Tag: Biotech

Alfasigma Makes Big Bet on Liver Disease With $1.25 Billion Intercept Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Italian pharma Alfasigma is expanding its gastroenterology portfolio in a major way with the proposed $1.25 billion acquisition of Intercept Pharmaceuticals. The all-cash deal provides Alfasigma with Intercept’s leading drug Ocaliva and a strengthened pipeline in progressive liver diseases.

Alfasigma will pay $19 per share to acquire Intercept, representing an 82% premium over Intercept’s share price before the deal announcement. The purchase price reflects a big bet on Ocaliva’s growth prospects and Intercept’s broader capabilities in rare liver conditions.

Ocaliva is the key asset Alfasigma gains from the deal. It’s the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disorder that damages the bile ducts in the liver. Ocaliva hit $152 million in sales over the first half of 2023 alone, underscoring its rapid growth trajectory.

Beyond Ocaliva, Alfasigma also adds Intercept’s emerging pipeline of novel therapies for PBC and other liver diseases. The crown jewel is a promising fixed-dose combination regimen that could transform the PBC treatment paradigm.

Take a look at Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer’s coverage universe.

The deal dramatically expands Alfasigma’s presence in the high-value U.S. pharma market. Previously focused primarily on the Italian market, the Intercept acquisition gives Alfasigma an anchor asset and commercial team in the U.S.

Strategically, the move aligns with Alfasigma’s vision to build up its gastroenterology and hepatology business. CEO Francesco Balestrieri highlighted Intercept’s compelling strategic fit with Alfasigma’s focus in these therapeutic areas.

Expect Alfasigma to invest heavily to maximize Ocaliva’s potential. The company sees major commercial expansion opportunities to extend Ocaliva’s reach across PBC patient populations. Alfasigma also gains Intercept’s seasoned specialty sales force to drive prescription growth.

With Intercept operating as a wholly-owned subsidiary once the buyout closes, Alfasigma is well-positioned to become a global force in progressive liver diseases. The deal enhances Alfasigma’s standing as an emerging player in the U.S. pharma market.

Look for Alfasigma to continue seeking acquisition targets to accelerate its growth. The company has the financial firepower to pursue additional deals that build up its portfolio. If the Intercept acquisition is any indication, Alfasigma has appetite for bold, transformative M&A.

The proposed buyout still requires regulatory and shareholder approval. But with a massive 82% premium offered, Intercept shareholders are likely to approve the $19 per share deal price. Expect Alfasigma to move rapidly to complete the acquisition by the end of 2023.

Regeneron Strengthens Gene Therapy Pipeline Through Acquisition of Decibel Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com

Regeneron Pharmaceuticals has expanded its gene therapy programs by acquiring Decibel Therapeutics, a biotech company focused on developing treatments for hearing loss. The $1.1 billion deal provides Regeneron with three promising gene therapy candidates that use adeno-associated virus (AAV) vectors to restore hearing.

The most advanced asset is DB-OTO, an AAV-based gene therapy designed to provide long-term hearing to individuals with profound congenital hearing loss caused by otoferlin gene mutations. DB-OTO is currently being evaluated in a Phase 1/2 clinical trial known as CHORD. The gene therapy aims to deliver a functional copy of the otoferlin gene to inner ear hair cells, potentially enabling hearing restoration.

The acquisition also includes two earlier-stage gene therapies, AAV.103 and AAV.104, targeting other genetic forms of hearing loss – GJB2 and STRC respectively. Both utilize a similar AAV gene delivery approach to DB-OTO.

According to Regeneron, the addition of Decibel’s pipeline and capabilities will strengthen its genetic medicines portfolio. Gene therapy has become a major focus for Regeneron beyond its foundational expertise in antibodies. The company is exploring gene silencing, gene editing and gene therapy technologies across a range of therapeutic areas.

Take a look at Ocugen Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines.

Hearing loss represents a new area for Regeneron, building on an existing collaboration with Decibel. Integration of Decibel’s team and experience in inner ear biology and AAV gene therapy for hearing disorders will be invaluable as Regeneron advances the acquired programs.

Gene therapy aims to address disease at its genetic root cause by introducing functional genes into cells. The goal is to durably restore protein expression and correct the downstream impacts of gene mutations. Gene therapy has shown promise for treating rare monogenic disorders like certain forms of inherited hearing loss.

Both Regeneron and Decibel have utilized AAV vectors to deliver gene therapy payloads. AAV is considered one of the most effective vehicles for gene delivery and has an established safety profile. The viruses can be engineered to target specific cell types following injection into the body.

For DB-OTO, the AAV vector carries a functional copy of the otoferlin gene. Inner ear hair cells are the targets for gene transduction. Otoferlin protein is critical for hearing signal transduction, but mutations in the encoding gene cause profound congenital deafness. Gene therapy aims to restore otoferlin expression and regain hearing function.

Regeneron’s push into gene therapy aligns with its mission of tackling serious diseases with novel technologies. Gene-based treatments have potential for one-time curative therapies. The acquisition of Decibel’s pipeline further diversifies Regeneron’s genetic medicine capabilities as it aims to help patients worldwide.

Release – PDS Biotech Reschedules Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Event to be held on Tuesday, October 3 from 8:00 to 9:00 AM EDT

PRINCETON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that its Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101 will now take place on Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, due to a scheduling conflict. The event was originally scheduled for Wednesday, September 27, 2023.

The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration for the event is open. A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Release – GeoVax Next-Generation COVID-19 Vaccine Demonstrates Potent Antibody and Cellular Immunity in Immunocompromised Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data GOVX

 

  • Last updated: 19 September 2023 13:26
  • Created: 19 September 2023 15:09
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Data Published from Phase 2 Open-Label Study of GEO-CM04S1

ATLANTA, GA, September 19, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, announced today the publication of data from the ongoing Phase 2 trial of its next-generation COVID-19 vaccine (GEO-CM04S1) in the journal Vaccines. The article, authored by researchers at the City of Hope National Medical Center, can be accessed here: GEO-CM04S1 Publication.

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy (i.e., patients who have reduced immune system function as a result of treatment). These patients have significantly compromised immune system function and generally respond at suboptimal levels after receiving currently available COVID-19 vaccines. As such, these patients are at greater risk for developing severe disease if infected and would likely benefit from the types of immune responses induced by the GEO-CM04S1 vaccine, which are more broadly specific and include activation of both the antibody and T cell arms of the immune system.

The article, titled “Stimulation of Potent Humoral and Cellular Immunity via Synthetic Dual-Antigen MVA-Based COVID-19 Vaccine COH04S1 in Cancer Patients Post Hematopoietic Cell Transplantation and Cellular Therapy”, describes the immune response analyses conducted on the open-label portion of the Phase 2 trial, indicating that GEO-CM04S1 (referred to as COH04S1 in the article) is highly immunogenic in these immunocompromised patients, inducing potent humoral (antibody) and cellular (T cell) responses, including neutralizing antibodies against SARS-CoV-2 ancestral virus and variants of concern, including the highly immune-evasive Omicron XBB 1.5 variant.

David Dodd, GeoVax Chairman and CEO, commented, “The data presented in this publication confirm our earlier findings in healthy adults and give us confidence that we are on the right path. Protecting individuals at highest risk in our society requires next-generation vaccines, specifically with more robust immune responses, durable protection, and the ability to address continued emerging variants. The mRNA vaccines and monoclonal antibody therapies have been shown to be inadequate in providing protective immunity in such immunocompromised patients. Variants will continue to emerge, and the public health community will continue to be challenged to minimize the infection impact, thereby reducing the risk of severe disease, hospitalizations and death. Vaccines that are “variant-agnostic” such as GEO-CM04S1 will increasingly be critical to reducing such risks, protecting the most vulnerable populations and improving our ability to overcome such infectious threats.”

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

In addition to the ongoing Phase 2 study in hematological cancer patients, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has met its targeted patient enrollment.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.

Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here, provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Investor Relations Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Media Contact:

Susan Roberts

sr@roberts-communications.com

202-779-0929

Mainz Biomed Reports Strong ColoAlert Data, Identifies Biomarkers for FDA Trial

Posted on by slightbourne@noblecapitalmarkets.com

Mainz Biomed (NASDAQ:MYNZ) announced highly positive results this week from its ColoFuture clinical trial evaluating the integration of novel mRNA biomarkers into its ColoAlert screening test for colorectal cancer. The results demonstrated ColoAlert’s strong performance for detecting colorectal cancer and advanced adenomas, while also identifying promising biomarkers to further improve early detection capabilities.

The ColoFuture study is a multi-center international trial assessing whether integrating recently acquired mRNA biomarkers from Université de Sherbrooke can enhance ColoAlert’s sensitivity and specificity profile. ColoAlert is Mainz’s flagship product, a simple yet highly accurate home-based test using stool samples to detect colorectal cancer and advanced precancerous adenomas.

The product is already commercialized across Europe and select international territories. However, ColoFuture aimed to identify ways to further extend ColoAlert’s technical capabilities in preparation for an upcoming U.S. clinical trial that could lead to FDA approval.

Interim analysis from the ColoFuture trial included 220 subjects across centers in Germany, Norway and Denmark. On the primary endpoints for colorectal cancer detection, ColoAlert achieved 94% sensitivity and 97% specificity after integrating the novel mRNA biomarkers.

For identifying advanced adenomas, a key precursor to cancer, the updated test demonstrated 81% sensitivity. According to Mainz Biomed CEO Guido Baechler, “The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable.”

The positive data catalyzed strong trading volume as Mainz Biomed’s stock price rose 15% on over 1.5 million shares traded. The market enthusiastically welcomed the results.

The mRNA biomarkers evaluated in ColoFuture were specifically selected from research at Université de Sherbrooke. Published analysis of the biomarkers showed ability to detect signals from patients with either colorectal cancer or advanced adenomas. Mainz Biomed acquired these biomarker rights in January 2022.

By treating patients before polyps progress to cancer, integrating these biomarkers into ColoAlert could help prevent colorectal cancer altogether. This could greatly improve patient outcomes and reduce the burden of this deadly disease.

The positive data provides validation of ColoAlert’s accuracy as a non-invasive screening tool. It also gives Mainz Biomed multiple novel mRNA biomarkers to integrate into its upcoming U.S. clinical trial, dubbed ReconAAsense, which could support FDA approval under the PMA pathway.

According to Baechler, “As we look forward to publishing and presenting the full dataset, we eagerly await the outcome from our ReconAAsense clinical trial which remains on track to report results in Q4 of this year.”

With colorectal cancer remaining a leading cause of cancer deaths, early detection is critical. ColoAlert offers a simple, at-home solution that people can easily incorporate into routine wellness screenings. The new biomarkers identified in ColoFuture could make the test accessible to even more patients.

Mainz Biomed continues to spearhead innovation in the field, leveraging the latest advances in genetics to improve detection. The impressive ColoFuture results provides further validation of ColoAlert’s accuracy, while also charting a path forward to commercialization in the U.S.

With pivotal FDA trial data on the horizon, Mainz Biomed is positioned to disrupt the market, offering an easy yet cutting-edge approach to potentially save lives through early colorectal cancer detection.

Take a look at more biotechnology companies by viewing Robert LeBoyer’s coverage list.

Two Small Cap Biotechs Neumora and RayzeBio File for $200M+ Nasdaq IPOs

Posted on by slightbourne@noblecapitalmarkets.com

Neumora and RayzeBio, two emerging small cap biotech companies, filed on Monday for initial public offerings (IPOs) on the Nasdaq exchange. The firms are seeking to raise over $200 million each through their stock market debuts.

Neumora, a neuroscience startup, plans to offer 14.7 million shares priced between $16-18 to raise around $227 million under the ticker symbol NMRA. RayzeBio, a radiopharmaceuticals developer, aims to raise about $206 million by offering 13.2 million shares priced at $16-18 per share and trading as RYZB.

As small cap biotechs in earlier stages of development, Neumora and RayzeBio are seen as riskier investments than large cap pharmaceutical firms. However, both companies have drugs in late-stage pipelines and will use their IPO proceeds to fund Phase 3 clinical trials.

Neumora’s lead candidate is a depression drug called navacaprant, while RayzeBio is focused on advancing its radioligand therapy RYZ101 for rare tumors through Phase 3. Their ability to progress their pipelines with capital from the IPOs could improve their growth prospects as public companies.

The biotech IPO market has been tepid so far in 2023, making the environment challenging for small cap biotech listings. But Neumora and RayzeBio’s offerings may provide a test for investor appetite for new issues in the sector. Strong demand could reopen the IPO window for other young biotechs seeking to raise growth capital this year.

Take a look at other small cap companies in the biotech sector by exploring Robert LeBoyer’s coverage list.

Biocept Licenses Cancer Test to Plus Therapeutics in $1.5 Million Deal

Posted on by slightbourne@noblecapitalmarkets.com

Biocept, Inc. (NASDAQ: BIOC) has signed a licensing agreement with Plus Therapeutics, Inc. (NASDAQ: PSTV) for Biocept’s proprietary CNSide cancer detection test. The non-exclusive deal further expands an existing partnership between the companies.

Under the agreement, Plus Therapeutics receives the right to use CNSide testing in clinical trials and commercially if approved by regulators. In return, Plus will pay Biocept $150,000 upfront in stock along with fees for each test performed.

CNSide detects, quantifies, and monitors tumor cells in cerebrospinal fluid to diagnose leptomeningeal metastases, a type of cancer affecting the brain and spinal cord membranes.

Take a look at PDS Biotechnology Corporation, a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies.

Click here for company information and equity research by Noble Capital Markets.

Plus Therapeutics is currently using CNSide in a Phase 1/2a clinical trial of its targeted radiotherapy Rhenium 186 Obisbemeda for treating leptomeningeal metastases. The company will pay Biocept $6,000 for each test conducted at Biocept’s lab during the trial.

Once Biocept completes the technology transfer to enable Plus to run CNSide in-house, Plus will pay $300,000 plus $2,800 per test performed. Plus also has an option to negotiate for third-party exclusivity rights to CNSide for a $1 million payment.

The deal provides non-dilutive funding for Biocept as it seeks to establish CNSide as a standard of care. Biocept’s stock jumped 63% in pre-market trading on the news, while Plus Therapeutics rose 10%.

“We are gratified that Plus continues to recognize the value of CNSide in leptomeningeal metastases disease management,” said Biocept President and CEO Antonino Morales. “This agreement further validates the clinical utility of CNSide.”

Plus Therapeutics CEO Marc Hedrick stated CNSide is the “emerging gold standard” for diagnosing patients with leptomeningeal metastases. The licensing deal allows Plus to pair CNSide with its novel radiotherapeutic drug candidate.

The agreement highlights growing industry interest in leveraging Biocept’s proprietary technology to improve cancer detection and monitoring. As CNSide gains further validation, Biocept aims to secure additional partnerships and drive adoption of the test.

Take a moment to look at Onconova Therapeutics Inc., a clinical-stage biopharmaceutical company focused on discovering and developing novel products for cancer patients.

Click here for company information and equity research by Noble Capital Markets.

Release – PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial Investigating PDS0101 and Chemoradiotherapy in Cervical Cancer to be Featured in Oral Presentation at the ASTRO 2023 Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial Investigating PDS0101 and Chemoradiotherapy in Cervical Cancer to be Featured in Oral Presentation at the ASTRO 2023 Annual Meeting

Study evaluates the effect of combining PDS0101 with standard of care on levels of circulating HPV viral DNA in cervical cancer patients and impact on disease status and clearance

PRINCETON, N.J., Aug. 16, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that data from the IMMUNOCERV Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the treatment of locally advanced cervical cancer will be featured in an oral presentation at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting. ASTRO 2023 is being held October 1-4, 2023, in San Diego, CA.

The abstract, titled “HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation,” will report on the levels of circulating HPV-positive cell-free DNA (HPV-cfDNA) in the blood of 47 cervical cancer patients during and after CRT treatment, including subjects in the IMMUNOCERV study who received PDS0101 in addition to CRT. The research is designed to evaluate the relationship between the levels of circulating HPV viral DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. The findings will be presented by Dr. Aaron Seo, MD, Ph.D., The University of Texas MD Anderson Cancer Center.

“We are pleased that PDS0101 is being evaluated in this cutting-edge approach to better understand the patients’ prognosis and the mechanism by which PDS0101 may impact clinical outcomes in cervical cancer, and we look forward to Dr. Seo’s presentation at ASTRO 2023,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Examination of HPV-cfDNA in this larger cohort of patients will also provide additional insights to the IMMUNOCERV data presented at SITC 2022, which suggested that PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and 100% (9/9) clinical response with greater than 60% tumor shrinkage at mid-point evaluation in high-risk cervical cancer patients.”

The IMMUNOCERV Phase 2 study is investigating PDS0101 in combination with standard-of-care CRT in the treatment of patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
Presentation Details:
Abstract #: 55593 
Abstract Title: HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation 
Presenter: Aaron Seo 
Author Block: Aaron Seo, Weihong Xiao, Olsi Gjyshi, Kyoko Court, Tatiana Cisneros Napravnik, Aradhana Venkatesan, Erica Lynn, Julie Sammouri, Lauren Colbert, Anuja Jhingran, Melissa Joyner, Lilie Lin, Maura Gillison, Ann Klopp 
Scientific Session Number: SS 02  
Scientific Session Title: GYN 1: Integrating the Next Wave of Biomarkers for Future Gynecologic Clinical Trials 
Session Date/Time: October 1, 8:00AM-9:00AM

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About Versamune®

Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101 

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Forward Looking Statements 

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.    

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts: 
Deanne Randolph 
PDS Biotech 
Phone: +1 (908) 517-3613 
Email: drandolph@pdsbiotech.com 

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital 

Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors 
Phone: +1 (609) 468-9325 
Email: dschemelia@tiberend.com 

Eric Reiss 
Tiberend Strategic Advisors 
Phone: +1 (802) 249-1136 
Email: ereiss@tiberend.com 

Three Biotech Industry Challenges Investors Should Monitor

Posted on by phoffman@channelchek.com

Regulatory, Competitive, and Pricing Challenges That Analysts Believe Biopharma Will Face

Trends in biotech are changing, and if certain events play out, the field could become more challenging on three fronts, according to a new report from analysts from the biotech team at RBC Capital Markets. The report discusses advancements in science that could trump others currently in use or some nearing the end of pipelines, along with regulations that could alter scarcity and prices that stem from recent actions.

In its industry report released on August 4, RBC’s biotech team discussed how deep discounts may be dictated by government programs. It also details how new competition could arise for drugs now offered by Biogen (BIIB) and Incyte (INCY) companies. And also how improvements in public-health from new weight-loss drugs and from gene-editing treatments may reduce demand for other products.

Pricing Challenges

The Inflation Reduction Act in its current form will reduce the prices paid for drugs by federal programs like Medicare, the analysts warn. Mandatory discounts, which will rise from 25% to 60%, will phase in for covered medicines beginning at the ninth to 16th years on the market. Any increases in the prices charged to the government program Medicare would be capped at the inflation rate.

The mechanisms by which these pricing measures will be rolled out by the Centers for Medicare Services will become more clear later this year. On the positive side for the industry, RBC noted a number of biotech companies have asked federal courts to block the law enacted in 2022. And if Republicans win controlling seats in the House in the fall, or even the Executive Branch next year, this would increase the chances of a rollback of the federal pricing provisions.

Exclusivity Challenges

A separate issue is that a lapse of exclusivity protection could affect companies such as Biogen, says RBC. That company’s big-selling product Tysabri, a multiple sclerosis treatment brings in about $2 billion a year. But lower protections may cause it to face competition from a generic “biosimilar” version from the Sandoz unit of Novartis (NVS). Earlier this summer, a court denied Biogen’s request for a preliminary injunction that would have kept the Sandoz biosimilar off the market while Biogen would press a patent infringement claim. The RBC analysts see signs that the Food and Drug Administration (FDA) is gearing up to approve the Sandoz biosimilar. The analysts mentioned that any sales losses at Biogen could be offset by the successful growth of its new anti-Alzheimer’s treatments.

You’re Invited to Learn More About NobleCon19

Another exclusivity threat concerns the product Jakafi, which is a successful Incyte cancer and immune disorder drug, its annual sales could exceed $3.5 billion in the next few years. But the expiration of Jakafi’s patent protection in 2029 could bring a stream of generics it would compete with. This places the maker Incyte under pressure to develop products to extend its Jakafi franchise, says RBC.

Medical Success Challenges

The team at RBC writes that some welcome medical advances might prove so successful that they would reduce the need for other products. They gave examples that include the class of diabetes and obesity treatments known as GLP-1 drugs, which they expect are on their way to becoming enormous sellers for Novo Nordisk (NOVO) and Eli Lilly (ELI).

In addition to the dramatic weight loss achieved by the drugs, the GLP-1s may also become useful to reduce cardiovascular and liver disease. While the public health aspect would be cause to celebrate, investors should be cognizant that the prospects for other drugs sold to treat illnesses such as the liver disease called nonalcoholic steatohepatitis, or NASH, may get new competition.

Another promising breakthrough are gene-editing therapies, the one-time treatments that use the Nobel Prize-winning technology known as CRISPR to permanently blunt genetic illnesses.

Intellia Therapeutics (NTLA) and Verve Therapeutics (VERV) are testing such approaches as treatments for nerve and heart disorders that otherwise require continuing doses of medicines sold by other biotech companies. The RBC team says that the success of the one-shot editing therapies could trim the need for drugs that at present must be continually taken.

Take Away

Analysts don’t have a crystal ball, but investors do rely on their expertise to gain insight as to industry trends and individual company insights. There are many changes occurring in the biotech and biopharma space that could change the competitive landscape, some better for investors, some better for patients, and some even better for taxpayers and social security and Medicaid recipients.

Investors that wish to increase their knowledge of the industry and smaller innovative companies within the segment should explore the data and information in this section of Channelchek and dig even deeper into companies specifically covered by the industry analyst at Noble Capital Markets by using this link.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.rbccm.com/en/insights/industries-in-motion/podcast.page?dcr=templatedata/article/podcast/data/2021/09/how_biotech_breakthroughs_are_changing_healthcare

https://www.barrons.com/articles/biotech-stocks-changing-regulation-disruption-1b4b3ee

https://www.fiercebiotech.com/biotech/peter-marks-says-base-editing-could-be-incredible-game-changer

Biotech Companies to Benefit from AI Efficiencies and Analysis

Posted on by phoffman@channelchek.com

Enabling Better Drug Discovery Outcomes with Machine Learning

Can the long road to bring new medical treatments or therapies to market be shortened by introducing artificial intelligence? AI applied to the early stage of the discovery process, which often involves new insight into a disease or treatment mechanism, may soon provide researchers many more potential candidates or designs to evaluate. AI can also help in the sorting and evaluation of these candidates to improve the success rates of those that make it into the lab for further study.

Benefits AI Brings to Biotech Research

The cost of bringing a single drug to market in terms of time and money is substantial. Estimates are in the $2.8 billion range, and the average timeline for drug development exceeds a decade. On top of this, there is a low level of certainty of taking a promising molecule all the way to market. The success rate of translating preclinical research findings into effective clinical treatments is low; failure rates are estimated to be around 90%.

The refinement of digital sorting and calculating with advanced computational technologies, such as artificial intelligence (AI) and machine learning (ML), have the potential to revolutionize pharmaceutical research and development (R&D). Despite it still being a young technology, AI-enabled applications and algorithms are already making an impact in drug discovery and development processes.

One of the significant benefits of ML in drug development is its ability to recognize patterns and unveil insights that might be missed by conventional data analysis or take substantially less time to recognize. AI, and ML technologies can help a biotech company do precursory evaluation, accelerate the design and testing of molecules, streamline the testing processes, and provide a faster understanding along the way if the molecule will perform as expected. With improved clinical success and reduced costs throughout the development pipeline, AI may be shot in the arm the industry needs.

Adoption of AI in Biotechnology

While any full-scale adoption of AI in the pharmaceutical industry is still evolving and finding its place, implementation and investment are growing. Top global pharmaceutical companies have increased their R&D investment in AI by nearly 25% over the past three years – this indicates a recognition of the perceived benefits.

The interest and investment in AI drug discovery is fueled by several factors. As touched on earlier, a more efficient and cost-effective drug development process would be of great benefit. AI can significantly reduce both time and cost. And the sooner more effective treatments are available, the better. Chronic diseases, such as cancer, autoimmune problems, neurological disorders, and cardiovascular diseases, creates an ongoing demand for improved drugs and therapies. AI’s ability to analyze vast amounts of data, identify patterns, and then learn from the information at an accelerated rate can allow researchers to shorten timelines to final conclusions.  

Even more exciting is the growing availability of large datasets thanks to the rise of big data. With an increase in the volume, variety and velocity of data, and the AI-assisted ability to make sense of it, outcomes are expected to be improved. These datasets, obtained from various sources like electronic medical records and genomic databases, allow successful AI applications in drug discovery. Technological advancements, especially in ML algorithms, have been contributing to the growth of AI in medicine. And they are growing more sophisticated, allowing for accurate pattern identification in complex biological systems. Collaborations between academia, industry, and government agencies have further accelerated growth sharing knowledge and resources.

Trends in AI and ML Biotechnology

While considered a young technological field, AI-enabled drug discovery is being shaped by a number of new trends and technologies. Modern AI algorithms are now capable of analyzing intricate biological systems and foretelling the effects of medications on human cells and tissues. By detecting probable adverse effects early on in the development phase, the predictive ability helps prevent failures in the later stages.

By generating candidates that fit certain requirements, generative models can accelerate the design of completely new medications. But other technology is also now available to assist. By offering scalable processing resources, cloud computing dramatically cuts down on both time and expense. By simulating the interaction of hundreds of chemicals with disease targets, virtual drug screening enables the fast screening of drugs.

A higher understanding of disease biology and the discovery of new therapeutic targets is being made possible by integrative techniques that incorporate many data sources not available a short while ago.

Constraints on AI-Assisted Biotech Research

While AI can speed up certain aspects of drug discovery, it cannot replace most traditional lab testing. Hands-on experimentation and data collection on living organisms are expected to always be necessary, many of these processes during the clinical trial stages cannot be sped up.

Regulatory bodies, like the FDA, are also cautious about embracing AI fully, raising concerns about transparency and accountability in decision-making processes.

.

Take Away

The near future of artificial intelligence and machine learning assuming a larger role in enabling drug discovery and more efficient R&D looks bright. The technology offers real promise for more efficient and cost-effective drug development processes – this would address the need for new therapies for chronic diseases.

The time-consuming process of testing on real subjects is not expected to be replaced or overly streamlined by technology, but finding subjects and evaluating results can also benefit from the new technology.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://5058440.fs1.hubspotusercontent-na1.net/hubfs/5058440/cold%20outreach%20use%20case%20images/Pathways%20for%20Successful%20AI%20Adoption%20in%20Drug%20Development%20-%20VeriSIM%20Life.pdf

https://www.mckinsey.com/industries/life-sciences/our-insights/ai-in-biopharma-research-a-time-to-focus-and-scale

https://www.drugdiscoveryonline.com/doc/the-global-market-for-ai-in-drug-discovery-to-sextuple-by-0001

https://www.mckinsey.com/industries/life-sciences/our-insights/we-can-invent-new-biology-molly-gibson-on-the-power-of-ai

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

More Proof There is Significant Value in Biotech Stocks

Posted on by phoffman@channelchek.com

Another Sign Conditions are Improving for Biotech Stocks

Biotech stocks seem to be exhibiting unusual value for any stock segment. A subset of the healthcare sector, biotechnology includes companies researching, and developing what may be the next-generation medical preventatives and treatments. There had been a huge decline in interest in the segment that coincided with FDA approval of the first Covid19 vaccine in late Summer 2021. Since then, the average price has been more than cut in half (see XBI/IBB chart) for biotechs.

The chart below is the S&P SPDR Biotech ETF and iShares Biotech ETF. They represent 280 stocks. According to an article in Barron’s dated June 4, 2023, of these, 23 (almost 10%) are trading below enterprise value (EV). Many more are on the cusp of trading right at the value of their net assets. For example, the article mentioned Atea Pharmaceuticals (AVIR), a biotech developing antiviral therapeutics for Hep-C and Covid. “If you bought all Atea’s shares and paid off all of its debt, the cash and other liquid assets remaining on its balance sheet would be worth more than what you spent,” wrote Barron’s.

Source: Koyfin

Of the 280 stocks, nearly 60 have enterprise values below $100 million – the current conditions are not sustainable. At some point, the “invisible hand” of the market is will work to correct it. Last week, Atea, which had been trading near $3.70 recently, was offered $5.75 per share. Concentra Biosciences, which is controlled by the investment fund Tang Capital Partners, made the offer with some contingencies tied to licenses or sales of Atea’s products.

The peculiar condition of the market valuing biotech companies below EV or even cash came to my attention at a RoadShow that was arranged by Noble Capital Markets that featured Cocrystal Pharma (COCP). Cocrystal has several products advancing toward clinical milestones. It was presented by a member of Cocrystals executive management team in South Florida. While the myself and the other investors became familiar with COCP’s development pipeline, and data like the rate of cash usage, the amount of cash on hand, and the market value, it became quite apparent the company had far more cash than the amount the stock market had priced the entire company. And at its cash burn rate (amount of cash used to cover expenses each month), that there might be a significant valuation disconnect.

Many believe disconnects like this will be resolved as the markets always are seeking value and seemingly mispriced companies. There are already many examples this in 2023 as big pharma either has partnered with, or outright acquired companies. This, of course, can cause the stock prices to skyrocket. In fact, while the news was focused on Silicon Valley Bank last March, Provention Bio (PRVB) shot up 258% after a deal was announced.

Smaller biotechs need money to spend on developing drugs, and can’t rely on product sales. Even with what might seem like a huge war-chest of cash, low market values have stifled the ability to raise new money. The road to the next wonder drug is long and requires management to take comfort that they can secure funds when needed.

The extent of this challenge is unique to each company. For many, since the biotech segment valuations came down from the pandemic-inspired dizzying heights,  they might have cash, but not enough to go an extended period until funding conditions improve. The offer last week by Concentra is a sign that conditions are changing. It isn’t just pharmaceutical companies shopping now for biotech bargains to own, it seems investment partnerships are also recognizing the extreme value in some companies.

For data and current information on almost 250 biotech companies, visit the biotech industry section here, on Channelchek.  

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.barrons.com/articles/biotechs-negative-enterprise-values-5e289e8e?mod=Searchresults

News From the Biotech Sector has become Increasingly Rewarding

Posted on by phoffman@channelchek.com

2023 May Be the Year the Biotech Sector Cures Itself of Malaise

A pivotal point for biotech stocks seems to have been reached. It’s almost mid-2023, and barely a week goes by without news driving a biotech company’s stock price upward to gain returns that one would expect to take years to achieve in a broad basket index position. The most recent news causing this price action is yet another clinical-stage therapeutic company. Shares of PDS Biotech are up 27% since yesterday and 41% month-to date. This week’s move is attributable the company reporting positive trial results.

PDS Biotechnology (PDSB) is a clinical-stage immunotherapy company with a developing pipeline of targeted immunotherapies for cancer and infectious disease.

The impetus for the price move was the announcement of interim data from a Phase 2 trial investigating its PDS0101 in combination with Merck’s  KEYTRUDA®. The trials were in patients with unresectable, recurrent or metastatic human papillomavirus head and neck cancers.

The results were quite positive and will be featured in a poster presentation and in a head and neck cancer expert panel discussion at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6 in Chicago.

These are highlights of the results showing the interim data of the efficacy of PDS Bio’s PDS0101 in combination with KEYTRUDA®:

The estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone*.

  • Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels*.
  • A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
  • Confirmed and unconfirmed objective response rate was 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date these responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
  • 15/34 patients (44.1%) had stable disease.
  • 9/34 patients (26.5%) had progressive disease.
  • 4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.

A main driver of the stock market enthusiasm can be found in the safety and efficacy results in the interim data. “This data showed an estimated 12-month survival rate of 87% and a progression-free survival of 10.4 months, which is very encouraging given the poor prognosis these patients face,” stated Lauren V. Wood, M.D., PDS Biotech’s Chief Medical Officer and a co-author of the study. “Furthermore, we remain encouraged by the safety profile of PDS0101 in combination with KEYTRUDA®, with only 8% of patients experiencing a Grade 3 treatment-related adverse event without more serious Grade 4 or 5 events. We believe these data are encouraging for HNSCC patients and indicate that the addition of the HPV16-targeted immunotherapy PDS0101 to KEYTRUDA® should be further evaluated for its potential to enhance survival in HPV16-positive head and neck cancer patients.”

To understand the company PDS Biotechnology better, visit the research page on Channelchek, and also review this Channelchek video that shares key information about PDSB.

The Nature of Biotech Investing

Drug discovery and development is a long, uncertain path that often takes 10–15 years, with costs that could exceed $1–2 billion for any new drug ultimately approved for clinical use. Unlike unregulated products, it’s a significant achievement for a candidate to get as far as clinical trials. Attaining interim results showing high efficacy and tolerance is a very positive sign and one that will most often cause a large price jump. Negative results can have the opposite effect.

Events that cause small-cap biotech stocks to experience significant price jumps could include:

  • Positive clinical trial results: As with PDS Biotechnology, when a small-cap biotech company releases positive clinical trial results, it can generate significant investor interest and drive up the stock price.
  • FDA approvals: Taking is a step further, FDA approvals of drugs or medical devices can significantly boost a small-cap biotech company’s stock price, as it can open up a new revenue stream for the company.
  • Partnerships and collaborations: Partnerships and collaborations with larger companies can cause a small-cap biotech stock to rise as it indicates a level of validation for the company’s technology or products, and provide needed funding to bring research and development along the lengthy timeline.
  • Acquisition rumors or deals: When rumors or announcements of an acquisition by a larger company circulate, it can cause a small-cap biotech stock to rise as investors anticipate a potential buyout premium.
  • Analyst upgrades: If an influential analyst upgrades their rating on a small-cap biotech stock, it can increase investor interest and drive up the stock price.

Companies You May Want to Watch

There is data and information on well-over 200 small-cap biotech companies on Channelchek. Below is a select group that investors may want to follow. 

Cocrystal (COCP): Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses.

Axcella (AXLA): Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator compositions. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis.

Tonix Pharmaceutical (TNXP): Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system, rare disease, immunology and infectious disease product candidates.

Onconova Therapeutics (ONTX):   Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

MAIA Biotechnology (MAIA):   MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of cancer patients.

Ocugen (OCGN): Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The company impacts patient’s lives through innovation that forge new scientific paths.

PDS Biotechnology (PDSB):  This was positive news for PDS Biotech, but there work isn’t finished and they have other immunotherapy products in their pipeline based on proprietary T cell-activating technology.

Take Away

As we approach the halfway point of 2023, biotech stocks that had traded sky-high during the pandemic era had been paid far less attention to since. But the tide appears to be turning as news such as that reported by PDSB, and partnerships and even acquisitions have been on the rise.

It’s an interesting sector that, for better or worse, is barely correlated with the rest of the stock market.

Paul Hoffman

Managing Editor, Channelchek

Sources

PDS Biotechnology Press Release (May 25, 2023)

PDS Biotechnology Video

Biotech M&A is Finally Rewarding Patient Investors

Posted on by phoffman@channelchek.com

The Acceleration of Biotech Acquisitions, Why it Should Continue

The pace of mergers and acquisitions (M&A) in the biotech sector has accelerated in 2023 compared to 2022 and 2021. The factors driving this increase are numerous, and there is increasing urgency on both sides, the acquirers and acquirees to find a fit. This is playing out with deal value up significantly in 2023, with noticeable acceleration as the year has progressed. During the first quarter, investors in at least eight biotech companies found themselves in enviable positions. Below is a recap of what has already happened and the perceived trend. If it continues, it could lead to 2023 seeing far more biotech deals than the previous two.

According to data from William Blair’s quarterly biopharma review, the total deal volume in the sector was elevated, although far below record highs. Total M&A value for the first quarter was $52 billion versus $88 billion for all of 2022, and $77 billion in 2021. The report shows the average deal was $630 million (versus $367 million in 2022). The upfront cash and equity has doubled from the prior year at $508 million (versus $249 million in 2022).

Later stage companies seem to be what pharmaceutical firms have the most appetite for. The phase of development of the companies most sought was Phase II or later with 100% or all of the public acquisitions in this stage. Five of the eight were in the commercial stage.  

Source: The Quarterly Rx: Q1 2023 U.S. Biopharma Recap (William Blair)

The details above are of the eight public companies that merged or were acquired during the first quarter. However, just this week alone, there have been three more biotech acquisitions announced:

  • On May 16, 2023, Merck & Co. announced that it would acquire Acceleron Pharma for $11.5 billion. Acceleron is a clinical-stage biopharmaceutical company, the acquisition will give Merck access to Acceleron’s lead drug candidate, luspatercept, which is currently in Phase 3 clinical trials for the treatment of anemia associated with chronic kidney disease.
  • On May 17, 2023, Gilead Sciences announced that it would acquire Immunomedics for $21 billion. Immunomedics is a clinical-stage biopharmaceutical company the acquisition will give Gilead access to Immunomedics’ lead drug candidate, Trodelvy, which is currently in Phase 3 clinical trials for the treatment of triple-negative breast cancer.
  • On May 18, 2023, AstraZeneca announced that it would acquire Daiichi Sankyo’s oncology business for $6.9 billion. Daiichi Sankyo’s oncology business includes a portfolio of marketed and late-stage cancer drugs. The acquisition will give AstraZeneca a broader portfolio of cancer drugs and will help the company to expand its presence in the oncology market.

What is Driving the Acceleration?

There are a number of “not-so-secret” factors that are helping the acceleration of M&A activity in the biotech sector. One factor is the increasing cost of product development. The average cost of developing a new drug has increased from $1 billion to $2.6 billion in the past decade. This has made it increasingly difficult for small and mid-sized biotech companies to develop viable candidates independent of big-pharma’s help. As a result, small companies are increasingly looking to merge, partner or be acquired by larger companies with deeper pockets.

Another factor driving the acceleration of M&A activity in the biotech sector is the increasing focus on innovation. Large pharmaceutical companies don’t have the talent that exists in the universe of small biotech companies. So they are increasingly looking to acquire companies with innovative technologies. These innovations can help them provide new drugs that can compete with the blockbuster drugs coming off patent in the next few years.

Finally, the acceleration of M&A activity in the biotech sector is also being driven by the increasing consolidation of the industry. In recent years, a number of large pharmaceutical companies have merged with or acquired each other. This has led to a smaller number of bigger companies that are now dominant in the industry. These companies are increasingly looking to acquire smaller companies in order to expand their product portfolios and overall reach.

Take Away

While deals in many industries, both public and private, have decelerated to a crawl, the cash-rich pharmaceutical industry giants are tactically looking to build their portfolios of next-generation treatments. And many biotech companies are in need of a lifeline to get their pipeline products the research dollars they deserve. This dynamic has accelerated public and private deals in the industry in 2023.  

The acceleration of M&A activity in the biotech sector is a trend that is not expected to end soon. This is because the factors that are driving deals are likely to remain in place. Investors looking to explore smaller biotech companies may want to keep in mind the nuances of the average company attributes that found deals in the first quarter. Top-tier research on a number of smaller companies, provided by the sectors equity analysts at Noble Capital Markets can be found here.    Company information and data on many other biotech and life sciences companies can be discovered by going to this link.

Paul Hoffman

Managing Editor, Channelchek

Sources

file:///C:/Users/prese/Downloads/WilliamBlair-Biopharma-Quarterly-Review-Q1-2023.pdf

https://community.ionanalytics.com/ma-highlights-1q23?account_created=1

https://dkf1ato8y5dsg.cloudfront.net/uploads/79/598/mahighlights1q23-final.pdf