On October 29, 2019, SELLAS Life Sciences Group, Inc., a Delaware corporation (the "Company"), reported that it entered into an Equity Distribution Agreement (the "Distribution Agreement") with Maxim Group LLC ("Maxim"), as sales agent, in connection with an "at the market offering" under which the Company from time to time may offer and sell shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $5,000,000 (the "Shares") (Filing, 8-K, Sellas Life Sciences, OCT 29, 2019, View Source [SID1234550094]). Shares sold under the Distribution Agreement will be offered and sold pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (Registration No. 333- 233869) (the "Registration Statement") and a prospectus supplement and accompanying base prospectus that the Company filed with the Securities and Exchange Commission (the "SEC") relating to the Shares on October 29, 2019.

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Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company has provided Maxim with customary indemnification rights, and Maxim will be entitled to a commission at a fixed commission rate equal to 3.0% of the gross sales price of all Shares sold. In addition, pursuant to the terms of the Distribution Agreement, the Company has agreed to reimburse Maxim for the documented fees and costs of its legal counsel reasonably incurred in connection with (i) entering into the transactions contemplated by the Distribution Agreement in an amount not to exceed $40,000 in the aggregate (inclusive of an advance of $20,000 payable to Maxim upon entrance into the Distribution Agreement) and (ii) Maxim’s ongoing due diligence, drafting and other filing requirements arising from the transactions contemplated by the Distribution Agreement in an amount not to exceed $5,000 in the aggregate per calendar quarter. Sales of the Shares, if any, under the Distribution Agreement may be made in transactions that are deemed to be "at the market offerings" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Distribution Agreement or terminate the Distribution Agreement. The Distribution Agreement will terminate upon the sale of all of the Shares under the Distribution Agreement unless terminated earlier by either party as permitted under the Distribution Agreement.

The Company currently intends to use the net proceeds from the offering, if any, for working capital, capital expenditures and other general purposes, including research and development of our product candidates (including clinical trial activities), and general and administrative expenses.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

The legal opinion of the Company’s counsel regarding the validity of the Shares is filed as Exhibit 5.1 to this Current Report on Form 8-K. The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the Company’s ability to sell Shares pursuant to the Distribution Agreement. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these statements, results or sales will be achieved or completed due in part to risks and uncertainties inherent in the Company’s business, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on March 22, 2019 and August 14, 2019, respectively. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

On October 29, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the third quarter ended September 30, 2019 (Press release, Corvus Pharmaceuticals, OCT 29, 2019, View Source [SID1234549964]).

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"There continues to be strong enrollment in all three of our ongoing clinical studies and we are scheduled to present data related to each at medical meetings during the fourth quarter," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "The highlight will be the updated data from the CPI-006 study in an oral presentation at SITC (Free SITC Whitepaper) in November, which will add to the biologic and clinical evidence supporting CPI-006’s unique dual-mechanisms of action, both in monotherapy and in combination with ciforadenant. We will also provide updated data supporting the potential for our Adenosine Gene Signature to serve as a biomarker capable of identifying patients that are most likely to respond to therapies targeting the adenosine pathway. In December, we will present the first clinical data on CPI-818 in patients with T-cell lymphoma."

Recent Achievements
CPI-006: Immunomodulatory Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b adaptive design clinical trial evaluating CPI-006 as a single agent and in combination with ciforadenant or pembrolizumab.
Selected recommended dose of 18 mg/kg and initiated the disease expansion phase in the monotherapy arm of the study.
The trial also continues to enroll patients in the dose escalation phase in the ciforadenant combination arm of the study.
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrollment of patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors. This trial is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy and form the basis for future biomarker driven studies.
Began enrolling patients with prostate cancer in the amended Phase 1b/2 clinical trial to evaluate activity of ciforadenant and Tecentriq in this disease
CPI-818: A small molecule ITK inhibitor

Continued enrolling patients with T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, in a Phase 1/1b study with CPI-818, an ITK inhibitor.
Clinical study sites now open in the United States, Australia and South Korea.
Anticipated Upcoming Events

Updated clinical and immunologic data from the Phase 1/1b clinical trial of CPI-006 monotherapy and combination with ciforadenant is scheduled to be presented in an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2019. This will build upon data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June 2019 that support a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
Updated data on the identification and role of biomarkers in adenosine pathway therapies, and specifically on the correlation of clinical activity with the Adenosine Gene Signature biomarker in renal cell cancer, is expected to be presented in a poster presentation at SITC (Free SITC Whitepaper).
Preclinical and early clinical data regarding CPI-818 is scheduled to be presented in a poster presentation in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Additional data is expected to be presented in an oral presentation at the T-cell Lymphoma Forum in January 2020.
Updated clinical data from the amended Phase 1b/2 clinical trial of ciforadenant in combination with atezolizumab in prostate cancer is anticipated to be presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (GU) in February 2020.
Financial Results
At September 30, 2019, Corvus had cash, cash equivalents and marketable securities totaling $86.4 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full-year 2019 net cash used in operating activities to be between $38 and $40 million and estimates ending 2019 with cash, cash equivalents and marketable securities of between $75 and $77 million.

Research and development expenses for the three months ended September 30, 2019 totaled $9.0 million, as compared to $8.4 million for the same period in 2018. The increase of $0.6 million was primarily due to an increase in CPI-006 and CPI-818 program and related costs, partially offset by a reduction in ciforadenant program costs.

The net loss for the three months ended September 30, 2019 was $11.0 million, compared to a net loss of $10.5 million for the same period in 2018. Total stock compensation expense for the three months ended September 30, 2019 and 2018 was $1.8 million.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, October 29, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2019 financial results. The conference call can be accessed by dialing 1-800-458-4121 (toll-free domestic) or 1-720-543-0206 (international) and using the conference ID 8706779. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These candidates are being studied in ongoing Phase 1/1b and 1b/2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant, and with pembrolizumab. Corvus’ third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

Tecentriq is a registered trademark of Genentech.

About Ciforadenant
Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

About CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. This antibody also possesses immunomodulatory activity resulting in activation of lymphocytes and effects on lymphocyte trafficking, which are independent of adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.

About CPI-818
CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas – similar to the role of Bruton’s tyrosine kinase (BTK) in B-cells. BTK is now an established target for treating various B-cell lymphomas, and two BTK inhibitors, ibrutinib and aclarabrutinib, have been approved by the U.S. Food and Drug Administration for lymphoma indications.

On October 29, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its financial results for the third quarter of 2019 (Press release, MorphoSys, OCT 29, 2019, View Source [SID1234549980]).

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"The third quarter of 2019 has significantly advanced our preparations for seeking regulatory approval in the U.S. for our key asset tafasitamab," said Dr. Jean-Paul Kress, Chief Executive Officer of MorphoSys. "Today we announced compelling topline data of Re-MIND, our retrospective study in relapsed/refractory DLBCL. Re-MIND compares real-world data based effectiveness of lenalidomide monotherapy with the efficacy outcomes of the tafasitamab/ lenalidomide combination in our L-MIND trial. We are very pleased that the study met its primary endpoint, showing a superior best objective response rate (ORR) of the tafasitamab/ lenalidomide combination compared to lenalidomide monotherapy. The data complements the L-MIND primary analysis data we published in June this year and considerably supports the BLA submission, which we plan to complete by end of this year. Rolling submission was initiated and the pre-clinical data package was already submitted to the FDA.

Our commitment to unlock tafasitamab’s full clinical potential as well as to maximize the value of our entire proprietary pipeline remains unchanged. We are well on track to start our first-line trial of tafasitamab in DLBCL later this year and we successfully activated the first clinical sites for the phase 1/2 trial with MOR202 in membranous nephropathy.

While we were clearly disappointed to learn that results from the interim analysis for futility of the MOR106 IGUANA study did not support continuation of the clinical development in atopic dermatitis, we remain fully committed to the development of our proprietary early and late-stage drug candidates," Dr. Kress continued.

"The last quarter was a successful quarter for Tremfya(R) and our partner Janssen," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Janssen submitted a sBLA for Tremfya(R) to the U.S. FDA for the treatment of patients with psoriatic arthritis and also recently announced the submission of a filing application in the same indication to EMA for Europe. Janssen reported a strong quarter for Tremfya(R) sales. This led us to adapt our expectations for the 2019 royalty income that we now anticipate in the range of EUR30-35 million."

Financial Review for the third quarter of 2019 (IFRS; all figures rounded)

In Q3 2019 MorphoSys continued to focus on the research and development of drug candidates both for its own account as well as with its partners. Group revenues came in at EUR12.5 million in Q3 2019 as compared to EUR55.0 million in the third quarter of the previous year. Revenues in Q3 2018 comprised the payment of EUR47.5 million for the license agreement for MOR106 with Novartis.

Revenues in Q3 2019 also included an estimate of royalties on net sales of Tremfya(R) amounting to EUR9.3 million (estimate only since royalties for Q3 2019 had not been reported by Janssen as of the balance date). Due to the strong sales Janssen reported for Tremfya(R) for Q3 2019, we adapted our royalty guidance for Tremfya(R). We now expect a royalty income ranging from EUR30-35 million at constant US dollar exchange rate, thus we anticipate to reach the upper end of our revenue guidance for 2019.

In the Proprietary Development segment, MorphoSys focuses on research and clinical development of its own drug candidates in the fields of cancer and inflammation. In Q3 2019, this segment recorded revenues of EUR1.4 million compared to EUR48.8 million in Q3 2018, which included the EUR47.5 million payment for the license agreement for MOR106 with Novartis. In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q3 2019, revenues in this segment amounted to EUR11.0 million compared to EUR6.2 million in Q3 2018.

Total operating expenses increased to EUR40.3 million in the third quarter of 2019 from
EUR25.3 million Q3 2018, based on the ramp-up of preparations for a potential tafasitamab U.S. commercialization as well as build-up of the MorphoSys U.S. operations. In Q3 2019, research and development expenses amounted to EUR25.9 million, as compared to EUR18.0 million in the third quarter of 2018. Expenses for proprietary R&D, including technology development, amounted to EUR23.7 million (Q3 2018: EUR15.9 million).

In the third quarter of 2019, cost of sales amounted to EUR1.0 million (Q3 2018: EUR0.9 million), selling expenses amounted to EUR4.4 million (Q3 2018: EUR1.3 million). General and administrative expenses increased from EUR5.1million in Q3 2018 to EUR9.0 million in Q3 2019.

Earnings before interest and taxes (EBIT) in Q3 2019 totaled EUR-27.0 million (Q3 2018: EUR30.1 million). The Proprietary Development segment reported an EBIT of EUR-30.5 million (Q3 2018: EUR30.3 million). EBIT in the Partnered Discovery segment was EUR8.8 million (Q3 2018: EUR3.8 million). In Q3 2019, the consolidated net loss was EUR-24.2 million (Q3 2018: net profit of EUR30.2 million). The earnings per share for Q3 2019 was EUR-0.76 (Q3 2018: earnings per share of EUR0.96).

At the end of Q3 2019, the Company had EUR412.4 million in cash, reported on the balance sheet under the line items "cash and cash equivalents"; "financial assets at fair value through profit or loss"; and current and non-current "other financial assets at amortized cost". On December 31, 2018, the Group’s liquidity position amounted to EUR454.7 million.

The number of shares issued totaled 31,927,958 at the end of Q3 2019 (year-end 2018: 31,839,572).

Results for the first nine months 2019

During the first nine months of 2019, group revenues amounted to EUR60.7 million (Q1-Q3 2018: EUR66.0 million). Revenues in the first nine months of 2019 comprised the milestone payment by GSK of EUR22.0 million due to the start of phase 3 clinical development of otilimab in RA, whereas revenues in the first nine months of 2018 reflected the upfront payment made by Novartis of EUR47.5 million in connection with the license agreement for MOR106. Expenditure for proprietary R&D, including technology development, amounted to EUR68.8 million in the first nine months of 2019 (Q1-Q3 2018: EUR55.1 million). Consequently, the EBIT in the first nine months of 2019 amounted to EUR-56.3 million, compared to EUR-13.0 million in the first nine months of 2018.

Financial Guidance and Operational Outlook for 2019

For the year 2019, MorphoSys re-affirms its financial guidance. The company expects revenues at the upper end of its guidance of EUR65 to 72 million. The company’s EBIT is expected to be in the range of EUR-105 to -115 million. Expenses for proprietary development and technology development are forecasted to remain in a corridor of EUR95 to 105 million. For Tremfya(R), MorphoSys adapted the royalty guidance and now expects royalty income ranging from EUR30-35 million at constant US dollar exchange rate (up from previously EUR23-30 million).

The guidance does not include revenues from potential future partnerships or licensing agreements for tafasitamab or any other compound currently in MorphoSys’s Proprietary Development segment. Effects from potential in-licensing or co-development deals for new development candidates are also not included.

In its Proprietary Development segment, MorphoSys expects the following events and activities until the end of 2019:

Tafasitamab (MOR208)
– L-MIND trial:

– Complete rolling submission of Biologics License Application to U.S. FDA by year-
end

– Re-MIND study

– Presentation of full data from retrospective observational study of patients treated with lenalidomide only in r/r DLBCL planned at ASH (Free ASH Whitepaper)

– B-MIND trial

– Continue phase 3 study evaluating tafasitamab plus bendamustine in r/r DLBCL

– Event-driven interim analysis for futility on track to be announced in Q4 2019

– Front-line DLBCL: Initiate phase 1b trial of tafasitamab in combination with R-CHOP or R2-CHOP in Q4 2019

– COSMOS: Data to be presented at a medical conference later in 2019

MOR202

– MorphoSys: Start of phase 1/2 trial of MOR202 in anti-PLA2R-antibody positive membranous nephropathy (aMN) in Q4 2019

– I-Mab: Continue two clinical trials of MOR202/TJ202 in r/r multiple myeloma in the Chinese region and expand trials to mainland China under recently IND clearances

MOR106

– MorphoSys, Galapagos and Novartis will explore the future strategy of the compound

In its Partnered Discovery segment, MorphoSys expects the following events until the end of 2019:

Tremfya(R) (guselkumab):

Janssen is currently conducting phase 3 trials of Tremfya(R) in psoriatic arthritis and plans to present data at upcoming medical conferences. Further, Janssen announced that submission of a Marketing Authorization Application to EMA has been completed and the review process has started.

Janssen plans the start of a phase 1 trial of guselkumab in Chinese healthy volunteers, a phase 2 trial of guselkumab in pityriasis rubra pilaris, a phase 2/3 trial in ulcerative colitis and a phase 3 trial in palmoplantar-non-pustular psoriasis, according to clinicaltrials.gov.

BPS-804 (setrusumab):

Mereo Biopharma is currently investigating the antibody setrusumab, directed against sclerostin, in Osteogenesis Imperfecta (OI, brittle bone syndrome). According to clinicaltrails.gov, primary completion of the phase 2b study in adult patients is scheduled for later this year and Mereo Biopharma announced plans to start a pediatric study in OI within 2019.

Other partnered programs: publication of clinical data and achievement of regulatory milestones from other partnered programs may occur during the remainder of 2019.

Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’s partners.

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

1) Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

2) Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK, and MOR106, for which MorphoSys and Galapagos have signed a global licensing agreement with Novartis.

PP – Percentage points

The interim statement for the third quarter of 2019 (IFRS) is available online at
View Source

MorphoSys will hold its conference call and webcast tomorrow, October 30, 2019 to present the third quarter financial results 2019 and a further outlook for 2019.

Dial-in number for the analyst conference call (in English) at 2:00pm CET; 1:00pm GMT; 9:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 97683318#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at www.morphosys.com.

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at www.morphosys.com.

On October 29, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") reported that it will release financial results for the period ended September 30, 2019 and provide a business update after market close on Tuesday, November 5, 2019 (Press release, Theravance, OCT 29, 2019, View Source [SID1234549996]).

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An accompanying conference call will be held at 5:00 pm ET on November 5, 2019. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, using the confirmation code 6281636. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through December 5, 2019. An audio replay will also be available through 8:00 PM ET on November 12, 2019 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 6281636.

On October 28, 2019 PharmaCyte Biotech (OTCQB: PMCB) reported that it has a technology that could very well change the way a host of hard-to-treat diseases are treated for the foreseeable future (Press release, PharmaCyte Biotech, OCT 28, 2019, View Source [SID1234549912]). The company is closer than ever to its upcoming Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) that could give patients a new lease on life by shrinking their tumors enough so that the tumors can be removed surgically. It is an outcome that would not go unnoticed.

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Clinical trials are essential for the development of new treatments, and PharmaCyte will enter this upcoming trial with two essential goals in mind—the future of its pancreatic cancer treatment and the future of its technology. First, successfully shrinking tumors would address a real unmet medical need for a group of patients that no longer realizes any benefit from either of the two first-line therapies. Second, and of equal importance for the small California-based biotech, will be to utilize the company’s first-ever clinical trial to validate or prove that its signature live-cell encapsulation technology, Cell-in-a-Box, is both effective and safe to use in humans.

When asked about the importance of validating its technology in a clinical trial setting in relation to the company’s future, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "PharmaCyte is on the precipice of completely changing the paradigm for how diseases are treated in the future. New cell lines are constantly being developed to treat a variety of diseases, particularly genetically engineered cells lines. With the validation of our technology, Cell-in-a-Box knows no bounds in helping these cell lines succeed in treating a disease in the way the cell line was designed to treat it."

During PharmaCyte’s clinical trial, it will introduce its Cell-in-a-Box technology to a public that is mostly unfamiliar with it and how it works. Cell-in-a-Box refers to a porous microcapsule that acts as a "protective cocoon" for the more than 20,000 genetically modified live cells inside. If this cellular therapy proves it can shrink tumors in a large group of patients during an FDA trial, while at the same time proving that the technology can remain where it’s placed inside the body and the cells inside the capsules can remain viable, it would certainly be welcomed news that would reverberate throughout the pancreatic cancer community—and likely well beyond that.

Commenting on PharmaCyte’s clinical trial, renowned oncologist and clinician Dr. Manuel Hidalgo, who will be the Principal Investigator for the trial, said, "The primary goal of the study is to determine the efficacy of this approach, compared to a standard of care treatment, in controlling LAPC. If this endpoint is met, the technology will be validated as a therapeutic option in patients with LAPC."

Dr. Hidalgo also knows the significance of shrinking tumors in patients with LAPC and stated, "Patients who undergo a successful operation may be indeed cured of the disease. So, if this strategy is able to increase the number of patients that can undergo surgery to remove their previously inoperable tumors, that could be a very important finding."

Prof. Walter H. Gunzburg, the co-founder and Chief Technical Officer of Austrianova, said of targeted cellular therapies and specifically Cell-in-a-Box, which Austrianova helped to develop, "This is the future of medicine, this is the new generation of how we’re going to be able to treat diseases—not only cancer but a whole plethora of other diseases. We’re going to be able to take cells; we’re going to program them to do what we want, and we’re going to put them back into patients’ bodies and they’re going to react to signals in the patient to produce medicines in the right way. So, what PharmaCyte is doing and what we’re doing with PharmaCyte is we’re actually taking the first few bold steps for the new medicines for the next generation."

Validating the Cell-in-a-Box technology in an FDA clinical trial will confirm that PharmaCyte has a role in shaping the future of treating diseases using cellular therapies. As monumental as it would be for PharmaCyte to shrink what were once considered inoperable tumors to the point that they are now made operable, validation of the technology is equally as monumental for patients worldwide who suffer from other hard-to-treat diseases and who could now find hope in Cell-in-a-Box to specifically treat some of those diseases.

PharmaCyte’s Chief Operating Officer, Dr. Gerald W. Crabtree, commenting on the upcoming clinical trial said, "Validating the technology simply means that we may have open to us a way to treat diseases for which any type of human cell can be employed—for example, stem cells. All that is needed is that the cells be pure and free from adventitious agents, so validating our technology would mean they can be derived from another human and/or genetically modified."

When Dr. Crabtree offers stem cells as an example, obviously a treatment for Type1 and insulin-dependent Type 2 diabetes has to be one of the hard-to-treat diseases at the forefront of his thinking. After all, an encapsulation technology that can live inside the body—staying exactly where that technology is implanted and acting as a protective home for the insulin-producing cells inside without any threat from the body’s immune response (eliminating the need for harmful immunosuppressive drugs), all while delivering insulin to diabetic patients—is considered the "Holy Grail" for a diabetes treatment, a disease that represents the largest healthcare crisis in the world.

Dr. Crabtree added, "The clinical trial in LAPC, if successful, will prove that the Cell-in-a-Box capsules with genetically altered human cells inside them are safe to use in other human beings. This safety aspect is very important to the FDA and this is why we have made it one of two primary objectives in our clinical trial protocol. A successful trial should also put to rest any doubts about whether the capsules can protect the cells inside from the body’s immune system attack for a reasonable amount of time."

Dr.’s Crabtree and Hidalgo agree that the treatment of numerous different cancers could very well be the future for both PharmaCyte and Cell-in-a-Box once the technology is validated. Dr. Crabtree points to the results of a published Phase 1/2 study using the Cell-in-a-Box technology in dogs that developed spontaneous mammary tumors as evidence that certain types of breast cancer where there are discrete tumor nodules could be a target for the technology.

Dr. Hidalgo expanded the list of possibilities saying, "As this technology is extremely versatile in the sense that different cell types with different genetic manipulations can be used, the range of cancer types that can be treated is vast. It is envisioned that this clinical trial will open the opportunity to explore the same technology in other hard-to-treat cancers like liver, cholangiocarcinoma, head and neck cancer, brain tumors and others. Furthermore, the range of cells that can be encapsulated in Cell-in-a-Box as well as the genetic modifications that can be made to these cells is just huge."

And the list doesn’t stop there. In addition to potential treatments for a number of cancers and for diabetes using different types of cells, the list of treatments grows exponentially when we discuss stem cells. In addition to encapsulating stem cells to treat diabetes, the encapsulation of stem cells can also be used to regenerate and repair diseased or damaged tissues in patients. These stem cell therapies are available for people with spinal cord injuries, Parkinson’s disease, Alzheimer’s disease, heart disease, strokes, burns and even cancer.

Researchers continue to develop new ways in which stem cells can be conducive to better regenerative medicine approaches, to be eventually applied in transplants. Again, protecting stem cells using PharmaCyte’s technology would solve the long-standing concern over safety and efficacy of stem cell therapy to treat diseases and conditions of organs and tissues in patients.

Today’s healthcare market offers few effective ways to treat the root causes of many diseases or conditions. In many cases, typical treatments can only manage a patients’ symptoms with medications or devices, providing only temporary symptomatic relief.

PharmaCyte’s CEO believes that validating Cell-in-a-Box will open many doors to the future of cellular therapies for his company. "What PharmaCyte is involved with can lead to a game-changing approach to treating numerous degenerative diseases. By encapsulating certain types of stem cells and protecting them, the body is given a chance to heal itself. This type of therapy is the future of medicine—medicine that offers the realistic promise of repairing damaged tissue and reversing the effects of many degenerative conditions, offering solutions for people with diseases that today are beyond repair."

It’s clear that cellular therapies could offer PharmaCyte a real opportunity to: (i) expand its own pipeline; (ii) partner with other biotechnology and pharmaceutical companies on the development of cellular treatments; and/or (iii) entertain suitors for specific indications, who have an eye on developing their own treatment(s)—all contingent upon Cell-in-a-Box performing as well as it has in the past and validating itself once and for all on the world’s biggest stage, an FDA clinical trial.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: View Source