opdivo and expects to report initial data from this cohort in the second half of 2021.

RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company is currently enrolling a 30 patient Phase 1b clinical trial assessing the safety and efficacy of RP1 in liver and kidney transplant recipients. Although the company recently dosed the initial patient, the study continues to be particularly impacted by COVID-19 due to the immune suppression that solid organ transplant patients receive and mitigation steps are therefore being taken to aid enrollment. Initial data from this clinical trial is intended to be presented in the second half of 2021.

RP1 in combination with Opdivo in MSI-H/dMMR tumors: The Company is accumulating data from the MSI-H/dMMR (anti-PD1 naïve) cohort. Based on the data, the Company expects to be able to decide whether to pursue MSI-H/dMMR tumors into registration-directed development by the end of 2021.

RP2 alone and in combination with Opdivo: RP2 is being evaluated in a Phase 1 clinical trial alone and combined with Opdivo in advanced solid tumor patients. In October 2020, Replimune presented positive data from the single agent RP2 portion of the clinical trial that showed deep and durable responses, including in patients with immune insensitive tumor types. Following the monotherapy phase, enrollment is currently underway in a 30-patient cohort in combination with Opdivo. Updated data from this clinical trial, including initial data with RP2 in combination with Opdivo, is expected to be presented mid-year.

RP3 alone and in combination with anti-PD-1 therapy: Replimune initiated dosing in its Phase 1 clinical trial of RP3 in December 2020. The Phase 1 clinical trial is designed to evaluate RP3 alone and combined with anti-PD1 therapy in advanced solid tumor patients. Initial data is expected to be presented in the second half of 2021.

Targeted evaluation for new indications is currently underway: An analysis of the solid tumor space is currently underway to define the later stage clinical development pathway initially intended for RP2 and/or RP3. This is from the perspective that RP2 and RP3 are intended to target less immune responsive tumor types, and follows from initial promising data having been generated with single agent RP2, including in immune non-responsive tumor types. The details of this initial development plan are intended to be announced mid-year.
Financial Highlights

Cash Position: As of December 31, 2020, cash, cash equivalents and short-term investments were $493.3 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $371.7 million in net proceeds from financing activities offset by cash utilized in operating activities largely associated with advancing our expanded clinical development plan.

R&D Expenses: Research and development expenses were $14.3 million for the third quarter ended December 31, 2020, as compared to $11.9 million for the third quarter ended December 31, 2019. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.5 million in stock-based compensation expenses for the third quarter ended December 31, 2020.

G&A Expenses: General and administrative expenses were $6.0 million for the third quarter ended December 31, 2020, as compared to $4.7 million for the third quarter ended December 31, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.6 million in stock-based compensation expenses for the third quarter ended December 31, 2020.

Net Loss: Net loss was $21.8 million for the third quarter ended December 31, 2020, as compared to a net loss of $16.2 million for the third quarter ended December 31, 2019.
About RP1

RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response through the expression of a GALV-GP R- fusogenic protein and GM-CSF.

About RP2 & RP3

RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

West to Host Fourth-Quarter and Full-Year 2020 Conference Call

On February 4, 2021 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release fourth-quarter and full-year 2020 financial results before the market opens on Thursday, February 18, 2021, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, FEB 4, 2021, View Source [SID1234574657]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 4095168.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the site three hours after the live call and will be available through Thursday, February 25, 2021, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 4095168.

Quest Diagnostics Increases Dividend 10.7% To $0.62 Per Quarter; Announces $1 Billion Increase in Share Repurchase Authorization

On February 4, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported the Company’s Board of Directors has authorized a 10.7% increase in its quarterly dividend from $0.56 to $0.62 per share (Press release, Quest Diagnostics, FEB 4, 2021, View Source [SID1234574656]). The increase is effective with the dividend payable on April 21, 2021 to shareholders of record of Quest Diagnostics common stock on April 7, 2021. With the increase, the annual dividend will be $2.48 per share. This dividend increase is the Company’s tenth since 2011.

Additionally, the Board of Directors has increased the Company’s share repurchase authorization by $1 billion. The increased authority is in addition to the $917 million that was available as of December 31, 2020 under the Company’s share repurchase program. For the three months ended December 31, 2020, the Company repurchased 2.0 million shares of its common stock for $250 million.

Quest will hold its quarterly conference call to discuss results for the Fourth Quarter and Full Year 2020 at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The Company suggests participants dial in approximately 10 minutes before the call.

Karyopharm Announces XPOVIO® (selinexor) Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma

On February 4, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that its partner Promedico Ltd., a member of the Neopharm Group, has received a principal approval letter from the Israeli Ministry of Health, Israel’s regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL) (Press release, Karyopharm, FEB 4, 2021, View Source [SID1234574655]). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and b) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Karyopharm expects Promedico to receive a registration license providing commercial and marketing authorization for XPOVIO in Israel during the second quarter of 2021. Separately, today’s announcement follows Karyopharm’s recently announced adoption of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending conditional approval for NEXPOVIO (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Karyopharm expects to receive a final decision from the European Commission by April 2021.

"The approval of XPOVIO in Israel represents its first regulatory approval outside the United States and is a tremendous milestone for both Karyopharm and the patients we hope to serve in the future," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The approval of XPOVIO in Israel further demonstrates our commitment to expand XPOVIO’s reach to cancer patients across the globe who are in need of novel therapies. We look forward to continuing to work closely with our dedicated partner, Promedico, and its world-class team to bring XPOVIO to patients in Israel."

Karyopharm has previously entered into an exclusive distribution agreement with Promedico, a member of the Neopharm Group, a leader in launching and marketing novel therapies in Israel, for the commercialization of XPOVIO (selinexor) in Israel and the Palestinian Authority.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved in the U.S.:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection(21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.