On December 11, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the closing of its upsized public offering of 6,900,000 shares of its common stock at a public offering price of $21.00 per share, which includes the exercise in full of the underwriters’ option to purchase 900,000 shares of common stock (Press release, Sutro Biopharma, DEC 11, 2020, View Source [SID1234572704]). The gross proceeds from this offering were $144.9 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro.

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Cowen, Piper Sandler and Wells Fargo Securities acted as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities acted as co-managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares were offered by Sutro pursuant to registration statements previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to this offering have been filed with the SEC. Copies of the final prospectus supplement may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, 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.

On December 11, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported efficacy and safety outcomes in a subgroup of patients from the NALA trial who had central nervous system (CNS) metastases at baseline, with a particular focus on CNS-specific endpoints, at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place (Press release, Puma Biotechnology, DEC 11, 2020, View Source [SID1234572700]). The presentation, entitled "Impact of neratinib plus capecitabine on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial," is being presented at a Spotlight Poster Discussion Session by Cristina Saura, M.D., Ph.D., Head of Breast Cancer Unit, Vall d’Hebrón University Hospital, an investigator of the trial. A copy of this poster presentation is available on the Puma website.

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The Phase III NALA trial was a randomized controlled trial of neratinib plus capecitabine (N+C) versus Tykerb (lapatinib) plus capecitabine (L+C) in patients with third-line HER2-positive metastatic breast cancer (NCT01808573). The trial enrolled 621 patients who were randomized (1:1) to receive either N+C or L+C. The co-primary endpoints of the trial were independently adjudicated progression free survival (PFS) and overall survival (OS). The NALA study met its primary endpoint, with the neratinib arm having significantly improved PFS vs. the lapatinib arm (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.93; stratified log-rank P = .0059; mean PFS 8.8 mo vs. 6.6 mo). The data showed no statistical difference in OS between treatment arms (HR 0.88; 95% CI, 0.72-1.07; P = .2098). Time to intervention for symptomatic central nervous system disease (also referred to as brain metastases) was a predefined secondary endpoint of the trial. In the ITT population, significantly fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8% vs. 29.2%; P = .043).

The poster presented at the 2020 SABCS meeting describes results for the subset of patients who entered the trial with CNS metastases. Of the 621 patients randomized to study treatment, 101 (16.3%) had asymptomatic CNS metastases at baseline (N+C, n=51; L+C, n=50). Within the CNS at baseline subgroup, the data suggested an association between N+C and improved PFS compared with L+C (HR 0.66; 95% CI, 0.41-1.05). The mean PFS was 7.8 months in the neratinb arm vs. 5.5 months in the laptinib arm. Consistent with results in the overall population, there was no apparent difference in OS between arms in the CNS at baseline group. With respect to the CNS-specific outcomes, N+C was associated with fewer interventions for CNS disease compared with L+C; the 12 month incidence of interventions for CNS metastases was 25.5% in the N+C arm and 36.0% in the L+C arm. The data also suggested an association between neratinib and improved CNS progression free survival (CNS-PFS), an ad hoc composite endpoint assessing disease progression in the brain or death from any cause (HR 0.62; 95% CI, 0.32-1.18). The median CNS-PFS was 12.4 months in the patients treated with N+C and 8.3 months in the patients treated with L+C.

As described in the poster, a unique feature of the NALA trial was the inclusion of patients with leptomeningeal disease (LMD), two of whom were treated with N+C with good outcomes (progression after 5.6 and 9.8 months, and OS times of 17.4 and 19.8 months, respectively). One patient with LMD received L+C and had disease progression after 4.3 months and an OS of 6.5 months.

The safety profile in patients with CNS metastases at baseline was consistent with that observed in the overall NALA safety population. Diarrhea, nausea, vomiting, and palmar-plantar erythrodysesthesia syndrome were the most common adverse events. Common CNS adverse events (grade 1-4) included headache (N+C, 18% vs L+C, 29%), dizziness (18% vs. 16%), hemiparesis (4% vs. 4%), seizure (4% vs. 4%), and gait disturbance (0% vs. 8%).

Cristina Saura, M.D., Ph.D., Head of Breast Cancer Unit, Vall d’Hebrón University Hospital, said, "The data suggest an association between neratinib and improved PFS and CNS outcomes in patients with CNS metastases from HER2-positive metastatic breast cancer. These findings are consistent with three other prospective studies."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "CNS metastases from HER2-positive breast cancer present a clinical challenge due to the limited availability of effective treatments. These findings from the NALA trial add to the growing body of data on the efficacy of neratinib in patients with HER2 positive metastatic breast cancer that has metastasized to the brain and may suggest a role for neratinib as a systemic treatment option in the management of patients with HER2-positive brain metastases following antibody-based HER2-directed therapies."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On December 11, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the closing of the offering of 1,000,000 shares of its common stock at a price of $14.65 per share, for total gross proceeds of $14.65 million, before deducting underwriting discounts and other offering expenses payable by the Company (Press release, Cel-Sci, DEC 11, 2020, View Source [SID1234572697]). Additionally, the Company has granted the underwriter a 30-day option to purchase up to 150,000 additional shares to cover over-allotments.

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Kingswood Capital Markets, division of Benchmark Investments, Inc. and Aegis Capital Corp. acted as the joint book-running managers for the offering.

This offering was made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC). A prospectus supplement and accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at View Source and may be obtained from Kingswood Capital Markets, Attention: Syndicate Desk, 17 Battery Place, Suite 625, New York, NY 10004, by email at [email protected], or by telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On December 11, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that additional data from its groundbreaking MINDACT study will be highlighted in an oral presentation by Laura van ’t Veer, Ph.D., Co-founder and Chief Research Officer, at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 11, 2020, View Source [SID1234572696]). These data highlight the ability of MammaPrint, Agendia’s 70-gene breast cancer recurrence assay, to further stratify patients with clinically low risk breast cancer which could impact physician-patient discussions and treatment planning.

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MINDACT (​M​icroarray ​I​n ​N​ode-Negative and 1-3 node-positive ​D​isease may ​A​void Chemo​T​herapy), the Phase 3, prospective, randomized clinical trial supported by the European Organization for Research and Treatment of Cancer (EORTC), was designed to determine whether MammaPrint could be used to safely de-escalate patients with early stage breast cancer from chemotherapy without compromising their outcomes. Updated outcome and treatment data from the trial shared at SABCS 2020 build upon nearly 9-year follow-up results debuted at ASCO (Free ASCO Whitepaper) 2020 and confirm MINDACT as a positive de-escalation study.

Dr. van ’t Veer’s presentation showed that the combination of clinical low risk and MammaPrint Low Risk results indicate excellent 8-year prognosis – these patients showed a distant metastasis-free survival rate of 94.7% with no chemotherapy. Of note, amongst the clinically low risk study population, distant metastasis free survival at 8 years was 3.6% better in MammaPrint Low Risk patients as compared to those with a High Risk result.

"Collectively, these data produce a significant library of evidence that will allow for the precise treatment of breast cancer, including insights into a patient population considered low risk," said Dr. van ’t Veer. "Within this population, further stratification by genomic signature into MammaPrint Low or High Risk should be weighed for further treatment planning."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 11, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported that trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens (Press release, Daiichi Sankyo, DEC 11, 2020, View Source [SID1234572695]).

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In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive.1,2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.1

Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from the pivotal phase 2 DESTINY-Breast01 trial, which were published in The New England Journal of Medicine, and the results from the phase 1 trial published in The Lancet Oncology. In the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated clinically meaningful and durable activity in patients who had received two or more prior anti-HER2 therapies. The safety and tolerability profile of trastuzumab deruxtecan seen in DESTINY-Breast01 was consistent with that observed in the phase 1 trial.

An updated analysis from DESTINY-Breast01, reinforcing the durable efficacy and long-term safety and tolerability profile of trastuzumab deruxtecan, was presented earlier this week at the 2020 San Antonio Breast Cancer Symposium (SABCS).

"We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe."

"The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting," said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. "If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2 positive metastatic breast cancer."

The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

About HER2 Positive Breast Cancer

Approximately 520,000 cases of breast cancer are diagnosed in Europe annually, with an estimated one in five cases being HER2 positive.1,2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast, gastric and lung cancers. HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3

There remain significant unmet clinical needs for patients with HER2 positive metastatic breast cancer. The disease remains incurable with patients eventually progressing after currently available treatment options.4,5

About DESTINY-Breast01

DESTINY-Breast01 is a pivotal phase 2, single-arm, open-label, global, multicenter, two-part trial evaluating the safety and efficacy of trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The primary endpoint of the trial is objective response rate, as determined by independent central review. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival.

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.

Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2 based regimens based on the DESTINY-Breast01 trial.

Trastuzumab deruxtecan (6.4 mg/kg) is also approved in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy, based on the DESTINY-Gastric01 trial.

About the Trastuzumab Deruxtecan Clinical Development Program

A comprehensive development program is underway globally, with nine pivotal trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 targetable cancers, including breast, gastric, colorectal and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In October 2020, trastuzumab deruxtecan was granted Priority Review from the U.S. Food and Drug Administration (FDA) for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In May 2020, trastuzumab deruxtecan received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation for gastric cancer, including GEJ adenocarcinoma.

In July 2020, the EMA’s CHMP granted trastuzumab deruxtecan accelerated assessment for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

In May 2020, trastuzumab deruxtecan had also received a Breakthrough Therapy Designation (BTD) for the treatment of patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.

About the Collaboration Between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.