On December 17, 2020 Allterum Therapeutics, Inc. reported that it completed its $1.8 million Series Seed offering to members of the FanninDirectSM investor group (Press release, Allterum, DEC 17, 2020, View Source [SID1234573011]). Allterum is developing a novel immunotherapy for treatment of IL7R-expressing cancers, including difficult to treat cases of pediatric acute lymphoblastic leukemia (ALL), a program which has received both Orphan Drug and Rare Pediatric Disease Designations from FDA. The company will use the proceeds for its pre-clinical antibody manufacturing and toxicology work and to continue to build the management team.

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Philip P. Breitfeld, MD, a pediatric oncologist and former Global Vice President, Therapeutic Centers of Excellence of IQVIA (the renamed Quintiles/IMS Health), has joined Allterum as Chief Medical Officer. Dr. Breitfeld has over thirty five years experience in clinical development, including at major pharmaceutical and biotechnology companies.

"Having been fortunate to be part of the care of many children and adolescents with ALL, it is a dream to be part of the Allterum team focused on bringing new therapeutic options to children with ALL," said Dr. Breitfeld.

Although a majority of pediatric patients with ALL are successfully treated with current chemotherapies, a subset of patients experience relapse. In particular, patients with recurring T-cell ALL have extremely limited therapeutic options; as a result, these patients frequently have a poor prognosis. Allterum’s immunotherapy, invented at the National Cancer Institute by Dr. Scott Durum and his colleagues, was designed to be effective in these patients. It is also expected to benefit a much larger group of patients with IL7-R-expressing cancers including additional patients with leukemias, as well as sub-populations of patients with solid tumors.

"We are delighted to welcome Dr. Breitfeld to the team," said Dr. Atul Varadhachary, Allterum President & CEO. "He will play a pivotal role in advancing our programs addressing unmet critical medical needs in both childhood leukemias and in solid tumors."

Allterum is partnering with the Therapeutics Advances in Childhood Leukemia & Lymphoma (TACL) consortium to design a Phase 1/2 clinical trial, with Dr. Eric Schafer (Baylor College of Medicine and Texas Children’s Hospital) and Dr. Susan Rheingold (Children’s Hospital of Philadelphia) as Chair and Vice-Chair, respectively, of the study. Allterum anticipates filing an Investigational New Drug (IND) application to the FDA in early 2021, leading to the launch of the clinical trial.

In addition to the initial sponsor funding by Fannin Partners and the Series Seed proceeds, Allterum has also received a $2.9 million Product Development grant from the Cancer Prevention Research Institute of Texas (CPRIT).

On December 17, 2020 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021, at 2:00 p.m. ET/11:00 a.m. PT (Press release, Alpine Immune Sciences, DEC 17, 2020, View Source [SID1234572971]).

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A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.

On December 17, 2020, Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM) (Press release, Blueprint Medicines, DEC 17, 2020, View Source [SID1234572990]). AYVAKIT is a potent and selective inhibitor of D816V mutant KIT, the primary driver of SM, and is being developed to treat advanced and non-advanced forms of the disease.

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Blueprint Medicines requested priority review for this application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the sNDA is complete and acceptable for filing. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia.

"Today’s submission is an important step toward our goal of bringing AYVAKIT to patients with advanced systemic mastocytosis, a debilitating and life-threatening rare disease," said Fouad Namouni, M.D., President, Research & Development. "Our application is based on an unprecedented clinical dataset in this disease, which showed that patients receiving AYVAKIT had high overall response and complete remission rates, with prolonged survival, and the treatment was generally well-tolerated. We look forward to working closely with the FDA during the review, as we seek to introduce the first precision therapy targeting the underlying cause of systemic mastocytosis."

About SM

SM is a rare disease driven by the KIT D816V mutation. Uncontrolled proliferation and activation of mast cells result in chronic, severe and often unpredictable symptoms for patients across the spectrum of SM. The vast majority of those affected have non-advanced (indolent or smoldering) SM, with debilitating symptoms that lead to a profound, negative impact on quality of life. A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia. In addition to mast cell activation symptoms, advanced SM is associated with organ damage due to mast cell infiltration and poor overall survival.

Debilitating symptoms, including anaphylaxis, maculopapular rash, pruritis, diarrhea, brain fog, fatigue and bone pain, often persist across all forms of SM despite treatment with a number of symptomatic therapies. Patients often live in fear of severe, unexpected symptoms, have limited ability to work or perform daily activities, or isolate themselves to protect against unpredictable triggers. Currently, there are no approved therapies for the treatment of SM that selectively inhibit D816V mutant KIT.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit www.AYVAKIT.com. This medicine is approved in Europe under the brand name AYVAKYT for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.

AYVAKIT/AYVAKYT is not approved for the treatment of any other indication, including SM, in the U.S. by the FDA or in Europe by the European Commission, or for any indication in any other jurisdiction by any other health authority.

Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and indolent SM.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of AYVAKIT in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for AYVAKIT in the rest of the world.

On December 17, 2020 Perrigo Company plc (NYSE; TASE: PRGO), reported that EVP and President of Consumer Self-Care Americas, Rich Sorota will present at the ICR Conference at 11:30 AM EST on Monday, January 11, 2021 (Press release, Perrigo Company, DEC 17, 2020, View Source [SID1234573012]).

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Perrigo President & CEO Murray S. Kessler and CFO, Ray Silcock, will present at the 39th Annual J.P. Morgan Global Healthcare Conference at 3:40 PM EST on Wednesday, January 13, 2021. Interested parties can access the presentation webcasts at View Source

On December 17, 2020 SCYNEXIS, Inc. (Nasdaq:SCYX) reported the pricing of its underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, DEC 17, 2020, View Source [SID1234572991]). The shares and warrants are being sold at a public offering price of $6.25 per share and accompanying warrants, and the pre-funded warrants are being sold at a public offering price of $6.249 per pre-funded warrant and accompanying warrants. The gross offering proceeds to SCYNEXIS from this offering are expected to be approximately $85.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants are being offered by SCYNEXIS.

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At closing, SCYNEXIS will issue 8,390,000 shares of its common stock and, pre-funded warrants to purchase 5,210,000 shares of common stock, and two series of warrants to purchase an aggregate of 13,600,000 additional shares of its common stock. The pre-funded warrants will be issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants will be issued separately. The Series 1 warrants to purchase up to 6,800,000 shares of common stock have a one-year term and an exercise price of $7.33 per share, and the Series 2 warrants to purchase up to 6,800,000 shares of common stock have a three-and-a-half-year term and an exercise price of $8.25 per share. The pre-funded warrants and the warrants in each series are exercisable immediately upon issuance. The warrants will be certified, and will be delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. are serving as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ: NHLD), are serving as co-lead managers for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC are serving as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on September 11, 2020, and was declared effective on October 1, 2020. The offering will be made only by means of a preliminary and final prospectus supplement and accompanying prospectus. When available, copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9658, or by email to [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; mail: [email protected]. The final terms of the offering will be disclosed in the final prospectus supplement to be filed with the SEC.

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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

In connection with the offering SCYNEXIS terminated its Controlled Equity OfferingSM Sales Agreements with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc.