On June 16, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its upsized underwritten public offering of 17,899,698 shares of its common stock, and to certain investors in lieu thereof, pre-funded warrants to purchase 3,030,302 shares of its common stock at an exercise price of $0.01 per share (Press release, Cogent Biosciences, JUN 16, 2022, View Source [SID1234616061]). The shares of common stock sold include 2,730,000 shares pursuant to the option to purchase additional shares granted by Cogent to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $8.25 and the public offering price of each pre-funded warrant was $8.24. The aggregate gross proceeds to Cogent from this offering were approximately $172.6 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

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The net proceeds from the offering will be used for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC acted as joint book-running managers for the offering. LifeSci Capital also acted as lead manager for the offering.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-264773) filed with the Securities and Exchange Commission (SEC), which became effective on May 24, 2022. A copy of the final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and may be obtained from the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC: Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, by telephone at 212-518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 that state or jurisdiction.

On June 16, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that has been invited to present data on reversing resistance to HER2 targeted immunotherapy at the HER2 Targeted Therapy Summit in Boston (Press release, INmune Bio, JUN 16, 2022, View Source [SID1234616042]).

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Mucin 4 (MUC4), a glycoprotein on the cell surface of some epithelial cancers, is an easily measured biomarker in women with breast cancer (BC). MUC4 expression is upregulated by soluble tumor necrosis factor (sTNF) produced by the patient’s breast cancer cells. MUC4 expression predicts worse survival in women with HER2+ BC treated with trastuzumab (p≤0.04) and predicts resistance to trastuzumab and trastuzumab based antibody drug conjugates in pre-clinical models.

Dr. Roxana Schillaci of Instituto de Biología y Medicina Experimental in Buenos Aires and RJ Tesi, M.D. have been invited to give a special joint presentation at noon on June 16 entitled Resistance to Immunotherapy Caused by MUC4 Expression in HER2+ Tumors – Bench to Bedside. The presentation will present both the science driving MUC4-based resistance mechanisms and the translation of these pre-clinical studies to the clinic. A link to the presentation can be found HERE.

Dr. Schillaci, working in collaboration with INmune Bio, has shown in preclinical studies that INB03, a novel DN-TNF biologic that neutralizes soluble TNF, reverses MUC4 expression in HER2+ BC pre-clinical models to reestablish sensitivity to trastuzumab (traz) and trastuzumab ADC (TDM-1). In addition, women with MUC4+/HER2+ BC have a cold tumor with fewer tumor infiltrating lymphocytes (TILs) than women who do not express MUC4 (p=0.018). In a nude mouse model of MUC4+HER2+ BC, the combination of INB03+traz increased the number of activated NK cells (p=0.01) and anti-tumor macrophages (p=0.01) in the tumor microenvironment (TME) and showed anti-tumor macrophage function is more important than NK cell function in controlling tumor growth.

"We have identified three reversable resistance mechanisms in women with HER2+/MUC+ breast cancer – resistance to trastuzumab, resistance to tyrosine kinase inhibitors (eg: lapatinib and tucatinib) and a "cold" immunosuppressive TME. All three resistance mechanisms are driven by soluble TNF produced by the tumor and are reversed by neutralization of soluble TNF in the TME by INB03," said Dr. Schillaci.

"We estimate that resistance to immunotherapy occurs in about a third of women with high, low or ultra-low expression of HER2," added RJ Tesi M.D., CEO of INmune Bio. "As of result of the rapidly changing trastuzumab-based immunotherapy landscape, half of all women with breast cancer are at risk for trastuzmab resistance. MUC4 is a biomarker of resistance that can be determined by staining of patient’s breast cancer biopsy enabling a clinical team to prospectively adjust treatment to potentially improve outcome."

About INB03

INB03 is a DN-TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF) or TNF receptors. Compared to currently available non-selective TNF inhibitors, INB03 preserves the immune response to cancer by decreasing immunosuppressive cells in the TME including TAM and MDSC while promoting recruitment of anti-tumor immune cells including cytolytic CD8+ lymphocytes, NK cells and anti-tumor macrophages. INB03 has completed an open label dose-escalation Phase I trial in patients with advanced cancer. In that trial, INB03 was found to be safe and well tolerated – no dose limiting toxicity was found. INB03 decreased blood biomarkers of inflammation in patients with advanced cancer. INMB is planning a Phase II trial that uses IN03 as part of combination therapy. More information about INB03 can be found by clicking here.

On June 16, 2022 Invectys, Inc. (Invectys), The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), a joint venture between MD Anderson and National Resilience, Inc., reported a strategic collaboration to jointly develop a reliable, compliant and scalable process for human leukocyte antigen (HLA)-G targeted chimeric antigen receptor (CAR) T cell therapy for solid tumors (Press release, Invectys, JUN 16, 2022, View Source [SID1234616043]).

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The collaboration will build upon the HLA-G platform pioneered by Invectys to advance novel CAR T cell therapies through preclinical development with CTMC into early-phase clinical studies at MD Anderson. The collaboration brings Invectys’ technology together with the cell therapy development and manufacturing expertise of CTMC and the clinical trials expertise of MD Anderson.

Uniting the complementary capabilities of Resilience and MD Anderson, CTMC was launched to accelerate the development and manufacturing of innovative cell therapies for patients with cancer.

"This agreement is truly about joining the strengths of each collaborator for the benefit of cancer patients," said Praveen Tyle, Ph.D., President and Chief Executive Officer of Invectys. "Invectys is a cancer immunotherapy company developing novel approaches to target HLA-G. With our combined expertise and shared goals, we can act quickly to advance impactful new cell therapies."

The HLA-G molecule is a powerful modulator of the human immune system that is normally found during pregnancy, when it acts to protect the fetus from rejection by the mother’s immune system. However, HLA-G is aberrantly expressed in cancer, making it an attractive tumor-specific antigen because the HLA-G tumor cells suppress a patient’s own innate immune responses. Invectys’ technology is designed to target and remove tumor cells that express HLA-G, thus reducing these immunosuppressive effects and thereby reactivating the patient’s own immune system.

"Immunotherapies have revolutionized the treatment landscape for cancer, but currently approved treatments are able to overcome immune suppression only in limited groups of patients," said Aung Naing, M.D., professor of Investigational Cancer Therapeutics at MD Anderson. "This novel HLA-G technology can revitalize immune cells by identifying and killing solid tumor cancer cells, thereby offering the potential to improve treatment outcomes for a wider group of cancer patients."

Together with researchers at Invectys, the CTMC team will work to develop a clinical-grade HLA-G targeted CAR T cell therapy for solid tumors that can be produced at scale. The collaboration will facilitate therapeutic development toward a Phase I clinical trial to be co-led by Naing and Samer Srour, M.D., assistant professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.

"CTMC was established to accelerate patient impact by addressing the hurdles associated with the development and manufacturing of cell therapies," said Jason Bock, Ph.D., Chief Executive Officer of CTMC. "We are excited to work with the Invectys team and their unique technology to enable the anti-HLA-G CAR T cell therapy to reach its full potential, hopefully bringing an effective new treatment option to patients in need."

On June 16, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark (Press release, Hoffmann-La Roche, JUN 16, 2022, View Source [SID1234616241]). This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas HPV test on a Roche molecular instrument.
Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment, and cultural influences. Roche’s self-sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.

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"The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer," said Thomas Schinecker, CEO Roche Diagnostics.

In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation’s global strategy to eliminate cervical cancer and reduce the overall mortality rate.3

About the cobas HPV test

The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. Test performance for this new sampling method demonstrates that selfcollected vaginal specimens tested using a molecular technology are fully adequate, and provide
results that are comparable to clinician-collected cervical samples.

Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas Systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers4 – and reporting the 12 other high-risk HPV types as a combined result, all in
one test and from one patient sample. More information about the cobas HPV tests is available at diagnostics.roche.com/cervicalcancer or cervicalcancer-screening.com.

The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. Learn more now: View Source

On June 16, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported the closing of its acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, JUN 16, 2022, View Source [SID1234616044]).

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The combined entity will focus on maximizing its extensive pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, colorectal cancer prevention and ovarian cancer.

"Closing this transaction achieves our goal of creating a diversified pipeline with an ability to hit multiple targets, four clinical stage assets, two of which are late-stage registration assets, thereby increasing the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Together, our capabilities will have an even greater chance to help more patients. The addition of CPP is an excellent fit that we feel produces substantial shareholder value."

The closing of the merger follows the satisfaction of all customary closing conditions, including the unanimous approval by the boards of directors of each company and the stockholders of CPP.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.