On December 6, 2022 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with diseases of the immune system, reported that it has commenced an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and accompanying warrants to purchase shares of its common stock (or pre-funded warrants) (Press release, X4 Pharmaceuticals, DEC 9, 2022, View Source [SID1234624995]). In addition, X4 expects to grant the underwriters a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities in the offering will be sold by X4. 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 actual size or terms of the offering.

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Piper Sandler, Stifel and Cantor are acting as joint book-running managers for the offering.

The offering will be made only by means of a written prospectus and related prospectus supplement forming part of a shelf registration statement on Form S-3 that was originally filed with the Securities and Exchange Commission (SEC) on October 19, 2020 and declared effective by the SEC on October 26, 2020. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available at the SEC’s website located at www.sec.gov, copies of which may be obtained, when available, from: Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at 415-364-2720 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected].

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 other 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 other jurisdiction.

On December 9, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a clinical collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) to evaluate the safety and anti-leukemia activity of pivekimab sunirine (pivekimab) in combination with magrolimab, a potential, first-in-class, investigational CD47 inhibitor, in patients with relapsed or refractory (R/R) CD123-positive acute myeloid leukemia (AML) (Press release, ImmunoGen, DEC 9, 2022, View Source [SID1234624994]).

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"AML is the most common form of acute leukemia among adults and accounts for the largest number of deaths from leukemia in both the United States and Europe," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "Given the potentially complementary mechanisms of action, the limited overlap in safety profiles, and the encouraging data seen with each agent in combinations to date, we are excited to explore this novel doublet in patients with relapsed/refractory AML, where few effective treatment options exist."

Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen’s 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML. The primary endpoint for this cohort is complete response (CR) rate. ImmunoGen’s 802 study is an open-label, multicenter, Phase 1b/2 trial to determine the safety and tolerability of pivekimab and assess the anti-leukemia activity of the agent when administered in combination with Vidaza (azacitidine) and/or Venclexta (venetoclax) in patients with relapsed and frontline CD123-positive AML.

ABOUT PIVEKIMAB SUNIRINE

Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the U.S. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN.

ABOUT MAGROLIMAB

Magrolimab is a potential, first-in-class, investigational treatment designed to inhibit the CD47 protein. CD47 binds to receptors on macrophages to transmit a "don’t eat me" signal used by cancer cells to escape natural cell death, called phagocytosis. Targeting the CD47 protein, magrolimab is intended to restore phagocytosis. Magrolimab is being studied in several hematologic cancers as well as solid tumor malignancies. Granted Fast Track Designation by the FDA for the treatment of myelodysplastic syndrome (MDS), AML, diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, magrolimab has also been granted Orphan Drug Designation by the FDA for MDS and AML and by the European Medicines Agency for AML. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.

Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established.

ABOUT ACUTE MYELOID LEUKEMIA (AML)

AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, more than 20,000 people will be diagnosed with AML this year and more than 11,000 will die from the disease.

On December 9, 2022 iBio, Inc. (NYSEA: IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported the closing of its previously announced underwritten public offering of an aggregate of 3,365,385 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,870,192 shares of common stock and Series B warrants to purchase up to 3,870,192 shares of common stock, at a combined public offering price of $1.04 per share (or pre-funded warrant in lieu thereof) and accompanying warrants, which includes the purchase of additional warrants to purchase up to 1,009,614 shares of common stock purchased pursuant to the partial exercise of the underwriter’s option to purchase additional Series A warrants and Series B warrants to purchase (Press release, iBioPharma, DEC 9, 2022, View Source [SID1234624993]). The Series A warrants have an exercise price of $1.04 per share, are exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series B warrants have an exercise price of $1.04 per share, are exercisable immediately upon issuance and will expire twenty-four months from the date of issuance.

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In connection with the offering, the Company granted the underwriter a 30-day option to purchase 504,807 additional shares of its common stock and/or warrants to purchase up to 1,009,614 additional shares of its common stock at the public offering price, less underwriting discounts and commissions, which the underwriter partially exercised on December 8, 2022 with respect to the warrants to purchase up to 1,009,614 additional shares of common stock.

H.C. Wainwright & Co. is acting as sole book-running manager for the public offering.

The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $3.5 million. The Company intends to use the net proceeds from the offering primarily for operating costs, including for research and development and other trial preparation expenses in addition to working capital needs and for other general corporate purposes, which may include retention and severance payments to certain of our employees or former employees and principal payments pursuant to the terms of its amended Credit Agreement.

The securities described above were offered by iBio pursuant to a shelf registration statement on Form S-3 (File No. 333-250973) that was previously filed with the Securities and Exchange Commission (the "SEC") on November 25, 2020 and became effective on December 7, 2020. The securities have been offered only by means of a prospectus, including a prospectus supplement filed with the SEC on December 8, 2022, forming a part of the effective registration statement. Electronic copies of the final prospectus supplement and accompanying base prospectus disclosing the final terms of the offering has been filed with the SEC and may be obtained on the SEC’s website at www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

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

On December 9, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported initial clinical validation data for its breast cancer radiation signature, Profile for the Omission of Local Adjuvant Radiotherapy (POLAR), at the 2022 San Antonio Breast Cancer Symposium (SABCS) (Press release, Exact Sciences, DEC 9, 2022, View Source [SID1234624992]). The meta-analysis of three independent, randomized clinical trials identified which early-stage breast cancer patients benefited from radiotherapy after breast-conserving surgery.

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POLAR is the first genomic signature that is both prognostic for the risk of local regional recurrence and predictive of radiotherapy benefit. The analysis found that patients at low risk for local regional recurrence following breast-conserving surgery did not benefit from radiotherapy (~25% of patients). SABCS selected this meta-analysis as part of its press program.

"Exact Sciences’ POLAR signature addresses a significant clinical need for those with early-stage, hormone receptor positive breast cancer, identifying which patients may benefit from radiotherapy and which may not," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Like chemotherapy, radiation therapy has significant physical, mental, and monetary costs associated with it. These data are a critical step toward providing patients with a new tool to help ensure better breast cancer treatment decisions."

The meta-analysis included 623 patients with lymph node-negative, estrogen receptor-positive, HER2-negative breast cancer who were enrolled in one of three randomized clinical trials, the Swedish SweBCG91RT trial, Scottish Conservation Trial, and Canadian trial from the Princess Margaret Hospital, examining the efficacy of breast-conserving surgery with and without local breast radiation therapy.

"In a patient-level meta-analysis, the POLAR gene profile successfully predicted which patients would and would not benefit from local radiation therapy," said lead author Per Karlsson, M.D., professor of oncology at the Sahlgrenska Comprehensive Cancer Center and the University of Gothenburg in Sweden. "To our knowledge, POLAR is the first genomic classifier that is both prognostic for the risk of local regional recurrence and predictive of radiotherapy benefit following breast-conserving surgery.

To validate the POLAR signature as both prognostic and predictive, the investigators analyzed gene expression in breast tumor samples to assign each patient a POLAR score. They then examined the impact of radiation therapy for patients with high and low scores. Among the 479 patients with high POLAR scores, those who did not receive adjuvant radiation therapy after breast-conserving surgery had a 63 percent greater risk of local recurrence compared with those who did receive adjuvant radiation therapy. For the 194 patients with low POLAR scores, there was no significant difference in local recurrence rate between those who received adjuvant radiation therapy and those who did not. After 10 years, five percent of patients who received radiation therapy experienced a local recurrence, compared with seven percent of those who did not receive radiation therapy.

On December 9, 2022 Erasca presented its corporate presentation (Presentation, Erasca, DEC 9, 2022, View Source [SID1234624991]).

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