On April 27, 2022 Novartis reported positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression (Press release, Novartis, APR 27, 2022, View Source [SID1234613053]). Novartis intends to submit these data to regulatory authorities, and will collaborate with BeiGene to present them at an upcoming medical meeting.

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"People living with esophageal cancer experience painful everyday challenges and typically have a poor prognosis, with a five-year survival rate of around five percent for metastatic cases, underscoring the urgency for more immunotherapy options," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients."

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.2 In the United States, it is estimated there will be more than 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers.3

RATIONALE 306 (NCT03783442) is a multi-regional Phase III, randomized, placebo-controlled, double-blind study of tislelizumab in combination with chemotherapy versus chemotherapy alone in patients with unresectable, locally advanced recurrent or metastatic ESCC. Approximately 649 study participants were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy alone. The primary endpoint is OS. Secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety.

Tislelizumab is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.

About Tislelizumab
Novartis is evaluating tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 14 pivotal clinical trials across a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries. Novartis four distinct therapeutic platforms (immunotherapy, radioligand therapy, cell and gene therapy, targeted therapy) offer a unique opportunity to study tislelizumab in differentiated, potentially synergistic combinations across our pipeline and portfolio of market compounds.

Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene.

On April 27, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it will today present as an invited speaker at the Novel Format Conjugates Summit, an industry conference focusing on next generation Non-Traditional Antibody Drug Conjugates (ADCs) for oncology and beyond (Press release, Starpharma, APR 27, 2022, View Source;mc_eid=bf52dd3418 [SID1234613052]).

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There is an increasing interest in novel approaches to the development of ADCs. The conference, organised by World ADC, brings together international thought leaders to share cutting-edge scientific advances from the world of alternative format conjugates. The industry event is taking place in Boston on 25-27 April 2022 and involves speakers and attendees from international companies, including AstraZeneca, Merck, Lilly, Sanofi, Takeda, Regeneron, Debiopharm, Bicycle Therapeutics, and Avidity.

Starpharma will present the company’s DEP platform, with a particular focus on the use of DEP in ADCs and radiotheranostics. Starpharma’s presentation ‘Targeted DEP Drug Delivery’ includes:

Overview of dendrimer enhanced products (DEP), including Starpharma’s targeted DEP ADCs and DEP radiotheranostics programs
Benefits of DEP in ADCs, including achieving high drug antibody ratio, enhanced PK/Biodistribution and efficacy outcomes, flexibility in targeting moiety and payload
Benefits of DEP in radiotheranostics, including superior tumour targeting and better efficacy outcomes, flexibility in targeting moiety and radioisotope of therapeutic or diagnostic applications
Starpharma will also be conducting partnering discussions with other pharmaceutical companies attending the conference.

An abridged copy of the presentation can be downloaded here: Novel Format Conjugate Summit 25-27 April 2022 (pdf file, 1975kb)

On April 27, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it will host an R&D call on Tuesday, May 03, 2022 at 9:00 AM Eastern Time (Press release, Panbela Therapeutics, APR 27, 2022, View Source [SID1234613050]). Panbela’s management team will be joined by leading experts for a deep dive on the company’s investigational drug, SBP-101, as a polyamine metabolism modulator in ovarian cancer.

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Replay Link: View Source

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On April 27, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing novel therapeutics that combine both targeted and immune-mediated mechanisms, reported a $15 million private investment in public equity (PIPE) financing from the sale of 3,149,912 shares of its common stock at a price per share of $2.36 and, in lieu of shares of common stock, pre-funded warrants to purchase up to 3,206,020 shares of its common stock at price per pre-funded warrant of $2.359 to EcoR1 Capital, LLC and Versant Venture Capital (Press release, Tempest Therapeutics, APR 27, 2022, View Source [SID1234613049]). Gross proceeds from the PIPE financings total approximately $15.0 million, before deducting offering expenses.

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"We are very pleased to have a top investor such as EcoR1 recognize the value in Tempest, and we strongly appreciate Versant’s continued support of the Company, which has been consistent since our inception," said Stephen R. Brady, chief executive officer of Tempest. "Given the current capital markets environment, we are also pleased with the equivalent value between the securities, and will continue to diligently execute towards the development of meaningful therapies for patients."

The closing of the PIPE financing is subject to customary closing conditions and is expected to close by April 29, 2022.

The securities sold in this private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Tempest Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement and the shares of common stock underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On April 27, 2022 Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed "NightHawk Biosciences"), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported to shareholders that its Elusys Therapeutics subsidiary has finalized a contract with the Canadian government to deliver ANTHIM (obiltoxaximab for injection), a treatment for inhalation anthrax, for use against a potential anthrax attack (Press release, NightHawk Biosciences, APR 27, 2022, View Source [SID1234613048]).

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ANTHIM will be delivered to Canada’s National Emergency Strategic Stockpile under a procurement contract totaling CAD $7.9 millioni. The goal of this program is to establish a Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats.

Jeff Wolf, CEO of Nighthawk and its Elusys subsidiary, commented, "We are excited to announce this first international contract to supply ANTHIM to Canada, which is particularly timely given the growing global geopolitical uncertainty and emerging threats. This agreement follows our recent acquisition of Elusys, which complements our broader biodefense initiatives. We are focused on expanding sales of ANTHIM, abroad and this first international contract is an important validation of our strategy."

According to the United States Centers for Disease Control and Prevention (CDC), if a bioterrorist attack were to happen, bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used, since these spores are easily found in nature, can be produced in a lab, and may remain in the environment for a prolonged period. In recent Congressional testimony, Gerald Parker, Associate Dean of Texas A&M’s College of Veterinary Medicine & Biomedical Sciences, indicated that the top three bioterrorist threats were "anthrax, anthrax, and anthrax."

Elusys has previously established a successful track record collaborating with U.S. government agencies including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the Strategic National Stockpile (SNS) and the Department of Defense (DOD). To date, Elusys has been awarded over $400 million in research and development grants, contracts and procurement orders from BARDA and SNS through ongoing, multi-year partnerships with the U.S. government.

This latest award follows NightHawk’s recent announcement of its planned 500,000+ square foot biodefense-focused biologics biomanufacturing facility in Manhattan, Kansas, which is being designed to scale production of ANTHIM, among other uses.

About ANTHIM
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.