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Kaleido Biosciences Announces Pricing of Public Offering of Common Stock

On February 3, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported the pricing of an underwritten public offering of 5,250,000 shares of its common stock at a public offering price of $11.50 per share (Press release, Kaleido Biosciences, FEB 3, 2021, View Source [SID1234574594]). In addition, Kaleido has granted the underwriters a 30-day option to purchase up to an additional 787,500 shares of its common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Kaleido from this offering are expected to be approximately $60.4 million, before deducting underwriting discounts and commissions and other estimated offering expenses and excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares are being offered by Kaleido. The offering is expected to close on February 8, 2021, subject to customary closing conditions.

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Morgan Stanley and Piper Sandler are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager for the offering.

Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund its continued research and development activities, including the completion of the ongoing clinical studies of KB109 in patients with mild-to-moderate COVID-19 and the ongoing clinical study of KB295 in patients with mild-to-moderate ulcerative colitis; to conduct additional studies or initiate preparation for commercialization of KB109 if current studies in patients with mild-to-moderate COVID-19 are successful; to generate additional data and/or begin clinical studies in other areas such as immuno-oncology, cardiometabolic and liver diseases and diseases associated with pathogens; to fund any other research and development activities that relate to its current and future clinical and preclinical activities; and the remainder for planned general and administrative expenses, working capital and other general corporate purposes.

The securities described above were offered by Kaleido pursuant to a shelf registration statement on Form S-3 (No. 333-240323) that was declared effective by the Securities and Exchange Commission (SEC) on August 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

This press release does 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 that state or jurisdiction.

PDS Biotech Announces Preliminary Efficacy Achievement in Phase 2 Combination Trial of PDS0101 Led by the National Cancer Institute

On February 3, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response (Press release, PDS Biotechnology, FEB 3, 2021, View Source [SID1234574593]). The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients. As a result of achieving this milestone, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial. The trial is evaluating the treatment combination in two patient groups: one in patients who failed prior treatment, but are naïve to checkpoint inhibitor treatment; and the second in patients who have failed treatment with checkpoint inhibitors. As prespecified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 or iRECIST among at least three of the first eight patients allows the trial to progress to full enrollment.

Pooled data from phase 1 and 2 trials reported in the October 2020 issue of the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (J ImmunoTher Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a first-in-class bifunctional fusion protein composed of the extracellular domain of human TGF-β (TGF-β "trap") fused to an IgG1 antibody blocking PD-L1 (anti–PD-L1) protein, demonstrated efficacy in checkpoint inhibitor-naïve patients with HPV-associated malignancies. The observed response rate was 30.5%. M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells. In preclinical studies performed at the NCI comparing each drug alone versus all three agents used in combination, the triple combination achieved the highest induction of tumor-specific CD8+ killer T-cells and superior antitumor effect (J ImmunoTher Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612).

"The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers."

The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Executive Officer and Chief Medical Officer respectively, are serving as PDS Biotech’s investigators.

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-CANCER (1-800-422-6237), email [email protected], or visit the website: View Source

OPKO Health to Report Fourth Quarter 2020 Financial Results on February 18, 2021

On February 3, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021 (Press release, Opko Health, FEB 3, 2021, View Source [SID1234574592]). OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.

Hansa Biopharma year-end report Jan-Dec 2020

On February 3, 2021 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and year-end report for January – December, 2020 (Press release, Hansa Biopharma, FEB 3, 2021, View Source [SID1234574591]).

Highlights for the fourth quarter 2020

Commercial launch activities in early launch countries within the European Union are underway as planned. During Q4’20, initial pharmacy level pricing for Idefirix was published in the first markets. National level reimbursement application processes have been initiated, and decisions by authorities in the first of the early launch countries are expected from mid-year onwards. Depending on the impact of the COVID-19 pandemic, access to special and local budgets for individual patients could be achieved by certain centers prior to the granting of national level reimbursement.
US trial: Discussions with the FDA about the study protocol are ongoing. Assuming agreement is reached in the coming months, Hansa will proceed to set up centers in the US. Depending on the impact of the COVID-19 pandemic in the US, enrollment is expected to complete in 2022, as previously guided, with a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.
Patient recruitment in the phase 2 studies in AMR and GBS was reinitiated in December 2020, as previously guided. The recruitment process in both studies had been temporarily paused due to the COVID-19 pandemic. In the AMR trial, 5 patients out of a target of 30 patients have been enrolled, and in the GBS trial 5 patients out of a similar target of 30 patients have been enrolled.
Following the publication of positive high-level data in the anti-GBM phase 2 trial at the end of September 2020, discussions with EMA/FDA will now be initiated to determine the regulatory path forward for this indication.
On October 29, 2020 Hansa Biopharma hosted its third Capital Markets Day. The three hour virtual CMD event was attended by more than 500 live viewers. A recorded version is available on the Company’s web.
Investments in SG&A and R&D increased in the fourth quarter to SEK 63.2m (Q4’19: SEK 53.4m) and SEK 50.4m (Q4’19: SEK 57.7m), respectively. Cash position was SEK 1,378m at the end of December 2020. Cash flow from operating activities for the fourth quarter ended at SEK -96.5m (Q4’19: SEK -75.0m).
COVID-19 Pandemic: The global COVID-19 pandemic may still adversely impact Hansa Biopharma’s operational business and trial activities.
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"Hansa Biopharma enters the new year well positioned to execute successfully on our key priorities and objectives for 2021, which are to ensure the successful launch of Idefirix (imlifidase) in leading transplantation centers in select European markets, initiate a randomized, controlled clinical study in the US to support a future filing of a BLA for imlifidase in highly sensitized patients waiting for a kidney transplant, and continue the strong current momentum behind our efforts to advance our pipeline of drug candidates within autoimmune diseases and gene therapy.

2020 was overall a very successful and transformative year for Hansa Biopharma – a year which saw significant milestones achieved, including the conditional approval of Idefirix by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

We are also very excited about the progress of our efforts to advance a valuable pipeline of drug candidates in therapeutic areas beyond transplantation. In July, we announced the achievement of a landmark milestone with the agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy for Duchenne muscular dystrophy and Limb-girdle muscular dystrophy in patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The partnership is progressing as planned, and during the second half of 2020 Sarepta initiated ongoing pre-clinical investigations with imlifidase in the gene therapy setting.

We also announced positive high-level data from an investigator-initiated phase 2 trial with imlifidase in anti-GBM antibody disease, evaluating safety, tolerability and efficacy of imlifidase in 15 severe anti-GBM patients. We are very encouraged by the positive outcome, demonstrating that two-thirds of the anti-GBM patients achieved dialysis independence six months after treatment. The positive data marks another important milestone for the advancement of a valuable pipeline of drug candidates targeting indications beyond transplantation.

While 2020 has been a transformative year for Hansa Biopharma with a lot of progress, we have also seen the negative effects from the escalating COVID-19 pandemic impacting our operational business and trial activities during the year. The global COVID-19 pandemic may still adversely impact Hansa Biopharma’s operational business and trial activities in 2021, and the Company will continue to take appropriate measures to protect employees and take social responsibility during this global healthcare crisis while working to limit the potential negative effects on our business.

In relation to COVID-19, we have seen our pipeline activities materially impacted during 2020 by the pandemic. Recruitment of patients in the GBS and AMR studies was temporarily halted during a large part of the year. In December 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach. Depending on the development of the COVID-19 pandemic and its impact, we expect to finalize recruitment in both studies towards the end of this year.

In the US, we are currently in ongoing discussions with the U.S. Food and Drug Administration (FDA) about a proposed study protocol for a new, randomized controlled study of imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients. Assuming a near term approval of the final study protocol, and depending on the development of the COVID-19 pandemic in the United States and its impact on patient enrollment, the Company expects to complete enrollment of this study in 2022, enabling a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.

Hansa Biopharma’s evolution into a fully integrated, commercial stage biopharmaceutical company is becoming a reality now. An exciting year lies ahead of us with the commercial roll-out of the Company’s first approved drug, Idefirix, developed to help highly sensitized patients get off dialysis by enabling a lifesaving transplantation.

I look forward to updating you on progress in our efforts to deliver on our mission to bring lifesaving and life altering therapies to the patients with rare diseases who need them and generate value to society at large."

Upcoming milestones and news flow
Q1 2021 Kidney transplantation EU: Commercial launch
H1 2021 3-year data read-out long term follow-up study in kidney transplant patients
H1 2021 NiceR: initiate IND-enabling tox studies
H1 2021 Kidney transplantation US: First patient dosed / RCT
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
2022 Kidney transplantation US: Complete enrollment / RCT
2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT
2023 Kidney transplantation US: BLA submission

Conference call details
Hansa Biopharma will host a telephone conference today Thursday February 4 14:00 CET / 8:00am EST

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentations" and will also be made available online after the call.

Guardant360 CDx submitted for regulatory approval in Japan

On February 3, 2021 Guardant Health Japan, an affiliate of Guardant Health Asia, Middle East & Africa (AMEA) reported that it has submitted its application to the Ministry of Health, Labour and Welfare (MHLW) for regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP) in patients with advanced solid cancerous tumors (Press release, Guardant Health, FEB 3, 2021, View Source [SID1234574590]).

"I am delighted to announce that we have submitted the regulatory application for Guardant360 CDx liquid biopsy test for approval by MHLW. Several clinical studies1,2 have shown that compared to invasive tissue-based testing, Guardant360 has a quicker turnaround time for reporting comprehensive genomic test results. For the patient, this means a shorter waiting time to get the most appropriate treatment while avoiding safety risks related to tissue biopsies. We are excited to make this a possibility in clinical practice for cancer patients in Japan," said Simranjit Singh, Chief Executive Officer of Guardant Health AMEA & Representative Director of Guardant Health Japan.

Guardant360 CDx is a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from the blood samples of patients with advanced solid tumors and identifies genetic alterations that may inform treatment decisions. In addition to the submission of Guardant360 CDx for tumor mutation profiling, Guardant Health Japan has simultaneously filed for a Companion Diagnostic (CDx) approval. On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360CDx for comprehensive genomic profiling across all solid cancers and as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). This approval represented the first FDA-approved liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.

Guardant Health Japan aims to contribute to precision oncology in Japan by supporting research and development efforts and drive broad clinical adoption of Guardant Health’s products.