Cancer Immunotherapy Stocks to Watch (NASDAQ: $ONCY) (TSX: $ONC.TO) (Nasdaq: $CADL) (Nasdaq: $BNTX) (NASDAQ: $IMTX) @Oncolytics @CandelTx @BioNTech_Group @immatics

 

Cancer Immunotherapy Stocks to Watch (NASDAQ: $ONCY) (TSX: $ONC.TO) (Nasdaq: $CADL) (Nasdaq: $BNTX) (NASDAQ:  $IMTX) @Oncolytics @CandelTx @BioNTech_Group @immatics

 

Tapping into Immune Systems for Next Generation Treatments  

 

February 15, 2024 -  Investorideas.com, a global investor news source covering biotech and pharma stocks issues a sector snapshot on cancer immunotherapy featuring Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology.

 

Read this in full at https://www.investorideas.com/news/2024/biotech/02151Cancer-Immunotherapy-Stocks.asp

 

According to the American Association for Cancer Research “Cancer immunotherapeutics work by unleashing the power of a patient’s immune system to fight cancer and, over the last decade, have emerged as one of the most exciting new approaches to cancer treatment.”

 

“The prolific growth in the cancer immunotherapy sector, fuelled by technological advances and a high prevalence of cancer-related cases, is set to significantly enhance the global market landscape. The market, which was valued at US$ 96.40 billion in 2023, is estimated to achieve a remarkable CAGR of 10.02% between the years 2023 and 2030, with projections placing its value at approximately US$ 188.11 billion by the end of the decade,” reports ResearchandMarkets.

 

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) is developing pelareorep, a unique immunotherapy with the power to awaken the immune system and unlock its antitumor potential. Pelareorep is delivered intravenously and is systemically active, setting it apart from other immunotherapies that must be injected into the tumor.

 

The Company just announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq^®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2^nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

 

“These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%^1-3,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

 

“We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population,” continued Dr. Coffey.

 

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, “One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease.”

 

“We look forward to building on the oncology community’s enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025.”

 

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups:

 

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic pancreatic cancer patients;

 

2. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

 

3. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients; and

 

4. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients.

 

Candel Therapeutics, Inc.(Nasdaq:CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer had big gains on news as it announced that the US Food and Drug Administration (FDA) granted Fast Track Designation for CAN-3110 -- a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate – for the treatment of patients with recurrent high-grade glioma (HGG) to improve overall survival.

 

“Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “As recently published in Nature, a strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110. We look forward to reporting additional data, including the potential benefits from multiple injections of CAN-3110, from the ongoing phase 1b clinical trial in the second half of 2024.”

 

From the news continued: In October 2023, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of ~12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. Positive HSV-1 serology was a predictor of response and was associated with improved survival (mOS in this population reached 14 months). Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response.

 

“Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” said Antonio Chiocca, MD, PhD, Head of Department of Neurosurgery at Brigham and Women’s Hospital, Professor at Harvard Medical School, and Principal Investigator. “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.”

 

BioNTech (Nasdaq:BNTX), an immunotherapy company pioneering novel therapies for cancer and other serious diseases and Autolus Therapeutics plc, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, recently announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

 

“The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way. Autolus' state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."

 

From the news continued: “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, CEO of Autolus. “We look forward to investing a portion of the capital raised on delivering on obe-cel’s path in adult acute lymphoblastic leukemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for accelerating our respective oncology pipeline programs and broadening the use of Autolus’ technology outside of autologous cell therapy applications.”

 

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.

 

Pharmaceutical Technology reports, “Immatics (NASDAQ: IMTX) is one of the leading patent filers in cancer immunotherapy. The biopharmaceutical company is focused on the development of T cell immunotherapies to fight against cancer. Immatics combines the discovery of targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against targets. It is committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Bristol-Myers Squibb and Fate Therapeutics are some of the other key patent filers in cancer immunotherapy.”

 

In mid-January  Immatics announced the pricing of an underwritten public offering of 15,925,000 ordinary shares at a public offering price of $11.00 per share. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $175 million.

 

For investors looking for the next trends in biotech, Pharmaceutical Technology also reports, “Cancer immunotherapy has shown remarkable success in treating various types of cancers and has revolutionized cancer treatment in recent years.”

 

Research more biotech stocks with Investorideas Biotech stock directory

https://www.investorideas.com/BIS/Stock_List.asp

 

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Breaking Medical Technology Stock News: Aethlon Medical (NASDAQ: $AEMD) Announces Fiscal Third Quarter Financial Results and Provides Corporate Update

 

 

 

 

Breaking Medical Technology Stock News: Aethlon Medical (NASDAQ: $AEMD) Announces Fiscal Third Quarter Financial Results and Provides Corporate Update

 

Conference Call to be Held Today at 4:30 p.m. ET

 

SAN DIEGO, CA, February 14, 2024 -- (Investorideas.com Newswire) Aethlon Medical, Inc. (NASDAQ:AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments.

 

Read this news, featuring AEMD in full at https://www.investorideas.com/news/2024/02141AEMD-Q3-Results-and-Corporate-Update.asp

 

 

Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier®, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. Aethlon is also investigating the use of the Hemopurifier in the organ transplant setting, initially focusing on the potential removal of viruses and exosomes with harmful cargo from recovered kidneys.

 

In October 2023, Aethlon received clearance from the Drug Controller General of India (DCGI), the country’s central drug authority, to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following completion of an in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

 

“In addition to an interested initial site in India, we have two interested sites in Australia that are also awaiting the data from our in vitro binding study,” stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer. “Our in vitro binding study of relevant oncology targets is complex and stands on the cutting edge of extracellular vesicle science. Our goal is to quantify the potential impact of our Hemopurifier on plasma from cancer patients that have been treated with anti-PD-1 monotherapy treatment in order to provide pre-clinical evidence to support our trial design.

 

“While our research and development team has started to quantify our internal data, the results, to date, are somewhat inconclusive. Therefore, while our internal team continues to finetune their work, in parallel we have engaged several third-party laboratories to independently perform assays on the samples.

 

“We are also maintaining a position in the use of our Hemopurifier as a treatment against life-threatening viral infections through our COVID-19 trial in India. We have two participating sites for this trial -- the Medanta Medicity Hospital and Maulana Azad Medical College, or MAMC. One patient has been treated thus far, however, we have been informed by our contract research organization that a new COVID-19 subvariant was recently detected in India. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care units at our two participating sites.

 

“Finally, since being named interim Chief Executive Officer three months ago, I have focused our efforts on our oncology program, as well as on reducing our expenses. As previously reported, we disclosed some interesting pre-clinical proof on concept data of the Hemopurifier in organ transplantation. As a result, we plan to submit one or more articles for publication on our pre-clinical data,” concluded Mr. Frakes.

 

Financial Results for the Third Quarter Ended December 31, 2023

As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million.

 

Consolidated operating expenses for the three months ended December 31, 2023 were approximately $3.6 million, compared to $2.8 million for the three months ended December 31, 2022. This increase of approximately $717,000, or 25.2%, in the 2023 period was due to increase in payroll and related expenses of approximately $871,000, offset by decreases in general and administrative expenses of approximately $92,000 and in professional fees of approximately $61,000.

 

The $871,000 increase in payroll and related expenses was primarily due to separation expenses for our former chief executive officer of $873,000 and an increase in salary expense of $81,000 associated with an increase in average headcount, offset by a decrease in stock-based compensation of $83,000.

 

The $92,000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense of approximately $399,000 and a $33,000 decrease in travel and conferences expenses. Decreases were offset by a $284,000 increase in supplies for manufacturing and research and development expense, a $31,000 increase in insurance expense, a $13,000 increase in depreciation expense and a $12,000 increase in outside services and repairs. The increase in insurance expense included $16,000 of health insurance related to the separation agreement with our former chief executive officer.

 

The $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting and a net $33,000 decrease in contract labor related to general research and development. These decreases were offset by an increase of $44,000 in legal expenses relating to the reverse stock split, an $11,000 increase in director fees associated with the addition of a new director and a $14,000 increase in investor relations and accounting fees.

 

As a result of the changes in expenses noted above, the company’s net loss increased to $3.6 million for the three months ended December 31, 2023, from $2.8 million in the three months ended December 31, 2022.

 

The condensed consolidated balance sheet for December 31, 2023, and the condensed consolidated statements of operations for the three- and nine-month periods ended December 31, 2023 and 2022 follow at the end of this release.

 

Conference Call

Aethlon Medical will hold a conference call today, Wednesday, February 14, 2023, at 4:30 p.m. ET to review its financial results for its fiscal third quarter ended December 31, 2023 and recent corporate developments. Interested parties can register for the conference by navigating to https://dpregister.com/sreg/10186345/fb902976dd. Please note that registered participants will receive their dial-in number upon registration.

 

Interested parties without internet access or who are unable to pre-register, may dial in as follows:

 

Participant Dial In (Toll Free): 1-844-836-8741
Participant International Dial In: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2024. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7691190.

 

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

 

Additional information can be found at www.AethlonMedical.com.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital and to successfully complete development of the Hemopurifier; the Company’s ability to successfully demonstrate the utility of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company’s ability to initiate its oncology clinical trials in India and Australia; the Company’s ability to manage and successfully complete its clinical trials, if initiated; the Company’s ability to maintain its Nasdaq listing; the Company’s ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials, and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

 

Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

 

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com  
917-513-5303

 

Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com

 

More info on AEMD at Investorideas.com Visit: https://www.investorideas.com/CO/AEMD/

 

Get News Alerts on Aethlon Medical

 

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. Disclosure: Aethlon Medical, Inc. (NASDAQ:AEMD) is a paid featured stock on Investorideas.com More disclaimer info:  https://www.investorideas.com/About/News/Clientspecifics.asp  https://www.investorideas.com/About/Disclaimer.asp

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Anal Cancer Treatment Market Expected to Reach $1.63 Billion by 2030 as Latest Clinical Studies Focus on New Therapies; @FNMgroup @Oncolytics

 Anal Cancer Treatment Market Expected to Reach $1.63 Billion by 2030 as Latest Clinical Studies Focus on New Therapies; @FNMgroup  @Oncolytics

 

Palm Beach, FL – February 14, 2024 – FN Media Group News Commentary – Recent reports project that the anal cancer market will continue its recent growth through 2030. An article on the MD Anderson website. It said: “More than 8,000 people in the U.S. are diagnosed with anal cancer each year. Due to higher rates of the human papilloma virus, a key risk factor, it affects women more than men. If found early, the disease can be successfully treated. Several types of tumors may be found in the anus. While some of them are malignant (cancer), others are benign (not cancer) or precancerous (may develop into cancer). The main types of anal cancer are: Carcinoma in situ is early cancer or precancerous cells. They are only on the surface cells of the anal canal. This also may be called Bowen’s disease; Squamous cell cancer (carcinoma) forms in the cells that line the anus. This is the most common type of anal cancer; Adenocarcinomas develop in the glands around the anus; and Skin cancers, including basal cell and melanoma, often are found when they are in advanced stages.  A report from Market Research Future projected that: “The Anal cancer market is anticipated to reach USD 1,638.5 Million by 2030 at 8.6% CAGR… through 2030.  It said: “Anal cancer is a rare type of cancer that begins in the anus, which is the orifice at the rectum’s end. Anal cancer has one of the highest rates of occurrence and prevalence in the globe. Lifestyle issues, aging, and diet are thought to be the primary causes of anal cancer. According to the World Health Organization (WHO), an increase of roughly 70% in anal cancer cases is projected globally over the Anal Cancer Market Analysis period (2030).  Squamous cell carcinoma, which develops from cells around or in the anal entrance or, in rare cases, in the anal canal, is the most common type of anal cancer. This malignancy is frequently linked to the human papillomavirus (HPV), with HPV malignancies or cervical cancers having a significant chance of progressing to anal cancer. Anal cancer has no specific symptoms; however, it might cause bleeding from the anal area, a tumor or swelling near the anus, or a change in bowel habits.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Pfizer Inc. (NYSE: PFE), BioXcel Therapeutics, Inc. (NASDAQ: BTAI), Bristol Myers Squibb (NYSE: BMY).

 

Read this in full at https://www.financialnewsmedia.com/anal-cancer-treatment-market-expected-to-reach-1-63-billion-by-2030-as-latest-clinical-studies-focus-on-new-therapies/

 

The report continued: “The income earned by medications used to treat anal cancer, as well as other screening tests, kits, and medical devices used to diagnose colorectal cancer, is tracked in the study. The high spending on public health initiatives, as well as the rapid rise in global healthcare expenditure and research and development expenditure in the field of oncology, are projected to provide substantial potential prospects and increase the market size.  The Americas are likely to lead the anal cancer market because of the increased prevalence of anal cancer. Europe is predicted to represent the second-largest share of the anal cancer market because of the increased prevalence of anal cancer and the presence of significant market participants. In The Middle East and Africa, due to the high incidence rate of anal cancer, the market is likely to develop gradually throughout the forecast period.”

 

Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort – Successful Stage 1 data showed a near tripling of Objective Response Rate compared to checkpoint inhibitor monotherapy, including a Complete Response, and supports expansion – Oncolytics Biotech® Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

 

“These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.”

 

“We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population,” continued Dr. Coffey.

 

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, “One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease.”

 

“We look forward to building on the oncology community’s enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025.”  CONTINUED… Read these full press releases and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/     

 

Other recent developments in the biotech industry of note for cancer events include:

 

Exelixis, Inc. (NASDAQ: EXEL) recently announced detailed results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).

 

“Patients with metastatic castration-resistant prostate cancer with prior progression on a novel hormone therapy and who have measurable soft tissue metastasis experience the worst outcomes among advanced prostate cancer patients and have limited treatment options,” said Neeraj Agarwal, M.D., FASCO, Senior Director for Clinical Research at Huntsman Cancer Institute at the University of Utah and the global lead investigator of the trial. “CONTACT-02 is the only phase 3 study evaluating a tyrosine kinase inhibitor and an immune checkpoint inhibitor to show a statistically significant improvement in progression-free survival and a trend for overall survival in these patients. I am encouraged by these results and the potential for cabozantinib plus atezolizumab to be a widely available treatment option for our patients.”

 

Arvinas, Inc. (ARVN) and Pfizer Inc. (NYSE: PFE) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment of adults with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas and Pfizer.

 

As described by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier. Vepdegestrant as a monotherapy is being studied in the ongoing Phase 3 VERITAC-2 clinical trial, which is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy.

 

BioXcel Therapeutics, Inc. (NASDAQ: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, recently announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions, fill unmet medical needs, and bring promising medicines to patients more quickly. Therapies granted this designation are given the opportunity for more frequent interactions with the FDA, a rolling review, and potential eligibility for accelerated approval and priority review.

 

“The FDA’s Fast Track designation for the investigation of BXCL701 in SCNC is an important recognition of our most advanced immuno-oncology asset and an acknowledgment of its potential to address the considerable unmet medical need in these patients. At the same time, it further validates the unique AI-based drug re-innovation approach that we used to discover this asset,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “BXCL701 has already demonstrated considerable potential in our clinical trials to date, and we plan to further define its development path while exploring strategic options for our OnkosXcel Therapeutics subsidiary.”

 

Bristol Myers Squibb (NYSE: BMY) recently announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMA’s centralized review process.

 

“Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applications underscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit.”

 

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