On January 10, 2023 Treadwell Therapeutics, a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant (Press release, Treadwell Therapeutics, JAN 10, 2023, View Source;breast-cancer-301717695.html [SID1234626167]).

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"There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail," said Dr. Mark Bray, Treadwell CSO and Co-founder. "CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors. We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer."

Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need. Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.

About ER+/Her2- Breast Cancer

Globally, breast cancer is the world’s most prevalent cancer and the 2nd leading cause of cancer death in women in many countries. The ER+/HER2- subtype is the most common subtype of breast cancer, accounting for 68% of all breast cancer types, with nearly 1.2 million women living with the disease in the US alone. Standard of care for ER+ patients is CDK4/6 inhibitors in combination with endocrine therapies, which have been very successful in prolonging survival for this patient population. However, resistance to this treatment occurs within a median of 2 years. As a result, the ER+ population resistant to this standard of care is growing and is an unmet medical need requiring new treatment options.

On January 10, 2023 Ajinomoto Co., Inc. ("Ajinomoto Co.") reported a license agreement with Exelixis, Inc. ("Exelixis") to incorporate AJICAP, Ajinomoto Co.’s proprietary site-specific bioconjugation and linker technologies, in the development of certain of Exelixis’ antibody-drug conjugate (ADC) programs (Press release, Ajinomoto, JAN 10, 2023, View Source [SID1234626166]).

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Exelixis is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Utilizing its network of biotherapeutics collaborations, the company is developing next generation ADCs for the treatment of various cancers. Ajinomoto Co. is a leading technology provider for biopharmaceuticals and the owner of CDMO Ajinomoto Bio-Pharma Services. AJICAP is Ajinomoto Co.’s proprietary site-specific bioconjugation and stable linker technologies compatible with commonly used antibody isotypes. AJICAP technology includes its "off-the-shelf" feature, allowing any therapeutic antibody at any stage of development to be conjugated to drug-payloads of choice without the need for antibody engineering or cell line development, and stable/hydrophilic linkers to generate antibody-drug conjugates with an enhanced therapeutic window.

As part of the license agreement, Exelixis will have the right to use the AJICAP technology to support its aim of advancing multiple ADCs with the potential for higher efficacy and lower toxicity than currently available options. Ajinomoto Co. is eligible to receive development, regulatory and commercial milestone payments as well as royalties on commercial sales.

Dr. Tatsuya Okuzumi, General Manager, Business Development Group, Bio-Pharma Services Department, Ajinomoto Co., expressed: "We are very excited to support Exelixis, a leader in oncology drug discovery, development, and commercialization, in the development of novel antibody-drug conjugates. The combination of Exelixis’ antibodies and payloads with Ajinomoto Co.’s AJICAP opens up a wide range of oncology applications and may be harnessed to provide a clinical benefit to patients."

About Ajinomoto Co. and Ajinomoto Bio-Pharma Services Based on the corporate message "Eat Well, Live Well.", Ajinomoto Co., Inc. has been scientifically pursuing the possibilities of amino acids to aim for future growth by creating new value through sustainable and innovative solutions for communities and society. For additional information about Ajinomoto Co. (TYO: 2802), please visit www.ajinomoto.com.

As its pharmaceutical arm, Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization (CDMO) with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. For more information about Ajinomoto Bio-Pharma Services, please visit www.AjiBio-Pharma.com.

In addition, Ajinomoto Co. and Ajinomoto Bio-Pharma Services offer a broad range of innovative platform technologies and capabilities for pre-clinical and pilot programs to commercial quantities, including AJIPHASE oligonucleotide manufacturing technology, CORYNEX and TALAMAX protein expression systems, AJICAP site-specific conjugation and linker technologies for ADCs, continuous flow manufacturing and more. For additional information on the platform technologies, please visit View Source

On January 10, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported its 2023 financial guidance and commented on its outlook for the upcoming year (Press release, Halozyme, JAN 10, 2023, View Source [SID1234626165]).

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"In 2022, we project we achieved record revenue of greater than $655 million and we completed the acquisition of Antares Pharma, opening up an expanded set of opportunities for our subcutaneous drug delivery business," said Dr. Helen Torley, president and chief executive officer. "In 2023, we project record revenue of $815 to $845M and greater than 30% growth in EBITDA to $415 to $440 million. As our ENHANZE pipeline advances, we are excited about the future royalty revenue opportunities represented in 2023 by the potential for two new commercial launches, SC efgartigimod and SC atezolizumab."

Anticipated 2023 Key Events:

Projected growth of >20% in the Company’s high-margin, recurring revenue stream from royalties to approximately $445 to $455 million driven by continued strength in Wave 2 products, including DARZALEX SC (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE technology, as well as full year auto-injector royalty contribution.

Two ENHANZE subcutaneous (SC) approvals and commercial launches by collaboration partners, including SC efgartigimod and SC atezolizumab.

Four Phase 3 study data readouts from products utilizing ENHANZE by the Company’s collaboration partners
SC efgartigimod in CIDP, ITP and Pemphigus (autoimmune disorders of the nervous system, blood and skin)
SC ocrelizumab for certain patients with multiple sclerosis
At least 2 new products utilizing ENHANZE entering Phase 1 development by the Company’s collaboration partners.
At least one new collaboration and licensing agreement for ENHANZE, for a partner to test our developmental large volume auto-injector plus ENHANZE, and for our small volume auto-injector.

Initiation of a clinical study to continue to evaluate the feasibility testing of our large volume auto-injector.
Up to $150 million in share repurchases, dependent on market conditions and other factors, as part of the $750 million three-year share repurchase plan authorized by Halozyme’s board of directors in December 2021 demonstrating the Company’s continued commitment to a balanced capital allocation strategy.

2023 Financial Guidance:

Revenue: Halozyme expects total revenue of $815 million to $845 million, representing growth of >20% over 2022 expected total revenue. The Company expects revenue from royalties to increase >20% over expected revenue from royalties in 2022, to a range of $445 million to $455 million.
EBITDA: Halozyme expects EBITDA of $415 million to $440 million, representing growth of >30% over 2022 expected EBITDA and excludes the impact of amortization costs in 2023 related to the Antares Pharma acquisition.
Earnings per Share: Halozyme expects Non-GAAP diluted earnings per share of $2.50 to $2.65. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.
Table 1. 2023 Financial Guidance

Guidance Range

Total Revenue

$815 to $845 million

Royalty Revenue

$445 to $455 million

EBITDA

$415 to $440 million

Non-GAAP Diluted EPS

$2.50 to $2.65

On January 10, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, will present at the Virtual Investor 2023 Companies to Watch Event on Thursday, January 19, 2023 at 3:00 PM ET (Press release, AEterna Zentaris, JAN 10, 2023, View Source;id=251411&p=2254175&I=1206939-c7Z3G6f3m8 [SID1234626164]).

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A live video webcast of the presentation will be available on the Events page of the Company’s website (www.zentaris.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On january 10, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that company management will participate in a fireside chat at B. Riley Securities’ 3rd Annual Oncology Conference, which is taking place virtually from January 18 – 19, 2023 (Press release, Cardiff Oncology, JAN 10, 2023, View Source [SID1234626163]).

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