On May 28, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab (Press release, MacroGenics, MAY 28, 2020, View Source [SID1234558601]). The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020.

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"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise," said Scott Koenig, M.D., President and CEO of MacroGenics. "We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."

MacroGenics is seeking approval of margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.

About HER2-Positive Breast Cancer

Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.

About Margetuximab

Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.

On May 28, 2020 orma Therapeutics, Inc. ("Forma"), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that two abstracts for the company’s investigational IDH1m inhibitor, olutasidenib, have been accepted as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program taking place May 29-31, 2020 (Press release, Forma Therapeutics, MAY 28, 2020, View Source [SID1234558600]).

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The abstracts, currently available on the ASCO (Free ASCO Whitepaper) website, are:

Abstract Number 2505
Oral Presentation: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant gliomas: Safety and efficacy as a single agent and in combination with azacitidine.
Date and Time: Available on ASCO (Free ASCO Whitepaper)’s website beginning May 29, 2020, at 8:00 a.m.
Oral Abstract Session: Central Nervous System Tumors
Presenter: Macarena de la Fuente, M.D., Sylvester Cancer Center, University of Miami

Abstract Number e16643
Online Publication: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant solid tumors: Safety and efficacy as a single agent.

Dr. de la Fuente will present findings regarding olutasidenib monotherapy in 26 patients (23 enhancing, three non-enhancing) with confirmed IDH1 gene-mutated advanced glioma, including data that indicate:

Olutasidenib, dosed twice daily at 150 mg, was well-tolerated in patients with mIDH1 glioma and no dose-limiting toxicities were observed with monotherapy;
As dosed, olutasidenib demonstrated clinically relevant concentrations in the cerebrospinal fluid, confirming the blood-brain barrier penetration observed in preclinical models;
Olutasidenib demonstrated a preliminary disease control rate of 50% in heavily pre-treated patients with predominantly enhancing, recurrent mIDH1 glioma, specifically:
One patient achieved a partial response, per investigator assessment by response assessment in neuro-oncology (RANO)
Four patients achieved tumor reduction greater than 50%, per a blinded independent central volumetric assessment (BICR)
Nine patients exhibited stable disease for more than four months
"These data indicate that olutasidenib is well-tolerated and may provide clinical benefit in patients with recurrent glioma, a patient population with very limited treatment options," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics.

Copies of the abstracts and the oral presentation will be available on Forma’s website here upon presentation at the meeting.

About Olutasidenib, or FT-2102

Olutasidenib is an oral, potent and small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. Forma is currently evaluating olutasidenib in a registrational Phase II trial for relapsed/refractory AML and in an exploratory Phase I trial for glioma.

IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.

On May 28, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it will host a conference call to review clinical updates and financial results for the three months ended March 31, 2020 on Monday, June 1, 2020 at 8:30 a.m. EDT (Press release, Can-Fite BioPharma, MAY 28, 2020, View Source [SID1234558599]). A press release reviewing the first quarter results and clinical updates will be issued prior to the call.

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Investors in the U.S. are invited to dial 877-423-9813. International investors may dial 201-689-8573. The conference ID is 13704594.

Investors may also participate via webcast: View Source

A replay of the webcast will be archived on Can-Fite’s website for a period of time.

On May 28, 2020 Achilles Therapeutics ("Achilles"), a clinical-stage oncology company developing personalised cell therapies targeting clonal neoantigens, a novel class of tumour target, reported that Iraj Ali, Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020, at 9:00 a.m. Eastern Time (Press release, Achilles Therapeutics, MAY 28, 2020, View Source [SID1234558595]).

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On May 27, 2020 Turning Point Therapeutics, Inc. (Nasdaq: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that the underwriters of its previously announced underwritten public offering of its common stock have exercised in full their option to purchase 812,500 additional shares of common stock at the public offering price of $60.00 per share (Press release, Turning Point Therapeutics, MAY 27, 2020, View Source [SID1234564372]). The initial sale of 5,416,667 shares of common stock was completed on May 21, 2020 and the sale of the additional 812,500 shares is expected to close on or about May 28, 2020, subject to satisfaction of customary closing conditions. The total gross proceeds to Turning Point from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Turning Point, are expected to be approximately $373.8 million.

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Goldman Sachs & Co. LLC, SVB Leerink and Guggenheim Securities are acting as joint bookrunning managers for the offering. Wedbush PacGrow is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the offering.

The shares of common stock described above are being offered by Turning Point pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (the "SEC") on May 15, 2020. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218 or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at 212-518-5548, 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 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.