On July 29, 2020 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported that it is commencing an underwritten public offering of $325,000,000 of common shares (Press release, CRISPR Therapeutics, JUL 29, 2020, View Source [SID1234561579]). In addition, the underwriters will have a 30-day option to purchase up to an additional $48,750,000 of common shares at the public offering price less the underwriting discount.

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Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running 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 or as to the actual size or terms of the offering.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a 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 laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

On July 28, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the body, reported it has advanced CUE-101 into cohort 5 in its ongoing multicenter, open-label, dose escalation Phase 1 monotherapy trial in patients with human papilloma virus-positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ HNSCC) (NCT03978689) (Press release, Cue Biopharma, JUL 28, 2020, View Source [SID1234608300]).

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Patients in cohort 5 will receive 2 mg/kg of CUE-101, which is two times the CUE-101 dose of 1 mg/kg in cohort 4. The first patient in cohort 5 received their dose and has been monitored for the initial protocol safety period of seven days with no evidence of adverse reactions. The next two patients in cohort 5 have been identified and have been scheduled to receive their first dose of CUE-101.

As previously noted in a press release dated June 15, 2020, three additional patients were enrolled in cohort 4 at the recommendation of the Safety Review Committee to further characterize immune activity and confirm safety after one of the first three patients in cohort 4 experienced a possible treatment-related dose limiting toxicity (DLT). That patient subsequently received the next planned dose of CUE-101 at the same 1.0 mg/kg dosage without an observed adverse event. As no serious (Grade 3 or higher) treatment-related adverse events were observed during a 21-day safety evaluation period for the three additional cohort 4 patients, Cue Biopharma received approval from the Safety Review Committee to initiate enrollment and treatment of patients in cohort 5.

"We are pleased to have enrolled three more patients in cohort 4 and to rapidly initiate cohort 5. Our progress is due, in large part, to the continued enthusiasm and support of our leading investigators during this challenging and uncertain time of COVID-19," said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "In parallel to evaluating CUE-101 at the cohort 5 dose level, we have identified additional patients to be enrolled in a further expansion of up to nine patients in cohort 4, as permitted per protocol. This allows us to further enhance our understanding of the pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of CUE-101 at what we believe could be a clinically active dose."

To date, sixteen patients have been dosed in the Phase 1 trial. Apart from a patient in cohort 4 with a possible treatment-related Grade 3 DLT as mentioned above, there have been no other DLTs. Importantly, the Grade 3 DLT and all other reported adverse events have resolved without further complications. To date, there have been no patient discontinuations from the trial due to adverse events.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

On July 28, 2020 Ivy Brain Tumor Center at Barrow Neurological Institute reported that the first patient has been dosed in an investigator-initiated Phase 0/2 clinical trial of infigratinib in recurrent high-grade glioma driven by FGFR genetic alterations (Press release, BridgeBio, JUL 28, 2020, View Source [SID1234576226]). Infigratinib is an investigational, orally administered, FGFR1-3 selective tyrosine kinase inhibitor being developed by BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate company QED Therapeutics, Inc.

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The investigator-initiated Phase 0/2 trial is designed to confirm drug effects within days of exposure, and only to continue dosing when the drug is active in a patient’s own tumor. The primary objective of the Phase 0 arm is to assess how effectively infigratinib can cross the blood-brain barrier – the most significant obstacle to developing new, effective therapies for aggressive brain tumors like glioblastoma. Patients with successful tumor penetration will receive infigratinib long-term in a Phase 2 expansion arm of the trial. The primary endpoint of the expansion phase is progression-free survival rate at six months. The study will also measure how well infigratinib is impacting its molecular target in each patient’s tumor.

FGFR (fibroblast growth factor receptor) genetic alterations have been shown to spur growth in malignant tumors. Five to seven percent of glioblastoma patients’ tumors are driven by FGFR signaling. During the trial screening process, the patient’s tumor tissue from prior surgery will be tested for the FGFR-TACC3 fusion gene or mutations in FGFR1 and FGFR3 genes. Patients with tumors that have these fusions or mutations are eligible for this study.

"In the preclinical studies, our pharmacokinetics program at the Ivy Brain Tumor Center tested seven FGFR inhibitors for their ability to cross the blood-brain barrier. Infigratinib was one of the most promising agents," said Shwetal Mehta, Ph.D., deputy director of the Ivy Brain Tumor Center.

"Infigratinib was previously tested in an uncontrolled Phase 2 study for recurrent high-grade gliomas," said Nader Sanai, M.D., director of the Ivy Brain Tumor Center. "The results were intriguing, but inconclusive. This Ivy Phase 0/2 trial seeks to provide direct biological evidence of drug effects in individual patients, allowing us to understand which glioblastoma patients may benefit from infigratinib."

"The launch of this investigator-initiated trial is an exciting step in the study of infigratinib for patients with recurrent, high-grade glioma," said Susan Moran, M.D., M.S.C.E., chief medical officer of QED Therapeutics. "We anticipate this study being conducted by the Ivy Center will generate valuable information on the ability of infigratinib to reach brain tumors, which is a critical first step in evaluating whether infigratinib, alone or in combination, could potentially provide a therapeutic option for patients with this dire disease."

On July 28, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported that it will hold a conference call on Thurs., August 6, 2020 at 4:30 p.m. ET to discuss its financial results for the second quarter ended Jun. 30, 2020 (Press release, ChromaDex, JUL 28, 2020, View Source [SID1234568249]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss the second quarter results and provide a general business update on Thurs., August 6, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available after 7:30 p.m. ET.

On July 28, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that its second quarter 2020 financial results will be released on Thursday, August 6, 2020 before the U.S. financial markets open (Press release, AMAG Pharmaceuticals, JUL 28, 2020, View Source [SID1234565142]). Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

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Dial-in Number
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4548238

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4548238

A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020

The webcast with slides will be accessible through the Investors section of the company’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.