On January 5, 2022 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company that aspires to develop medicines to make chemotherapy safer and thereby more effective to save more patients’ lives, reported a business update and outlined the company’s strategic priorities for 2022 (Press release, Aileron Therapeutics, JAN 5, 2022, View Source [SID1234598195]).

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"All cancer patients undergoing chemotherapy – still the standard of care for most patients – experience chemotherapeutic side effects to varying degrees, from unpleasant to fatal. Utilizing a biomarker strategy, we are developing ALRN-6924 as a selective chemoprotective agent to shift the paradigm from accepting these side effects to preventing them for patients with p53-mutated cancer regardless of type of cancer or chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "In 2022, we expect several key milestones may propel us toward this vision, including our planned initiation of a clinical trial in breast cancer patients receiving neoadjuvant chemotherapy in the first half of the year with interim results in the fourth quarter, as well as planned interim and topline data readouts for our ongoing NSCLC trial in the second and fourth quarters, respectively."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron employs a precision medicine approach to exclusively treat those patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and that is expected to improve efficacy of chemotherapy.

2022 Strategic Priorities and Business Update

Initiate clinical trial in neoadjuvant (pre-operative) breast cancer in 1H22, with interim results in 4Q22. Aileron plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow and other toxicities in ER+/HER2- breast cancer patients treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial will enroll up to 30 patients in a parallel group design trial with a dose expansion cohort. Aileron will provide more details on the planned neoadjuvant breast cancer trial design at the time of trial initiation.
Advance ongoing NSCLC trial to interim (20-patient) and topline (60-patient) readouts, in 2Q22 and 4Q22, respectively. Aileron is currently enrolling patients in the US and EU with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. As previously guided, Aileron anticipates reporting interim results on 20 patients in 2Q22, and topline results on 60 patients in 4Q22. Aileron has dosed the first 10 patients in the trial and plans to conduct a blinded safety evaluation on these patients after one cycle in 1Q22, as previously guided.
Continue to progress ongoing Healthy Volunteer Study. Aileron is continuing to progress its ongoing Phase 1 pharmacology study which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The company presented initial data from the study in 2021, confirming the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated cancers. Aileron anticipates reporting additional findings from the study this year.

Expanded patent portfolio in 2021 with issuance of 11 new foreign and U.S. patents. Aileron was issued 7 new international patents and 4 U.S. patents over the past 12 months, including new patent protection for ALRN-6924 in China. These newly issued patents add to Aileron’s robust intellectual property portfolio, which includes over 170 U.S. and foreign patents, with another 47 applications in prosecution. These patents and applications include ALRN-6924 methods of manufacture, methods of use, drug product formulations, and compositions of matter (COM). The COM patent in the US expires in 2033 with up to 5 additional years subject to patent term extensions. Of note, Aileron maintains exclusive rights to its proprietary peptide drug technology and ALRN-6924 worldwide.

On January 5, 2021 AbbVie (NYSE: ABBV) reported that it will announce its fourth-quarter and full-year 2021 financial results on Wednesday, February 2, 2022, before the market opens (Press release, AbbVie, JAN 5, 2022, View Source [SID1234598194]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. CT. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On January 5, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported an update on eganelisib clinical development plans and 2022 guidance (Press release, Infinity Pharmaceuticals, JAN 5, 2022, View Source [SID1234598172]).

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"Eganelisib is a unique drug for which we have presented positive results in multiple indications where checkpoint inhibitors have provided little to no patient benefit. Based on these strong data, we will be initiating a registration study in frontline TNBC in 2022 – due to the magnitude of the unmet need in this very large patient population and the magnitude of the eganelisib benefit. Eganelisb combination therapy has demonstrated tumor volume reductions of 92.8% and 85.2%, and disease control rates of 92.8% and 81.4%, in PD-L1(+) and PD-L1 (-) frontline TNBC patients, respectively, as well as improvements in progression free survival over standard of care benchmarks regardless of PD-L1 status," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals.

"We are aggressively advancing a registration focused study in TNBC with the goal of bringing eganelisib to patients in need as quickly as possible. We also continue to be encouraged by the overall survival benefit seen in patients with urothelial cancer, and to support the initiation of future registration trials in 2023 and beyond, we are also expanding the development of eganelisib in a platform study in additional indications where checkpoint inhibitors and other current therapies have offered little benefit," said Robert Ilaria, Jr. M.D., Chief Medical Officer, Infinity Pharmaceuticals.

Program Updates and Guidance:

The Company plans to initiate a frontline mTNBC randomized, double-blind, pivotal trial by the end of 2022 with progression free survival (PFS) and overall survival (OS) as endpoints. In the PD-L1 negative patients eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet) vs chemotherapy. In the PD-L1 positive patients the eganelisib triplet will be evaluated vs chemotherapy and a checkpoint inhibitor. Pending feedback from a MARIO-3 end-of-Phase 2 meeting with global regulatory authorities, Infinity will finalize the MARIO-4 trial design.
Infinity also plans to initiate MARIO-P, a platform study to evaluate the clinical benefit of eganelisib to support the initiation of future registration focused studies across various solid tumor indications, on a rolling basis in 3Q 2022.
The Company expects multiple data releases in 2H 2022:
MARIO-3 study in mTNBC patients
MARIO-3 study in renal cell carcinoma patients
MARIO-275 study in urothelial cancer patients
Window of Opportunity IST study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
2022 Financial Guidance:

Infinity ended 2021 with approximately $81 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2021 financial results in March 2022. The Company expects to end 2022 with between $25 million to $35 million in cash and investments based on its current operating plans, which excludes additional financing or business activities. The company expects net loss for 2022 to range between $45 million to $55 million.

On January 5, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematological cancers reported that members of IMV’s executive management team will be presenting virtually at the Biotech ShowcaseTM 2022 investor conference which will be held January 10-12 and at the H.C. Wainwright Bioconnect 2022 conference held January 10-13 (Press release, IMV, JAN 5, 2022, View Source [SID1234598171]).

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A copy of IMV’s presentation for both of these events will be made available in the ‘Events, Webcasts & Presentations’ section of IMV’s website on the morning of January 10, 2022. Additionally, a webcast link to the H.C. Wainwright Bioconnect 2022 conference will also be available at 7:00 AM EST on January 10.

On January 5, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) reported a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a debilitating, disfiguring and painful disease that impacts about one in three people in the United States during their lifetime (Press release, BioNTech, JAN 5, 2022, View Source [SID1234598170]). The collaboration builds on the companies’ success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020.

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Under the terms of the agreement, the companies will leverage a proprietary antigen technology identified by Pfizer’s scientists and BioNTech’s proprietary mRNA platform technology used in the companies’ COVID-19 vaccine. The parties will share development costs. Clinical trials are planned to start in the second half of 2022. Pfizer will have rights to commercialize the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights. The companies will share gross profits from commercialization of any product.

"Pfizer and BioNTech co-developed the world’s first mRNA vaccine, providing a well-tolerated and effective tool to help address COVID-19 – the most devastating pandemic in a century – and demonstrating consistent, agile and high-quality manufacturing on an unprecedented scale," said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. "With this agreement, we continue on our journey of discovery together, by advancing mRNA technology to tackle another health challenge ripe for scientific innovation, supported by our world-class manufacturing network."

"The collaboration aims to develop a new mRNA-based vaccine against shingles, leveraging the expertise and resources of both companies," said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "Adults aged 50 years and older as well as vulnerable populations like cancer patients are at an increased risk of shingles. Our goal is to develop an mRNA vaccine with a favorable safety profile and high efficacy, which is at the same time more easily scalable to support global access."

Under the terms of the agreement, Pfizer will pay BioNTech $225 million in upfront payments, including a cash payment of $75 million and an equity investment of $150 million. BioNTech is eligible to receive future regulatory and sales milestone payments of up to $200 million. BioNTech will pay Pfizer $25m for the company’s proprietary antigen technology.

About Shingles (Herpes Zoster Virus)
Shingles (HZV) is a chronic form of the varicella zoster virus (VZV), which causes an initial chickenpox infection. After chickenpox disease, the virus remains dormant in human nerve cells and can re-activate later in life, due to a trigger such as stress or immunocompromise. This attack can lead to extremely painful, disfiguring patches, which may continue to be painful after the episode has resolved, a condition known as postherpetic neuralgia (PHN). In rare conditions, shingles can also lead to facial paralysis, deafness and blindness.

According to the U.S. Centers for Disease Control and Prevention, studies show that more than 99 percent of Americans 40 years and older have had chickenpox, even if they don’t remember having the disease.

While there are currently approved vaccines for shingles, there is an opportunity to develop an improved vaccine that potentially shows high efficacy and better tolerability, and is more efficient to produce globally, by utilizing mRNA technology.