On May 20, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported it has entered into a clinical trial collaboration with Merck (NYSE: MRK), known as MSD outside the United States and Canada, through a subsidiary, to evaluate the safety and efficacy of combining Surface’s SRF617, an investigational antibody therapy targeting CD39, with Merck’s KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States (Press release, Surface Oncology, MAY 20, 2020, View Source [SID1234558318]). This combination will be studied as a component of the first-in-human Phase 1/1b study of SRF617 and will be evaluated in patients with solid tumors, with a focus on patients with gastric cancer and those who have developed resistance to checkpoint inhibition — both areas of high unmet need.

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SRF617 inhibits CD39, an enzyme critical both to the breakdown of adenosine triphosphate (ATP) and the production of adenosine. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, in gastric cancer, immune cells within the tumor often express high levels of CD39, which may impair an overall anti-cancer immune response even in the presence of an anti-PD-1 antibody. The combination of SRF617 and KEYTRUDA has the potential to overcome this barrier to immune system activation and promote anti-tumor immunity.

"Surface is committed to delivering truly breakthrough therapies that can transform treatment for people with cancer. This collaboration with Merck will add an important dimension to our clinical program for SRF617, and allow us to more rapidly assess its potential," said Robert Ross, M.D., chief medical officer at Surface Oncology. "We have demonstrated in preclinical studies that the inhibition of CD39 results in substantial activation of both the innate and adaptive arms of the immune system. Encouragingly, we also found that activation is heightened in combination with anti-PD-1 treatment and that this combinatory approach has the potential to overcome anti-PD-1 resistance."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On May 20, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy (Press release, Fate Therapeutics, MAY 20, 2020, View Source [SID1234558311]). FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 expression. The Company plans to initiate clinical investigation of three once-weekly doses of FT538 as a monotherapy in acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-directed monoclonal antibody therapy, for the treatment of multiple myeloma.

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"We are very pleased to expand the clinical application of our proprietary iPSC product platform to multiple myeloma, where rates of relapse remain high," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Clinical data suggest that deficiencies in NK cell-mediated immunity, which are evident even at the earliest stages of myeloma, continue to accumulate through disease progression. We believe administration of FT538 to patients can restore innate immunity, and that the anti-cancer effect of certain standard of care treatments, such as monoclonal antibodies, can be more effective when combined with the engineered functionality of FT538."

The three functional components of FT538 are designed to boost the innate immune response in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to endogenous NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action including:

Expression of the hnCD16 Fc receptor, which improves antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells;
Expression of the IL-15RF cytokine complex, which promotes NK cell survival and persistence and induces trans-activation of endogenous NK cells and CD8 T cells; and
Elimination of CD38 expression, which enhances innate effector function, including granzyme and perforin levels and resistance to oxidative stress, and prevents anti-CD38 antibody-mediated NK cell death.
The first-in-human, multi-center, dose-escalation Phase 1 clinical trial of FT538 is designed to determine the maximum tolerated dose (MTD) of three once-weekly doses of FT538 in up to 105 adult patients across four dose cohorts (100M cells per dose; 300M cells per dose; 900M cells per dose; and 1.5B cells per dose). The study will assess two treatment regimens: Regimen A as a monotherapy in patients with relapsed / refractory AML; and Regimen B in combination with daratumumab, an FDA-approved anti-CD38 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy. In addition, the Company may initiate a third treatment regimen in combination with elotuzumab, an FDA-approved anti-SLAMF7 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy starting at one dose level below the MTD of Regimen B. For all regimens, multiple indication- or dose-specific dose-expansion cohorts of up to 15 patients per cohort may be enrolled to further evaluate the clinical activity of FT538.

FT538 is the fourth off-the-shelf, iPSC-derived NK cell product candidate from the Company’s proprietary iPSC product platform cleared for clinical investigation by the FDA. The Company has initiated clinical manufacture of FT538 at its GMP facility in San Diego, CA.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

On May 20, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, reported it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for XPOVIO (selinexor), its first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a new treatment for patients with previously treated multiple myeloma (Press release, Karyopharm, MAY 20, 2020, View Source [SID1234558310]).

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"Earlier this year, we reported positive top-line results from the pivotal Phase 3 BOSTON study evaluating the combination of XPOVIO (selinexor), once-weekly Velcade (bortezomib) and low-dose dexamethasone (SVd) as a second line treatment for patients with relapsed or refractory multiple myeloma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The full study results, which were included in the sNDA, will be presented on May 29, 2020 at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program. In the BOSTON study, the SVd arm demonstrated a statistically significant reduction in the risk of disease progression or death, along with a 47% increase in median progression-free survival, as well as a significantly higher overall response rate, as compared to the standard Velcade and dexamethasone (Vd) regimen. If approved, we believe XPOVIO could become an important addition to the treatment paradigm for patients with relapsed or refractory multiple myeloma, and we look forward to working with the FDA during the review process."

Karyopharm also plans to submit a Marketing Authorization Application to the European Medicines Agency requesting approval for XPOVIO in this same indication later this year. The abstract for the Phase 3 BOSTON clinical data to be presented at the 2020 ASCO (Free ASCO Whitepaper) annual meeting and can be found on ASCO (Free ASCO Whitepaper)’s website, here.

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. A supplemental New Drug Application was accepted by the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and selinexor has received Fast Track and Orphan designation and Priority Review from the FDA with a scheduled PDUFA date of June 23, 2020 for this patient population. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), for which Karyopharm announced positive top-line results in March 2020. In May 2020, Karyopharm submitted a supplemental New Drug Application based on the data from BOSTON. Additional, ongoing trials for selinexor include 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.

IMPORTANT SAFETY INFORMATION

Thrombocytopenia

XPOVIO can cause thrombocytopenia, leading to potentially fatal hemorrhage. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3-4) thrombocytopenia occurred in 61% of patients treated with XPOVIO. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia and fatal hemorrhage occurred in <1% of patients.

Monitor platelet counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia

XPOVIO can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3-4) neutropenia occurred in 21% of patients treated with XPOVIO. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.

Obtain neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G-CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Gastrointestinal Toxicity

Gastrointestinal toxicities occurred in patients treated with XPOVIO.

Nausea/Vomiting

Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with XPOVIO. The median time to onset of the first nausea event was 3 days.

Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with XPOVIO. The median time to onset of the first vomiting event was 5 days.

Provide prophylactic 5-HT3 antagonists and/or other anti-nausea agents, prior to and during treatment with XPOVIO. Manage nausea/vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti-nausea medications as clinically indicated.

Diarrhea

Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with XPOVIO. The median time to onset of diarrhea was 15 days.
Manage diarrhea by dose modifications and/or standard anti-diarrheal agents; administer intravenous fluids to prevent dehydration in patients at risk.

Anorexia/Weight Loss

Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with XPOVIO. The median time to onset of anorexia was 8 days.

Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days.

Monitor patient weight at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.

Hyponatremia

XPOVIO can cause hyponatremia; 39% of patients treated with XPOVIO experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days.

Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Infections

In patients receiving XPOVIO, 52% of patients experienced any grade of infection. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. Grade ≥3 infections were reported in 25% of patients, and deaths resulting from an infection occurred in 4% of patients. The most commonly reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not associated with neutropenia and were caused by non-opportunistic organisms.

Neurological Toxicity

Neurological toxicities occurred in patients treated with XPOVIO.

Neurological adverse reactions including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients, and severe events (Grade 3-4) occurred in 9% of patients treated with XPOVIO. Median time to the first event was 15 days.

Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes.

Embryo-Fetal Toxicity

Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20%) are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65.3% had the dose of XPOVIO interrupted. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia. The rate of fatal adverse reactions was 8.9%.

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 [SID1234558309]). The 2020 ASCO (Free ASCO Whitepaper) conference is being held virtually from May 29 to May 31, 2020.
Details of the presentations are as follows:

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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 DfuseRxSM 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 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has raised gross proceeds of approximately $28.9 million through its At-the-Market, or ATM, facility with participation based on interest received from EcoR1 Capital LLC, Venrock Healthcare Capital Partners, BVF Partners L.P., and RS Investments, a Victory Capital investment franchise (Press release, Surface Oncology, MAY 20, 2020, View Source [SID1234558308]). Surface Oncology sold approximately 10.9 million shares of its common stock at a purchase price of $2.66, the market price at the time of the sale. This transaction exhausts the balance on the $30 million ATM facility. JonesTrading Institutional Services LLC is acting as the sales agent for the ATM facility.

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These funds strengthen Surface Oncology’s balance sheet and will be used to advance its pipeline, including the clinical development of SRF617 (targeting CD39) and SRF388 (targeting IL-27), and the advancement of SRF813 (targeting CD112R, also known as PVRIG), as well as for working capital and other general corporate purposes.

The shares of common stock described above were sold by Surface Oncology pursuant to a shelf registration statement on Form S-3 (File No. 333-231114), including a sales agreement prospectus, which was declared effective by the Securities and Exchange Commission on May 8, 2019. Copies of the sales agreement prospectus may be obtained from JonesTrading Institutional Services LLC, 32133 Lindero Canyon Road, Suite 208, Westlake Village, CA 91361, Attention: Compliance Department or via telephone at (844) 566-6587 or via email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.