On October 4, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that the Company will present novel biomarker data from the ongoing phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 in Washington D.C., and virtually (Press release, Candel Therapeutics, OCT 4, 2021, View Source [SID1234590752]).

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Poster details:

Title: Detection of viral antigen and immune activation after intra-tumor injection of CAN-3110 (ICP-34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma
Abstract Number: 395
Primary Author/Presenter: Francesca Barone, MD, PhD, Vice President, Head of Research, Candel Therapeutics, Inc.
Date/Time: November 12, 2021, 7:00 am – 8:30 pm ET

Full text of the abstract will be released on the SITC (Free SITC Whitepaper) website at 8:00 a.m. ET on Tuesday, November 9, 2021. Details from the presentation will be available on the Candel website at View Source

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

For more information on this clinical study, please visit View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the local release of tumor-specific neoantigens. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

On October 4, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present an oral presentation on its lead program, ST101, at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2021 (Press release, Sapience Therapeutics, OCT 4, 2021, View Source [SID1234590750]). The meeting is being held in a virtual format from October 7-10th, 2021.

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Oral presentation details are as follows:

Date/Time: Saturday, October 9, 2021, 4:00 pm-5:40 pm ET
Session: Plenary Session 6, New Drugs on the Horizon II
Abstract Number: #4993
Abstract/Presentation Title: ST101, a peptide targeting oncogenic transcription factor C/EBPβ: Initial safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) data from an ongoing phase 1 dose escalation study in patients with advanced metastatic solid tumors

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation for the treatment of glioma by the European Commission.

On October 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre reported an exclusive commercialization agreement for tabelecleucel (tab-cel) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers (Press release, Atara Biotherapeutics, OCT 4, 2021, View Source [SID1234590749]). Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America.

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Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre.

Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

"Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships," commented Pascal Touchon, President and CEO of Atara. "Our Companies’ complementary capabilities will expand access to tab-cel, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers."

Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.

"Tab-cel is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’" said Eric Ducournau, CEO of Pierre Fabre. "We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients."

PJT Partners served as the exclusive financial advisor to Atara.

Atara Conference Call
In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company’s website for 30 days.

About Tabelecleucel
Tabelecleucel (tab-cel) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

Tab-cel is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.

Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel has orphan drug designation in the U.S. and EU.

On October 4, 2021 Centessa Pharmaceuticals plc ("Centessa" or "Company") (Nasdaq: CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, reported that it has entered into a $300 million financing agreement with funds managed by Oberland Capital Management LLC ("Oberland Capital") (Press release, Centessa Pharmaceuticals, OCT 4, 2021, View Source [SID1234590748]).

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Oberland Capital will purchase up to $300 million of 6-year, interest-only, senior secured notes ("Notes") from the Company under the following terms:

•$75 million funded October 4, 2021 ("First Purchase Date")
•$125 million available to be funded in tranches of $75 million and $50 million within 24 months of First Purchase Date at the option of the Company
•$100 million available to fund M&A, in-licensing, or other strategic transactions, at the option of the Company and Oberland Capital
•The Notes are interest-only for the full 6-year term; principal on the Notes will be due
October 4, 2027, with certain contingent and capped payments due up to ten years from First Purchase Date
•Flexible structure with no financial covenants

This $300 million facility, combined with the Company’s existing cash balance as of June 30, 2021, provides access to over $900 million to advance the Company’s pipeline of clinical and pre-clinical programs and enable the Company to pursue strategic business development opportunities.

"Our ability to secure such a flexible, long-term financing arrangement with a 6-year, interest-only period is directly enabled by our broad portfolio of uncorrelated programs based on compelling biology. On the heels of our recent positive Phase 2 readout of SerpinPC and upcoming registrational trial for lixivaptan, this financing will allow us to further scale up our development activities and provide enhanced balance sheet flexibility for pipeline expansion," said Gregory Weinhoff, MD, MBA, Chief Financial Officer of Centessa.

"We are excited to be partnering with Centessa to help bring their portfolio of innovative product candidates to patients as quickly as possible," said Andrew Rubinstein, Managing Partner of Oberland Capital. "Our flexible financing structure is designed to allow the Centessa team to maintain maximum optionality as their pipeline matures, with two programs entering potential registrational studies next year and multiple INDs expected."

Additional details regarding the financing are available in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission today. The foregoing summary of certain terms of the financing agreement and related agreements is qualified in its entirety by reference to the full text of such agreements, which will be filed as exhibits to our next Form 10-Q.

On October 4, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that members of the management team will participate in analyst-led fireside chats at the following upcoming investor conferences (Press release, VBI Vaccines, OCT 4, 2021, View Source [SID1234590747]):

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Guggenheim 2nd Annual Vaccines & Infectious Disease Conference

Discussion to be held with Evan Wang – Equity Research Senior Associate

Date: Tuesday, October 5, 2021
Time: 10:30-10:55 AM ET
Webcast Link: View Source
H.C. Wainwright 2nd Annual Hepatitis B Virus (HBV) Conference

Discussion to be held with Patrick Trucchio – Managing Director, Senior Healthcare Analyst

Date: Wednesday, October 13, 2021
Time: 4-4:30 PM ET
Webcast Link: View Source
Live webcasts of the presentations will also be available on the Investors page of VBI’s website at: View Source A replay of each webcast will be archived on the Company’s website following the presentation.