On May 20, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results for the quarter ended March 31, 2020 (Press release, ORIC Pharmaceuticals, MAY 20, 2020, View Source [SID1234558325]).

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"Throughout 2019 and the first quarter of 2020, we made substantial progress across all aspects of our business, including important advancements with respect to our programs, people and funding," said Jacob Chacko, president and chief executive officer. "With the success of our recently completed initial public offering and key additions to our leadership team over the last eighteen months, ORIC is well-positioned to execute our strategy of developing a broad pipeline of novel treatments that address mechanisms of therapeutic resistance in cancer."

First Quarter 2020 and Other Recent Highlights

First Patient Dosed in ORIC-101 Phase 1b Combination Trial for Prostate Cancer: In January 2020, ORIC announced the dosing of its first patient in a Phase 1b clinical trial being conducted under a collaboration with Astellas Pharma, Inc., to evaluate the combination of ORIC-101 with XTANDI (enzalutamide) as a treatment for patients with metastatic prostate cancer that is progressing on enzalutamide. This marked ORIC’s second Phase 1b clinical trial of ORIC-101, following the initiation in 2019 of a Phase 1b trial of ORIC-101 in combination with Abraxane (nab-paclitaxel) in patients with solid tumors.

Preclinical Data on CD73 Inhibitor Program Presented at AACR (Free AACR Whitepaper): In April 2020, ORIC presented research that led to the discovery of ORIC-533, an orally bioavailable small molecule inhibitor of CD73, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting I. ORIC’s small molecule CD73 inhibitor demonstrated more potent blocking of adenosine production compared to an antibody

approach in preclinical studies. ORIC-533 demonstrated significant anti-tumor single agent efficacy when dosed once a day, with corresponding reduction of adenosine levels in the tumor microenvironment.

Completed Initial Public Offering: On April 28, 2020, the company completed its initial public offering selling 8,625,000 shares of common stock, which included the full exercise by the underwriters of their option to purchase up to 1,125,000 additional shares, at $16.00 per share. Gross proceeds from the IPO, excluding underwriting discounts and commissions and other estimated offering costs, were $138.0 million.

Strengthened Executive Leadership and Board: In April 2020, the company appointed Christian V. Kuhlen, MD, as its General Counsel, following his most recent tenure as General Counsel of Synthorx, Inc. In March 2020, the company appointed Mardi C. Dier, a 20+ year biotech leader and current CFO/CBO of Portola Pharmaceuticals, Inc, to its board of directors.

Response to the COVID-19 Pandemic: The company implemented certain risk mitigation measures and adjusted its operations in response to the COVID-19 pandemic and continues to evaluate the impact of the COVID-19 pandemic on its business.

Anticipated Milestones

ORIC expects to select the recommended Phase 2 dose for its two ongoing ORIC-101 combination trials in the second half of 2020 and to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.

ORIC expects to file an Investigational New Drug Application for ORIC-533 with the Food and Drug Administration in the first half of 2021.

First Quarter 2020 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents totaled $79.4 million as of March 31, 2020, which excludes the gross proceeds of $138.0 million from the company’s initial public offering, compared to $89.2 million as of December 31, 2019. The company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2023.

R&D Expenses: Research and development expenses were $7.3 million for the three months ended March 31, 2020, compared to $5.2 million for the three months ended March 31, 2019, an increase of $2.0 million. This increase was primarily driven by $1.2 million higher personnel costs related to the addition of a clinical development team and $0.8 million of external costs driven by the advancement of ORIC-101 trials and ORIC-533 preclinical development.

G&A Expenses: General and administrative expenses were $1.9 million for the three months ended March 31, 2020, compared to $1.1 million for the three months ended March 31, 2019, an increase of $0.8 million. The increase was primarily due to higher professional services and personnel costs to support the growth of the company.

On May 20, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it has commenced concurrent offerings of $750.0 million of shares of its common stock ("Common Stock") and $750.0 million of shares of its Series A Mandatory Convertible Preferred Stock ("Mandatory Convertible Preferred Stock" and, together with the Common Stock, the "securities"), subject to market and other conditions (the "offerings") (Press release, Boston Scientific, MAY 20, 2020, View Source [SID1234558324]). Boston Scientific expects to grant the underwriters separate 30-day options to purchase up to an additional $112.5 million of shares of Common Stock and up to an additional $112.5 million of shares of Mandatory Convertible Preferred Stock.

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Boston Scientific intends to use a portion of the combined net proceeds from the offerings to repay in full the remaining $750.0 million outstanding under its $1.25 billion term loan credit facility maturing on April 2021 and to pay related fees, expenses and premiums, after which it will be terminated. The remaining proceeds will be used for general corporate purposes, which may include refinancing or repayment of other outstanding indebtedness and funding potential future acquisitions and investments.

Each share of Mandatory Convertible Preferred Stock will have a liquidation preference of $100.00 per share. Unless earlier converted, each share of Mandatory Convertible Preferred Stock will automatically convert into a variable number of shares of Common Stock on or around June 1, 2023. The conversion rates, dividend rate and the other terms of the Mandatory Convertible Preferred Stock will be determined at the time of pricing.

The closing of each offering is not contingent upon the closing of the other offering.

J.P. Morgan and BofA Securities are acting as joint book-running managers for the offerings.

The offerings are being made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission (the "SEC"). Each offering will be made by means of a prospectus and related preliminary prospectus supplement only. An electronic copy of each preliminary prospectus supplement, together with the accompanying prospectus, is available on the SEC’s website at www.sec.gov. Alternatively, copies of each preliminary prospectus supplement and accompanying prospectus relating to either offering or information concerning this offering may be obtained by contacting the joint book-running managers: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, Email: [email protected]; or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, Email: [email protected].

Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 20, 2020 Incyte (NASDAQ:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) reported the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody (Press release, Incyte, MAY 20, 2020, View Source [SID1234558323]). The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process.

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This press release features multimedia. View the full release here: View Source

"The EMA’s validation of the MAA for tafasitamab is a critical step on the path to making tafasitamab available for use in combination with lenalidomide in eligible patients with r/r DLBCL in Europe," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "We will continue to work closely with the EMA to progress the review of this application, with the hope of bringing this novel therapy to eligible patients as soon as possible."

"We are pleased to have achieved this important milestone, which moves tafasitamab in combination with lenalidomide into the formal regulatory review process in the European Union," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "Following the U.S. FDA’s acceptance of our Biologics License Application filing for tafasitamab for Priority Review earlier this year, this represents another major step forward. We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients in need."

The MAA, submitted by MorphoSys, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with r/r DLBCL; and is supported by the Re-MIND study, an observational retrospective study in r/r DLBCL. If approved, Incyte will hold the marketing authorization, and has exclusive commercialization rights for tafasitamab outside of the United States, including Europe.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide – comprising 40% of all cases1. It is an aggressive disease affecting the B-cells of the immune system with 30-40% of patients who do not respond to initial therapy or relapse thereafter, leading to a high medical need for new, effective therapies2.

About L-MIND

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Two-year data, assessed by an independent review committee (November 30, 2019 cut-off), evaluating 80 patients receiving tafasitamab and lenalidomide corroborate previously reported primary analysis data.

For more information about L-MIND, visit View Source

About Re-MIND

Re-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND was met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

For more information about Re-MIND, visit View Source

About Tafasitamab

Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing.

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being studied as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND, as well as the ongoing Phase 3 B-MIND study evaluating the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being evaluated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

XmAb is a trademark of Xencor, Inc.

On May 20, 2020 Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary non-viral gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported the first patient has been dosed in its Phase 1 clinical trial evaluating P-PSMA-101, its autologous CAR-T therapeutic candidate, in metastatic castration-resistant prostate cancer (Press release, Poseida Therapeutics, MAY 20, 2020, View Source [SID1234558322]). The study represents a promising advancement in evolving cell therapies to treat solid tumors.

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"Extending our gene engineering technology to solid tumors represents the next opportunity in oncology where we believe our proprietary platforms and approach have advantages over others in the space," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "Our platform technologies, which include the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, are driving our diverse pipeline of next-generation CAR-T treatments for hematologic and solid tumors, as well as gene therapies addressing rare diseases."

As part of its research, Poseida’s Phase 1 open label, multi-center, dose-escalating trial will include cohorts receiving single and multiple doses of P-PSMA-101, with the goal of determining the best dose with the fewest side effects.

P-PSMA-101 is designed to target prostate-specific membrane antigen (PSMA), which is expressed on metastatic castration-resistant prostate cancer cells. It was developed using Poseida’s proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T (TSCM) cells. TSCM cells are long-lived, self-renewing and multipotent, with the capacity to reconstitute the entire spectrum of T cell subsets, including effector T (TEFF) cells, the most maturated cells which are tumor killing.

Poseida believes this higher composition of TSCM cells is central in addressing the challenges associated with earlier generation CAR-T therapies, including safety and duration of response. Based upon clinical data to date, the Company has observed a strong correlation between the percentage of TSCM cells in the product candidate and best clinical response. In addition to these observations, there is a growing body of scientific evidence and recognition that TSCM is correlated with efficacy in the clinic.

Metastatic castration-resistant prostate cancer spreads to other parts of the body and is an indication where new advancements like CAR-T therapy are needed. Most prostate cancer deaths are typically the result of metastatic castration-resistant prostate cancer and, historically, the median survival has been less than two years.

Poseida is also developing a fully allogeneic, or "off-the-shelf," CAR-T product candidate targeting PSMA, P-PSMA-ALLO1, currently in preclinical development. This could bring the additional advantages of the Company’s allogeneic platform to prostate cancer patients once preliminary tolerability and clinical activity with P-PSMA-101 are established.

Click to Tweet: Poseida Therapeutics announces first patient dosed by expanding its #geneengineering technology for CAR-T therapy in metastatic castration-resistant prostate cancer #celltherapy #genetherapy

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.