On December 6, 2022 Akeso Inc. (HKEX Code: 9926.HK, "Akeso", or the "Company"), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported a collaboration and license agreement (the "Agreement") with Summit Therapeutics Inc. (NASDAQ: SMMT) (the "Summit"), to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan (the "License Territories") (Press release, , DEC 6, 2022, View Source [SID1234624861]). In addition, the Company will co-brand the product in the License Territories.

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Ivonescimab, known as AK112 in China and Australia and also as SMT112 in the License Territories, is a novel, potential first-in-class bispecific antibody independently developed by the Company. Ivonescimab combines the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. It is our belief that the novel design has the potential to reduce side effects and safety concerns. Ivonescimab is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic: there are no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration ("FDA") or the European Medicines Agency ("EMA").

Currently, Akeso is conducting a phase III clinical trial of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of Ivonescimab plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. Ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications: the two aforementioned indications, as well as combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.

As presented at ASCO (Free ASCO Whitepaper) 2022, ivonescimab treatment was associated with an overall response rate (ORR) in a Phase II study in patients with NSCLC who have failed EGFR-TKI’s of 68.4% and a median Progression-Free Survival (mPFS) time period of 8.2 months when combined with combination chemotherapy (pemetrexed and carboplatin) as compared to historical mPFS of 4.3 months in patients treated with combination chemotherapy (pemetrexed and platinum-based chemotherapy) alone, the current standard of care. In a separate cohort, ivonescimab combined with docetaxel in patients who have failed PD-(L)1 and chemo therapies demonstrated a mPFS of 6.6 months as compared to a historical mPFS of 4.5 months with docetaxel alone, a current standard of care regimen for these patients. The study which similarly had patients receiving ivonescimab plus chemotherapy as their first line therapy for metastatic disease, was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events.

"Ivonescimab has demonstrated the potential to deliver superior clinical benefit for patients." said Dr. Michelle Xia, co-founder, Chairwoman, CEO, and President of Akeso, "The Akeso team has been dedicated to the development of ivonescimab in the past 8 years and advanced the molecule to the clinical Phase III stage. The global value of ivonescimab awaits great work from a great team to realize. We are so pleased to partner with the world-class Summit team, who has the track record of successfully bringing over a dozen indications to market for the first-in-class blockbuster drug IMBRUVICA (ibrutinib). Following intense and in-depth strategic, scientific, and operational discussion on ivonescimab between the Akeso and Summit teams in recent months, we are more confident than ever on a winning path for ivonescimab’s global development. With this tremendous momentum, we look forward to the swift execution of clinical development and commercial plan in a global setting for ivonescimab."

"The partnership between Summit and Akeso is a strategically compelling opportunity," stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. "It represents bringing together Akeso’s extraordinary team, which has built an innovation engine capable of creating novel bispecific technologies, and the talented members of team Summit with their proven track record of success of global clinical development, regulatory approvals, and commercialization, particularly in oncology. We believe the potential exists for enormous creation through this partnership. We are extremely encouraged by ivonescimab and the potential for improving the quality and duration of patients’ lives based on clinical data to support this point. Summit team is honored and enthusiastic to partner with Akeso. Our shared mission and vision are to create a significant difference for the betterment of patient healthcare outcomes around the world."

"After reviewing a substantial number of opportunities, much of which was focused on potential treatments for solid tumors, we have found the ideal partnership with the potential to change the paradigm for treating patients facing difficult odds with devastating diagnoses," added Dr. Maky Zanganeh, Co-Chief Executive Officer, President, and a member of Summit’s Board of Directors. "Ten years ago, metastatic lung cancer patients rarely survived for more than ten to twelve months from diagnosis. Today, survival can be measured in years. Our goal is to improve the quality of life of a patient facing immeasurable odds while extending the duration of that patient’s life. Our focus is always on how we can improve the lives of patients. We sought patient-friendly medicinal therapies through our search to expand our pipeline portfolio, and we are proud to take this meaningful step towards accomplishing this goal. We have significant work to do, but we are steadfastly committed to bringing ivonescimab into the hands of patients who need it most. We are thrilled to reach this agreement with Michelle and the team at Akeso, and we are excited to make this vision a reality. I am proud of Summit team who have diligently worked these past few months to establish a strong bond with the team at Akeso, and I would like to thank the talented people of Team Akeso for spending so much quality time creating this meaningful partnership."

Under the terms of the Agreement, Akeso will receive US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab. The Summit will receive the exclusive rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. In addition, Dr. Michelle Xia will be appointed as one member of the board of directors of Summit. The deal is subject to customary closing practices, including applicable waiting periods under the Hart-Scott-Rodino (HSR) Act.

On December 6, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported positive results for HER2X in a range of clinical scenarios, demonstrating the test’s reliability (Press release, REVEAL GENOMICS, DEC 6, 2022, View Source [SID1234624860]). This new validation data confirms its suitability for general use in clinical practice.

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The results of 4 studies (APT, ATEMPT, DAPHNe and GOM) have been made public during the San Antonio Breast Cancer Symposium (SABCS), held from December 6 to 10 in San Antonio, Texas (USA).

"We are delighted to share important new results for HER2DX during SABCS, which confirm the robust ability of the test to predict long-term survival and response to anti-HER2 therapy. The HER2DX risk score and pCR score have now been validated across more than 1800 and 800 patients, respectively," says Dr. Aleix Prat, Co-founder and CSO of REVEAL GENOMICS.

"These extraordinary results will undoubtedly be key to achieving our goal of making HER2DX available globally and reaching all patients with HER2+ breast cancer. We are very excited about what the future holds for us as a company," adds Dr. Patricia Villagrasa-Gonzalez, Co-founder and CEO of REVEAL GENOMICS.

APT and ATEMPT studies: confirming the HER2DX️ risk score

The analysis of the HER2DX in the APT and ATEMPT studies is the result of the agreement between REVEAL GENOMICS and Dana-Farber Cancer Institute (US), consisting of using the test to analyze tumor samples from 471 patients with early-stage HER2+ breast cancer from both Phase II trials.

The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated that a de-escalation treatment strategy based on weekly paclitaxel during three months and one year of trastuzumab is highly efficacious for a large proportion of stage 1 patients.

The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, demonstrated that 17 cycles of the anti-HER2 antibody drug-conjugate trastuzumab emtansine (T-DM1, Kadcyla, Roche) is highly useful for a large proportion of stage 1 patients, and can help them avoid alopecia when compared to paclitaxel.

The results presented at SABCS 2022 during a Spotlight Session show that HER2DX risk score was significantly associated with relapse-free interval despite the low number of events in both studies. Overall, these results show that HER2DX can reliably identify patients who might be ideal candidates for de-escalation of systemic therapy.

DAPHNe and GOM studies: confirming the HER2DX pCR score

The analysis of the HER2DX in DAPHNe and GOM studies is the result of the agreement between REVEAL GENOMICS and Dana-Farber Cancer Institute (US) and Hospital Universitario Gregorio Marañón (Spain), respectively, consisting of using the test to analyze tumor samples from 235 patients with early-stage HER2+ breast cancer from both trials.

The DAPHNe clinical trial was a single-arm prospective academic phase II trial in which patients with treatment-naïve stage II-III HER2+ breast cancer received a de-escalated neoadjuvant regimen of weekly paclitaxel for 12 cycles along with trastuzumab and pertuzumab (THP) every 3 weeks for 4 cycles. The results of this study have prompted the COMPASS-HER2-pCR study, led by ECOG-ACRIN, which aims to recruit more than 2000 patients.

The GOM study is a prospective observational study, ongoing since 2018, of consecutive patients with newly diagnosed stage I III HER 2 breast cancer candidates for 6 cycles of neoadjuvant docetaxel, carboplatin and trastuzumab (TCH) or TCH plus pertuzumab (TCHP) across 7 public hospitals in Spain.

The results presented at SABCS 2022 show that HER2DX pCR scores were found to strongly predict pCR in both trials, independently of known clinical-pathological variables and intrinsic subtype. It was also observed that the group with high pCR likelihood according to HER2DX benefited from the inclusion of pertuzumab to trastuzumab-based neoadjuvant chemotherapy, in contrast to the group with low pCR. Notably, the pCR rate of the DAPHNe group of patients with a HER2DX high pCR likelihood HER2DX result was 93%.

Overall, these results show that HER2DX pCR score can reliably identify patients who might be ideal candidates for neoadjuvant paclitaxel, trastuzumab and pertuzumab.

About HER2DX️

HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low, and HER2+ breast cancer.

On December 6, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company (Press release, RedHill Biopharma, DEC 6, 2022, View Source [SID1234624859]). The offering consisted of 32,000,000 units/pre-funded units consisting of (a) one American Depositary Share ("ADS") (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS (the "Warrants") at a price to the public of $0.25 per unit (or $0.249 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. RedHill intends to use the net proceeds of the offering for working capital, acquisitions, and general corporate purposes.

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Aegis Capital Corp. acted as the sole book-running manager for the proposed public offering.

The securities described above were offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-258259) declared effective by the Securities and Exchange Commission (the "SEC") on August 9, 2021.

The securities were offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and, is available on the SEC’s website at www.sec.gov and may also be obtained from Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On December 6, 2022 Novartis reported results from the RIGHT Choice Phase II trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) against combination chemotherapy (CT) in the first-line setting for pre- and perimenopausal patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2−) metastatic breast cancer (MBC), including patients with visceral crisis (Press release, Novartis, DEC 6, 2022, View Source;and-perimenopausal-patients-with-aggressive-hrher2-metastatic-breast-cancer-compared-to-chemotherapy-301696189.html [SID1234624858]). CT has remained the preferred option for patients with rapidly progressing disease and visceral crisis, despite the widespread adoption of CDK4/6 inhibitors (CDK4/6i) plus ET as first-line treatment for HR+/HER2- MBC. Kisqali demonstrated a nearly one-year progression-free survival (PFS) benefit in the study, supporting the superiority of Kisqali plus ET for this hard-to-treat patient population. RIGHT Choice is the first randomized study comparing a CDK4/6i plus ET vs. combination CT in aggressive HR+/HER2− MBC; data from this open-label, multi-national trial will be presented as a late-breaker oral presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) and included in the SABCS press program.

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"Younger patients with aggressive disease often show resistance to treatment, resulting in worse prognoses – so it is encouraging to see RIGHT Choice data demonstrating a significant one-year benefit for this patient population when using ribociclib plus endocrine therapy compared to combination chemotherapy. Patients on the ribociclib arm had also lower rates of adverse events, such as diarrhea and fatigue, compared to chemotherapy, which could potentially impact quality of life," said Dr. Yen-Shen Lu, Division Chief of Medical Oncology at Department of Oncology, National Taiwan University Hospital. "With these improvements in outcomes and tolerability, oncologists should consider ribociclib plus ET as a treatment option for patients with aggressive forms of HR+/HER2− MBC, including patients with visceral crisis."

The study enrolled 222 patients with aggressive forms of HR+/HER2− MBC (i.e., with symptomatic visceral metastases, rapid disease progression or markedly symptomatic non-visceral metastases), including more than 50% of patients with visceral crisis as determined by investigators; Kisqali plus ET doubled the median PFS vs. combination CT at 24.0 months compared to 12.3 months (HR=0.54; 95% CI: 0.36-0.79; p=.0007) in the first-line setting. Median time to treatment failure with Kisqali plus ET was 18.6 months compared to 8.5 months with combination CT (HR=0.45; 95% CI: 0.32-0.63). Furthermore, patients in the Kisqali plus ET arm of the trial reported lower rates of treatment-related serious adverse events (AEs) and lower rates of discontinuation due to treatment-related AEs, compared to patients in the combination CT trial arm. Overall, the Kisqali safety profile was consistent with previously reported data1.

"Kisqali is a unique CDK4/6 inhibitor with the most robust evidence demonstrating overall survival and quality of life benefits for a wide spectrum of patients, including those with aggressive disease," said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology at Novartis. "RIGHT Choice adds to the breadth of data that supports Kisqali as the first-line treatment of choice for patients with MBC, including those with visceral crisis."

About Kisqali (ribociclib)
Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all three pivotal Phase III advanced breast cancer trials2-13 and is recognized by the National Comprehensive Cancer Network (NCCN) guidelines as the only CDK4/6i with overall survival benefit in first-line HR+/HER2- advanced breast cancer14. Additionally, Kisqali has the highest rating of any CDK4/6i on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line premenopausal patients with HR+/HER2- advanced breast cancer15. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6i, received a score of four out of five for postmenopausal patients with HR+/HER2- advanced breast cancer treated in the first line16.

Kisqali has been approved in more than 95 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission, for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination either with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. Kisqali in combination with fulvestrant is approved as initial endocrine-based therapy or following disease progression on endocrine therapy in men by the FDA17.

Novartis is committed to continuing to study Kisqali in breast cancer. NATALEE is a large Phase III clinical trial of Kisqali plus endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)18. Additionally, Novartis is collaborating with SOLTI, who is leading HARMONIA, to test whether Kisqali changes tumor biology to enable a better response to endocrine-based therapy compared to Ibrance* for patients with advanced HR+/HER2-, HER2-enriched subtype19, and with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant Phase II trial studying the effects of Kisqali in HR+/HER2- early breast cancer to discover the potentially unique underlying mechanism of action20.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Indications

KISQALI (ribociclib) is a prescription medicine used to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with:

an aromatase inhibitor as the first endocrine-based therapy; or
fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.
It is not known if KISQALI is safe and effective in children.

Important Safety Information

What is the most important information I should know about KISQALI?

KISQALI may cause serious side effects, including:

Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including:

trouble breathing or shortness of breath
cough with or without mucus
chest pain
Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain/burning; blistering of the lips, eyes, or mouth; or blisters on the skin or skin peeling, with or without fever.

Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.

Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems:

yellowing of your skin or the whites of your eyes (jaundice)
dark or brown (tea-colored) urine
feeling very tired
loss of appetite
pain on the right side of your stomach area (abdomen)
bleeding or bruising more easily than normal
Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.

What should I tell my health care provider before taking KISQALI?
Before you take KISQALI, tell your health care provider if you:

have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
have ever had a heart attack
have a slow heartbeat (bradycardia)
have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
have fever, chills, or any other signs or symptoms of infection
have liver problems
have any other medical conditions
are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby
If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI.
Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI.
Talk to your health care provider about birth control methods that may be right for you during this time.
If you become pregnant or think you are pregnant, tell your health care provider right away.
are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

What should I avoid while taking KISQALI?
Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood.

The most common side effects of KISQALI include:

decreased white blood cell counts
decreased red blood cell counts
abnormal liver function tests
infections
nausea
increased kidney function test
tiredness
decreased platelet counts
diarrhea
vomiting
headache
constipation
hair loss
cough
rash
back pain
low blood sugar level
KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you.

Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

On December 6, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it plans to offer and sell, subject to market and other conditions, $150 million of shares of its common stock in an underwritten public offering (Press release, Syndax, DEC 6, 2022, View Source [SID1234624854]). Syndax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in the public offering. All of the shares in the proposed offering are to be sold by Syndax.

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Goldman Sachs & Co. LLC, J.P. Morgan and Cowen are acting as joint book-running managers for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected] Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.