On November 17, 2022 Bavarian Nordic A/S (OMX: BAVA) reportes the signing of a joint procurement agreement with HERA, the European Commission’s Health Emergency Preparedness and Response Authority for the supply of up to 2 million doses of the Company’s MVA-BN monkeypox vaccine during 2023 and 2024 (Press release, Bavarian Nordic, NOV 17, 2022, View Source [SID1234624212]).

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The joint procurement agreement allows EU Member States and additional countries in the European Economic Area (EEA) as well as Western Balkan countries to purchase Bavarian Nordic’s monkeypox vaccine. So far, 14 eligible countries have already confirmed their participation in the joint procurement, indicating an initial demand of a total of approximately 700,000 doses for delivery in 2023 under the framework contract.

Since June 2022, HERA has purchased more than 330,000 doses of the vaccine which are being distributed to EU Member States throughout 2022 in response to the current monkeypox outbreak. The likelihood of monkeypox spreading further in at-risk communities is still high and the new joint procurement agreement will ensure that countries remain prepared to tackle the outbreak beyond this year.

Paul Chaplin, President and CEO of Bavarian Nordic said: "We are pleased to strengthen our collaboration with the EU authorities and others on securing the continued preparedness against monkeypox across Europe. While more and more countries have started to recognize the need for building a stockpile for the longer term, most EU Member States continue to rely on the availability of the vaccine through HERA, and this joint procurement agreement will help to reinforce the response across the entire region."

About HERA
The European Health Emergency Preparedness and Response Authority (HERA) was established by the European Commission in September 2021 with the purpose to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.

About the monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX in Europe, JYNNEOS in the U.S. and IMVAMUNE in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. In addition to smallpox, the U.S. Food and Drug Administration, Health Canada and the European Commission have also approved the vaccine for use against monkeypox as the only vaccine having obtained this to-date.

Bavarian Nordic has ongoing supply contracts with USA and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with multiple governments and supranational organizations to ensure rapid access to the vaccine in more than 70 countries to-date and is working to expand its manufacturing capacity to fulfil the global demand in the medium- to long term.

On November 17, 2022 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company") a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies reported the financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Rakovina Therapeutics, NOV 17, 2022, View Source,September%2030%2C%202022%2C%20respectively. [SID1234624211]).

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Corporate Update

Rakovina Therapeutics has continued to communicate progress in the Company’s research and development programs through presentations at peer-reviewed scientific meetings and publications:

On October 31, 2022, the Company announced our presentation at the 34th Annual AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium;
On November 14, 2022, the Company announced the preprint publication of a manuscript entitled ‘A bi-functional PARP-HDAC inhibitor with activity in Ewing sarcoma’. The manuscript reports research results of our kt-3000 dual PARP-HDAC inhibitor drug candidate in HR-proficient Ewing sarcoma models.
"Our data support advancing lead compounds from our kt-3000 PARP-HDAC inhibitor series as a novel approach in the treatment of Ewing sarcoma," stated Prof. Mads Daugaard Rakovina Therapeutics’ president and chief scientific officer. "This concept will likely be relevant in the treatment of cancer indications beyond Ewing sarcoma and potentially offer an opportunity to overcome therapeutic resistance to PARP-inhibitor treatment."

Rakovina Therapeutics’ kt-3000 series is a novel class of bi-functional small-molecule drug candidates that has been designed to combine inhibition of both poly(ADP)-ribose polymerase (PARP) and histone deacetylase (HDAC) in a single molecule as a novel approach to providing meaningful clinical benefit to cancer patients.

Data presented demonstrate that the kt-3000 prototype lead compound performs 30-40 times better than the FDA-approved PARP inhibitor olaparib (Lynparza) and 5-10 times better than the FDA-approved HDAC-inhibitor vorinostat (Zolina) in Ewing sarcoma 3D spheroid models. In an Ewing sarcoma metastasis model, a kt-3000 drug candidate prevented metastatic cancer growth in the lungs of mice inoculated with an aggressive Ewing sarcoma cell line. The Company believes that these data provide proof-of-concept validation of kt-3000 drug candidates to address significant unmet needs in the treatment of Ewing sarcoma and other solid tumors.

Ewing sarcoma is a cancer that occurs primarily in the bone or soft tissues and is the second most common type of bone cancer affecting children and young adults. The development of new and improved treatments for Ewing sarcoma represents a significant unmet medical need. Approximately thirty percent of patients will experience recurrence within five years following treatment. The prognosis for patients with recurrent or progressive Ewing sarcoma is poor with average survival from the time of relapse of only 14 months.

A kt-3000 series drug candidate for the treatment of recurrent Ewing sarcoma may qualify for an FDA priority review voucher. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

If received, a priority review voucher could be used to accelerate the regulatory review of another Rakovina Therapeutics drug candidate or it could be sold to a third party. During 2022, multiple companies sold priority review vouchers at prices ranging from US$100 million to US$110 million.

"Based on our progress to date, we are confident that we may be in a position to file regulatory documentation to begin human clinical trials with a kt-3000 series drug candidate in the second half of 2023," stated Prof. Daugaard. "Because early-stage clinical trials in the cancer field are often ‘open label’, we will have the opportunity to report continued progress of our future clinical trials at peer-reviewed scientific meetings."

The Company also reported continued progress within its other research programs.

kt-2000 series drug candidates are being optimized to achieve PARP-1 selectivity and therapeutically relevant brain penetration. Recent research has suggested an improved safety profile for PARP-1 selective compounds vs. PARP-1/2 inhibitors.

Currently, the four FDA-approved PARPi are all PARP-1/2 inhibitors with limited brain penetration. Rakovina Therapeutics believes that a PARP-1 selective brain-penetrant drug candidate from our kt-2000 series will provide attractive opportunities to establish collaborations with leading pharmaceutical companies.
kt-4000 series drug candidates combine a targeted DNA-damaging functionality with potent PARP inhibition in a single molecule. Earlier this year, the Company presented data at the American Association of Cancer Research Annual Meeting demonstrating that treatment with kt-4000 series candidates leads to G2/M cell cycle arrest and cell death in HR-proficient cancer cells, normally resistant to PARP inhibitor treatment.
Summary Financial Results for the quarter ended September 30, 2022

The Company commenced operations on March 25, 2021, concurrent with the closing of the qualifying transaction with Vincero Capital Corp. and began trading on the Toronto Venture Exchange under the symbol RKV on April 1, 2021. At September 30, 2022, the Company had positive working capital of approximately $1.4 million.

For the three and nine months ended September 30, 2022, the Company reported a net loss of $715,880 and $2,143,808 respectively. Research and development expenses were $541,447 and $1,427,949 for the three and nine months ended September 30, 2022, respectively. General and administrative expenses were $185,903 and $736,671 for the three and nine months ended September 30, 2022, respectively. Total cash expenses related to research and development and general and administrative expenses for the three months ended September 30, 2022 were $529,462.

On November 17, 2022 Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad pipeline targeting cancer and infectious disease, reported that expanded data from the Company’s Phase 1 study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with advanced sarcoma (Press release, Agenus, NOV 17, 2022, View Source [SID1234624210]). The data demonstrate that the combination offers strong durability and superior efficacy compared to what has been reported in separate trials for standard of care and other investigational therapies in sarcoma, including in sarcoma subtypes historically unresponsive to immunotherapy. The results will be presented tomorrow in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in Vancouver, BC, Canada.

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"The superior efficacy and durable responses achieved with botensilimab and balstilimab in advanced sarcoma build on the unprecedented clinical responses we have observed with this combination in multiple cold, treatment-resistant cancers," said Steven O’Day, MD, Chief Medical Officer at Agenus. "We are advancing multiple randomized Phase 2 trials to evaluate the therapeutic potential of this agent across a range of solid tumors."

Study Design and Highlights:

A total of 13 evaluable patients with advanced sarcoma received either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg balstilimab every 2 weeks.

Patient Demographics:

Heavily pre-treated, with a median of 3 prior lines of therapy
31% had received prior immunotherapy
82% had a known tumor mutation burden of less than 10 mutations per megabase
Majority were PD-L1 negative by IHC
All of these biomarkers are associated with poor response to immunotherapy.

The botensilimab/balstilimab combination produced superior responses and strong durability relative to what has been reported in separate trials for standard of care and other combinations currently in development.

Objective responses:

46% overall response rate
Other PD-(L)1 + CTLA-4 combinations in a comparable patient population achieved only 12-16% response rates1,2
69% disease control rate (complete response + partial response + stable disease)
Durability:

67% objective responses ongoing at data cut-off
Median duration of response has not been reached
Survival:

12-month overall survival of 77%
Median overall survival has not been reached
Patient Sub-Populations:

Objective response rate of 56% and disease control rate of 78% in 9 patients with angiosarcoma, including 3 of 4 patients with visceral angiosarcoma
Other PD-(L)1 + CTLA-4 combinations achieved only 20-25% response rates in patients with angiosarcoma, with no reported responses in 7 patients with visceral angiosarcoma2,3
Responses observed in additional patients with sarcoma subtypes historically resistant to immunotherapy, including liposarcoma with leiomyosarcomatous differentiation
Tolerability:

Botensilimab was well tolerated; no grade 4 or 5 treatment-related adverse events in this cohort
Safety profile similar to what has been previously reported in the Phase 1 botensilimab program, with no new immune-mediated safety signals observed
"At present, available treatments for advanced soft tissue sarcoma patients only have modest activity, and response rates for other immunotherapy combinations for most types of sarcoma are well below 20 percent," said Breelyn Wilky, MD, Principal Investigator and Director of Sarcoma Medical Oncology at the University of Colorado School of Medicine. "The clinical responses demonstrated by botensilimab and balstilimab in this study are compelling and support plans for further development of this combination in sarcoma."

Presentation Details:

Abstract Number: 1294633

Abstract Title: Results from a Phase 1a/1b Study of Botensilimab (a Novel CTLA-4 Engager) Plus Balstilimab (Anti-PD-1 Antibody) for the Treatment of Patients with Advanced Sarcomas

Presenting Author: Breelyn A. Wilky, MD, Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research, University of Colorado Cancer Center

The data will be presented on November 18th at 4:15 PM PDT in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in Vancouver, BC, Canada. An archived version of the presentation will be available on the Agenus website at agenusbio.com.

On November 17, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported that it has commenced an underwritten public offering of $75 million of its common stock (Press release, RAPT Therapeutics, NOV 17, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-proposed-public-offering-common-0 [SID1234624207]). In addition, RAPT expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of its common stock on the same terms and conditions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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J.P. Morgan, Evercore ISI, Guggenheim Securities and Cantor are acting as joint book-running managers for the proposed offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (the "SEC"), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary 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. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, New York 10022, 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 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 jurisdiction.

On November 17, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, reported that members of the management team will participate in fireside chats at two upcoming investor conferences (Press release, PureTech Health, NOV 17, 2022, View Source [SID1234624206]). Webcasts of the presentations will be available at View Source

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Piper Sandler 34th Annual Healthcare Conference

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