On May 20, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology reported first quarter 2020 financial results (Press release, Cumberland Pharmaceuticals, MAY 20, 2020, View Source [SID1234558326]). Net revenues from continuing operations during the quarter were $8.3 million. Total revenues were $9.1 million, as the company recorded an additional $750,000 in revenue in the first quarter associated with divested product rights.

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The Company’s financial position included over $97 million in total assets, $48 million of total liabilities, and nearly $50 million of shareholders’ equity at the end of the quarter.
"Our thoughts go out to those currently suffering from the novel coronavirus pandemic, and we extend our sincere gratitude to those on the front lines treating patients and performing essential jobs that allow our society to function," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Cumberland has remained open during this pandemic, since we are considered to be an essential business by the United States Department of Homeland Security. We have faced the same headwinds that have affected many healthcare companies, but we have implemented measures to lessen the impact of the coronavirus on our company during 2020."
RECENT COMPANY DEVELOPMENTS:
Next Generation Caldolor Product
In January 2020, Cumberland launched the next generation of its Caldolor (ibuprofen) Injection product. This formulation of Caldolor comes in a ready-to-use bag that may be administered without dilution for pain relief. This launch follows FDA approval in 2019 of the product’s new delivery method.
A non-steroidal anti-inflammatory drug (NSAID), Caldolor may be used as the sole method of treatment for mild-moderate pain or as part of a multimodal treatment for severe pain. The new formulation of Caldolor comes in a pre-mixed bag containing 800 mg of ibuprofen in a 200 mL patented low-sodium formulation for injection that is ready to use. It is the first FDA-approved pre-mixed bag of ibuprofen. Caldolor is still available as an 800 mg/8mL single-dose vial (100mg/mL) for dilution in addition to the ready-to-use bag (4 mg/mL). The new, premixed presentation provides healthcare professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.
Caldolor Pediatric Study
Cumberland previously received FDA approval for the use of Caldolor in pediatric patients six months of age and older and is the first and only injectable NSAID approved for use in children. The Company then initiated a study to collect data on the use of Caldolor in children ranging in age from birth up to six months of age. Enrollment in that multi-center study was completed in 2019.

In March 2020, the Company announced topline results that indicated the use of Caldolor was well tolerated in children from birth up to six months of age. Following that announcement, the Company completed that data analysis and study report which was submitted to the FDA. Next steps include preparation of a study manuscript and determination of whether an additional pediatric indication will be available.
Acute Care Product Special Supply Arrangements
In March 2020, Cumberland announced an initiative to expand the availability of Vibativ along with special financial arrangements for hospitals and clinics to help ensure supply during this unprecedented healthcare crisis. In addition, the Company sponsored a national program with infectious disease experts to provide information on the management of complicated respiratory infections resulting from COVID-19.
Additionally, in March 2020, the Company announced another initiative to expand the availability of Caldolor with special supply and financial arrangements, including favorable pricing and payment terms for hospitals and clinics to help ensure timely access to Caldolor during the coronavirus crisis.
In April 2020, the Company announced a third COVID-19-related initiative. This initiative increased the availability of Vaprisol to hospitals and clinics including special supply and financial arrangements, with favorable pricing and payment terms, to help ensure timely access to Vaprisol during this healthcare crisis.
Environmental, Social and Governance (ESG) Activities
In April 2020, Cumberland released its first Sustainability Report. This report describes the company’s activities pertaining to Environmental, Social and Governance (ESG) matters, otherwise known as corporate sustainability. It includes details about Cumberland’s community involvement, ethical marketing and drug safety.
Cumberland’s board appointed Caroline R. Young, former president of the Nashville Health Care Council, as the company’s first ESG board director.
The report notes that, during 2019, Cumberland provided nearly 4 million patient doses of products, safely disposed of over 9,700 pounds of expired and damaged products and had no product recalls. The Company had no product listings on the FDA’s Safety Alerts Database and no products identified in the FDA Adverse Event Reporting System during 2019.
Ifetroban Phase II Clinical Programs
Enrollment in Cumberland’s clinical studies declined during the first quarter due to the COVID-19 pandemic. While enrollment of new patients is currently limited, the Company is working to ensure that patients already entered into a trial continue to receive their study drug.
Cumberland has completed three pilot Phase II studies involving ifetroban in 1) patients suffering from hepatorenal syndrome, a life-threatening condition involving liver and kidney failure, 2) patients with portal hypertension associated with chronic liver disease and 3) patients suffering from aspirin-exacerbated respiratory disease, a severe form of asthma. A follow-up Phase II study is currently underway for this asthma indication.
In addition, the Company is currently evaluating ifetroban in two pilot Phase II studies of 1) patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy. This rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

Cumberland is awaiting further study results before deciding on the best path for approval for ifetroban, its first new chemical entity.
FINANCIAL RESULTS:
Net Revenues: For the three months ended March 31, 2020, net revenues from ongoing operations were $8.3 million. Total revenues were $9.1 million as another $750,000 in revenue was recorded associated with product rights which had been divested. Net revenue from continued operations in 2019 was $8.7 million.
Net revenue by product for the three months ended March 31, 2020, included $3.3 million for Kristalose,$2.4 million for Vibativ, $1.1 million for Caldolor, $0.7 million for Acetadote (including the brand and Company’s Authorized Generic), $0.2 million for Vaprisol, and $0.1 million for Omeclamox-Pak.
Operating Expenses: Total operating expenses for the three months ended March 31, 2020 were $10.2 million, similar to $10.1 million during the prior year period.
Earnings: Net income (loss) for the first quarter 2020 was $(1.1) million or $(0.07) a share, compared to $(0.1) million or $0.00 a share for the prior year period.
Adjusted Earnings for the first quarter were $0.2 million or $0.01 per diluted share, compared to $0.7 million or $0.04 per diluted share for the prior year period. The definition and reconciliation of Adjusted Earnings to net income is provided in this release.
Balance Sheet: At March 31, 2020, Cumberland had $97.4 million in total assets including $27.0 million in cash and marketable securities. Total liabilities were $47.6 million, including $18.5 million outstanding on the Company’s revolving line of credit, resulting in Total shareholder’s equity of $49.9 million.

Conference Call and Webcast
A conference call and live Internet webcast will be held on Wednesday, May 20, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 1692495. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and oncology market segments. These medical specialties are categorized by moderately concentrated prescriber bases that we believe can be penetrated effectively by targeted sales forces. The Company’s portfolio of FDA approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;

Caldolor (ibuprofen) Injection, for the treatment of pain and fever;

Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;

Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;

Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;

Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
For more information on Cumberland’s approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company’s website www.cumberlandpharma.com.
The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").
About Acetadote (acetylcysteine) Injection
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com.
About Caldolor (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.
About Kristalose (lactulose) Oral Solution
Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com.
About Vibativ (telavancin) for Injection
Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin

and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information please visit www.vibativ.com.
About Omeclamox-Pak (omeprazole, clarithromycin, amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. For full prescribing and safety information, visit www.omeclamox.com.
About Vaprisol (conivaptan hydrochloride) Injection
Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.

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