On July 6, 2020 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the MELANI-01 trial has been placed on clinical hold by the U.S. Food and Drug Administration (FDA) (Press release, Cellectis, JUL 6, 2020, View Source [SID1234561697]).

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This clinical hold which impacts one of the three Cellectis product candidates currently in clinical studies, was initiated following the submission of a safety report regarding one patient enrolled in the MELANI-01 study at dose level two (DL2), with relapsed and refractory multiple myeloma. This patient, who had been treated unsuccessfully, prior to enrollment with numerous lines of prior therapy, including autologous CAR T-cells, experienced a fatal treatment-emergent adverse event of cardiac arrest. Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected.

Of note, prior to the clinical hold being issued by the FDA, Cellectis had decided to expand enrollment at DL1, which may be the appropriate dose for further evaluation in the expansion portion of the trial and potentially the recommended Phase 2 dose based on an assessment of the preliminary clinical and translational data. The Company had begun executing updates to the clinical protocol to reflect this as well as to monitor and mitigate for additional potential risks given its novel mechanism of action.

"We share the FDA’s commitment to patient safety and are working collaboratively with the agency and the investigators to resolve this clinical hold," said Carrie Brownstein, MD, Chief Medical Officer, Cellectis. "The safety of patients enrolled in our clinical trials is our utmost priority and we at Cellectis remain committed to safely resuming the clinical development of UCART product candidate targeting CS1 for patients with multiple myeloma and unmet medical need."

Cellectis is working closely with the FDA to address the agency’s requests including changes to the MELANI-01 clinical protocol designed to enhance patient safety, and expect to submit requested information including an amended protocol in due course.

Patient enrollment is ongoing in our two other proprietary Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.

About MELANI-01

MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clinical study evaluating UCARTCS1A product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). UCARTCS1A is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on MM tumor cells.

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM’s pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,110 new cases of MM will be diagnosed, and 12,960 deaths are expected to occur in 2019 in the U.S. alone.

On July 6, 2020 Ascendis Pharma A/S (Nasdaq:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that it has commenced an underwritten public offering of $500,000,000 of American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis (Press release, Ascendis Pharma, JUL 6, 2020, View Source [SID1234561695]). All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 of ADSs at the public offering price, less the underwriting commissions. 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, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink are acting as joint book-running managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 30, 2018 and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected].

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

On July 6, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 1,705,500 of the Company’s American Depositary Shares (ADSs), at a purchase price of $2.00 per ADS, in a registered direct offering (Press release, Can-Fite BioPharma, JUL 6, 2020, View Source [SID1234561691]). Can-Fite has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 852,750 ADSs. Each ADS represents thirty (30) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offering is expected to close on or about July 8, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $2.50 per ADS and will be exercisable at any time upon issuance and will expire four and one-half years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future cash exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be approximately $3.4 million. Can-Fite intends to use the net proceeds for funding research and development and clinical trials, payment of a consulting fee, and for other working capital and general corporate purposes.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by Can-Fite pursuant to a "shelf" registration statement on Form F-3 (File No. 333-220644) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on September 26, 2017 and declared effective by the SEC on October 11, 2017. The offering of the ADSs is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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 ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs 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.

On July 6, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported that the confirmatory Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint of progression-free survival (PFS), as well as key secondary endpoints in brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease (Press release, Immunomedics, JUL 6, 2020, View Source [SID1234561690]).

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"The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC. Based on these data, sacituzumab govitecan has set a new benchmark in scientific and clinical innovation for patients with mTNBC by offering a novel alternative to the common drugs currently in clinical practice. Importantly, the ASCENT topline data also validate the manageable safety profile of sacituzumab govitecan, rendering it a good partner candidate for combination with other therapies, including immunotherapy," stated the study principal investigator, Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School.

In the ASCENT study, Trodelvy demonstrated a statistically significant improvement in the primary endpoint of PFS compared to chemotherapy, with a hazard ratio of 0.41 (95% confidence interval (CI), 0.32-0.52). The median PFS for patients treated with Trodelvy was 5.6 months (95% CI, 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001). Trodelvy also met key secondary endpoints of the study, including overall survival and objective response rate. The safety profile of Trodelvy observed in the ASCENT study remained consistent with the U.S. Food and Drug Administration (FDA)-approved label, with neutropenia and diarrhea as the most common Grade 3 or 4 adverse events and no new safety signals were observed. Full results will be presented at an upcoming medical conference.

"Given the poor prognosis associated with mTNBC, we are excited that Trodelvy demonstrated improved clinical outcomes for these patients," said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. "We are grateful to all the patients, their families and healthcare providers, as well as our colleagues at Immunomedics, who participated in the ASCENT study and overcame many obstacles, including the COVID-19 pandemic, to complete the collection and analyses of these important data. We look forward to presenting full results at an upcoming medical conference, as well as sharing them with the FDA in support of the full approval of Trodelvy in this difficult-to-treat cancer."

Trodelvy was recently approved by the FDA as a third-line treatment for adult patients with mTNBC under the agency’s Accelerated Approval Program based on the objective response rate and duration of response observed in a single-arm, multicenter Phase 2 study. The Phase 3 confirmatory ASCENT study was designed under an FDA Special Protocol Assessment (SPA) to validate the promising safety and efficacy activity of Trodelvy that supported its accelerated approval.

"It is gratifying to see the final confirmatory results of Trodelvy in a randomized study supporting the previously reported Phase 2 data that formed the basis of the accelerated approval of Trodelvy. These results provide important additional information for patients and their treating physicians to understand the definitive benefits they are deriving," commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "Importantly, the strong ASCENT data reinforce the promise of our unique ADC technology and embolden us to continue our work to change the treatment paradigm for patients with difficult-to-treat cancers."

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1

Conference Call

The Company will host a conference call and live audio webcast today at 8:00 a.m. Eastern Time to discuss the ASCENT data. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 8872919. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

About ASCENT

The international, open-label confirmatory Phase 3 study enrolled more than 500 patients with metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either Trodelvy or a physician’s choice of chemotherapy. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, time to onset of response, and other measures of safety and tolerability. More information about ASCENT is available at View Source

About TRODELVY

Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers. Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells. Immunomedics has an extensive development program for Trodelvy, including multiple ongoing studies in triple-negative breast cancer, metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents. Visit View Source for more information.

About triple-negative breast cancer (TNBC)

TNBC is an aggressive type of breast cancer, accounting for up to 20 percent of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American and Hispanic women. TNBC cells do not have estrogen or progesterone hormone receptors, or very much of the human epidermal growth factor receptor 2 – hence the term triple negative. This means that medicines that target these receptors are not typically effective in TNBC. There is currently no approved standard of care for people with previously-treated mTNBC.

On July 6, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that, based on currently available information, it estimates that both reported and organic revenue1 growth will be approximately 10% for the second quarter ended June 27, 2020 (Press release, Thermo Fisher Scientific, JUL 6, 2020, View Source [SID1234561689]).

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The better-than-expected organic revenue growth was primarily driven by strong global sales of PCR-based tests and other products and services supporting the COVID-19 response, which contributed more than $1.4 billion of revenue in the second quarter and reflects the scale of the company’s role in helping customers battle the pandemic.

Thermo Fisher will release its financial results for the second quarter on Wednesday, July 22, 2020, before the market opens, and will hold a conference call to discuss those results and provide a business update on the same day at 8:30 a.m. ET.

To listen, call (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 1239877. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, July 31, 2020.