On January 24, 2023 Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, reported an agreement with AstraZeneca and Daiichi Sankyo, for the development, clinical validation and early adoption of an AI-powered product to aid pathologists with an accurate and reproducible assessment of HER2 immunohistochemistry (IHC) scoring in breast cancer patients (Press release, Ibex Medical Analytics, JAN 24, 2023, https://www.prnewswire.com/news-releases/ibex-medical-analytics-enters-collaboration-with-astrazeneca-and-daiichi-sankyo-to-develop-ai-based-her2-scoring-product-301729092.html [SID1234626511]).

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Scoring of HER2 (human epidermal growth factor receptor 2) protein expression in breast cancer is used to identify patients who are likely to benefit from HER2-directed therapies. Currently, pathologists routinely score HER2 in tumor samples visually using a microscope, which can be challenging in cases of low HER2 expression as scoring is subjective and may lead to varied interpretations. Computational tools developed using Artificial Intelligence have the potential to support pathologists in accurate and objective scoring of HER2, which can help oncologists in selecting therapies that are approved for treating patients with HER2-positive or HER2-low breast cancer.

"Recognizing the vital role pathologists play in the diagnosis and treatment of cancer patients, we are thrilled to partner with AstraZeneca and Daiichi Sankyo to clinically validate our automated HER2 scoring product and offer it to laboratories around the world," said Joseph Mossel, Co-founder and CEO of Ibex Medical Analytics. "As the most commonly diagnosed cancer in women, this collaboration will allow pathologists to utilize our technology to optimize breast cancer diagnosis and ultimately improve the identification of patients eligible for HER2-directed therapy."

Ibex’s Galen Breast HER2 is an IHC scoring product that detects tumor areas and quantifies HER2 expression into four standard categories, 0, 1+, 2+ and 3+, based on the 2018 ASCO (Free ASCO Whitepaper)/CAP scoring guidelines1. As part of this collaboration, Ibex will work with AstraZeneca and Daiichi Sankyo to develop and clinically validate its HER2 IHC scoring product and generate evidence that further supports adoption of the technology.

A multi-site validation study on Galen Breast HER2 involved a cohort of 453 breast tumors of diverse subtypes. The study demonstrated that Galen’s AI algorithm provides an accurate and automated HER2 score for pathologists and was recently presented at the San Antonio Breast Cancer Symposium2.

Beyond this collaboration, Ibex supports pathologists with AI-based diagnostic solutions that help detect and grade different types of invasive and non-invasive breast cancer and other tumor types, and are used in everyday practice in laboratories, hospitals and health systems worldwide. Ibex’s Galen Breast solution demonstrated robust outcomes in detecting and grading multiple types of breast cancer and other clinically relevant features across clinical studies performed on numerous diagnostic workflows, one of which was recently published in Nature’s peer-reviewed npj Breast Cancer journal3,4.

In addition to HER2, Ibex is further expanding Galen Breast to include automated quantification of additional IHC-stained slides, such as ER, PR and Ki-67, intended to provide pathologists with a comprehensive set of tools for breast cancer diagnosis. With these expanded capabilities, Galen Breast may further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, improving treatment decisions and patient care.

On January 24, 2023 CTI BioPharma Corp. (NASDAQ: CTIC) reported that an authorized subcommittee of the Compensation Committee of its Board of Directors granted an equity award to a new employee as an equity inducement award outside of the Company’s Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employee’s acceptance of employment with the company (Press release, CTI BioPharma, JAN 24, 2023, View Source [SID1234626510]). The equity award was approved on January 23, 2023, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employee received options to purchase 22,000 shares of CTI BioPharma common stock. The options will be issued upon the employee’s grant date (the "Grant Date"), and all stock options included within the equity inducement award will have an exercise price equal to the closing price of CTI BioPharma common stock on the Grant Date. One-fourth of the options will vest on each anniversary of the employee’s Grant Date, subject to the employee’s continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

On January 24, 2023 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported positive interim data from Part A of the ongoing RAMP 201 (ENGOTov60/GOG3052) international registration-directed Phase 2 study evaluating the safety and efficacy of avutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer (LGSOC) (Press release, Verastem, JAN 24, 2023, View Source [SID1234626509]). The Company is also providing a regulatory update following a productive meeting with the U.S. Food and Drug Administration (FDA).

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"The interim data from the ongoing phase 2 RAMP 201 trial show that the combination of avutometinib with defactinib yields encouraging response rates with a well-tolerated safety profile in women with heavily pre-treated recurrent low-grade serous ovarian cancer," said Dr. Susana Banerjee, MBBS, MA, PhD, FRCP, global lead investigator of the study, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London. "The contribution of defactinib, rates of tumor shrinkage in both KRAS mutant and KRAS wild-type LGSOC and a high disease control rate seen so far are important initial findings leading to the decision to move forward with the combination regimen. We look forward to the final analysis."

Results of RAMP 201 Part A Interim Analysis

The objective of Part A (selection phase) of the RAMP 201 LGSOC study was to select the go forward regimen between avutometinib monotherapy or the combination of avutometinib and defactinib to be studied in Part B (expansion phase) of the study. In addition, the efficacy was assessed in both KRAS mutant and KRAS wild type LGSOC. Part A randomized eligible patients to avutometinib monotherapy (n=33) or the combination of avutometinib and defactinib (n=31). The combination of avutometinib and defactinib has been declared the go forward treatment regimen based on a higher rate of confirmed objective responses in a planned interim analysis with prespecified criteria.

Overall, patients on the combination arm were heavily pretreated with an average of 4 prior systemic regimens (up to 11), including prior platinum-based chemotherapy, endocrine therapy and bevacizumab in most patients and prior MEK inhibitor therapy in about 20% of patients.

Of the 29 patients evaluable for response by blinded independent central review (BICR) in the combination arm, the initial results showed a confirmed objective response rate (ORR) of 28% in all patients and 27% vs 29% in KRAS mutant (n=15) and KRAS wild-type (n=14) LGSOC, respectively. Three additional patients with KRAS mutant LGSOC showed an unconfirmed partial response. In addition, the vast majority of patients showed tumor regression, as the overall disease control rate (stable disease plus partial response) was 93%. Most evaluable patients (62%) were still on study treatment on the combination arm at the time of the data cut with a minimum follow-up of 5 months.

The confirmed ORR for the monotherapy arm by BICR was 7% in evaluable patients (n=30). The overall disease control rate for the monotherapy arm by BICR was 90%.

Across both the combination and monotherapy arms, there have been no additional safety signals reported with a continued favorable safety and tolerability profile. The most common treatment-related adverse events for the combination in all treated patients were diarrhea, nausea, blood creatine phosphokinase (CPK) increased, vision blurred, dermatitis acneiform and rash, fatigue and peripheral edema, most of which were mild to moderate, with 9% discontinuation due to adverse events.

"LGSOC is a difficult disease to treat and one in urgent need of more effective and tolerable therapies. The majority of patients with LGSOC present with advanced stage disease and experience chronic symptoms from their cancer. Prior studies have shown disappointing response rates with conventional chemotherapy or hormonal therapy and there are currently no agents that are FDA approved specifically for the treatment of this cancer," said Rachel N. Grisham, M.D., Section Head, Ovarian Cancer and Director, Westchester Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center NY, and the study’s principal US investigator. "The interim positive data from RAMP 201 are encouraging and indicate the combination of avutometinib and defactinib remains a promising approach for treating patients with recurrent LGSOC."

Target enrollment for the combination arm in RAMP 201 has been achieved. The Company is planning a RAMP 201 presentation at a scientific conference in mid-2023.

Regulatory Update Following Type B FDA Meeting on LGSOC Program

A recent FDA meeting was held to discuss the encouraging results to date of the ongoing RAMP 201 trial evaluating avutometinib ± defactinib among patients with recurrent LGSOC, confirm the go forward treatment regimen selection and discuss the regulatory path forward. The combination of avutometinib with defactinib has been selected vs monotherapy as the go forward treatment in all recurrent LGSOC regardless of KRAS status, acknowledging the demonstrated contribution of defactinib.

The Company intends to include mature data from RAMP 201, the Verastem sponsored clinical trial, and the FRAME study, led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust to potentially support filing for accelerated approval. Both studies are evaluating avutometinib and defactinib in patients with recurrent LGSOC. The Company is in ongoing discussions with the FDA on the confirmatory study and plans to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.

"We appreciate the productive and ongoing discussions with the FDA regarding the progress of our LGSOC program, including the alignment around key next steps as part of our breakthrough therapy designation," said Brian Stuglik, CEO of Verastem Oncology. "With the encouraging results of the RAMP 201 Part A interim analysis and the FRAME study, we will work expeditiously to prepare to file for an accelerated approval that encompasses the totality of the data from both trials as well as progress on the confirmatory study."

Conference Call, Presentation and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Tuesday, January 24, 2023, at 6:00 PM ET. The conference call can be accessed by clicking here. The webcast of the conference call and accompanying slides can also be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

Dr. Banerjee and Dr. Grisham have consulting relationships with Verastem Oncology.

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. As part of the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate. Approximately 6,000 women in the U.S. and 80,000 worldwide are living with this disease. Mutations in the KRAS gene are present in 30% of cases of LGSOC. LGSOC is most often diagnosed in women between the ages of 45-55 years and has a median survival of approximately ten years. The majority of patients experience severe pain and complications as the disease progresses. Chemotherapy is the standard of care for this disease, with limited treatment options currently available.

About RAMP 201

Verastem Oncology has initiated a Phase 2 registration-directed trial evaluating avutometinib alone and in combination with defactinib in patients with recurrent LGSOC as part of RAMP (Raf And Mek Program). RAMP 201 (ENGOTov60/GOG3052) is an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT) and the Gynecologic Oncology Group (GOG) and sponsored by Verastem Oncology. It is an adaptive, two-part multicenter, parallel cohort, randomized, open-label trial to evaluate the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. The first part of the study will determine the optimal regimen of either avutometinib monotherapy or in combination with defactinib in patients with recurrent LGSOC randomized 1:1 in each treatment arm. The determination of which regimen to take forward into the expansion phase of the trial will be made based on objective response rate data. The expansion phase of the study will examine efficacy and safety parameters of the regimen selected.

On January 24, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has entered into a definitive agreement to sell approximately 2.1 million shares of its Series B Convertible Preferred Stock (the "Preferred Stock") to affiliates of BVF Partners L.P. in a private placement to raise aggregate gross proceeds of up to approximately $60 million in two tranches, before deducting fees to the placement agent and other estimated offering expenses payable by the Company (Press release, Verastem, JAN 24, 2023, View Source [SID1234626508]). The initial tranche, consisting of 1.2 million shares of Preferred Stock for gross proceeds of approximately $30 million, representing a purchase price per common share equal to $0.5901, is anticipated to close on January 27, 2023, subject to the satisfaction of customary closing conditions. The second tranche, consisting of 0.9 million shares of Preferred Stock for gross proceeds of approximately $30 million, resulting in a purchase price per common share equal to $0.75, will close within seven trading days of the Company’s common stock trading for a 10-day volume weighted average price of at least $1.125 per share with aggregate trading volume during the same 10-day period of at least $25 million within 18 months from the closing date of the initial tranche.

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Truist Securities acted as sole placement agent for the private placement.

The shares of Preferred Stock are convertible into the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at the option of the holders at any time, subject to certain limitations, at a conversion rate equal to $0.5901 per share, a premium above the 5 day average closing price of $0.5860 as of January 24, 2023. The holders will initially be prohibited from converting Preferred Stock into Common Stock if, as a result of such conversion, any holder, together with its affiliates, would beneficially own 9.99% or more of the total Common Stock then issued and outstanding immediately following the conversion of such shares of Preferred Stock.

Shares of Preferred Stock will have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Preferred Stock will be required to amend the terms of the Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, holders of Preferred Stock are entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of the Common Stock, an amount equal to $1.00 per share of Preferred Stock ("Liquidation Preference"). After payment of the Liquidation Preference, each holder of shares of Preferred Stock shall be entitled to participate pari passu with the holders of the Common Stock on an as-converted basis. Holders of Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the Common Stock, an equivalent dividend, calculated on an as-converted basis. Shares of Preferred Stock are otherwise not entitled to dividends.

The Preferred Stock ranks (i) senior to all of the Common Stock; (ii) senior to all other classes and series of equity securities of the Corporation that by their terms do not rank senior to the Preferred Stock; (iii) senior to all shares of the Company’s Series A Convertible Preferred Stock; (iv) on parity with any class or series of capital stock of the Company hereafter created specifically ranking by its terms on parity with the Preferred Stock; (v) junior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms senior to any Preferred Stock; and (vi) junior to all of the Company’s existing and future debt obligations.

Verastem intends to use the net proceeds from the private placement for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial expenditures, commercial expenditures, milestone payments under in-license agreements, and possible acquisitions.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Preferred Stock and the shares of Common Stock issuable upon the conversion of the Preferred Stock issued in the private placement no later than the 10th day after the filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On January 24, 2023 Precigen, Inc. (Nasdaq: PGEN) reported it has commenced an underwritten public offering of $75.0 million of its common stock (Press release, Precigen, JAN 24, 2023, View Source [SID1234626507]). In addition, Precigen intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the offering. All of the shares in the proposed offering are to be sold by Precigen.

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J.P. Morgan Securities LLC is acting as the lead book-running manager for the offering. Cantor Fitzgerald & Co. is also acting as book-running manager. JMP Securities, a Citizens company, is acting as lead manager and H.C. Wainwright & Co., LLC is acting as co-manager.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (SEC) and became effective on July 2, 2020. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and base prospectus relating to this offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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