Q BioMed to Present at 2019 BIO CEO & Investor Conference

On February 1, 2019 Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, reported the Company’s CEO Denis Corin will deliver a corporate presentation and conduct one-on-one meetings with investors and potential business partners at the BIO CEO & Investor Conference on February 11th -12th, 2019 in New York City (Press release, Q BioMed, FEB 1, 2019, View Source;investor-conference-300788230.html [SID1234533016]). The BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies.

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Mr. Corin is scheduled to present at 3:00 PM on Monday, February 11th in the Chelsea room of the New York Marriott Marquis.

He will provide an update on the Company’s robust clinical pipeline including its FDA approved non-opioid drug Metastron, which relieves the severe pain associated with cancer that has metastasized to the bones. Metastron is expected to begin generating revenues for the Company in 2019.

TCR2 Therapeutics Launches Proposed Initial Public Offering

On February 1, 2019 TCR2 Therapeutics Inc., a clinical-stage immunotherapy company developing the next generation of novel T cell receptor therapies for patients suffering from cancer, reported that it has launched an underwritten initial public offering of 5,000,000 shares of its common stock at an initial public offering price expected to be between $14.00 and $16.00 per share (Press release, TCR2 Therapeutics, FEB 1, 2019, View Source [SID1234533015]). TCR2 also intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock. All of the shares to be sold in the proposed offering will be offered by TCR2. TCR2 has applied to list the shares on the Nasdaq Global Market under the symbol "TCRR".

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Jefferies, SVB Leerink and BMO Capital Markets are acting as joint book running managers for the offering. Wedbush PacGrow and China Renaissance are acting as co-managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The proposed offering will be made only by means of a prospectus. When available, a copy of the prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by e-mail at [email protected], or by phone at (800) 808-7525, ext. 6132; or BMO Capital Markets Corp., Attn: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, tel: (800) 414-3627, email:[email protected]

Important Information
A registration statement, including a prospectus, relating to these securities and describing the terms of the proposed offering has been filed with the U.S. Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The registration statement may be obtained free of charge at the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.

Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

On February 1, 2019 Pfizer reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations (Press release, Pfizer, FEB 1, 2019, View Source [SID1234533014]). The CHMP’s opinion will now be reviewed by the European Commission (EC).

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Vizimpro was approved by the U.S. Food and Drug Administration (FDA) in 2018 for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. It was also recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.

"Patients with EGFR-mutated non-small cell lung cancer, a disease that is associated with low overall survival rates, are in need of more treatment options. This positive CHMP opinion is an important step toward bringing this treatment to patients in Europe as a potential new first-line treatment option," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Vizimpro’s development is a direct result of Pfizer’s focus on precision drug development to create tailored options that improve patient outcomes."

The Marketing Authorization Application (MAA) for Vizimpro was based on results from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with locally advanced unresectable, or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225).

About Vizimpro (dacomitinib)

Vizimpro is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Vizimpro is approved in the U.S. for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Vizimpro is also approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC. The applications in the US and Japan were reviewed and approved under the Priority Review program.

In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under the terms of this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize Vizimpro globally.

About ARCHER 1050

The efficacy of Vizimpro was demonstrated in ARCHER 1050, a global Phase 3 head-to-head trial conducted in patients with locally advanced unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225). Randomization was stratified by region and EGFR mutation status. The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review. Key secondary endpoints included objective response rate (ORR), duration of response (DoR), overall survival (OS), and patient-reported outcomes (PROs).

VIZIMPRO (dacomitinib) IMPORTANT SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

There are no contraindications for VIZIMPRO.

Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed.

Diarrhea: Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.

Dermatologic Adverse Reactions: Rash and exfoliative skin reactions occurred in patients treated with VIZIMPRO. Rash occurred in 78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold VIZIMPRO for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of VIZIMPRO, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.

Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VIZIMPRO and for at least 17 days after the final dose.

Adverse Reactions: The most common (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).

Drug Interactions: Concomitant use with a proton pump inhibitor (PPI) decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist. Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

Lactation: Because of the potential for serious adverse reactions in breastfed infants from VIZIMPRO, advise women not to breastfeed during treatment with VIZIMPRO and for at least 17 days after the last dose.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. The recommended dose of VIZIMPRO has not been established for patients with severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment. The recommended dose of VIZIMPRO has not been established for patients with severe renal impairment.

Please see full prescribing information at www.VIZIMPRO.com.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer worldwide, with more than two million new cases diagnosed globally in 2018.1 About 85 percent of all lung cancers are identified as non-small cell, and approximately 75 percent of these are metastatic, or advanced, at diagnosis.2

EGFR is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive resulting in cancer cells to form. EGFR mutations may occur in 10 to 35 percent of NSCLC tumors globally, and most common activating mutations are deletions in exon 19 and exon 21 L858R substitution, which together account for more than 80 percent of known activating EGFR mutations. The disease is associated with low survival rates and disease progression remains a challenge.1,2

OncoSec Provides KEYNOTE-695 Clinical Update And Outlines 2019 Milestones

On February 1, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it provided a clinical data update regarding KEYNOTE-695, as well as progress of its ongoing clinical development efforts and its outlook for 2019 (Press release, OncoSec Medical, FEB 1, 2019, View Source [SID1234533013]).

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KEYNOTE-695 (TAVO + KEYTRUDA (pembrolizumab) for metastatic/recurrent melanoma)

With one fifth of patients in the study now evaluated, the observed preliminary response rate is approximately 24% (5/21) with enrollment ongoing
The observed preliminary ORR of approximately 24% is encouraging given the primary endpoint of KEYNOTE-695 is a 20% ORR
As of December 15, 2018, 21 patients have been treated and evaluated for tumor response by RECIST v1.1
Five of these 21 patients have experienced objective tumor responses, of which four were partial responses and one was a complete response
Responses have been determined at approximately three months and subsequently confirmed at approximately six months by either the investigator or by blinded independent review at the first assessment timepoint
Currently, all five responding patients continue to be treated with KEYTRUDA; two patients are no longer being treated with TAVO due to regression of all TAVO accessible lesions
Durable responses have been observed, with all responding patients still on study from 6 to 10 months
Responding patients demonstrate regression of both distant internal (or visceral) lesions and lesions not treated with TAVO
All patients entered KEYNOTE-695 with late-stage, progressive metastatic melanoma and had large, bulky established tumors
All patients unequivocally failed prior treatment with either KEYTRUDA or OPDIVO according to their approved labels
33 patients have been enrolled in the study and approximately 100 patients are planned to be enrolled
Safety profile mirrors earlier TAVO studies; nearly exclusively Grade 1 or 2 adverse events; safety profile is a key strength
Enrollment is ongoing at sites in the U.S, Canada and Australia
Filing for E.U. Advanced Therapy Classification will occur later this year
Study enrollment completion is anticipated in 2019, with a potential filing for accelerated approval in the U.S. in 2020 and a potential application for conditional approval in Europe shortly thereafter
OMS-150 Cervical Cancer Study (TAVO and commercially available KEYTRUDA for recurrent/persistent cervical cancer)

Registration-enabled study of TAVO in recurrent/persistent cervical cancer to be conducted in collaboration with the Gynecologic Oncology Group (GOG), a world-renowned non-profit organization conducting clinical research for the prevention and treatment of all gynecologic cancers, including cervical cancer
Single-arm study of TAVO and KEYTRUDA by prescription, expected to enroll 80 or more patients, powered to detect a response meaningfully higher than seen with KEYTRUDA monotherapy of 14% ORR
Along with GOG, study preparations are underway with first site initiation and patient enrollment expected to begin in the U.S. in the first half of 2019, with potential expansion into other countries
Anticipated U.S. regulatory filing in 2021
With only two drugs approved in the past 30 years, there is a significant need for better treatment options for advanced cervical cancer
A press release announcing this collaboration can be found here
KEYNOTE-890 (TAVO + KEYTRUDA for triple negative breast cancer (TNBC))

Study enrolling as expected with eight of 25 patients currently enrolled in the study
Anticipated study enrollment completion in 2019
Plan to report preliminary data later this year
New Product Candidate

Based upon immunological findings made from previously treated TAVO patients, OncoSec’s research laboratory has designed a new, second product candidate targeting not only IL-12, but also other important, immunologically relevant targets
IND filing for this new product candidate expected in 2H 2019
Details regarding this new product candidate, including pre-clinical data, will be presented at a major medical meeting this year
Expanding TAVO to Interior Lesions with new Visceral Lesions Applicator (VLA)

Significant opportunities exist with OncoSec’s current technology, which allows physicians to treat accessible lesions up to a depth of 15 millimeters
TAVO’s mechanism of action is likely to be relevant in nearly all solid tumors
Considering the therapeutic benefit and associated market impact, expansion is planned beyond accessible lesions, with the development of a new applicator able to access internal, or visceral, lesions
OncoSec’s engineering and research groups have successfully miniaturized the new visceral applicator or VLA, achieving the requisite energy parameters and therapeutic effect in multiple tumor models
VLA can be used with both the current clinical generator and planned next generation generator, allowing for a minimally invasive, safe and effective delivery of local IL-12 and other important, immunologically relevant targets into visceral tumors
"2018 was a busy and productive year for OncoSec, and as we enter 2019, we are well-positioned to continue advancing our lead program, TAVO, towards registration in multiple tumor settings in the United States beginning as early as 2020," said Daniel O’Connor, OncoSec’s Chief Executive Officer. "Our focus in 2019 will be moving TAVO towards registration in our current indication of PD-1 refractory, late-stage melanoma, progressing our recently announced registration-enabled clinical study in cervical cancer, expanding our ability to target tumors affecting internal organs, advancing a new, second pipeline candidate for which we expect to file an IND in 2019, and completing KEYNOTE-890, our combination study with TAVO + KEYTRUDA in TNBC. We believe that executing on this plan will extend the long-term valuation of our company and, most importantly, bring meaningful new treatments to patients and clinicians who very much need them."

Anticipated 2019 Milestones

Receive Advanced Therapy Medicinal Product (ATMP) Classification in Europe by EMA’s committee for Advanced Therapies for melanoma in 1H 2019
Initiate European trial sites in KEYNOTE-695 this year
Complete enrollment in KEYNOTE-695 2H 2019
Dose first patient in OMS-150 cervical cancer study in 1H 2019
Provide preliminary data update for the KEYNOTE-890 TNBC study in 2H 2019
Present New Product Candidate at a major medical meeting this year
File IND for New Product Candidate in 2H 2019
Conference Call and Webcast Information
OncoSec will host a conference call and live audio webcast today at 9:00 a.m. ET. To access the live conference call, please dial (844) 562-3893 (domestic) or (409) 220-9946 (international) at least five minutes prior to the start time, and refer to conference ID 4067388.

An accompanying presentation will be referenced during the conference call and can be accessed under "Events and Presentations" in the Investors section of OncoSec’s website at ir.oncosec.com. A replay will be available shortly after the conference call and can be accessed for 30 days following the call.

Iovance Biotherapeutics to Present at Upcoming Investor and Medical Conferences

On February 1, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will participate and present at the following upcoming conferences (Press release, Iovance Biotherapeutics, FEB 1, 2019, View Source;p=irol-newsArticle&ID=2385716 [SID1234533012]):

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5th Annual Immuno-Oncology 360° conference in New York, February 6-8, 2019
Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Session: Next Generation Cell Therapy Plenary
Title: Advancing the Development of Tumor Infiltrating Lymphocytes for Solid Tumors
Location: Crowne Plaza Times Square
Date/Time: February 8 at 11:10 a.m. EST

Guggenheim Healthcare Talks Idea Forum Oncology Day in New York on February 14, 2019
Date/Time: Thursday, February 14, 2019 at 3:00 p.m. EST
Location: The St. Regis New York Hotel
Webcast: A live and archived audio webcast of the presentation will be available in the Investors section at www.iovance.com.

ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco, February 28-March 2, 2019
Presenter: Amod Sarnaik, M.D. – H. Lee Moffitt Cancer Center
Poster Presentation Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients previously treated with at least one prior systemic therapy
Abstract Number: 136
Date/Time: The poster will be presented on Friday, March 1, 2019 from 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST (Poster Session B, Board F1)
Location: San Francisco Marriott Marquis