On January 12, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ: INCY) reported that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody (Press release, MorphoSys, JAN 12, 2021, View Source [SID1234573909]). 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 (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).

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"With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist."

"This important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys.

The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL.

Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter2, leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

About L-MIND
The L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study’s primary endpoint is Overall 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.

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 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 (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 relapsed or refractory 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 a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

XmAb(R) is a registered trademark of Xencor, Inc.

The safety and efficacy of tafasitamab is under review and the market authorization in Canada has not yet been obtained.

On January 12, 2021 Primmune Therapeutics reported the close of its Series A financing round with the addition of $4.0 million from Bioqube Ventures, a European life sciences venture capital firm (Press release, Primmune Therapeutics, JAN 12, 2021, View Source [SID1234573908]). This brings the total of the Series A financing raise to $31.4 million. These funds will be used to support the development of PRTX007, a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist as a therapeutic-adjuvant for acute viral diseases and cancer.

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Concurrently, Debbie Dumont, Co-founder and Managing Partner at Bioqube Ventures has joined Primmune’s Board of Directors as an observer. Elina Zuniga, Ph.D., Professor of Molecular Biology at the University of California, San Diego has joined the company’s scientific advisory board.

"We are excited to have Bioqube Ventures join our investor syndicate because of their expertise and experience in establishing European operations. Bioqube Ventures will facilitate the establishment of our Belgium subsidiary to complement our Australian presence and enable us to effectively partner and run clinical studies in the European Union as well as in the United States and Australia," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "Dr. Elina Zuniga will be important in guiding our TLR7 agonist strategy as part of our scientific advisory board given her deep knowledge regarding the interplay between toll-like receptor signaling, endogenous poly-interferon antiviral responses, and host innate immune modulation."

On January 12, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported in Cancer Prevention Research, a Journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), that expands on foundational clinical study findings to include a key younger population (Press release, Exact Sciences, JAN 12, 2021, View Source [SID1234573907]). Study results show that among average-risk adults between the ages of 45 and 49 Cologuard (mt-sD­­­­NA) demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions or negative findings at colonoscopy and 96.3% in only those with negative colonoscopy findings. These analyses support potential risk mitigation and cost prevention due to unnecessary diagnostic procedures when using Cologuard as a colorectal cancer screening tool in this younger population. ­­­­­

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

Study is among the first to evaluate the use of a colorectal cancer screening method in patients between ages of 45-49.
Cologuard is a U.S. Food & Drug Administration (FDA)-approved, non-invasive stool DNA test for colorectal cancer for average-risk people. In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

"These new data support the critical role an effective, non-invasive option like Cologuard plays in screening people ages 45 to 49," said Kevin Conroy, chairman and CEO of Exact Sciences. "Cologuard may appeal to this younger screening population because they can collect sample at home, without missing work or undergoing bowel prep and anesthesia, and only those patients with a positive Cologuard will require a diagnostic colonoscopy."

In a previously published, large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers, including 94% in stages I and II. Specificity for this over 50 population was 87%.

Colorectal cancer is the second leading cause of cancer death for men and women in the United States, in part because many cancers go undetected until later stages when treatment is less effective. Colorectal cancer can be prevented or detected early through screening; however, approximately 44 million Americans remain unscreened, including an estimated 19 million between ages 45 and 49.

The incidence of colorectal cancer in people under the age of 50 has dramatically increased in the last 20 years. Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50. More than half of these cases were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low.

"This study is among the first to evaluate the use of a colorectal cancer screening method in patients between the ages of 45 and 49," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "The American Cancer Society guidelines and the 2020 draft United States Preventive Services Task Force (USPSTF) guidelines now say that screening should begin at 45, and these data support the use of Cologuard as a first line screening option."

The prospective study included 816 evaluable participants who all completed a Cologuard test and underwent a colonoscopy. Participants were enrolled at 31 sites in the United States from November 2018 through June 2019. They completed Cologuard, followed by a screening colonoscopy within approximately 60 days of enrollment. Participants collected their sample for the Cologuard test prior to doing any bowel preparation necessary for the colonoscopy. All colonoscopies were performed blinded to the Cologuard results.

Specificity was the primary outcome and was measured in participants without colorectal cancer or advanced precancerous lesions and in the subgroup of participants with negative colonoscopic findings. None of the study participants had colorectal cancer, 49 had advanced precancerous lesions, 253 had non-advanced adenomas and 514 had negative colonoscopies. Specificity did not differ between men and women.

On January 12, 2021 GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported preliminary, unaudited net product sales for the fourth quarter and full year 2020 and key priorities for 2021 (Press release, GW Pharmaceuticals, JAN 12, 2021, View Source [SID1234573906]). Justin Gover, GW’s Chief Executive Officer, expects to discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 12th at 10:00 a.m. ET.

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"Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients’ experience on this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved Tuberous Sclerosis Complex indication, leads us to expect continued strong growth in 2021 in both the US and Europe," said Justin Gover, GW’s Chief Executive Officer. "Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year. In addition to our previously announced pipeline activities, we are leveraging our world leadership in cannabinoid science to design and synthesize novel cannabinoid molecules and expect our first novel product candidate to enter the clinic in 2021."

Preliminary Unaudited Fourth Quarter and Full-Year 2020 Net Product Sales

Based on preliminary unaudited financial information, the Company expects total net product sales to be approximately $148 million for the fourth quarter and approximately $526 million for the year ended December 31, 2020. Total net product sales of Epidiolex are expected to be approximately $144 million for the fourth quarter, comprising $129 million in the US and $15 million ex-US. Total net product sales of Epidiolex for the year ended December 31, 2020 are expected to be approximately $510 million compared to $296 million in 2019. Cash and cash equivalents at December 31, 2020 were approximately $486 million.

Key Priorities for 2021

EPIDIOLEX commercialization:

Continue to drive revenue growth in US and Europe:
• Execute on TSC label expansion and continued penetration in Dravet and LGS
• Build further on expanded payer coverage achievements
• Accelerate adoption across a broader prescriber base
• Increase penetration in long-term care segment
• Continue launches in Germany and UK and achieve successful pricing and reimbursement, and launch execution in France, Spain and Italy, as well as other European countries
• Obtain approval of the Tuberous Sclerosis Complex indication in Europe
Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex "composition" patent
Commence pivotal trial in fourth target orphan epilepsy indication
Nabiximols in the US:

Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
Achieve data from at least one pivotal MS spasticity trial in 2021
NDA submission expected following first positive pivotal MS spasticity trial
Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury
Additional pipeline:

Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
Conduct placebo-controlled trials with both CBDV and CBD in autism
Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
Complete Phase 1 trial for novel botanical drug candidate GW541
Advance first novel NCE cannabinoid candidate into Phase 1

On January 12, 2021 Enveric Biosciences Inc. (NASDAQ: ENVB), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 2,221,358 shares of Enveric’s common stock and common stock equivalents, at a purchase price of $4.5018 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Enveric Biosciences, JAN 12, 2021, View Source [SID1234573905]). Enveric has also agreed to issue to the investors unregistered warrants to acquire 1,666,019 shares of Common Stock at $4.9519 per share, exercisable immediately and terminating five years after the date of issuance. The closing of the offering is expected to occur on or about January 14th, 2021, subject to the satisfaction of customary closing conditions.

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The gross proceeds to Enveric from this offering are expected to be approximately $10 million, before deducting advisory and other offering expenses. Enveric intends to use the net proceeds from this offering for working capital and general corporate purposes.

Palladium Capital Group, LLC acted as a financial advisor to the issuer.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Enveric pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233260) previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2019, and declared effective by the SEC on November 19, 2019. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Enveric has agreed to register the shares of common stock issuable upon exercise of the warrants for resale pursuant to a customary registration rights agreement.

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