On December 09, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported it has entered into an exclusive worldwide license agreement with Novartis (NYSE: NVS) for naporafenib, a Phase 2 pivotal-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRAS mutant (NRASm) melanoma and other RAS/MAPK pathway-driven tumors (Press release, Erasca, DEC 9, 2022, View Source [SID1234634765]). To date, naporafenib has been dosed in over 500 patients across multiple trials and has demonstrated preliminary clinical proof-of-concept as well as favorable safety and tolerability data both as a single agent and in combination with other molecularly targeted and immuno-oncology therapies.

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As separately announced, Erasca has priced a $100 million equity offering with select healthcare investors.

"Naporafenib aligns with our mission by expanding our addressable patient population and is a perfect strategic fit for Erasca based on its strong synergy with our pipeline," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "This Phase 2 pivotal-ready molecule with favorable clinical safety, tolerability, and proof-of-concept data significantly accelerates our transition into a late-stage development company, bringing us closer to realizing our aspiration of delivering novel cancer therapies to patients in need. This license, coupled with our simultaneous financing from leading healthcare investors, solidifies our leadership in advancing treatments for RAS/MAPK pathway-driven cancers."

Naporafenib (LXH254) is a potent and selective inhibitor of BRAF and CRAF, with a potential first-in-class and best-in-class profile. Safety, tolerability, and preliminary proof of concept of naporafenib alone or in combination have been shown in over 500 patients treated to date in NRASm melanoma and other RAS/MAPK pathway-driven tumors. Erasca plans to initially focus on advancing and securing potential regulatory approval for naporafenib plus trametinib (MEKINIST) in RAS Q61X tissue agnostic solid tumors as part of the planned Phase 2 SEACRAFT-1 trial and NRASm melanoma as part of the planned Phase 3 SEACRAFT-2 trial.

Under the terms of the license agreement, in exchange for an exclusive worldwide license to develop and commercialize naporafenib, Erasca will pay to Novartis a one-time upfront cash payment of $20 million and $80 million of shares in Erasca common stock at a price of $6.50 per share. Novartis is eligible to receive up to $80 million in cash upon the achievement of regulatory milestones covering two indications in the United States, Europe, and Japan, as well as up to $200 million in cash upon the achievement of sales milestones. Novartis is also eligible to receive a low single-digit percentage royalty on net sales of naporafenib.

Conference Call and Webcast Information
Erasca will hold a conference call and webcast today at 8:30 am ET. The webcast link for the conference call is View Source The dial-in number is 1-877-407-0792 (U.S./Canada) or 1-201-689-8263 (international). The conference ID for all callers is 13734524. The live webcast and replay may be accessed by visiting Erasca’s website at Erasca.com/events.

On December 9, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, reported data presented on the ongoing CFI-402257-CL-001 clinical study of the Company’s CFI-402257 program in advanced solid tumors, continued to show a tolerable safety profile and demonstrated clinical benefit both as a monotherapy as well in combination with fulvestrant. Data were presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Treadwell Therapeutics, DEC 9, 2022, View Source [SID1234626020]).

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"CFI-402257 is well-tolerated and showed signs of anti-tumor activity either as a monotherapy or in combination with Fulvestrant, including some patients who were with durable disease control after progression on prior CDK4/6 inhibitor therapy" said Dr. Philippe Bedard, Study investigator and Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada.

"CFI-402257 continues to demonstrate an encouraging clinical profile, and we look forward to further developing the molecule for the treatment of ER+ breast cancer," added Dr. Michael Tusche, Treadwell co-CEO.

2022 SABCS Poster Presentations and Details:

An Update to a Phase I Trial of CFI-402257, an oral TTK Inhibitor, in Patients with Advanced Solid Tumors with HER2-Negative Breast Cancer Expansion Cohorts

Poster Number: P6-10-13

Date: December 9th, 7:00 am CT

Data presented on CFI-402257, an oral, best-in-class TTK inhibitor, continue to show a tolerable safety profile at the recommended Phase 2 dose of 168 mg once daily with manageable, dose-dependent neutropenia being the primary toxicity. In this heavily pre-treated population (N=86), the overall response rate was 6% for monotherapy patients (4/66) and 10% for ER+/HER2- breast cancer patients treated in combination with fulvestrant (2/20). The clinical benefit rate (CR+PR+SD>6 months) for monotherapy and combination were 12% and 25%, respectively. Patients achieving stable disease or better stayed on treatment for a median of 242 days (range: 112 to 673). Significantly, several ER+ breast cancer patients who previously failed CDK4/6 inhibitors in the combination cohort remained on therapy for a year or more. The most common drug related toxicities of any grade, which occurred in greater than 10% of all patients, included fatigue (48%), nausea (48%), decreased appetite (34%), diarrhea (34%), vomiting (24%), constipation (21%) and headache (21%).

As previously disclosed, on July 13, 2020, Bio-Path Holdings, Inc. (the "Company") entered into an At-TheMarket Offering Agreement (the "Offering Agreement") with H. C. Wainwright & Co., LLC ("Wainwright"), as sales
agent and/or principal, pursuant to which the Company could offer and sell, from time to time, through or to
Wainwright, shares of the Company’s common stock, par value $0.001 per share ("Common Stock").

On December 7, 2022, the Company received written notice from Wainwright that Wainwright had elected,
pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7,
2022. The Company will not incur any material early termination penalties in connection with the termination of the
Offering Agreement.

As of immediately prior to the termination of the Offering Agreement, offers and sales of shares of Common
Stock under the Offering Agreement were being made pursuant to a shelf registration statement on Form S-3 filed with
the U.S. Securities and Exchange Commission (the "Commission"), which was declared effective by the Commission on
June 14, 2022 (File No. 333-265282) (the "2022 Shelf Registration Statement"), and a related prospectus filed with the
Commission on June 14, 2022, as supplemented and amended pursuant to a prospectus supplement filed with the
Commission on July 29, 2022 (as supplemented and amended, the "ATM Prospectus"). The ATM Prospectus covered
the offer and sale of shares of Common Stock having a maximum aggregate offering price of up to $3.0 million.

As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of Common
Stock remained available for sale pursuant to the ATM Prospectus and the Offering Agreement. As a result of the
termination of the Offering Agreement, the Company will not offer or sell any additional shares of Common Stock under
the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of Common Stock included in
ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement.

A copy of the Offering Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Commission on July 14, 2020. The description of the Offering Agreement contained in this Current Report
on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Offering Agreement.

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On December 9, 2022, the Food and Drug Administration (FDA) reported that it approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) (Press release, US FDA, DEC 9, 2022, View Source [SID1234625694]).

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Efficacy was evaluated in Study ML39345 (NCT03141684), an open-label, single-arm study in 49 adult and pediatric patients with unresectable or metastatic ASPS. Eligible patients were required to have histologically or cytologically confirmed ASPS incurable by surgery and an ECOG performance status of ≤2. Patients were excluded for primary central nervous system (CNS) malignancy or symptomatic CNS metastases, clinically significant liver disease, or a history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis on imaging. Adult patients received 1200 mg intravenously and pediatric patients received 15 mg/kg (up to a maximum of 1200 mg) intravenously once every 21 days until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) determined by an independent review committee using RECIST v1.1. ORR was 24% (95% CI: 13, 39). Of the 12 patients who experienced an objective response, 67% had a DOR of 6 months or more, and 42% had a DOR of 12 months or more.

The median patient age was 31 years (range: 12-70); 47 adult patients (2% were ≥65 years of age) and 2 pediatric patients ≥12 years of age were enrolled; 51% were female, 55% White, 29% Black or African American, 10% Asian.

The most common adverse reactions (≥15%) were musculoskeletal pain (67%); fatigue (55%); rash (47%); cough (45%); nausea, headache, and hypertension (43% each), vomiting (37%), constipation and dyspnea (33% each), dizziness and hemorrhage (29% each), insomnia and diarrhea (27% each), pyrexia, anxiety, abdominal pain and hypothyroidism (25% each), decreased appetite and arrhythmia (22% each), influenza-like illness and weight decreased (18% each), and allergic rhinitis and weight increased (16% each).

The recommended atezolizumab dosage for adult patients is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. The recommended dosage for pediatric patients 2 years of age and older is 15 mg/kg (up to a maximum of 1200 mg) every 3 weeks until disease progression or unacceptable toxicity.

View full prescribing information for Tecentriq.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 weeks ahead of the FDA goal date.

This application was granted priority review and breakthrough designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The application also was granted orphan drug designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email [email protected]

As previously disclosed, on July 13, 2020, Bio-Path Holdings, Inc. (the "Company") entered into an At-The Market Offering Agreement (the "Offering Agreement") with H. C. Wainwright & Co., LLC ("Wainwright"), as sales agent and/or principal, pursuant to which the Company could offer and sell, from time to time, through or to Wainwright, shares of the Company’s common stock, par value $0.001 per share ("Common Stock") (Filing, Bio-Path Holdings, DEC 9, 2022, View Source [SID1234625298]).

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On December 7, 2022, the Company received written notice from Wainwright that Wainwright had elected,
pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7, 2022. The Company will not incur any material early termination penalties in connection with the termination of the Offering Agreement.

As of immediately prior to the termination of the Offering Agreement, offers and sales of shares of Common
Stock under the Offering Agreement were being made pursuant to a shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "Commission"), which was declared effective by the Commission on June 14, 2022 (File No. 333-265282) (the "2022 Shelf Registration Statement"), and a related prospectus filed with the Commission on June 14, 2022, as supplemented and amended pursuant to a prospectus supplement filed with the Commission on July 29, 2022 (as supplemented and amended, the "ATM Prospectus"). The ATM Prospectus covered the offer and sale of shares of Common Stock having a maximum aggregate offering price of up to $3.0 million.

As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of Common
Stock remained available for sale pursuant to the ATM Prospectus and the Offering Agreement. As a result of the
termination of the Offering Agreement, the Company will not offer or sell any additional shares of Common Stock under the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of Common Stock included in ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement.

A copy of the Offering Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Commission on July 14, 2020. The description of the Offering Agreement contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Offering Agreement.