On October 28, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that data on patient-reported tolerability assessment of intraprostatic injections will be presented in a virtual poster session at the 28th Annual Prostate Cancer Foundation Scientific Retreat (Press release, Candel Therapeutics, OCT 28, 2021, View Source [SID1234592129]).

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Date: Thursday, October 28, 2021
Presenter: Laura K. Aguilar, MD, PhD, Chief Medical Officer at Candel Therapeutics, Inc.
Presentation Title: Patient experience with intraprostatic injection of CAN-2409 or placebo followed by valacyclovir in a phase 3 clinical trial for localized prostate cancer in combination with standard of care radiation therapy with or without androgen suppression.
The data were generated from the company’s ongoing phase 3 clinical trial, which is evaluating safety and efficacy of intra-prostatic injection with CAN-2409 or placebo followed by oral valacyclovir prodrug in combination with standard of care (radiation therapy ± short-term androgen deprivation therapy) in patients with localized prostate cancer having intermediate-risk or a single NCCN high-risk factor.

Clinical trial enrollment has been completed with a diverse population of 745 patients from 51 sites in the U.S. More than 2,000 injection procedures have been performed (40% transperineal, 56% transrectal, 4% not reported). Information on the patient experience is being collected with a questionnaire, and data is available from 32 patients who completed the questionnaire within 3 months of completing treatment. For the transperineal procedure, 65% of patients reported the intra-prostatic injections to be "the same or better" tolerated than a prostate biopsy, 30% "a little harder" to tolerate and 4% "much harder" to tolerate than a biopsy. For the transrectal procedure, 89% of patients reported the injections to be "the same or better" tolerated than a biopsy and 11% "a little harder" to tolerate than a biopsy. All patients (100%) reported overall feeling positive about their involvement in the study.

"These data further support the tolerability and patient receptiveness of intra-prostatic injection of CAN-2409 and its comparability to routine biopsies being performed in this patient population," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "Listening to patients is important as we look towards the commercialization of CAN-2409, if approved. We believe CAN-2409 holds great promise as a treatment for patients with localized, non-metastatic prostate cancer, which may improve disease outcome, while eliminating the need for long-term androgen deprivation therapy and its associated side effects."

Details from the presentations will be available on the Candel website at 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 release of tumor-specific neoantigens in the microenvironment. 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.

About the Phase 3 Clinical Trial in Prostate Cancer

The pivotal phase 3 study of CAN-2409 immunotherapy in patients with intermediate-high risk localized prostate cancer is a placebo-controlled, randomized clinical trial to evaluate CAN-2409 treatment in combination with valacyclovir added to standard of care (radiation therapy ± short-term androgen deprivation therapy). The primary endpoint of the study is disease-free survival. Secondary endpoints include prostate cancer specific survival, overall survival, freedom from biochemical failure, patient reported health-related quality of life, and safety.

On October 28, 2021 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics (EPBs), today provided a corporate update and reported financial results for the first half of 2021 (Press release, Ambrx, OCT 28, 2021, View Source [SID1234592145]).

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"I want to thank the entire Ambrx team for their efforts in making our June IPO such a success. I believe we have created a strong foundation on which to grow our company. Subsequently, we provided several clinical updates regarding our ARX788 program in gastric cancer and our ARX517 program in PSMA expressing tumors. For ARX788, the first patient was dosed in our co-sponsored ACE-Gastric-02 Phase 2/3 clinical study and updated positive data from our co-sponsored ACE-Gastric-01 study was presented at The Chinese Society of Clinical Oncology (CSCO) annual meeting. We were also able to dose the first patient in our Phase 1 trial of ARX517 in the United States," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "Additionally, during the period, Ambrx strengthened its leadership team with the formation of a Scientific Advisory Board, the appointment of Sonja Nelson as CFO, and the addition to our Board of Directors of Olivia Ware and Katrin Rupalla. I am proud of how far Ambrx has come and look forward to carrying forward the momentum we have built into the end of the year and beyond."

1H 2021 and Subsequent Highlights

Positive Data on ARX788 for the Treatment of HER2+ Gastric Cancer Presented at CSCO. In October, NovoCodex Pharmaceuticals Ltd., Ambrx’s partner in China, presented positive interim data from the ACE-Gastric-01 Phase 1 clinical study of ARX788 for the treatment of HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer at CSCO. The data presented added to and updated initial trial data presented by both companies at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2021.
Advanced the Development of ARX788 in Three Trials. Subsequent to the end of first half of the year, Ambrx dosed the first patient in a global Phase 2/3 clinical study of ARX788 (ACE-Gastric-02) in patients with HER2+ gastric/GEJ cancer, initiated a global Phase 2 basket clinical study of ARX788 (ACE-Pan tumor-02) for HER2-mutated or HER2-amplified/over-expressed solid tumors, and initiated a Phase 2 clinical study of ARX788 (ACE-Breast-03) in patients with HER2+ metastatic breast cancer.
First Patient Dosed in a Phase 1 Trial for ARX517. In August, Ambrx announced that the first patient had been dosed in a Phase 1, multicenter, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics, and anti-tumor activity of ARX517, an ADC being developed to treat subjects with prostate specific membrane antigen (PSMA) expressing tumors.
BMS Provided Update on FA Relaxin Program. In August, BMS provided notice that it closed the FA Relaxin Studies CV019-008 and CV019-010 based on internal considerations and not upon any observed safety concerns.
Completed Successful Initial Public Offering. In June, Ambrx successfully completed its initial public offering raising $126.0 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. Ambrx’s American Depository Shares (ADSs) began trading on the New York Stock Exchange under the symbol "AMAM" on June 18, 2021. In addition, in early July, the underwriters partially exercised their greenshoe option resulting in additional gross proceeds to Ambrx of approximately $16.1 million prior to deducting underwriting discounts, commissions and offering expenses.
Reorganization. During the second quarter of 2021, Ambrx completed a reorganization of its corporate structure. As a result, Ambrx Shanghai and Ambrx Hong Kong became wholly owned subsidiaries of Ambrx Biopharma Inc.
Formed a Scientific Advisory Board (SAB). In June, Ambrx announced the formation of a Scientific Advisory Board comprised of industry leaders in oncology and protein sciences. The board is chaired by Peter Schultz, Ph.D., President and CEO of Scripps Research and a professor of chemistry. The other founding members of the Ambrx SAB include: Stuart Lutzker, M.D., Ph.D., an industry veteran with decades of oncology drug development experience; Jakob Dupont, M.D., a renowned expert in oncology, immunology and cell therapy; Melissa Starovasnik, Ph.D., an accomplished scientific leader and 28-year Genentech veteran; Luisa Salter-Cid, Ph.D., M.Sc., the Chief Scientific Officer at Pioneering Medicines; and Feng Tian, Ph.D., the Chairman of the Board of Directors, President and CEO of Ambrx.
Appointed Sonja Nelson as CFO. In June, Sonja Nelson joined Ambrx as its Chief Financial Officer. Ms. Nelson is an experienced financial executive, who joined Ambrx with 10 years of executive experience within the biotechnology industry. Most recently, she served as Chief Financial Officer at NantKwest, now ImmunityBio.
Strengthened Board of Directors with Two New Appointments. In April, Ambrx appointed Olivia C. Ware, an accomplished biotech and pharmaceutical executive, and Katrin Rupalla, Ph.D., Senior Vice President of Regulatory Affairs, R&D Quality and Medical Information at Lundbeck, to its Board of Directors.
Anticipated Near-Term Milestones

Additional data from the Phase 1 clinical study of ARX788 (ACE-Breast-01) in patients with HER2+ metastatic breast cancer in 2H 2021.
Submit an Investigational New Drug (IND) application for ARX305 in patients with cancer (renal cell carcinoma (RCC) and other cancers) in 1H 2022.
Financial Highlights

Cash and Cash Equivalents: Cash and cash equivalents were $167.2 million as of June 30, 2021. In July, the underwriters partially exercised the greenshoe option resulting in net proceeds of $14.9 million to Ambrx.
Revenue: Revenue was $5.1 million for the six months ended June 30, 2021, as compared to $6.5 million for the six months ended June 30, 2020. The decrease was primarily driven by revenue recognized associated with upfront payments related to our R&D agreements, partially offset by increased 3rd party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $22.1 million for the six months ended June 30, 2021, as compared to $9.9 million for the six months ended June 30, 2020. The increase of $12.2 million was mainly due to increased costs related to new clinical trial programs and related manufacturing costs as well as personnel related costs including stock-based compensation expense.
General and administrative (G&A) expenses: G&A expenses were $8.4 million for the six months ended June 30, 2021, as compared to $2.6 million for the six months ended June 30, 2020. The increase of $5.8 million was mainly attributable to professional services and fees in connection with preparing for Ambrx’s IPO, expenses associated with the corporate structure reorganization, and personnel related costs including stock-based compensation expense.
Other expenses: Other expense, net, for the six months ended June 30, 2021 was $3.9 million, which is primarily due to a change in fair value of Ambrx’s redeemable noncontrolling interest liability in connection with the purchase of shares held by minority shareholders in Ambrx Shanghai which was part of Ambrx’s reorganization of its corporate structure, completed during the second quarter of 2021.
Net loss: Net loss for the six months ended June 30, 2021 was $29.0 million, as compared to $5.4 million for the six months ended June 30, 2020.

On October 28, 2021 RingCentral, Inc. (NYSE: RNG), a leading provider of global enterprise cloud communications, video meetings, collaboration, and contact center solutions, reported that Susan G Komen, the world’s leading breast cancer organization, has turned to RingCentral MVP (Message Video Phone) to drive business communications across its entire operations (Press release, Susan G Komen, OCT 28, 2021, View Source [SID1234592161]). Since implementing RingCentral, Susan G. Komen has shifted its workforce to be fully remote, enabling employees to work from anywhere. The company has also ceased outsourcing its call center by deploying RingCentral Contact Center, bringing their helpline in-house. With these combined savings, the non profit organization is able to become more operationally efficient and dedicate more funds in support of its mission programming, such as advocacy, research, patient care, and support.

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Susan G. Komen has invested more than $3 billion in groundbreaking research, community health outreach, advocacy, and programs in more than 60 countries since its founding in 1982, which is funded by donations from organizations and individuals—many of them pledged over the phone. For that reason, the nonprofit organization needed a more reliable communications solution as its previous on-premise communications system caused frequent outages, which meant a loss of potential donor funding. Additionally, the lack of mobility from their previous phone system prevented them from being able to implement a fully remote workforce.

"RingCentral gives us so much mobility and freedom. If I’m on a call or a RingCentral Video meeting on my laptop, and I need to run an errand, I can just switch the call to my mobile phone and head out. It’s fantastic for keeping us all productive and connected without tying us to our desks—or tying us anywhere for that matter," said Carlos Soto, hosted system administrator for Susan G. Komen. "The best part of being able to go 100% remote is that we can better invest that money into furthering our fight against breast cancer. I’ve never seen a more win-win situation for our organization."

Upon rolling out RingCentral Contact Center as its new customer support solution, support teams are improving many aspects of Komen’s operations and are now able to offer an elevated level of service. For example, Komen now has the capability to escalate a call with RingCentral’s three-way functionality to dial in a supervisor or emergency services if a patient exhibits the potential for self-harm. Having this solution in place for higher intensity calls brings their team confidence and peace of mind. To further assist the Helpline Specialists’ daily operations, the organization is using RingCentral’s out of the box integration with Salesforce. The integration enables its agents to easily take notes during a call and not have to re-enter the data. Those notes go straight into that caller’s Salesforce profile, where the next agent can see them, offering continuity and a more personalized level of service for future calls.

"It is so humbling and inspiring to see organizations like Susan G. Komen change the world for the better using our solutions," said Faiza Hughell, chief customer officer for RingCentral. "Empowering teams to keep doing the great work they do is our ultimate goal. Yes, the integrations we’ve built into our tools make things more efficient for support agents. However, they’ve let us know that the best part about capabilities like these is that for a person going through something as challenging as breast cancer, not having to retell their story each time makes for a much more comfortable experience."

On October 28, 2021 AbClon (CEO Jong-seo Lee) and Lee Ensage (CEO Lee Bong-hee) reported business partnership agreement for joint development of CAR-NK cell therapy using gene editing technology (MOU) (Press release, AbClon, OCT 28, 2021, View Source;wr_id=150 [SID1234638632]).

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AppClone developed CAR-T through joint research with Ensage. Beyond platform technology CAR-NK expanding the scope of research and development with technology, In particular, the strategy is to target the cell therapy market from various angles by combining the company’s antibody discovery technology with Nsage’s gene scissors technology.

CAR-NK Cell therapy is a recombinant antigen receptor(CAR, Chimeric Antigen Receptor) Natural killer cells(NK cell) It is a cell therapy product that combines, NK cells and destroys abnormal cells or cancer. Responsible for immunity.

CAR-NK NK cells used to manufacture cell therapy products are isolated from the blood of healthy people. After culturing, these cells are GVHD (graft-versus-host disease), which is a rejection reaction to injection of other cells,Side effects The advantage is that it is low and mass production is possible. CAR-NK cell therapy has not yet been approved at home or abroad, but , is a pipe that global Big Pharma is trying to dominate. As a line, a lot of research and development is underway worldwide.

NSAGE uses a large amount of gene editing Cas12a material and Automated factory-type cell therapy production platform ‘Harmony’ Holds. NSAGE’s gene editing platform is a technology that targets specific targets for incurable diseases, existing stem cells. It is evaluated that it can overcome the limitations of treatment. Major The pipeline is a hemophilia target CAR-NK cell therapy.

AbClone is a new epitope(Epitope, antigenic determinant) Antibody discovery technology targeting ‘NEST (Novel Epitope Screening) Technology)’ has a platform. The NESTplatform provides a large-scale antibody database. It is a technology that can be used in the development of various cell gene therapy products,the company utilizes this to develop antibodies suitable for the purpose. We plan to select CAR-NK and apply it to the development of cell therapy. past 6month IND Blood cancer applied CAR-T Cell therapy ‘AT101’also NEST platform It was discovered through.

Jong-seo Lee, CEO of AppClon, said "the cooperation between the two companies and Through technological convergence, CAR-NK expands the pipeline to cell therapy CAR We will lay the foundation to lead the related industry by upgrading our technology"he emphasized.

Nsage CEO Lee Bong-hee said "AppClone’s Antibody discovery technology and CAR-T technology and our Cas12a gene scissors technology and NK automated production using domain libraries for cell activation, etc., Based on close cooperation between the two companies, highly effective and low-cost allogeneic CAR-NK cells for target cancers such as lung cancer remedy He said that he expects to be able to secure the pipeline early".

On October 27, 2021 EpiAxis Therapeutics reported at three conferences this week – Australia Biotech Invest & Partnering 2021; Europe’s largest life science partnering conference, BIO-Europe 2021; and Wholesale Investor’s STEM 2021 Conference (Press release, EpiAxis Therapeutics, OCT 27, 2021, View Source;utm_medium=rss&utm_campaign=epiaxis-headlines-three-key-biotech-conferences [SID1234591993]).

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CEO of EpiAxis Therapeutics, Dr Jeremy Chrisp, presented at the Australia Biotech Invest & Partnering 2021 earlier this week which is Australia’s premier life sciences investment conference. It’s an interactive digital showcase, designed to foster growth and drive business-to-business investment and collaboration in what continues to be a significant time for life sciences and medical research. The conference was held online on Tuesday, October 26, 2021. Engaging capital with innovation, it was an opportunity for companies to present their technology and story to a network of potential international partners and investors. Investors include those in venture capital, private equity, HNW individuals, research analysts and brokers, as well as industry executives from major global pharmaceutical companies. The program also featured keynote sessions from investment leaders on industry trends and market updates.

The international BIO-Europe 2021 gathering is being held digitally from October 25-28, bringing the global biopharma and investment leaders together to build partnerships that facilitate innovation and medical breakthroughs.

Chrisp will also appear at Wholesale Investor’s STEM 2021 Conference on Thursday, October 28. EpiAxis recently joined Wholesale Investor, Australasia’s leading investment platform for connecting innovative, emerging companies that are looking to raise capital with an active, engaged and growing ecosystem of more than 29,300 high-net-worth investors, fund managers, family offices, PE and VC firms, government bodies and industry participants. The showcase includes everything investors need to capitalise on STEM investment opportunities.

"We are delighted to be presenting at these conferences with our biotech peers to raise the profile of EpiAxis and the importance of epigenetic therapies as a new approach to treating cancer," Chrisp said. "It has also been an excellent opportunity to network with potential investors and familiarise them with our novel approach, which targets cancer stem cells that can evade chemotherapy and immunotherapy, to ‘reprogram’ them back to normal cells."