On October 21, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported it has closed its previously announced registered direct offering with institutional investors for the purchase and sale of 2,048,294 shares (the "Shares") of common stock at a price of $1.30 per share and concurrent private placement of common warrants (the "Warrants") to purchase up to 2,662,782 shares of common stock at an exercise price of $1.50 per common share for gross proceeds of $2,662,782 before deducting placement agent fees and other offering expenses payable by the Company (Press release, BioAffinity Technologies, OCT 21, 2024, View Source [SID1234647295]). The Warrants are initially exercisable on the date that the Company’s stockholders approve the exercise of the Warrants and the issuance of the shares upon exercise thereof and will expire five years from the date of such approval.

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The Company intends to use the net proceeds from the offering for general corporate purposes, including using funds for working capital.

WallachBeth Capital acted as sole placement agent for the offering.

The Shares of common stock were issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No: 333-275608) previously filed with the U.S. Securities and Exchange Commission (SEC), under the Securities Act of 1933, as amended, and declared effective by the SEC on Nov. 27, 2023. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA. The private placement of the Warrants will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On October 21, 2024 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, ranked among the nation’s top 5 cancer centers by U.S. News & World Report and a national leader in providing cancer patients with best-in-class, integrated supportive care programs, reported that it will present new data on integrative oncology research and clinical trials at the 21st International Conference of the Society for Integrative Oncology taking place Oct. 25 to 27 (Press release, City of Hope, OCT 21, 2024, View Source [SID1234647294]).

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Integrative oncology is a patient-centered field of cancer care that combines conventional cancer treatments with complementary, evidence-based therapies to improve outcomes and quality of life. The hybrid conference hosted by City of Hope in Costa Mesa, California, will include more than 170 oral and poster abstracts evaluating supplements and herbal therapies, traditional medicine such as acupuncture, lifestyle choices like diet and exercise, mind-body practices, and use of artificial intelligence and machine learning in integrative oncology.

"City of Hope and other experts will share the best science that’s occurring in the field of integrative oncology, which aims to optimize health, quality of life and clinical outcomes," said Richard T. Lee, M.D., Cherng Family Director’s Chair for the Center for Integrative Oncology at City of Hope, medical director of supportive and integrative medicine at City of Hope Orange County and co-chair of the SIO conference. "City of Hope is leading a national effort to make evidence-based integrative oncology a routine and interwoven part of optimal cancer care and survivorship. City of Hope is bringing together leaders in the field to create the most holistic approach to cancer care."

A $100 million gift from Panda Express Co-CEOs Andrew and Peggy Cherng has enabled City of Hope to lead efforts to accelerate research, therapeutic development and clinical trials for the advancement of evidence-based integrative oncology practices so that cancer patients nationwide and their doctors have access to safe, proven approaches.

Some of the leading-edge data City of Hope will present include the following oral abstracts.

Massage therapy during infusion lessens the side effects of chemotherapy in a pilot study
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m.
Christy DiCristofano, a City of Hope massage therapist, led a pilot study assessing the therapeutic effects of massage on cancer patients. The research team surveyed 232 individuals who collectively received 500 hand and/or foot massages while undergoing an infusion. They found that massage therapy is a beneficial additional treatment for symptoms induced by chemotherapy. The therapy had no reported side effects and proved useful in managing symptoms, such as anxiety, pain, shortness of breath, nausea and neuropathy, which is marked by shooting pain, numbness or tingling. Further research is needed to comprehensively evaluate the benefits of this intervention during infusion.

Increasing white button mushroom intake could slow the progression of prostate cancer
Presentation time and location: Sunday, Oct. 27 in the Lido Room from 10:45 a.m. to noon
Bidirectional translational research led by Xiaoqiang Wang, M.D., Ph.D., City of Hope staff scientist, and Shiuan Chen, Ph.D., professor and chair of City of Hope’s Department of Cancer Biology and Molecular Medicine and the Lester M. and Irene C. Finkelstein Chair in Biology, revealed that consuming white button mushrooms can alter androgen levels and boost anti-cancer immunity. The comprehensive research included preclinical experiments, mouse models and prostate cancer patients participating in an ongoing phase 2 clinical trial. The physician-scientists collected blood samples from both mouse models and humans, analyzing myeloid-derived suppressor cells that are responsible for squelching immune responses and assisting tumor growth. They found that consuming white button mushrooms enhances anti-tumor immunity and slows prostate cancer progression. They expect to learn more once the phase 2 clinical trial is completed.

Can intermittent fasting decrease the side effects of radiotherapy and enhance its efficacy?
Presentation time and location: Friday, Oct. 25 in the Mesa Verde Room from 2:30 to 3:45 p.m.
Several clinical and preclinical studies suggest that time-restricted eating, more commonly called intermittent fasting, may enhance anti-tumor response, decrease side effects and improve quality of life during systemic therapy. Ziyi Huang, M.D., City of Hope research fellow, and Yun Rose Li, M.D., Ph.D., assistant professor of radiation oncology at City of Hope, are leading an ongoing randomized phase 2 trial testing whether patients with pelvic malignancies who practice time-restricted eating could experience reduced levels of radiotherapy-induced side effects and enhanced radiotherapy efficacy. The time-restricted eating group are asked to fast for 12 to 14 hours on radiotherapy days. Researchers collect diet logs, stool, urine and blood samples alongside patient- and clinician-reported toxicities. Thus far, the results are encouraging and support the tolerability and feasibility of intermittent fasting during pelvic radiotherapy, especially among patients with prostate cancer. Enrollment in the trial is expected to be completed in spring 2025.

Nurses can videoconference cancer patients to provide supportive care and improve quality of life
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m.
Psychosocial support services can be limited in small urban and rural areas. Up to 70% of patients with advanced cancer experience elevated levels of fear of cancer progression characterized by intrusive thoughts, distress and difficulty making future plans. Anne Reb, Ph.D. N.P., assistant professor of nursing research and education at City of Hope, and Betty Ferrell, Ph.D., M.S.N., CHPN, City of Hope director and professor of nursing research and education, led a pilot study to assess the feasibility and preliminary effects of a nurse-guided videoconferencing intervention to manage fear of cancer progression levels in patients with Stage 3 or 4 gynecologic or lung cancer. Some 82% of the 30 study participants completed all five nurse-led videoconferencing sessions and reported using the tools the nurses introduced like attention training and detached mindfulness to focus, connect with what is most important to them and gain control over daily life stressors. The intervention showed improvement in fear and other quality-of-life outcomes. Feasibility and acceptability was established in this small sample size and suggestions for improvement were established.

The potential risk of drug interactions with cannabis use
Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 11:30 a.m. to 12:45 p.m.
In one of the first studies to assess cannabis-related drug interactions in patients receiving cancer treatment, Elyssa Kim, B.S., former City of Hope research assistant, and Richard T. Lee, M.D., City of Hope clinical professor of supportive and integrative medicine, found that a significant proportion of cannabis users are at risk of moderate to major potential medication interactions. Of the 313 participants, 61 were actively using a form of cannabis to address insomnia (46%), pain (41%) and mood (39%). The most common medications whose effectiveness could be compromised due to cannabis use were noted to be medications for pain or inflammation (acetaminophen, dexamethasone), anti-nausea (ondansetron) and even chemotherapy (paclitaxel, doxorubicin). Researchers say that more states are legalizing cannabis and more cancer patients turn to cannabis to alleviate cancer symptoms, but we need more data on the therapeutic effects and pitfalls of cannabis use during cancer treatment.

A mix of mindfulness meditation, gentle exercise and spirituality is linked to improved emotional well-being among breast cancer survivors
Presentation time and location: Saturday, Oct. 26 in the Lido Room from 11:30 a.m. to 12:45 p.m.
Breast cancer survivors often report experiencing anxiety, depression, poor sleep and cognitive impairment. Frank Munoz, a City of Hope chaplain, conducted a pilot study of meditative movement effects on this patient population, taking blood samples to measure serotonin-related (HTR1F and SLC6A4) and mood/cognitive function-related (BDNF, IL6 and IL1b) gene expression levels. The intervention resulted in a biological change in scores of anxiety, depression, sleep quality and cognitive function. This small study, which demonstrated changes in gene expression, suggests that meditative movement such as tai chi and meditation may help breast cancer survivors recover from persistent mental and emotional symptoms.

On October 22, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the strengthening of a previously announced co-development agreement with Orano Med, a clinical-stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), where both companies will develop and market 212Pb-based Radio-DARPin Therapeutics for the treatment of cancer (Press release, Molecular Partners, OCT 21, 2024, https://investors.molecularpartners.com/news-releases/news-release-details/molecular-partners-and-orano-med-strengthen-agreement-co-develop [SID1234647291]).

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This revision builds on the original agreement signed in January 2024, under which both companies agreed to co-develop Radio-DARPin Therapeutics. For the first program, MP0712, a DLL3-targeting Radio-DARPin, Molecular Partners holds the commercialization rights. The amended agreement now targets four programs, with each company holding the commercialization rights to two of these programs. Both companies anticipate initiating first-in-human studies for MP0712, pending regulatory clearance, in 2025. Molecular Partners will hold the second program’s commercialization rights, and Orano Med will have the rights to develop and commercialize programs three and four.

"The continued progress and strengthening of our collaboration with our partner Orano Med is a strong testament not only to the DARPin platform, but also to the strong teamwork between our companies. Behind DLL3, slated to go into clinical development in 2025, we are building a strong portfolio of candidates," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Molecular Partners expects no immediate impact on its financial forecast for the fiscal year 2024 from the expansion of the co-development agreement and maintains its funding guidance into 2027. Cash and cash equivalents (including short-term time deposits) as of September 30, 2024, are currently estimated at approximately CHF 140 million (unaudited).

On October 21, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported that they will be participating in and hosting two webinars that are open to the public during October (Press release, Lantern Pharma, OCT 21, 2024, View Source [SID1234647290]).

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Lantern expects to discuss in detail how big data and AI are being leveraged to advance the development of multiple indications for drug-candidates LP-184 and LP-284 during the "Leveraging Artificial Intelligence to Develop Therapies for Brain and Childhood Cancers". Lantern will also discuss how their algorithm for blood-brain-barrier (BBB) penetrability played a critical role in supporting the development of LP-184 across multiple CNS cancer indications, including GBM. This webinar will be hosted by Tribe Public and feature Panna Sharma, Lantern’s President and CEO. Both LP-184 and LP-284 are currently enrolling patients in Phase 1 trials.

Webinar Wednesday will focus on Lantern’s AI-focused collaboration with Actuate Therapeutics, a clinical-stage biopharmaceutical company that went public in August 2024. Andrew Mazar, Ph.D., Chief Operating Officer of Actuate, and Lantern’s computational biologist Joseph McDermott, Ph.D., will discuss the multi-year research and development collaboration that accelerated the development of Actuate’s lead drug candidate, Elraglusib.

Links to Register for October Webinars

Tribe Public Webinar on October 28, 2024 – https://bit.ly/3BVgPb5
Lantern Pharma Webinar Wednesday on October 30, 2024 – https://bit.ly/3YsL2XN

On October 21, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the first patient has been dosed in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Revolution Medicines, OCT 21, 2024, View Source [SID1234647288]).

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RASolute 302 is a global, randomized, open-label Phase 3 study designed to evaluate the safety and efficacy of RMC-6236 monotherapy for patients with metastatic pancreatic cancer compared with standard of care chemotherapy. The trial is anticipated to enroll approximately 460 patients worldwide who had received one prior line of therapy with a 5-fluorouracil (5-FU)-based or gemcitabine-based regimen. The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation. The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov.

"Treating the first patient in RASolute 302 is a significant milestone for Revolution Medicines as we seek to revolutionize treatment for patients with RAS-addicted cancers," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "RMC-6236 is designed to directly inhibit RAS(ON) signaling, which is the primary oncogenic driver of pancreatic cancer. Supported by the encouraging initial PFS and OS observations and safety profile reported from the Phase 1 RMC-6236 monotherapy trial, the randomized RASolute 302 trial will formally assess the potential for this bold investigational drug to make a meaningful difference for people living with metastatic PDAC, one of the most difficult-to-treat cancers."

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.

About RMC-6236
RMC-6236 is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. RMC-6236 suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so across oncogenic RAS mutations G12X, G13X and Q61X, in major cancers including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).